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Natural Medicine Journal Podcast

Natural Medicine Journal's interviews with thought-leaders in the field of natural and integrative medicine dig deep into the most important topics in the field. Whether it's a one-on-one with top researchers in integrative medicine or a conversation with a practitioner about treating hard-to-tackle conditions, each episode promises to provide trusted, cutting-edge, evidence-based knowledge about natural medicine that you won't find anywhere else.
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Now displaying: 2019
Dec 11, 2019

In this interview, Esther M. Sternberg, MD, provides an overview of the research initiatives taking place at the University of Arizona Andrew Weil Center for Integrative Medicine. She describes the center's 2-pronged approach to the use of wearable devices to track biomarkers in sweat and monitor the impact of built environments. Sternberg emphasizes collaboration, integration, strong science, and clinical relevance in wearable device research.

About the Expert

Esther M. Sternberg, MD, holds the Inaugural Andrew Weil Chair for Research in Integrative Medicine at the University of Arizona College of Medicine and is research director of the Andrew Weil Center for Integrative Medicine, and director of the University of Arizona Institute on Place, Wellbeing & Performance. She earned her degree in medicine from McGill University and did both her residency in internal medicine and her fellowship in rheumatology at McGill University in Montreal, Canada. She has received many awards, including an honorary doctorate in medicine from Trinity College in Dublin, and was named by the National Library of Medicine as one of 300 women who changed the face of medicine. She is the author of 2 best-selling books, Healing Spaces: The Science of Place and Well-Being and The Balance Within: The Science Connecting Health and Emotions. She is an international leader in the science of mind-body interactions, stress and illness, and the impact of the built environment on health, wellbeing and performance. For more information, visit esthersternberg.com.

Nov 5, 2019

Michael Lewis, MD, FACPM, FACN, is the president of the Brain Health Education and Research Institute, which he founded in 2011 upon retiring as a Colonel after a distinguished 31-year career in the US Army. In this interview, Lewis provides listeners with an overview and update on the clinical applications of cannabidiol (CBD). In addition to discussing recent research, Lewis describes mechanisms of action, safety, and dosage of CBD in clinical practice.

About the Expert

Michael D. Lewis, MD, FACPM, FACN, is an expert on nutritional interventions for brain health, particularly the prevention and rehabilitation of brain injury. In 2012 upon retiring as a Colonel after 31 years in the US Army, he founded the nonprofit Brain Health Education and Research Institute. He is a graduate of the US Military Academy at West Point and Tulane University School of Medicine. Lewis is board-certified and a Fellow of the American College of Preventive Medicine and American College of Nutrition.

He completed postgraduate training at Walter Reed Army Medical Center, Johns Hopkins University, and Walter Reed Army Institute of Research. He is in private practice in Potomac, MD, and is a consultant to the US Army and Navy as well as several nutrition companies around the world. A highly sought-after speaker, Lewis has done hundreds of radio shows, podcasts, medical conferences, and television appearances and is the author of the Amazon best-selling book, When Brains Collide: What Every Athlete and Parent Should Know About the Prevention and Treatment of Concussions and Head Injuries.

About the Sponsor

CV Sciences is on a mission to improve the well‐being of people and planet. We believe that the future of hemp is unlimited. Through innovative and responsible application of science, we strive to enhance the prosperity and health of our employees, customers, and communities. We are committed to pioneering the CBD evolution as the leading producer of quality hemp CBD products under the PlusCBD™ Oil brand. For more information please visit www.PlusCBDoil.com.

Transcript

Karolyn Gazella: Hello. I'm Karolyn Gazella, publisher of the Natural Medicine Journal. Today I'll be talking with Dr Michael Lewis about the clinical applications of cannabidiol, or CBD. Before we begin, I'd like to thank the sponsor of this topic, who is CV Sciences Incorporated. Dr Michael Lewis is the president of the Brain Health Education and Research Institute, which he founded after retiring as a colonel in the US army. Dr Lewis, thank you so much for joining me.

Michael Lewis, MD, FACPM, FACN: Oh, it's a great pleasure to be with you today.

Gazella: So before we begin, I'm always curious about why physicians are interested in what they're interested in. So, as a physician, what draws you to the use of CBD in clinical practice?

Lewis: Well, the easy answer is because it's effective, but of course there's always a longer story. How did I fall into this? I mean, I spent 31 and a half years, my entire adult life in the army. And cannabis is not something that's a particularly ... It's rather frowned upon as, as you might guess. And so I really had no experience with cannabis or cannabidiol at all, but I've always been open to nutrition, and in the last 10, 15 years more much more open towards is there ways we can use targeted nutrition or nutritional therapy to ... I was in the army, so I was looking at it for helping people, helping soldiers recover from traumatic brain injury or concussions. So it really started out of fish oil and omega 3s, because the brain's made of fat. And then it kind of ... As I started to learn more and more, there started to be this interaction with the CBD industry. I finally, after I retired from the army, took a good look at it, and, more importantly, started to get great experiences with my patients using the combination of fish oil and CBD.

Gazella: Yeah. And you focus a lot on brain health, so that makes sense, the connection between a traumatic brain injury. So what conditions ... In addition to, I'm assuming traumatic brain injury, what conditions do you feel that CBD works well for either as a primary or adjuvant treatment or even as proactive prevention?

Lewis: Well, the biggest thing is as far as any specific one thing I would have to say anxiety, for sure. So 100% of my patients have issues with anxiety, and pretty much there's lots of anxiety just in today's society, with a 24-hour news cycle and all the craziness that's going on in the world. So it's about balance, and CBD, it interacts with our cannabinoid receptors and it's really about kind of achieving that balance. Not so much like that pharmaceutical model where you kind of hit something and you shut off a process and relieve the symptoms. The use of CBD is really much more about achieving a better balance, and nowhere has that been more important for my patients than in the world of anxiety. Helping calm that voice down in the back of your head. But I also find that it helps with chronic pain, particularly headaches. Can help decrease it. It doesn't always eliminate them, but I can tell you without a doubt, anxiety is my number one reason, whether you have a head injury or just dealing with anxiety.

Gazella: Yeah. That makes a lot of sense. Now you're talking about balance and that speaks to potential mechanisms of action, how CBD actually works in the body. Can you expand on that a little bit more? How much do we really know about how CBD works in the human body?

Lewis: Well, the interesting thing is we've known about CBD and its uses medicinally for thousands of years. Every major culture in the history of the world has used cannabis for medicinal purposes. So we know a lot, but yet we don't. Because of the issues with prohibition and then the war on drugs … we really kind of missed this golden era of clinical research, scientific research where we're really able to understand the mechanisms. Whereas in for thousands of years it was used because we just knew it was effective. Now we have a much better way of understanding why, and the why is really ... The why and the how is really it turned out that we have these indigenous cannabinoid receptors throughout our body and principally in our brains, CB1, or cannabinoid type one receptors, CB1 receptors in our brain associated with neurons and, and neuronal function and CB2 type receptors more closely associated with our immune system.

So when you're out of bounds and you think about you're out of balance on your immune system, you're more susceptible to colds and viruses and infections and stuff like that. So it's about this homeostasis, this balance, not just with your immune system but with our brains, with how we're thinking. And the really neat and interesting thing is ... One way to try to describe it is the CB1 receptors in particular, we have these chemicals that are in our bodies. I mean, we know about serotonin and therefore you have serotonin reuptake inhibitors, for example, SSRIs for antidepressant medicines. Well, we also have these internal cannabinoids that we now know about. One in particular, anandamide ananda meaning bliss, or an anandamide bliss molecule, and it's an on-demand thing.

So we used to call them endorphins. That runner's high, we would say that's an endorphin rush. We now know that that's our own body making on demand this stuff called anandamide that interacts with these receptors that keeps us happy, keeps us calm, keeps us thinking more clearly. And you can imagine, as somebody that's struggling with brain health issues maybe from concussion or from chemotherapy or just chronic stress in life, that can really make a difference. Whether or not somebody's happy and functioning in life is whether their cannabinoid system is working internally, but nature also gives us a way to interact with that through the cannabis plant, and as well as diet and exercise.

Gazella: Yeah, it does seem like we're learning more and more about the endocannabinoid system and the fact that that system in the body has such wide-reaching health effects, and I'd like to talk a little bit about the research. I understand what you're saying that we lost some opportunities in researching this plant because it was, frankly, hard to get and illegal and researchers had difficulty in doing really highly organized research. However, it does seem like the research is increasing. Now recently I read a study that was presented at the International Society of Sports Nutrition conference specifically on CBD. Can you tell us a little bit about that study?

Lewis: Well, I wasn't involved in the study. I'm only somewhat familiar with it, but it was a placebo-controlled randomized clinical trial and it was really looking at healthy people and to see if CBD versus a placebo would make a difference in everyday life events, such as quality of sleep and perception of how clear am I thinking, how am I doing throughout the day, energy levels and so on. And there was a ... It hasn't been published yet, but there was a, I'll say, statistically significant difference, particularly, my understanding is with the quality of sleep that those people that were put on the active CBD versus the placebo had a much greater reported quality of sleep, using very standardized sleep quality indexes that are used in research every day.

Gazella: Yeah. That's what drew me to this study is the fact that it was done on healthy people and it did in fact impact sleep quality, because that's a huge issue. And somebody can be deemed as being healthy and yet still struggle with sleep. So I really liked that about that study. Now, what else does the previous published research tell us about the efficacy of CBD? Have there been a lot of studies on efficacy and CBD?

Lewis: There's not been ... Relative to a lot of other things, whether you're talking omega 3s, fish oil or pharmaceuticals, there's not been a lot of research, published research. So it's really just because we're kind of coming out of this prohibition era, there's lots of research starting to get done, and there's some issues on how to actually go about doing some of the research, because your cannabis plant and my cannabis plant may not be the same.

Gazella: So Dr Lewis, you were just talking about the variance between the plants, the cannabis plant, like one plant can be different from another plant. So when we're dealing with any botanical, the way that we extract the active compounds is so important. Tell us about the extraction process that's used for CBD oil.

Lewis: Well, so the extraction is really important, but it actually starts way before that. If you want a consistent product at the end, you've got to have consistency all the way through. And one of the things about Plus CBD Oil that I really like is ever since they even began, when they started to import ... And they're the largest importer of European hemp. It's grown in the Netherlands, it's processed in Germany. But ever since the very beginning, they've only used 2 strains of the cannabis plant. And so the seeds are highly controlled, always using these 2 strains, and so you get consistency all the way from the seed through the entire process. If you're buying hemp left and right from Colorado and from California and from Europe and from Kentucky, you're not going to get that kind of consistency. And I would hope that that's what people want in a product.

Certainly one of the things that I think sets Plus CBD Oil apart is that consistency. And then when it's extracted from the plant, it's not using solvents and alcohol or other things that can adulterate the plant. And we certainly see that with some of the cheap brands that are out on the market. But what we use is a CO2 extraction. So you're not getting that issue with solvents and other things that can adulterate it. And so consistency is really, really important. Not just to me, but to the product and hopefully to the consumer, all the way from the seed to the end product that sits on the shelf.

Gazella: Yeah, that makes a lot of sense. Consistency from seed to extraction. Now, is there anything else that you look for when choosing an effective CBD product?

Lewis: Well, one of the things of course is good documented third party testing. So as an example, there's a barcode or what's the ... QRS code? I always forget the name of those little square codes, but they're on the label of every product and you can scan that and actually pull down that third party certificate of analysis of what's in that particular lot of that particular bottle of that product. And so you're able to look at that and that's really, I think, very important to know what it is that you're taking. One of the concerns is the cannabis plant is widely varied. Everything from how much THC content to CBD content to the turpines to the flavonoids, to the minerals and so on, and different strains, different products are going to be widely varied and so you really want to know what you're going to consume. It's helpful to have that kind of a third party analysis that's right there available to anybody that wants it.

Gazella: Oh, I agree. And the convenience factor alone is great for our healthcare professionals who want to look at that third party testing. That's great. Let's talk a little bit about dosage. So what dosage do you recommend for CBD, and more importantly, does the dosage vary based on if you're using it for proactive prevention or if you're using it for treatment, and if you're using it for treatment for anxiety versus dramatic brain injury? Talk a little bit about dosage and how it's used in clinical practice.

Lewis: Well, it's one of the greatest challenges, I think, that we face as practitioners is knowing what dosage to use because everybody's different. And here's the problem is that your dose and my dose may be very different. And so we've got to start somewhere. And I've got a pretty typical way that I like to start with patients, but I'm always ... It's all about educating the patient and to emphasize that you've got to find your individual dose.

So if we look at the Plus CBD Oil products, I think the thing that's made the biggest difference for me and my patients was about 3 or so ... 3 or 4 years ago, they came out with little soft gels, tiny little pearl-sized soft gels. That to me may make all the difference in the world. I mean, tinctures and drops under the tongue and lysosomal and all these different ways to do and deliver CBD are great, but patient compliance is so much better when it's just a tiny little pill, and you know, for example, the gold soft gel, you're getting 15 milligrams of CBD as part of the whole plant, broad-spectrum hemp complex. But you know every soft gel you're getting 15 milligrams, and you can look at the certificate of analysis and third party studies by consumer labs and so on to know that they're always dead on, and there that's not necessarily the case with a lot of other products. They're widely varied.

So I think that that is really important. I like 2 different products and the 3 main lines, they have soft gels, they have a red label, which is for their raw product and that's actually mostly CBDA, the acidic form of the cannabinoid, of CBD and the other cannabinoids. And then it's gently heated because you have to decarboxylase the CBDA and the other cannabinoids to make them active, which is why in terms of marijuana you have to smoke marijuana or bake it because you have to activate it for it to be active for it to cross the blood-brain barrier and do the job on the brain that you want to use THC for. But with hemp of course we're only dealing with trace amounts of THC, virtually none, but still trace amounts. So I actually ... The function of CBDA in their raw product is very different than the CBD.

It's great for inflammation, great for the body. And then I like to combine that with one that's really good for the brain, and that's their more concentrated product, their gold product. So I actually start patients on a gold and a red soft gel, and I start them twice a day, one of both morning and bedtime, and then have to educate. Some people, they don't like how the gold makes them feel during the day and they like to only take it at night. I have patients that take 3 at night and none during the day. I have people that take 2 every couple of hours during the day. So it just really depends on the person. But the easiest thing is start twice a day and adjust from there, either more frequently, or to a higher amount.

Gazella: Yeah, that makes a lot of sense. Because we are very individualized, especially when it comes to a substance like this. So let's talk a little bit about the future. As a clinician, I'm curious as to what you would like to see happen with CBD in the future? What more needs to be done from a research or clinical perspective when it comes to the use of CBD?

Lewis: Well, I think the obvious thing is that it's not widely accepted, and this holds true for a lot of botanicals, but the stigma that cannabis has had for the last 70, 80 years, it's going to take a little bit of time to overcome that. And one of the ways we can overcome that is with good science to prove that it works, but we'd certainly have challenges because the variability in a plant and the variability in products. We always try to boil it down to what's that one thing? And that one thing we always [inaudible 00:19:04] nomenclature we say at CBD ... Well, when we talk about CBD oil, almost always we're talking about not really CBD oil. We're talking about industrial hemp oil that happens to have CBD and has a lack of THC. But that strain and this strain can be very different.

So that consistency among products is really difficult. How do you do research around something that varies so widely? And that's one of the bigger challenges. Well, again, we will always want to boil it down to that one thing and that's why the FDA approved Epidiolex, because it's 99.9% pure CBD, but it misses out on all of those other important things in the hemp plant that make that entourage effect, that synergistic effect between all the different things. And so the safety profile is actually very different compared to something like Plus CBD Oil that has a tremendous safety profile.

Gazella: Yeah, I was actually going to ask you about safety. So are there any patients who should not use CBD?

Lewis: Every once in a while you run into a patient that just is exquisitely sensitive to pretty much anything. And so whether it's Tylenol or Benadryl or other things. Most patients, if you give them Benadryl, it makes them sleepy. That's why I send Tylenol PM or Advil PM, so on. But every once in a while you run into that patient that is a hyper metabolizer, and Benadryl makes them wired. It keeps them awake.

Well, you can have a similar thing with CBD, it's processed through the P450 system in the liver. So genetically some people are just prone to have different effects in medications that are metabolized by the liver. So those are the ones that you have to watch out for. So what I typically do is I drop them way back and start them really, really low dose, like get a dropper, and we just do one drop or one spray once a day and see how they do, and then go to 2 and then 3 and then 4 and build them up so that their body gets used to it. It doesn't mean that they don't need CBD or else I wouldn't be doing this with a patient, but their bodies just need a much slower ramp up to be able to adjust to it.

Gazella: You know, that makes a lot of sense. Because I've heard about the reverse effect with other substances like melatonin, you mentioned Benadryl. It's good to know that if there is that reverse effect that you don't have to just stop completely. You can just do this titration where you start really small and just ramp up slowly, so that's good to know. And you've had good luck with that in clinical practice?

Lewis: Very much so. And those are the patients that ... I'm dealing, again, with head injury patients or concussion patients that have been struggling for months or even years with the symptoms following a concussion and they're the ones that really need it. They really need the CBD. And so I'm not so quick to just say, "Stop taking it." But where I've found the success is, all right, we're going to start back over at ground zero and we're going to step up really cautiously, really slowly. And once you work through that process over a month or so, it is absolutely life-changing for those patients.

Gazella: That's great. That's good to know. And I would agree with you. I think in the future it would be good to see the stigma ... To overcome that stigma, to get some more consistency with the plant and some more human trials associated with the efficacy of CBD. I think those are all really great future goals for this particular substance. Well, Dr Lewis, once again, thank you for joining me today, and I'd also like to thank the sponsor of this topic, and that is CV Sciences Incorporated. Thanks again, Dr Lewis.

Lewis: Oh, my pleasure. Hopefully we can do it again sometime soon.

Gazella: Absolutely. Let's stay in touch. Well, have a great day everyone.

Nov 5, 2019

Michael Lewis, MD, FACPM, FACN, is the president of the Brain Health Education and Research Institute, which he founded in 2011 upon retiring as a Colonel after a distinguished 31-year career in the US Army. In this interview, Lewis provides listeners with an overview and update on the clinical applications of cannabidiol (CBD). In addition to discussing recent research, Lewis describes mechanisms of action, safety, and dosage of CBD in clinical practice.

About the Expert

Michael D. Lewis, MD, FACPM, FACN, is an expert on nutritional interventions for brain health, particularly the prevention and rehabilitation of brain injury. In 2012 upon retiring as a Colonel after 31 years in the US Army, he founded the nonprofit Brain Health Education and Research Institute. He is a graduate of the US Military Academy at West Point and Tulane University School of Medicine. Lewis is board-certified and a Fellow of the American College of Preventive Medicine and American College of Nutrition.

He completed postgraduate training at Walter Reed Army Medical Center, Johns Hopkins University, and Walter Reed Army Institute of Research. He is in private practice in Potomac, MD, and is a consultant to the US Army and Navy as well as several nutrition companies around the world. A highly sought-after speaker, Lewis has done hundreds of radio shows, podcasts, medical conferences, and television appearances and is the author of the Amazon best-selling book, When Brains Collide: What Every Athlete and Parent Should Know About the Prevention and Treatment of Concussions and Head Injuries.

About the Sponsor

CV Sciences is on a mission to improve the well‐being of people and planet. We believe that the future of hemp is unlimited. Through innovative and responsible application of science, we strive to enhance the prosperity and health of our employees, customers, and communities. We are committed to pioneering the CBD evolution as the leading producer of quality hemp CBD products under the PlusCBD™ Oil brand. For more information please visit www.PlusCBDoil.com.

Transcript

Karolyn Gazella: Hello. I'm Karolyn Gazella, publisher of the Natural Medicine Journal. Today I'll be talking with Dr Michael Lewis about the clinical applications of cannabidiol, or CBD. Before we begin, I'd like to thank the sponsor of this topic, who is CV Sciences Incorporated. Dr Michael Lewis is the president of the Brain Health Education and Research Institute, which he founded after retiring as a colonel in the US army. Dr Lewis, thank you so much for joining me.

Michael Lewis, MD, FACPM, FACN: Oh, it's a great pleasure to be with you today.

Gazella: So before we begin, I'm always curious about why physicians are interested in what they're interested in. So, as a physician, what draws you to the use of CBD in clinical practice?

Lewis: Well, the easy answer is because it's effective, but of course there's always a longer story. How did I fall into this? I mean, I spent 31 and a half years, my entire adult life in the army. And cannabis is not something that's a particularly ... It's rather frowned upon as, as you might guess. And so I really had no experience with cannabis or cannabidiol at all, but I've always been open to nutrition, and in the last 10, 15 years more much more open towards is there ways we can use targeted nutrition or nutritional therapy to ... I was in the army, so I was looking at it for helping people, helping soldiers recover from traumatic brain injury or concussions. So it really started out of fish oil and omega 3s, because the brain's made of fat. And then it kind of ... As I started to learn more and more, there started to be this interaction with the CBD industry. I finally, after I retired from the army, took a good look at it, and, more importantly, started to get great experiences with my patients using the combination of fish oil and CBD.

Gazella: Yeah. And you focus a lot on brain health, so that makes sense, the connection between a traumatic brain injury. So what conditions ... In addition to, I'm assuming traumatic brain injury, what conditions do you feel that CBD works well for either as a primary or adjuvant treatment or even as proactive prevention?

Lewis: Well, the biggest thing is as far as any specific one thing I would have to say anxiety, for sure. So 100% of my patients have issues with anxiety, and pretty much there's lots of anxiety just in today's society, with a 24-hour news cycle and all the craziness that's going on in the world. So it's about balance, and CBD, it interacts with our cannabinoid receptors and it's really about kind of achieving that balance. Not so much like that pharmaceutical model where you kind of hit something and you shut off a process and relieve the symptoms. The use of CBD is really much more about achieving a better balance, and nowhere has that been more important for my patients than in the world of anxiety. Helping calm that voice down in the back of your head. But I also find that it helps with chronic pain, particularly headaches. Can help decrease it. It doesn't always eliminate them, but I can tell you without a doubt, anxiety is my number one reason, whether you have a head injury or just dealing with anxiety.

Gazella: Yeah. That makes a lot of sense. Now you're talking about balance and that speaks to potential mechanisms of action, how CBD actually works in the body. Can you expand on that a little bit more? How much do we really know about how CBD works in the human body?

Lewis: Well, the interesting thing is we've known about CBD and its uses medicinally for thousands of years. Every major culture in the history of the world has used cannabis for medicinal purposes. So we know a lot, but yet we don't. Because of the issues with prohibition and then the war on drugs … we really kind of missed this golden era of clinical research, scientific research where we're really able to understand the mechanisms. Whereas in for thousands of years it was used because we just knew it was effective. Now we have a much better way of understanding why, and the why is really ... The why and the how is really it turned out that we have these indigenous cannabinoid receptors throughout our body and principally in our brains, CB1, or cannabinoid type one receptors, CB1 receptors in our brain associated with neurons and, and neuronal function and CB2 type receptors more closely associated with our immune system.

So when you're out of bounds and you think about you're out of balance on your immune system, you're more susceptible to colds and viruses and infections and stuff like that. So it's about this homeostasis, this balance, not just with your immune system but with our brains, with how we're thinking. And the really neat and interesting thing is ... One way to try to describe it is the CB1 receptors in particular, we have these chemicals that are in our bodies. I mean, we know about serotonin and therefore you have serotonin reuptake inhibitors, for example, SSRIs for antidepressant medicines. Well, we also have these internal cannabinoids that we now know about. One in particular, anandamide ananda meaning bliss, or an anandamide bliss molecule, and it's an on-demand thing.

So we used to call them endorphins. That runner's high, we would say that's an endorphin rush. We now know that that's our own body making on demand this stuff called anandamide that interacts with these receptors that keeps us happy, keeps us calm, keeps us thinking more clearly. And you can imagine, as somebody that's struggling with brain health issues maybe from concussion or from chemotherapy or just chronic stress in life, that can really make a difference. Whether or not somebody's happy and functioning in life is whether their cannabinoid system is working internally, but nature also gives us a way to interact with that through the cannabis plant, and as well as diet and exercise.

Gazella: Yeah, it does seem like we're learning more and more about the endocannabinoid system and the fact that that system in the body has such wide-reaching health effects, and I'd like to talk a little bit about the research. I understand what you're saying that we lost some opportunities in researching this plant because it was, frankly, hard to get and illegal and researchers had difficulty in doing really highly organized research. However, it does seem like the research is increasing. Now recently I read a study that was presented at the International Society of Sports Nutrition conference specifically on CBD. Can you tell us a little bit about that study?

Lewis: Well, I wasn't involved in the study. I'm only somewhat familiar with it, but it was a placebo-controlled randomized clinical trial and it was really looking at healthy people and to see if CBD versus a placebo would make a difference in everyday life events, such as quality of sleep and perception of how clear am I thinking, how am I doing throughout the day, energy levels and so on. And there was a ... It hasn't been published yet, but there was a, I'll say, statistically significant difference, particularly, my understanding is with the quality of sleep that those people that were put on the active CBD versus the placebo had a much greater reported quality of sleep, using very standardized sleep quality indexes that are used in research every day.

Gazella: Yeah. That's what drew me to this study is the fact that it was done on healthy people and it did in fact impact sleep quality, because that's a huge issue. And somebody can be deemed as being healthy and yet still struggle with sleep. So I really liked that about that study. Now, what else does the previous published research tell us about the efficacy of CBD? Have there been a lot of studies on efficacy and CBD?

Lewis: There's not been ... Relative to a lot of other things, whether you're talking omega 3s, fish oil or pharmaceuticals, there's not been a lot of research, published research. So it's really just because we're kind of coming out of this prohibition era, there's lots of research starting to get done, and there's some issues on how to actually go about doing some of the research, because your cannabis plant and my cannabis plant may not be the same.

Gazella: So Dr Lewis, you were just talking about the variance between the plants, the cannabis plant, like one plant can be different from another plant. So when we're dealing with any botanical, the way that we extract the active compounds is so important. Tell us about the extraction process that's used for CBD oil.

Lewis: Well, so the extraction is really important, but it actually starts way before that. If you want a consistent product at the end, you've got to have consistency all the way through. And one of the things about Plus CBD Oil that I really like is ever since they even began, when they started to import ... And they're the largest importer of European hemp. It's grown in the Netherlands, it's processed in Germany. But ever since the very beginning, they've only used 2 strains of the cannabis plant. And so the seeds are highly controlled, always using these 2 strains, and so you get consistency all the way from the seed through the entire process. If you're buying hemp left and right from Colorado and from California and from Europe and from Kentucky, you're not going to get that kind of consistency. And I would hope that that's what people want in a product.

Certainly one of the things that I think sets Plus CBD Oil apart is that consistency. And then when it's extracted from the plant, it's not using solvents and alcohol or other things that can adulterate the plant. And we certainly see that with some of the cheap brands that are out on the market. But what we use is a CO2 extraction. So you're not getting that issue with solvents and other things that can adulterate it. And so consistency is really, really important. Not just to me, but to the product and hopefully to the consumer, all the way from the seed to the end product that sits on the shelf.

Gazella: Yeah, that makes a lot of sense. Consistency from seed to extraction. Now, is there anything else that you look for when choosing an effective CBD product?

Lewis: Well, one of the things of course is good documented third party testing. So as an example, there's a barcode or what's the ... QRS code? I always forget the name of those little square codes, but they're on the label of every product and you can scan that and actually pull down that third party certificate of analysis of what's in that particular lot of that particular bottle of that product. And so you're able to look at that and that's really, I think, very important to know what it is that you're taking. One of the concerns is the cannabis plant is widely varied. Everything from how much THC content to CBD content to the turpines to the flavonoids, to the minerals and so on, and different strains, different products are going to be widely varied and so you really want to know what you're going to consume. It's helpful to have that kind of a third party analysis that's right there available to anybody that wants it.

Gazella: Oh, I agree. And the convenience factor alone is great for our healthcare professionals who want to look at that third party testing. That's great. Let's talk a little bit about dosage. So what dosage do you recommend for CBD, and more importantly, does the dosage vary based on if you're using it for proactive prevention or if you're using it for treatment, and if you're using it for treatment for anxiety versus dramatic brain injury? Talk a little bit about dosage and how it's used in clinical practice.

Lewis: Well, it's one of the greatest challenges, I think, that we face as practitioners is knowing what dosage to use because everybody's different. And here's the problem is that your dose and my dose may be very different. And so we've got to start somewhere. And I've got a pretty typical way that I like to start with patients, but I'm always ... It's all about educating the patient and to emphasize that you've got to find your individual dose.

So if we look at the Plus CBD Oil products, I think the thing that's made the biggest difference for me and my patients was about 3 or so ... 3 or 4 years ago, they came out with little soft gels, tiny little pearl-sized soft gels. That to me may make all the difference in the world. I mean, tinctures and drops under the tongue and lysosomal and all these different ways to do and deliver CBD are great, but patient compliance is so much better when it's just a tiny little pill, and you know, for example, the gold soft gel, you're getting 15 milligrams of CBD as part of the whole plant, broad-spectrum hemp complex. But you know every soft gel you're getting 15 milligrams, and you can look at the certificate of analysis and third party studies by consumer labs and so on to know that they're always dead on, and there that's not necessarily the case with a lot of other products. They're widely varied.

So I think that that is really important. I like 2 different products and the 3 main lines, they have soft gels, they have a red label, which is for their raw product and that's actually mostly CBDA, the acidic form of the cannabinoid, of CBD and the other cannabinoids. And then it's gently heated because you have to decarboxylase the CBDA and the other cannabinoids to make them active, which is why in terms of marijuana you have to smoke marijuana or bake it because you have to activate it for it to be active for it to cross the blood-brain barrier and do the job on the brain that you want to use THC for. But with hemp of course we're only dealing with trace amounts of THC, virtually none, but still trace amounts. So I actually ... The function of CBDA in their raw product is very different than the CBD.

It's great for inflammation, great for the body. And then I like to combine that with one that's really good for the brain, and that's their more concentrated product, their gold product. So I actually start patients on a gold and a red soft gel, and I start them twice a day, one of both morning and bedtime, and then have to educate. Some people, they don't like how the gold makes them feel during the day and they like to only take it at night. I have patients that take 3 at night and none during the day. I have people that take 2 every couple of hours during the day. So it just really depends on the person. But the easiest thing is start twice a day and adjust from there, either more frequently, or to a higher amount.

Gazella: Yeah, that makes a lot of sense. Because we are very individualized, especially when it comes to a substance like this. So let's talk a little bit about the future. As a clinician, I'm curious as to what you would like to see happen with CBD in the future? What more needs to be done from a research or clinical perspective when it comes to the use of CBD?

Lewis: Well, I think the obvious thing is that it's not widely accepted, and this holds true for a lot of botanicals, but the stigma that cannabis has had for the last 70, 80 years, it's going to take a little bit of time to overcome that. And one of the ways we can overcome that is with good science to prove that it works, but we'd certainly have challenges because the variability in a plant and the variability in products. We always try to boil it down to what's that one thing? And that one thing we always [inaudible 00:19:04] nomenclature we say at CBD ... Well, when we talk about CBD oil, almost always we're talking about not really CBD oil. We're talking about industrial hemp oil that happens to have CBD and has a lack of THC. But that strain and this strain can be very different.

So that consistency among products is really difficult. How do you do research around something that varies so widely? And that's one of the bigger challenges. Well, again, we will always want to boil it down to that one thing and that's why the FDA approved Epidiolex, because it's 99.9% pure CBD, but it misses out on all of those other important things in the hemp plant that make that entourage effect, that synergistic effect between all the different things. And so the safety profile is actually very different compared to something like Plus CBD Oil that has a tremendous safety profile.

Gazella: Yeah, I was actually going to ask you about safety. So are there any patients who should not use CBD?

Lewis: Every once in a while you run into a patient that just is exquisitely sensitive to pretty much anything. And so whether it's Tylenol or Benadryl or other things. Most patients, if you give them Benadryl, it makes them sleepy. That's why I send Tylenol PM or Advil PM, so on. But every once in a while you run into that patient that is a hyper metabolizer, and Benadryl makes them wired. It keeps them awake.

Well, you can have a similar thing with CBD, it's processed through the P450 system in the liver. So genetically some people are just prone to have different effects in medications that are metabolized by the liver. So those are the ones that you have to watch out for. So what I typically do is I drop them way back and start them really, really low dose, like get a dropper, and we just do one drop or one spray once a day and see how they do, and then go to 2 and then 3 and then 4 and build them up so that their body gets used to it. It doesn't mean that they don't need CBD or else I wouldn't be doing this with a patient, but their bodies just need a much slower ramp up to be able to adjust to it.

Gazella: You know, that makes a lot of sense. Because I've heard about the reverse effect with other substances like melatonin, you mentioned Benadryl. It's good to know that if there is that reverse effect that you don't have to just stop completely. You can just do this titration where you start really small and just ramp up slowly, so that's good to know. And you've had good luck with that in clinical practice?

Lewis: Very much so. And those are the patients that ... I'm dealing, again, with head injury patients or concussion patients that have been struggling for months or even years with the symptoms following a concussion and they're the ones that really need it. They really need the CBD. And so I'm not so quick to just say, "Stop taking it." But where I've found the success is, all right, we're going to start back over at ground zero and we're going to step up really cautiously, really slowly. And once you work through that process over a month or so, it is absolutely life-changing for those patients.

Gazella: That's great. That's good to know. And I would agree with you. I think in the future it would be good to see the stigma ... To overcome that stigma, to get some more consistency with the plant and some more human trials associated with the efficacy of CBD. I think those are all really great future goals for this particular substance. Well, Dr Lewis, once again, thank you for joining me today, and I'd also like to thank the sponsor of this topic, and that is CV Sciences Incorporated. Thanks again, Dr Lewis.

Lewis: Oh, my pleasure. Hopefully we can do it again sometime soon.

Gazella: Absolutely. Let's stay in touch. Well, have a great day everyone.

Oct 21, 2019

In this interview, leading botanical researcher Ajay Goel, PhD, AGAF, describes 3 herbs that he has studied which show great promise in cancer care: curcumin, boswellia, and French grape seed extract. Goel discusses the research associated with these botanicals, as well as any contraindications or safety issues.

 

About the Expert

Ajay Goel, PhD, AGAF, is a professor and chair of the Department of Translational Genomics and Oncology at the Beckman Research Institute City of Hope Comprehensive Cancer Center in Duarte, CA, as well as director of biotech innovations at the City of Hope Medical Center. He has been recognized as an American Gastrointestinal Association Fellow (AGAF) for his research on colorectal cancer. Goel has spent more than 20 years researching cancer. He has been the lead author or contributor to more than 300 scientific articles published in peer-reviewed international journals and has also authored several book chapters. Goel is currently researching the prevention of gastrointestinal cancers using integrative and alternative approaches, including botanical products. Three of the primary botanicals he is investigating are curcumin (from turmeric), boswellia, and French grape seed. 

About the Sponsor

EuroMedica® specializes in bringing proven natural medicines to the United States and in developing unique formulas containing clinically tested, safe, and effective ingredients. EuroMedica’s founder and president, Terry Lemerond, has more than 45 years' experience in the nutritional supplement industry, beginning with the founding of his first companies, Enzymatic Therapy and PhytoPharmica, and culminating in his current company, EuroMedica.

Terry Lemerond is credited as the first to introduce standardized ginkgo, glucosamine sulfate, and IP-6 to the United States. Several of EuroMedica’s products have been featured in published scientific papers. New clinical trials, some including the well known BCM-95®/Curcugreen™ Curcumin, are now underway at prestigious research centers. EuroMedica is perhaps best known for Curaphen® Professional Pain Formula and CuraPro® products, both containing BCM-95®/Curcugreen™ Curcumin. Additonally, EuroMedica provides unique and proprietary products including EurOmega-3®, Traumaplant® Comfrey Cream from Germany, Bladder Manager® featuring the clinically studied SagaPro®, ProHydra-7™ with SB-150™ Seabuckthorn Oil, and Clinical Glutathione™ with Sublinthion®.

Transcript

Karolyn Gazella: Hello. I'm Karolyn Gazella, the publisher of the Natural Medicine Journal. Today we'll be talking about three key botanicals for cancer care, but first I'd like to thank the sponsor of this topic who is EuroMedica. My guest today is Dr Ajay Goel, who is a professor and chair of the molecular diagnostic department with the Beckman Research Institute at the City of Hope Comprehensive Cancer Center. Dr Goel, thank you so much for joining me.

Dr Ajay Goel: Good morning. Thanks for having me on the show. It's a pleasure.

Gazella: So before we dig into our topic, I'm always curious as to what motivates researchers. And in your case, why were you drawn to the study of botanicals?

Goel: Thanks for asking this very relevant question. So I think my answer would be twofold. One, I've always been a firm believer, and there's a lot of data gathered over the last decades or even centuries, that natural medicines are a lot more potent, lot more valuable, a lot more effective then we have given them credit for. If you look at some of the oldest systems of medicines like Chinese traditional system medicine or Indian system of Ayurvedic medicine, they've been there for centuries. They've been there for a long time and we knew that some of the botanicals which were used in these traditional medicinal approaches, they work beautifully. What we didn't have was, we didn't have all the science behind it, but we can negate the fact that these botanicals did not work. So that's one.

Second, I work in oncology and I work very closely with my oncology colleagues and what bothered me all this time is that first, we don't have good modern drugs for treating patients with cancer. So that's one, but whatever drugs we have, the problem is they don't work on most patients. But even in the patients, very small number of patients where they work, they have huge toxicity profile. They have adverse effects associated with them, which makes them almost, I've seen patients who would say that I would rather give up my care rather than accepting any of these modern drugs. So I think that's a twofold answer. One, the natural medicines are lot more powerful. And second, they don't have all the baggage, they don't have all the side effects and toxicity, which most of the modern drugs give us. So I think those were the two motivational reasons for me to continue to research the field of botanical medicine.

Gazella: Yeah, that makes a lot of sense to me. Now today we're going to be focusing on three botanicals in particular. I'd like to start with curcumin, and I have to say, we here at the Natural Medicine Journal really enjoy talking about curcumin because the science is so fascinating and interesting. And there's just a lot of it frankly. So specific to cancer, what are the key mechanisms of action when it comes to curcumin?

Goel: So again, very wonderful question, and just like you said, curcumin is probably, and I check this on a daily basis or a weekly basis, the body of scientific evidence behind curcumin and especially in the context of cancer grows on a daily basis. You know? So to the best of my knowledge, this is the only botanical for which we have the most amount of scientific evidence. And by that I mean, scientifically peer reviewed publications showing the efficacy of curcumin in virtually every kind of cancer, and all kinds of other diseases as well. Now, what is the mechanism of action? How does it work in patients who have cancer? Actually, we can talk about it all day long because there's not one singular mechanism which stands out. But if have to pick one or two, I think it boils down to curcumin's ability to fight inflammation.

So I think it's probably one of the most potent anti-inflammatory agent. And as we recognize all the molecular underpinnings are the basis of most disease, including cancer. We recognize that although once a patient has cancer, we know that many of the genes are not behaving the way they're supposed to. But what is the process which starts this misbehavior of genes? It's always inflammation.

And when we talk about inflammation, we're not talking about acute inflammation, something which we all can easily recognize if you fall or get hurt, we have a bruise or a localized pain somewhere. Now what we're talking about is chronic inflammation, which is completely asymptomatic, there are no symptoms for that. But that is very intimately linked with our foods and diets and lifestyles, and as you would know our lifestyles have changed a lot in the last few years and few couple of decades. And that is the reason why we have such a huge epidemic of cancer because chronic inflammation stays there, and if it continues to persist, it leads to many diseases including cancer. And so if I have to pick one mechanism, it'll be anti-inflammatory activities of curcumin.

Gazella: And you said that there might be another second mechanism that you're drawn to as well.

Goel: Yeah, so the second mechanism would be it's antioxidant potential. What that essentially means is, its ability to capture and get rid of all the free articles floating around in ourselves. Because if we let these free radicals, which are very reactive, hang around in the cells, they begin to oxidize lipids and fats and proteins, basically rupturing all the cells. So if you can capture and scavenge, or just absorb all of these free radicals, get rid of this and increase this amount of antioxidative stress that is the second properties. It's a very, very potent antioxidant along with its anti-inflammatory potential.

Gazella: Great. Now I know that you have done some work with curcumin and cancer. Can you describe some of your research? I realized that there's a lot of research in this area, so maybe choose some of the more recent published trials on curcumin.

Goel: Yes, absolutely. So curcumin is one of my most favorite botanicals. As you can tell I've worked on it for a long time, and we have published quite a bit on curcumin. So if I have to highlight some of the trials which we are very proud of would be fairly simple in a way. So one of the things we recognize, how do cancer cells grow? So cancer cells love to grow because that's in their benefit, that's to their advantage. And one of the ways cancer cells continue to grow without dying is they basically shuttle away all the nutrition from the surrounding healthy cells around them. So they are very slick. They are clever. So for their own survival they need nutrition. And the way they get this nutrition is by fooling the healthy cells around them by telling them this is to their advantage. Please allow me to continue to derive all the nutrition from you, away from you.

And what we showed in one of the beautiful studies, which has been cited a lot, is that cancers don't grow in a silo, they grow in communication. We call it tumor microenvironment, which basically means tumor cells are growing, your healthy cells are growing, your stromal cells are growing. And if some strategies, some drug, some botanical, can basically block that sense of communication between cancer cells and healthy cells, what would happen? Healthy cells would not give the nutrition to the cancer cells. And when that happens, the cancer cells will die. And that's exactly what we showed in a very elegant study a few years back. There had been cancer cells are treated with curcumin, within a matter of hours or days, these cells begin to wither away. And what we showed was this is exactly curcumin does.

It basically stops a communication of cancer cells with the healthy cells. And once that happens and the healthy cells stop giving the nutrition to the cancer cells and eventually the cancer cells die away. So that's one mechanism which is very, very important. Second, which is very relevant to a lot of the patients who get cancer actually, they typically would meet their physician saying, I already have a cancer and you're prescribing me the chemotherapy or radiation therapy. Can I take curcumin along with, maybe it'll enhance the benefits of my treatment? And most of the times if the physicians are not aware of the beneficial effects of curcumin, they will tend to suggest, no, please don't interfere with my care and don't take anything, any supplement, especially along with my care.

And that is not true because we showed, and there are many other studies done on this aspect too where we very clearly showed that patients who have, especially colon cancer or even pancreatic cancer, because those are the areas of my research, that in these cells, in these patients, if these patients are given curcumin along with their standard of care chemotherapy, actually the efficacy of the chemotherapy multiplies many, many fold. And the quality of life of these patients while they're already on chemotherapy when they take curcumin along with improves significantly. Which is a good thing because now the patient don't have to experience all the toxicity from the chemotherapy, but continue to improve the quality of life.

On the same lines, we published another study where we showed actually the combination of chemotherapy along with curcumin, actually, if you use it, you can reduce the dose of chemotherapy by tenfold, or 10 times, and still have the same level of benefit which you would have with chemotherapy alone. So this is amazing because what that means is you could reduce not only the dose of the chemotherapy by 10 times, you're reducing that expense by 10 times. And you also, more importantly, reducing the toxicity by tenfold, but still having the same level of benefit. So these are some of those studies which are very, very important. And more recently, which we'll probably cover in the conversation later, we have begun to see that when we combine curcumin with other drugs or other botanicals there's a lot of synergy between these. Which is, again, something which we are very excited about.

Gazella: Yeah, I mean this is some amazing research, and we could probably talk about curcumin all day long, just focusing on the research. But I would like to talk about the form of curcumin, because there is a lot of debate, some controversy surrounding the form of curcumin that can be used or should be used for efficacy. Now this is due in part because of absorption issues. I'm curious as to what form you prefer to use in your research, and why do you prefer that form over the several other forms of curcumin that are presently on the market?

Goel: Thank you for asking this question, I think this is very, very relevant to anybody who would consider taking curcumin because the form of curcumin I've used in my research for the last 10 plus years is called BCM 95 curcumin. And the reason I chose this curcumin for all my research for over the years is simply threefold. One, this is a high absorption curcumin. So what that means is, curcumin by itself, if you take a generic curcumin, one of the challenges or limitations of curcumin is that it is poorly absorbed by our human bodies. If you take some amount of it, most of it will come out of your body within a matter of hours. So if that's the case, your body is not going to be healed. Your body is not going to derive all the benefits of curcumin if much of it comes out so fast. So it is very, very important that anybody considering taking curcumin, they should take a curcumin which is high absorption curcumin.

So that is the reason I use BCM 95 curcumin because there's been studies done that it is somewhere between 10 to 12 times better absorbed compared to generic acumen. That's one. Second, not only is it absorbed in the body 10 to 12 fold better, but it stays in the body longer too, which is almost a no brainer that if you are taking something for therapeutic purposes you would want that thing to stay in the body longer, because longer it stays there it'll continue to fight inflammation like we talked. It'll continue to fight oxidative stress. So the second thing is it stays in the body longer. Third, which is equally important is that this is, I call it a clean curcumin, because it's all natural. So one of the limitations of many forms of curcumin is that people, many of the manufacturers or vendors will try to increase their yield of curcumin from turmeric.

And in the process they will use strong synthetic chemicals to get as much curcumin they can get out of turmeric. And in the process what happens is you have curcumin, but as a consumer, as a patient, or as a physician when you're giving this curcumin to your patients, you're basically ingesting small amounts of chemicals which are not good for your body. So that's the third reason I used BCM 95 because it does not use any strong chemicals. It is all natural and one of the mechanisms, the way it is better absorbed in the bodies is that the curcumin is actually mixed together with the natural essential oils which are present in the root of turmeric, and that is a way to enhance its absorption. So it's all natural, better absorbed, stays in the body longer.

Gazella: That makes a lot of sense. Now are there any contra indications or safety issues with curcumin specific to oncology?

Goel: To the best of my knowledge, no. There have been studies done, we call these dose escalation studies where people will take highest possible dose of curcumin until they see some toxicity. And these studies have been done in human trials and people have used up to 12 grams of curcumin a day for, I think, I believe it was six months, and virtually no toxicity or adverse effects at all. Some people do sometimes feel for a very short term, some sort of upset stomach, but that only lasts for a day or two. But typically in terms of toxicity or serious adverse effects or any concerns, absolutely zero.

Gazella: Okay, good. Now before we move on to our next botanical, what is the therapeutic dosage that you recommend of the BCM 95 in oncology? I imagine it varies based on the individual and their circumstances, but is there a general dosage range?

Goel: Absolutely. So again, we can't, because curcumin and other botanicals they're not drugs, so there's a fair degree of range of forgiveness if you take a little bit more, or a little bit less, because they are very safe. So we don't have to worry that much. So based on my experience, especially if you're working with a high quality curcumin extract such as BCM 95 I think for the oncology patient a general range should is somewhere around two grams to three grams a day. Which should be split equally in three or four doses over their entire days. You don't want to take your all two or three grams in one dose. So it should be split in, you know, morning, afternoon, evening, or maybe four doses if somebody can manage. So somewhere in the range of two to three grams a day. And then depending upon their disease severity stage of the cancer and so forth I've seen patients even using up to five grams, but I think that would be extreme situation. But about three grams I would say is the average dose over entire day.

Gazella: Okay, perfect. So let's talk about boswellia. Now when we think of boswellia, I personally think about joint pain and osteoarthritis. How does boswellia work when it comes to cancer care? And just describe for us the oncology mechanisms of the actions for this particular botanical.

Goel: Absolutely. Again, so boswellia, just like you said, most people when they think about boswellia they think about joint pains and osteoarthritis and so forth because that's where it's been used for longest times. And one of the traditional uses for boswellia has been in arthritis, and even in patients who have actually another condition would be asthma. People have used boswellia quite a bit there. But in terms of cancer, I mean evidence is not there that much, but we have done quite a bit of studies. And I would say in the last three to five years there's a lot more studies around cancer. And one of the ways it helps in patients who have cancer is, again, it's ability to fight inflammation. So when we talk about inflammation, we just covered earlier we were talking about again, chronic inflammation. And when we talk about chronic inflammation, inflammation in our body is not controlled by one pathway.

There are multiple pathways of controlling inflammation. We just talked about curcumin. And one of the preferred ways curcumin functions there is by inhibiting an enzyme called cyclooxygenase two or COX-2. So that's a very, very key pathway which basically triggers inflammation, and curcumin works beautifully there. But there's another pathway which is equally important when it comes to inflammation we call it five lipoxygenase pathway, or 5-LOX pathway, and if that pathway is active, that will mean there'll be increased inflammation in our body which we don't want. And what we have shown is that in cancer patients, if they take boswellia, what happens is this 5-LOX activity goes down. And when that goes down there is a reduced inflammation and these patients tend to do so much better in terms of the response to cancer. So I think one of the preferred mechanism for boswellia, especially in the context of cancer, will be anti-inflammatory activity, and that activity mediated through 5-LOX pathway.

Gazella: And now you mentioned that these are human clinical trials involving boswellia and oncology, is that the case?

Goel: Not really. Some of these things are preclinical studies, but my understanding is there a couple of trials currently being planned. But for curcumin there are many human trials. And of course [crosstalk 00:18:40]. But for boswellia, most of the evidence so far has been preclinical evidence, which means before human trials.

Gazella: Got it. Okay. So now I understand when it comes to boswellia that boswellic acids are important. So what should practitioners look for when deciding on which a boswellia product to use, or what form of this botanical would be the most effective?

Goel: Again, thanks for asking such an important question. So just like we covered curcumin, and again, I think that's a normal notion that when we take any botanicals we have to be sure that we're taking the best product out there for which we have the best science. So when it comes to boswellia, I think one must consider taking... So when we look at boswellic acids, which are extracted from boswellia serrata tree, it's actually a combination of multiple boswellic acids present in there. And some of them are actually anti-inflammatory, while other actually ingredients or the actives in total boswellic extract could be pro-inflammatory, which is something you don't want. So if you have something pro-inflammatory is going to increase more inflammation, which is not desired. So one of the most important active anti-inflammatory boswellic acid is called AKBA, or one keto alpha boswellic acid.

So as a consumer who is desiring to take boswellic acid for cancer or for other indications to fight inflammation, you have to look for a boswellia extract which is highly enriched for AKBA. So you need to look for a product which is pure and has highest amount of AKBA content, because that is the one which has most anti-inflammatory activities. If you take a total extract with other boswellic acid in there, there may be some component of pro-inflammatory boswellic acid. So one has to pay attention to the extract which is rich and AKBA.

Gazella: Can you spell that for me Dr Goel?

Goel: Yes. So the acronym is A-K-B-A. So it stands for one alpha keto boswellic acid.

Gazella: Perfect. Yeah. A lot of our healthcare professionals who are listening will want to know that, so thank you for that. Now are there any safety concerns with boswellia?

Goel: Again, to the best of my knowledge, no. But again, compared to curcumin, we don't have too many safety studies. But based on my experience, based on our studies we have done, I think one of the things when we talk about safety we have to keep in mind the amount of, or the dose of, any product we are using, whether it's curcumin or boswellia or anything else for that matter, anything in life. So I think if you're going to cover this, so boswellia, again, in the context of cancer patients, I think those are for about two to three gram also has shown a lot of anti-inflammatory and anti-cancer activity. So I think to the best of my knowledge, if somebody is using these range or even twice as much, I don't think there's any concern for toxicity of any sort.

Gazella: Okay, that's good to know. So now I want to talk about the third and final botanical, which is French grape seed extract. And again, we don't often think about cancer when it comes to this particular botanical. So how does the preliminary research show us that French grape seed extract works when it comes to oncology?

Goel: Yeah, so I'm very excited, and when we begin to work quite a bit on a French grape seed extract, just like you said, when people think about grape seed extract, or grapes in general, I think most people think about resveratrol and so forth. Which is used in many different contexts and especially anti-aging products and so forth. But if you know, resveratrol typically comes from the skin of grapes and from the flesh of the grapes. But grape seed extract, just like the name says, comes from the seeds of the grapes. And it's unfortunate that being in US, we tend to go to stores and many times we ended up finding grapes which are very proudly sold as seedless grapes. So I think it's not necessarily a good thing. But when we look at grapes with seeds, they have these very, very active molecules.

We call them OPCs, oligomeric polys anthocyanidins. So OPCs, and they are present in grape seed extract, which are again very, very important anti-inflammatories, antioxidants. And we are particularly excited about this particular VX1 French grape seed extract, because if you take a genetic grape seed extract, it'll have lot of tannins and a very small amount of OPCs. So if you ground up all the grape seed extract it'll have probably majority of it will be large molecular weight tannins. So as a consumer, if you take the generic grape seed extract, what happens is you're thinking you're taking 300 or 500 milligram of grape seed extract. But most of it, more than 90% of it will never enter our cells.

That's what we want because if it goes into the cells it produces anti-inflammatory or antioxidant activity. But most of the generic grape seed extracts are so enriched in high molecular tannins, which are unable to enter our cells. But this particular grape seed extract, French grape seed extract is unique because it gets rid of all these large molecular tannins, and it is enriched for these very, very small OPCs which can easily enter the cells, cause this anti-inflammatory activity, antioxidant activity, and give health to patients who have cancer. So we have done several studies in the last two, three years, and we are seeing phenomenal results as an anti-cancer agent.

Gazella: Well that's great. And here again, we have another example where the form is important. And it's my understanding that with this particular extract you should look for it to be standardized to contain that appropriate concentration of polyphenols. So to get the most therapeutic effect, what specific form of this extract do you recommend? What should practitioners look for on the label?

Goel: So I think what they should be looking for a grape seed extract which is highly enriched or standardize for highest amount of OPCs, which is again oligomeric proanthocyanidins. So you have to look for a extract which is enriched for these because these are the small polyphenols which can enter our cells and show the activity what we're looking for. Because if you're just using a generic extract, which is not standardized for OPCs, you will not get the benefits what you seek.

Gazella: Right, exactly. And it won't match what's happening in the research literature.

Goel: Absolutely.

Gazella: Again, any safety issues with this one?

Goel: Nope, not at all. But these are very, very safe compounds for the most part. And we have done quite a few studies where we use very large doses of these compounds and we have not seen any sort of adverse effect or toxicities.

Gazella: Okay, perfect. Now in the beginning of our interview you mentioned the synergies, specifically with curcumin, that when you combine curcumin with other botanicals. So regarding these three herbs that we just discussed, do you see any synergy between the three? Would there be any advantages to using these three in particular together?

Goel: Absolutely. Although we have not done studies on all three together, but we have done studies where we've combined curcumin with boswellia. Again, the curcumin extract being BCM 95 curcumin, and boswellia being extract which is named as BosPure, which is highly enriched for AKBA. So we have done studies where we have combined curcumin and boswellia together and we have seen amazing synergistic activity. And the reason I say it is amazing is because we have compared the efficacy of this combination of curcumin with boswellia, and we have compared it to the efficacy to standard of care chemotherapies. And it was amazing to see that just the combination of these two compounds was much more potent than chemotherapy alone. That's beautiful because now you don't need to worry about taking a chemotherapy because if you can take these two natural, safe, inexpensive compounds and have the same level of benefit for chemotherapy or even better, then this is a win/win.

More recently we have done a study where we have combined curcumin with this French grape seed extract, same kind of activity. That the combination was so potent, a lot more efficacious compared to standard of chemotherapy. And another thing in this particular study we noticed where we combine curcumin with French grape seed extract, that this combination was very, very important in killing cancer stem cells. Which is very important because patients who have cancer, we can get rid of the cancer cells, but most times we leave behind something we know, cancer stem cells, which are basically super powered version of the cancer cells, which those who don't respond to any kind of treatment.

And if you leave them behind, these patients will experience, you know, cancer coming back in six months or one year because these cells are left behind. But what in this study where we have used combination of curcumin and French grape seed extract we have shown actually this combination is not only very, very promising in killing cancer cells, but it gets sort of most of the cancer stem cells, which is wonderful news for the cancer patients. What that means is if they use this combination, there's a very less or likelihood that their cancer will ever come back. So we are very excited. We are planning on studies, we will try to combine all three compounds together. But so far we have looked at individual combination of these two.

Gazella: Yeah, that is exciting, especially about the stem cell. Now I'm assuming that so far these have been all in vitro studies.

Goel: Actually no. So this reasons study that we did, we call it a ex vivo study, which what that means is we actually using human cancer sample from a patient itself. So in this combination study, we actually took the colon cancer tissue from the patient who had colon cancer, and we have developed a unique way to grow this tumor outside of the human body. But the good news is we are looking at actual cancer sample from an actual patient who have colon cancer. So these are not real human trials, but they are not neither in vitro studies. So we call them ex vivo studies where we can continue to see the effect of these compounds, these botanicals and drugs, on the actual human tumor.

Gazella: That's great. Yeah. And you know, it makes sense, and the curcumin and boswellia in particular makes sense because you were talking about the two different inflammatory pathways that they impact. One, you know COX-2, and then the one is the 5-LOX pathway. So that would make sense that combining the two you're going to have even a heightened anti-inflammatory effect.

Goel: Absolutely. And similarly when we combine curcumin with this French grape seed extract, because this French grape seed extract works on absolutely very different anti-inflammatory pathways too. And I think although we are still working on the mechanistic aspects of this, but what we are seeing is that when you combine curcumin with this French grape seed extract, I think in a matter of few days we can see the effect, which is very, very, very pronounced and very important in killing cancer cells.

Gazella: Well that's great. Well, you know Dr Goel, you have been a true leader when it comes to researching botanicals in oncology care. So I'm curious about, you know, what your thoughts are on what the future holds when it comes to the utilization of botanicals and cancer care? What can we expect to see in this area of integrative oncology?

Goel: I think that's a very important question. And I think, I've been working in those fields for 20 plus years, and I can already tell you I've seen a change already. And I think we will continue to see this change. And by change I mean as that patients have become a lot more smarter because they have access to all the scientific studies and literature, which is online and so forth. So they become more curious. They ask the right questions, they desire to use some of these integrative approaches in their cancer care and so forth. And I can tell you that every single day, you know, I hear from a lot more patients who are beginning to adopt some of these integrative approaches on their own, sometimes with the consent of their physician, sometimes on their own. But since you asked me what are the future, I think the future is that we are going to see continued awareness and continued educational effort of recognizing the benefits.

And at the same time, that's where we started, the benefits of these botanicals as well as the safety of these compounds in helping patients who have cancer and other diseases. And I have no doubt about it, we are already seeing a huge growth and awareness about the potential of these natural medicines. And I can only imagine that it'll continue to grow. And I think at some point the mainstream modern medicine will begin to use these things. Maybe not stand alone, but possibly as adjunct or in combination with the standard modern drugs they're using. So the future is bright.

Gazella: I would agree, and I hope that certainly does happen. It's exciting to watch, honestly. Well, this has been very informational. Once again, I would like to thank our sponsor who is EuroMedica. And Dr Goel, I'd like to thank you for joining me today. Let's stay connected so we can stay on top of the research, the exciting research that you're doing.

Goel: Absolutely. Thank you so much for having me on the show, and I really enjoyed it.

Gazella: Great. Have a great day.

Goel: You too. Bye-bye.

Oct 21, 2019

This article is part of the 2019 Oncology Special Issue of Natural Medicine Journal. Read the full issue here

 

Tina Kaczor, ND, FABNO, interviews Shauna Birdsall, ND, FABNO, on what clinicians need to know about skin cancers. From preventing squamous cell carcinomas to recognizing melanoma, Birdsall details the essentials of cancer-related dermatology.

This interview includes a broad review of what you can do to help patients prevent skin cancer. Do you remember the ABCDE’s of recognizing melanoma? Where do squamous and basal cell carcinomas usually occur? What is the ideal range for serum vitamin D? What other supplements have evidence for reducing the risk of squamous cell cancers? We cover all this and more in this in-depth discussion between integrative oncology experts.

About the Expert

Shauna M. Birdsall, ND, FABNO, is a naturopathic physician and fellow of the American Board of Naturopathic Oncology. Birdsall graduated from National University of Natural Medicine in 2000. After completing a residency at Cancer Treatment Centers of America (CTCA) at Midwestern Regional Medical Center in 2002, she provided patient care and supervised naturopathic medical students there until 2008. She took on a leadership role at Western Regional Medical Center at CTCA in Goodyear, AZ, in 2008 and was later elected vice chief of the medical staff there. She also chaired the Medical Executive Committee, Credentials Committee, Peer Review Committee, and served as the Medical Director of Integrative Oncology until 2018. Birdsall recently joined Avante Medical Center in Anchorage, AK. One of Phoenix Magazine’s Top Doctors 2014-2018, Birdsall is strongly committed to providing individualized, compassionate, evidence-based care to empower and provide hope to cancer patients.

Transcript

Tina Kaczor, ND, FABNO: Hello. I'm Tina Kaczor, editor-in-chief here at the Natural Medicine Journal. I'm talking today with Dr. Shauna Birdsall about skin cancers, and Dr. Shauna Birdsall has graduated from the National College of Natural Medicine in the year 2000. After that, she went to Cancer Treatment Centers of America, and she has been a specialist in integrative oncology since graduation. She's most recently taken a position at Avante Medical Center in Anchorage, Alaska, where she'll be providing patient care in a hospital-based setting. Shauna, thanks so much for joining me.

Shauna Birdsall, ND, FABNO: Oh, thank you for having me.

Kaczor: Dr. Birdsall, you've recently worked closely with a lot of dermatologists in a dermatologist setting, and you and I got talking about that. I was intrigued by a lot of the things that you learned, and I would like you to elaborate a little bit on how working closely alongside these dermatologists maybe changed your perspective of oncology and skin cancer specifically.

Birdsall: I have to say I was blown away, and this is a bit embarrassing. Working with patients undergoing chemotherapy and radiation for cancers like breast cancer and pancreatic cancer, I had always seen dermatology as more on the periphery. Working with dermatologists showed me how often dermatologists are diagnosing things like melanoma and really saving people's lives. It completely changed my perception around the integral nature of the specialty.

Kaczor: Yeah. I think that's what struck me, because you and I have parallel universes in the idea of our professions. We both graduated in the same year, and we've both been doing integrative oncology. I have to say I haven't worked closely with dermatologists. I share your inclination to say, "Ah, yeah, skin, we can catch that. No problem. We always catch skin cancer," and, I mean, that's despite the fact that of course we've both worked with people with metastatic melanoma.

We'll get to that and the importance of prevention, especially to prevent such tragedies as metastatic disease. I'd like you to give us a primer, and just give us a really basic overview for the clinicians out there on the types of skin cancers that there are, and who they most likely effect as well.

Birdsall: Sure. First of all, skin cancer is the most common type of cancer, and in the United States this year, more than 5 million people will be diagnosed with skin cancers. First and foremost, we like to talk about actinic keratoses. These are also known as AKs, and they are really precancerous lesions. You'll hear, the resounding themes of those that have sun exposure as being at risk for these cancers as I go on, but essentially actinic keratoses are often flaky or scaly patches of skin, and it's important that those are identified and treated, as sometimes they can lead to squamous cell carcinoma.

The most common type of skin cancer is basal cell carcinoma or BCC. This accounts for about 80% of skin cancers, and BCCs usually look like a flesh-colored pearl or bump, or a pinkish patch of skin. All of these skin cancers are going to be more prevalent in patients with fair skin, although patients with skin of all colors can develop these skin cancers.

Then, as I mentioned we're going to repeatedly talk about risk with sun exposure, and that means that the areas of the body that are most frequently exposed to sun such as the face, head, chest, arms and legs are going to be the most prevalent areas that you can see these cancers.

Squamous cell carcinoma is the most second type of skin cancer, and you're going to also see squamous cell cancers on areas like the rim of the ear. You really need to be able to make sure that those are identified, as those cancers can spread more deeply into tissues and cause additional damage, as well as metastasize elsewhere.

Melanoma, as we talked about earlier, is the deadliest form of skin cancer. It's actually been on the rise for the last 50 years. Melanoma in situ annual incidents in the United States is 9.5%, and in the United States melanoma has become the fifth-most common cancer in men and women. Melanoma increases with age, and you do see again the sun exposure and fair skin as common risk factors. I think later on, we'll talk about more risk factors for melanoma.

Kaczor: Yeah. That's an incredible statistic. Nearly 10% incidence for in situ melanoma. Wow.

Birdsall: Yes. Which is why I really started waking up to the issues with skin cancer detection and prevention, working with dermatologists, because I just was blown away, as I mentioned, with how often they were diagnosing either melanoma in situ or melanomas.

Kaczor: That's just checking. I mean, that's just skin checks, not coming in with that complaint.

Birdsall: Yes.

Kaczor: Most of our listeners are practitioners that are primary practitioners. Very few are going to be specialists in skincare, of course. I'd like us to maybe, if you could, go through how to recognize melanoma, and maybe making sure that when we are seeing our patients ... and this could be in a specific skin exam, or it could also just be an incidental finding on their arm or their face or whatever. What are we looking for with melanoma?

Birdsall: Melanomas frequently develop in a mole or suddenly appears as a new dark spot on the skin. If you'll recall, we have the ABCDE warning signs, and I'm just going to go through those just for all of our review. A stands for asymmetry. B stands for border, either irregular, scalloped or poorly defined. C stands for color, varied really from one area to another in the same mole, and you can see shades of tan and brown, black, white, pink, red or blue. I think one of the most shocking melanomas that I saw was a melanoma inside the web of the toes in a patient that just looked like a little pink spot.

D stands for diameter. While melanomas are usually greater than 6 millimeters in size, which is the size of a pencil eraser, when initially diagnosed they can be smaller. E stands for evolving, a mole or a skin lesion that looks different from the rest or is changing in size, shape or color.

What is important to know as well is that melanomas don't necessarily read the textbooks. As I mentioned, they can look like something that, for those of us who are not dermatologists, may not look like something of concern, which is why I became aware of the need for annual skin exams.

Kaczor: Yeah. Yeah. It is remarkable that some of them don't look like much, and I think that erring on the side of caution, especially as our patients get older and older, because aging is a risk factor for all cancers, and I'm assuming skin cancer is included in there. Okay. Is there anything else? Last notes besides ABCD and E, and anything else that people should be looking for clinically before we close that discussion?

Birdsall: An area that's itching, bleeding. An area that opens up and appears to heal over, and then opens up again. Anything like that also needs to be evaluated.

Kaczor: Okay. Yeah. Referral to a dermatologist is simple enough that I think it's ... again, erring on the side of caution seems like a smart thing to do. We talked about melanoma, and experience shows us that of course it's the most likely to go somewhere. It's most likely to spread and become fatal for some patients, but I'm curious. Basal cell and squamous cell carcinoma, what is the risk of any local or metastatic disease with those?

Birdsall: In the majority of patients with cutaneous squamous cell carcinoma or basal cell carcinoma, the disease remains limited to the skin and with appropriate treatment is considered, "cured," which you and I both know we don't get to use that word very often in oncology. It's exciting that something can be cured with appropriate treatment. However, in 3 to 7% of patients with cutaneous squamous cell carcinoma, and rarely in individuals with basal cell carcinoma, local, regional or distant metastases can occur, which increases the risk for mortality or death.

Kaczor: Do you happen to know, is this analogous to melanoma in that the depth of the lesion has anything to do with it? Do you know?

Birdsall: Yes. For both basal cell and squamous cell carcinomas, both the depth and the size can contribute to risk, which is why even though a patient might only have a small spot, why it's important that it be caught early and treated, because left to its own devices, the larger it gets, the more at risk a patient is.

Kaczor: Okay. Well, that makes logical sense. As far as melanomas go, you mentioned in situ is nearly 10%. Are most of them still caught in the early stages, before they go anywhere?

Birdsall: Yes. Yeah. About 85% of melanomas are caught when there's only localized disease, so Stage I or Stage II at presentation, which as you and I both know, that's when you see the best survival rates. At diagnosis, about 15% have regional nodal disease, and only about 2% have distant metastases at the time of diagnosis. We're getting better at diagnosing skin cancers and melanoma, and it's theorized that dermatologists are more likely to biopsy these days because of seeing a higher prevalence.

Kaczor: I see. Okay. Can I ask one question? That is, in some states, including where I am in Oregon, naturopathic physicians can do minor surgery. The question I have ... I know my opinion on this, but I want to hear your opinion on this. It's not uncommon for shave biopsies to happen in-office. This is true of primary care physicians across the board, not just naturopaths. If someone suspects a melanoma, yea or nay on something like a biopsy of that, whether it's a punch biopsy or a shave biopsy?

Birdsall: Nay, and the reason is that there is research that the sooner after initial diagnosis ... so the sooner after initial biopsy ... that patient is able to get definitive treatment for their melanoma, the better. One of the risks, if someone other than a dermatologist or another health professional biopsies melanoma, is that there's then a delay potentially in getting the patient in to the provider that's going to be able to provide definitive treatment for that melanoma. That's one of the risks. Really, you want to see the highest level of specialty if you suspect a melanoma.

Kaczor: Okay. I think that needs to be reiterated time and again, because every once in a while you come across those patients, and your hair stands up when they tell you what first happened to their lesion, and you just hope that it didn't go anywhere. Okay. Let's talk about, again, we're talking to our audience is generally practitioners that are frontline folks, and which patient populations, which types of people, should there be particular vigilance for skin cancers, like higher levels of suspicion, and who exactly?

Birdsall: Okay. I warned you that we'd keep going back to a couple of things. Fair-skinned individuals, particularly those with blonde hair, red hair, lighter-colored eyes, blue eyes, although again, the warning that skin cancers can occur in patients of any skin color, and then that hallmark UV, exposure to UV radiation. More sun exposure, more risk. Also, however, living in sunny climates or higher altitudes, again because you're getting more direct exposure to UV radiation, as well as lower latitudes. Moles, patients that have more than 50 moles are at higher risk, and patients that have had a history of dysplastic nevi nearby or abnormal moles.

Patients with actinic keratoses are at higher risk. Patients with either a family history of skin cancer or a personal history of skin cancer, and immune suppression. I want to just take a moment to talk about immune suppression, because that can include a variety of different patient populations. That can include patients living with HIV or AIDS, or oncology patients that maybe are receiving chemotherapy or maybe their immune system hasn't recovered from prior chemotherapy, and it does include patients on immunosuppressive drugs such as for organ transplants. Patients who've had an organ transplant are at high risk for skin cancers because they're likely to have a lifetime of immune suppression because of those immunosuppressive drugs.

Lastly, exposure to radiation. You and I think of patients that have been exposed to radiation like breast cancer patients, lung cancer patients, et cetera. However, sometimes patients are exposed to radiation for skin conditions like basal cell carcinoma or eczema or acne, just different types of radiation. Then, exposure to chemical substances like arsenic can also increase risk, and then age increases risk. We're just at higher risk, the longer that we're living a lifetime out, being exposed to the sun.

Kaczor: Is it true that childhood exposures can have an effect decades later? Like someone who grew up down in San Diego, for example, but they live in Minnesota?

Birdsall: Yes, especially to melanoma. I am a-fair skinned person and I had an unfortunate history of a couple of different blistering sunburns, and that history of childhood sunburns and history of blistering sunburns can increase risk, especially for melanoma.

Kaczor: Okay. Yeah. That's good to have validated, because I've always heard that. Maybe in our patient intakes, it's something we should put on our intake forms. Not only where did you grow up, but did you get burned, sunburned?

Birdsall: Yes.

Kaczor: Back in the day, of course, there was a time when people intentionally went out there and called a burn halfway to a tan.

Birdsall: That actually reminds me. I don't think of indoor tanning frequently these days, but exposure to indoor tanning and tanning beds. Maybe your patient is very responsible now as an adult, but maybe in their teenage years had a long history of exposure to tanning beds.

Kaczor: Yeah, yeah. It's something that's easily overlooked in an intake. Maybe we should make sure that that's top of mind. Let's talk a little bit about screening and prevention, and how can we make sure that we do catch things early, especially melanoma. What are the current recommendations, even, for skin cancer prevention?

Birdsall: It's interesting. As far as screening, it remains somewhat of a controversy, which surprised me. US Preventive Task Force is considered one of the authorities on screenings, and to date, the US Preventive Task Force hasn't found sufficient evidence either for or against skin screenings. What's interesting is there is a lot of debate amongst other experts in the field. The American Cancer Society actually recommends a cancer-related checkup every three years for patients between age 28 to 40, and then also encompassed in that cancer-related checkup is other kinds of screenings in addition to skin cancer screenings, and then every year for anyone over 40. Interestingly, the American Medical Association really sees it as individualized, and recommends that a patient should talk to their physician about frequency for skin cancer screenings, and those at moderate risk even should see their PCP or dermatologist annually.

The American Academy of Dermatology issued a statement regarding their disappointment over the recommendation by the US Preventive Task Force, and felt that the public should know that that recommendation that was neither for nor against annual skin cancer screening did not apply to individuals with suspicious skin lesions or those with increased skin cancer risk, and does not apply to the practice of skin self-exams. The American Academy of Dermatology recommends that patients really function as their own health advocate by regularly conducting skin self-exams and that if the patients see anything unusual, that they should see a dermatologist. Unfortunately, we all know that there's not always consistency with patients regarding advising for self-exam, and a patient can't necessarily see the back of their neck or their back, that may have had a lot of sun exposure. A number of dermatology providers still recommend annual skin exams, which after working with dermatologists, I'm definitely an advocate for as well.

Kaczor: Yeah. Yeah, that makes sense. All it takes is a few cases. We're all a product of our experience, right? You see a few cases where it could have been prevented, and it seems and it is tragic. What can we do? I guess once we identify patients who are at higher risk, due to either childhood or exposure or fair skin or immune suppression, like what can we do to prevent skin cancers?

Birdsall: Again, not to sound like a broken record, but decreasing sun exposure is the first thing. Interestingly enough, while I was just reviewing the research when I was preparing for our interview, I was looking at the Environmental Working Group and sunscreens, because there are definitely sunscreen ingredients these days that people have concerns about. For a patient that might be more holistically inclined, they might feel somewhat reluctant to put some of the ingredients that are in sunscreens on their skin, and so there's still a number of things that we can recommend. One is the physical sunscreens that are more of a barrier, and zinc oxide and titanium dioxide were considered generally safe and effective by the Environmental Working Group, and those are sunscreens with definitely friendlier ingredients that people may feel a lot more comfortable using and recommending. Secondly, wearing clothing shields our skin from sun exposure. There's some really interesting sun-protective clothing that is coming out as well if people are in the sun more frequently. Just trying to stay out of the sun during the peak periods or during high heat indexes is also something that patients can do as well. Then, doing annual skin exams. Because as you and I talked about, we may not feel concerned about a lesion that a dermatologist may instantly pick up on as something that may need to be further evaluated.

Kaczor: Yeah. On that note, I don't remember when I read this, but years ago I remember reading they did surveys of lesions, and they had primary care physicians and dermatologists assess them and see who was most accurate. Nobody bats a thousand, but it was remarkable how much better the dermatologists were at visually assessing lesions correctly.

Birdsall: Well, what was interesting working with dermatologists is I'd ask them why they were attracted to their field, why they went into dermatology, and they said because it's actually a field of medicine that you visually diagnose. You can visually see what's going on. Internal medicine, you might look at the results of a patient's lab work or a chest X-ray, but dermatology, you can actually see pathology and treat it.

Kaczor: Yeah. How interesting. Yeah, so I guess you're good at that. Some people are better than others, I think. We are naturopaths, and so let's talk a little bit about diet and supplements and other things that we can do. What can we do from a supplement standpoint? Is there anything we can add or anything we should avoid, for that matter, that could lower the risk of developing cancer, skin cancer specifically?

Birdsall: There was a really interesting Phase 3 randomized trial of nicotinamide for skin cancer prevention published in the New England Journal of Medicine in October of 2015, and in the study, 386 participants who had a history of at least 2 non-melanoma skin cancers ... again, that's basal cell carcinoma or squamous cell carcinoma ... in the past 5 years were randomized to receive 500 milligrams of nicotinamide twice daily or placebo for 12 months. They were seen by dermatologists every 3 months.

At the end of the study, the rate of new non-melanoma skin cancers was lowered by 23% in the nicotinamide group, and noteworthy was the fact that there was no benefit after the nicotinamide was discontinued. I would say about 70% of the dermatologists that I was working with recommended nicotinamide to their patients. That's actually compelling data from my perspective in regards to a supplement.

There's another supplement that has less research but is something interesting to watch called polypodium leucotomos, which is a fern from Central and South America. It was actually shown in studies to prevent both UVA- and UVB-induced toxicity and DNA damage. There was a study showing that 240 milligrams of a supplement containing that ingredient twice daily suppressed sunburn, and was found to extend the time outdoors before skin started to tan, so that's another possibility. I think we know as naturopathic doctors that vitamin C, E, zinc, beta carotene, omega-3 fatty acids, lycopene and polyphenols, especially in things like green tea, do also help to prevent free radical damage, which is what the exposure to UV radiation causes as well.

Kaczor: Okay. Yeah. Is there a specific role ... I don't I honestly don't remember where I have this idea from, so you can validate or invalidate my presumption ... about using vitamin A specifically for actinic keratosis?

Birdsall: Sure. There was a study on high-dose vitamin A reducing the incidence of actinic keratosis converting to squamous cell carcinoma, and the study looked at doses ranging from 25,000 IU a day, 50,000 IU a day and 75,000 IU a day. They did indeed find that that did prevent those AKs from turning into SCCs pretty significantly. However, from my perspective, there'd need to be a risk/benefit weighing of that for any particular patient.

Kaczor: Yeah. Because 25,000 to 75,000 IU daily for an extended period is ...

Birdsall: Correct. I had some concern after looking at that.

Kaczor: Yeah. Yeah. Recently, I mean, I generally wasn't too concerned with vitamin A levels as we gave them until ... because we would often use this dose for antiviral effects. Recently I came across a study that did suggest that high doses for prolonged periods actually can lead to or at least are correlated with fatty liver. I was a little surprised by that. I came upon it, of course, by way of patient care and doing a little due diligence. Anyways, that's just a little caveat

Birdsall: Right. I just am looking at that study and thinking about the fact that you would need to be on that long-term. I just had some concerns about using that particular amount of time.

Kaczor: Yeah, yeah. Not just the known, but the unknowns. Okay. Let's turn to vitamin D, because that whole "Do I'd get enough sun for vitamin D, am I getting so much sun that I'm increasing my risk of skin cancer," it seems to be a bit of a conundrum. On the same note and maybe in the context of this, is there a difference between sunburns and suntans and their link to skin cancer?

Birdsall: Okay. I think that there's definitely good evidence to suggest that vitamin D production from sun exposure poses too much of a risk for skin cancer. That's probably not the way that we want to be getting enough vitamin D, and there is more risk with a sunburn. However, suntans, our concept of tanning as being something that adds to our attractiveness, which I think in this day and age has faded with all the concern and the risk. Tanning does pose a risk too. That is still damage to your skin. Actually, as I was reviewing the research and thinking about this interview ... I'm just going to throw this in now, even though it's a little tangential and random ... if you have patients that are worried about the anti-aging, about the appearance of their skin, really the very best thing that they could do is to avoid sun exposure, to apply sunscreen, et cetera, because even that tanning still actually represents damage.

Kaczor: Okay. The vitamin D, what I hear you saying is it's best taken supplementally.

Birdsall: Yes.

Kaczor: Because we have access of doing labs for our patients and such, is there an ideal dose to give, or do we base it on laboratory values? What is your opinion on that?

Birdsall: My opinion is that we need to base it on laboratory values, because there's so much individual variation on intake of vitamin D and the impact of that intake. One patient may consume a lot of dietary sources of vitamin D and actually be at perhaps not an optimal, optimal level, but not be deficient in vitamin D. Another patient may take some vitamin D supplements and actually get to pretty high levels of vitamin D pretty quickly. I think the only thing that we can do for our patients right now is to do lab testing.

Having said that, there is a lot of controversy over what the right values are, what the right range is. Again, when I was doing research just to make sure that I was totally up to date before we talked, it looks like people are in agreement over the fact that a 25-hydroxy vitamin D level below 20 nanograms per milliliter is considered deficient and does need repletion. We have more concurrence over that value.

What's still controversial is what is that optimal range? Is it between 30 and 40? Is it 50? What we do know is that vitamin D can reach toxic levels, and that that's not good either, and that there is more and more data on too high of a level of vitamin D posing risk. I think that that again argues for making sure that we're adequately testing our patients, because say they're deficient, we decide that they need repletion. It's still hard to monitor, without doing that testing, where they're at from a vitamin D level as you're doing repletion.

Kaczor: Sure. Sure. Yeah, I totally agree. I think that laboratory values should be just part of a routine lab for most people, given the many ways that vitamin D adequacy protects us from so many diseases.

My last question is having to do with those who know they have a family history of skin cancers, maybe even particularly melanoma, but skin cancers in general. Is it appropriate, I suppose, for certain patients with a strong family history to look at genetic predispositions and hereditary syndromes that include skin cancer?

Birdsall: That's interesting, again still a little bit of a controversy. We can test for a couple of genetic mutations related to melanoma. People who have a mutation on a gene known as CDKN2A have a higher risk of developing melanoma, pancreatic cancer, or a tumor of the central nervous system. A mutation on the gene called BAP1 means a higher risk of getting melanoma, melanoma of the eye or mesothelioma, and kidney cancer. However, the challenge is that if a patient carries a mutation on one of those genes, their lifetime risk of getting melanoma ranges from 60% to 90%. However, only about 10% of the people who develop melanoma have one of these genes.

What we do know is that we're still evolving our scientific knowledge of genetic mutations, and it's highly likely that there are additional genetic mutations that we just haven't found yet for melanoma. This is a really important conversation for a patient to have with their healthcare provider, or even ideally with a genetic counselor, who can counsel them on the risks and benefits of genetic testing overall.

Kaczor: Yeah. Yeah. Genetic counselors are a great referral for us to have, because we don't need to figure everything out and they have it all either at their fingertips or in their minds, so they're they're great professionals to ally with. All right. Well, I think that that's a really good survey and a nice review of reminders of things we may know, and maybe some things that are definitely new to our listeners. I can't thank you enough for taking some time and sharing your expertise with us today. Thanks, Shauna.

Birdsall: Thanks. Thanks for having me.

Kaczor: Take care.

Oct 16, 2019

The mission of the Climate Collaborative is to leverage the power of the natural product industry to positively impact climate change. Their goal is to bring the industry together in an effort to reverse climate change. In this interview, the organization's director, Erin Callahan, describes how they intend to achieve this lofty goal.

Here's more NMJ coverage on how climate change will impact our food supply:

About the Expert

Erin Callahan, director of the Climate Collaborative

Erin Callahan is the director of the Climate Collaborative, responsible for management and execution of the Collaborative’s work, including all programming, communications, and outreach. Erin has a range of corporate campaigning and sustainability experience. She previously worked for CDP, managing corporate engagement for the We Mean Business coalition’s commitments campaign. In that role, Erin worked with hundreds of the world’s largest companies, industry groups, and investors, supporting them in making leadership commitments on climate change. She has also worked in public relations and international development and earned a master’s degree in international relations and economics from Johns Hopkins University School of Advanced International Studies. She is based in Oakland, CA.

Transcript

Karolyn Gazella: Hello. I'm Karolyn Gazella, the publisher of the Natural Medicine Journal. Today we are tackling the big topic of reversing climate change. My guest is Erin Callahan, who is the director of Climate Collaborative. Erin, thanks so much for joining me.

Erin Callahan: Thanks for having me.

Gazella: Well, first let's have you tell us a little bit about the history of the Climate Collaborative.

Callahan: Yeah. I'd love to. Well, thank you again for having me, I'm really excited to talk about some of our work. So the first thing to note is that we're a relatively new organization. We launched about 2 and a half years ago, just over that, at Natural Products Expo West, which is the largest food show in the US.

And we launched because it did become really clear that within the natural product space, which is the fastest growing part of the food and ag sector and full of innovative companies, who are really helping define their mission and work via social impact and issues related to it, there wasn't yet a convening space for companies to come together on climate change. And we in fact did this study that showed that around 97% of the companies we surveyed really understood the urgency to be doing something on climate change, but almost 80% of them didn't know how to translate that understanding into action. There was a big gap between knowing that they wanted to do something and having the capacity to tackle it within their businesses.

And so we launched to kind of address that gap. We really wanted to create a community of companies within the industry who could learn from each other, move forward together and get the rest of the industry really excited about climate change. And so that's what we've been trying to do for the past 2 and a half years. And I can certainly talk about the ways in which we do that, if that would be useful.

Gazella: Yeah. Let's start with what you've been focusing on since 2017 when you started. So what's been the focus over the last couple of years?

Callahan: Yeah. Well, you know, when Jessica Roth, the founder of Happy Family Organics the baby food company, and Lara Dickinson, the founder of OSC2, they were the cofounders of the Climate Collaborative and they really wanted to launch it as an industry collaboration.

So we're a project of 2 organizations, SFTA and OSC2, and have collaboration deeply built into our model. And so over the past year we've really been working to try and extend that, kind of, baseline of collaboration and understanding that to tackle a problem as big as climate change, we can't act alone. No one in the industry can think that they're going to solve it on their own in a silo, so we've really been trying to build robust industry collaboration.

And we've done that by creating this roadmap of nine commitment areas that represent the key emissions drivers for most companies in the sector. So it's packaging, food waste, agricultural practices, transportation, policy engagement, and we ask companies to make commitments, public commitments, in one or all of those areas. And that sends a message out to the industry that, "Hey. We are taking this seriously, we're setting public goals, and we are working as part of a bigger movement within the industry to do this."

And so we asked companies to make commitments and then we help them on the implementation side. So we host webinars, we connect companies to partners and solutions providers, we try to connect companies to case studies and representations of what best practice looks like within the industry and work really closely with a really wide range of partners. And, crucially, we do this all for free.

We're a nonprofit, so it's really important to us to not have cost, or any other issue, be a barrier to entry for companies. We work mostly with small and medium-sized companies who otherwise might not have the resources to start tackling this stuff. And so we really want to enable companies, regardless of where they're getting started, to be able to get on a pathway to action. And to do so as part of a really whole of industry movement.

So we have everything from farmers and producers, to distributors and food retailers and brands, all working together collectively across the supply chain. Recognizing you need every link to really make change. And so that's been the baseline for the past 2 and a half years has really been building a strong base of companies who are committed to action. Kind of building this movement within the industry, and then starting to go down the road of providing really robust programming that can help them on the implementation side.

You know, our theory of change is commit, act, impact, and we're kind of trying, you know, over the course of years of being around, to move companies from making these public commitments toward acting on them and then ultimately seeing real impact in the industry. And that's been the journey so far.

Gazella: Yeah. I think it's brilliant. I mean, that's really why I was drawn to your organization, because you have this holistic collaborative from start to finish and you're getting commitments from organizations. So how many organizations have made this commitment that you're talking about? You know, you have 9 commitment areas, and they need to commit to 1 or all, how many organizations have done so?

Callahan: Yeah. It's really incredible. We've got over 400. We've got nearly 450 companies signed up. We're at about 440 companies who've made over 1,600 commitments.

And that's, I think, over 2 a day. I did the math recently, since we launched, commitments coming in. And, in fact, our busiest single month ever was this past August 2 and a half years in. And so I think what that shows is that the energy and momentum and sense of importance and value of what we're doing is only picking up as companies see climate change impacting their supply chains more and more and hear their customers talking about it and inherit it becoming a policy issue ahead of the 2020 elections. It's only becoming more important and central to what companies are doing, and that is incredibly heartening to see. We are so happy to see that progress.

And so, yeah, we've got about 440 companies committed. They've made... You know, those represent General Mills and Dannon, really large food companies that everyone here has heard of and probably have their products in the pantry, but also really small startups and everything in between. So we're really happy to work with kind of a really wide range of companies who are at every stage of the sustainability journey and kind of going really deeply on things. Like packaging, in some cases, and, in some cases, trying to tackle everything. And, you know, so we really do have the full spread represented.

Gazella: That's great. Well, congratulations on that progress so far. Now, obviously, your organization feels climate change is a big problem and we here at The Natural Medicine Journal are trying to cover this as well, so how concerned should we be about climate change? You know, what damage can and will occur with climate change if we don't act together, as you're talking about?

Callahan: Yeah. Well, a lot is the short answer. And I think... I feel like everyone, this year especially, something's changed and we're all kind of scared of looking around and seeing... You know, this August, for example, all of us were watching sort of helplessly as the Amazon burned, and Hurricane Dorian just hovered as this slow-moving, giant storm over The Bahamas, and just these great tragedies affecting millions of lives and livelihoods and communities and just not being able to do anything. And, you know, that's a trend that's only worsening.

I'm from the Mississippi/Gulf Coast and grew up watching hurricanes get worse throughout my childhood. And Katrina destroyed my hometown. And so these are very visceral things that I think we're starting to see and not be able to not connect... We can no longer avoid connecting it to climate change, and so I think everyone's sort of feeling it very viscerally.

And then, you know, on the data side, we've got a huge amount of evidence to back up the fact that climate change is happening. It's getting worse. We're already seeing the impacts, and if we don't act quickly and at scale, the problems are going to be tremendous. You know, when we look at UNFCCC Reports, and even an EPA report that came out in November 2018, that showed that absent action, this could slash 1/10 of the US economy by 2100. You know, the UN has showed us that we have about 10 years to act to avoid catastrophic damage. We're on a road to exceed 1.5 degree increase in global temperatures, and we have to stop that. We have to take action to reverse it.

And, you know, I moved to California year ago and within a couple of months was wearing a mask to avoid the smoke and fires, and saw my friends have to pull their kids out of school, and so I... It's a very emotional thing and it's a very practical thing that we have a lot of evidence backing up the risk of inaction. And getting into the health a little bit, it's very clear that climate change is absolutely a public health issue, in addition to an environmental issue and so many other types of issues. And so I think part of the conversation is how do we break this scary complex issue out of a silo of just being isolated to kind of environmentalism? And really focus on how is this having an impact on generations? How is it impacting the lives and livelihoods of the poorest people who are the most vulnerable to climate impacts? The youngest people who are going to bear the brunt of the problems that we see now?

So, you know, I think that that's all becoming increasingly clear and hard to ignore, which is, you know, both heartening and terrifying. It's been really great to see the type of action that happened last week at the climate strikes in New York, right? I think they had to shut down Battery Park because there were so many people gathered. And this is all because of 16-year-old climate activists, Greta Thundberg, who, I think, is just been one person who has created this giant, global movement that gives me real hope. But it also just shows the energy and strength behind how many young people are recognizing the threat to their future that they see.

Gazella: Yeah. I would agree. Well said. And before we get into the practical information, you know in the description of this an interview, I called your goal to reverse climate change lofty. I was actually surprised when I read on your website that the goal was to reverse climate change. What do you think? Is this a pretty lofty goal? And, even more important, is that a realistic goal?

Callahan: Well, yes, it is a very lofty goal. And I think we absolutely can't do it single-handedly, so I don't have any illusions. As much as it would be wonderful if I could work with these 450 companies to single-handedly reverse climate change, I don't think that's possible.

I think what we're trying to do at the Climate Collaborative is highly ambitious, and, essentially, what we're trying to do is create a new model of doing business within the natural product space that is replicable and scalable. And that shows that there is a way that companies can take advantage of the tremendous opportunity that responding to climate change represents. Be first movers on creating new systems and ways of doing business that are an inevitability, I really believe. In terms of new ways of doing agriculture that helps restore carbon in the soil, new types of packaging, reductions in food waste. The shift toward these types of practices is inevitable, and why not have this innovative industry be at the helm of creating those shifts?

And so, you know, that is really... We want to create a model that then cascades across the food sector. And I think... So when you ask, are we looking to really reverse climate change? I think that when you look at the fact that the food and agricultural system accounts for about 23% of global emissions, it's going to be absolutely key to solving climate change and have this huge kind of double-edged sword of being a huge potential opportunity as a solution, through carbon soil sequestration and other mechanisms, but also is a tremendous risk factor if we don't take action. And so I really look towards the types and group of companies that we work with as leaders in creating those new systems.

And so maybe not reversing all of the climate change, but maybe reversing how the food sector responds to climate change. And any company with an agricultural supply chain, how they can shift their practices to really create a new model for the food system. And so I hope we can do at least that much. I still believe that is an incredibly lofty goal, in that there are a lot of structural barriers to getting there. When you look at certain policies that disincentivize the types of practices that our companies are looking to start making or already making, and then the absence of things like a price on carbon and absence of policy and incentives rather than disincentives for farmers to be changing their practices to help restore carbon in the soil and all of that.

So that's why policy is such a crucial piece of what we do as one of our 9 commitment areas. And it's potentially the most important, because every company in our network could get to net zero emissions and it would be the drop in the bucket, when you look at global emissions. So policy has to go alongside whatever action that companies take, and my hope is you can then create a virtuous circle where you have companies acting and proving policy mechanisms can support these actions at scale, and then wider set of businesses taking up these policies and then you kind of create that virtuous circle.

So, that's my hope. But I completely agree, it is still really lofty. But I think we don't have really any other choice but to be ambitious and lofty in our goal setting these days. So, I am hopeful.

Gazella: Well, I agree. And I was going to ask you, "Why the natural health industry?" But you bring up such a good point, if you can create this new model that can then be replicated, you could have that ripple effect and have that, as you mentioned, cascade into the food sector. So to me that makes sense, so now I'm feeling better about my term lofty. Because I think-

Callahan: Oh. Good.

Gazella: Yeah. That makes total sense to me now. So let's get to the heart of the matter. So exactly how is your organization going to reverse climate change? Or, you know, if we put this into more digestible pieces, how is your organization going to create this new model of doing business that can then be replicated?

Callahan: Yeah. Well, the first thing is getting companies to make public events. And I think that... You know, I mentioned before, and kind of getting to your point around why the natural health and products industry, and I think that is because it's almost a quarter of global emissions when you look at the food and land system. There was just a Land Use Report that the Intergovernmental Panel on Climate Change put out that just showed how critical the sector is in responding to climate change, and that kind of double-edged sword of it being a solution and a problem.

So that's why these companies. And, you know, I think that within the food sector, our companies already have a status of first movers. When you look at issues like organic and non-GMO, fair trade, the natural products space, they've been first movers on those. And then have then become standards that we all know, we all shop and look for those labels, and we're all kind of very aware and it's cascaded across the food sectors. So we have model of what it could be and how that scale could work and look, and now we need to make climate that issue.

And that's part of the type of model we've tried to adopt here at the Climate Collaborative. In terms of how we do that on climate, it is predominantly through our commitment areas. So we have these 9 commitment areas. They're focused around carbon farming and regenerative agricultural practices. So it's changing on-farm practices so that you're pulling carbon into the soil and keeping it there, and that things like compost applications and cover crops. Intensive rotational grazing, when you're looking at pastures with animals. So changing your on-farm practices to really help draw down carbon, and that's a huge opportunity.

If, you know, you're familiar with Paul Hawken's Project Drawdown, which is this giant list of climate solutions, that's number 11 on the list. Another one that we work on, number 3 of his solutions, is food waste. And that is, you know, about a third of food is wasted and so we're trying to help at least the corporate part of that, so companies and their supply chains, to reduce food waste. And at source. So not just looking at waste diversion and donations, but really looking at how can we reduce the waste that's produced in the first place and make a more efficient supply chain from producers to grocers selling it to consumers? So we had a big project this year where we did intensive consultations with retailers in the US on reducing their food waste in store.

Packaging is another really big issue that we look at. It's the single biggest challenge for companies, you know? Everyone, I think, has paid attention to the plastic straw bans, and plastic in the oceans, and been very aware... It's a very visceral thing because you hold it in your hands and you see it, and then you throw it in the trash or the recycling and... It was just a very visceral way to be aware of your footprint, I think. And so that has been the single biggest issue and challenge area for the companies we work with and we do a lot to try and help them reduce their packaging impact. And, you know, there's policy, energy efficiency, switching to renewable energy, so we're looking at very concrete practical solutions that are very action-focused.

You know, I would say that for companies it's also really important to take a look at your footprint and say, you know, "Where are my emissions concentrated?" Start measuring and setting goals, and so we do encourage that. And, above all, we want companies to just say, "Okay. Let's start taking action. Let's start doing something and be part of, kind of, a larger community of companies within the industry doing that." So we do that through working groups. We have one on regenerative ag, we have on consumer engagement, one just for retailers and we really try to just kind of get companies able to talk to each other a little bit more about their efforts.

So that's a little bit. I'm happy to go into more detail, but those are a few of our projects.

Gazella: No. I think that's great because what we're going to do is we're going to put a link to the Climate Collaborative website, and I know that you list these 9 commitments. And you have a ton of information on your website, videos and such, so I highly recommend that any manufacturers who are listening, you know, or anybody really, click over to the Climate Collaborative to learn more.

Now, technically our journal is a part of the integrative health community and not necessarily the natural health community, per se, with a lot of retailers and manufacturers and such, but I'm wondering how our readers, are individual doctors, can help with this effort. So what advice do you have for the individual? And, in particular, I mean, our doctors are seeing patients and they're influential, you know? So what advice do you have for them to make an impact in this area of climate change?

Callahan: Yeah. Well, a couple of things come to mind there.

Firstly, we host one day of the year called Climate Day, which is my favorite day of the year. It's where we bring the whole industry together and get a set of thought leadership speakers, and everyone in the room just talking about the biggest issues that we need to tackle on climate change over the next year. And last year one of our keynotes with Yvon Chouinard, the founder of Patagonia, which, I think, if there's a company who's doing just fantastic work on climate change and making their whole mission focused around reversing, it's Patagonia. They've just been real leaders. And he was interviewed by Dr. Zach Bush who some of your listeners might be familiar with. I actually wasn't too familiar with him, but it might be an interesting conversation to reference in this because his whole talk was really around the relationship between the microbiome in all of us and climate, our biome. And what are those connecting, and how does one impact the other, and how does how we manage the climate then filter down to the nutrition and the food that we eat? And, overall, the microbiome and health of our bodies?

And so I just want to reference that, because I think that there's a lot of interesting stuff happening. A lot of interesting research happening there right now that I'm fascinated by and there's a lot to mine there. So, that is one thing. The other thing is, I think when it comes to doctors, or really anyone as an educated, active citizen, 1) voting and advocacy matters. And then, 2) being a really conscious consumer. And asking the businesses that you're purchasing from and working with what their practices are, and asking them questions about their packaging, asking them questions about their footprint. And business is new because of stakeholder action and requests and consumers are such a crucial stakeholder. It's why we're launching this consumer aspect of the product this year.

But I think creating an aware base of people who are talking to these companies, and working with them, in some cases, and shopping for... You know, with their products. Make smart choices but with your dollars. We have a group of fantastic companies that are really piloting new work and it's really important that we acknowledge that through engagement with those companies, through dialoguing. By pushing them farther and getting engaged in their mission, but also just generally when shopping by making really informed choices about the company that you're looking at.

And that's a very hard thing to do. I mean, I'm a consumer and it's really hard to hold the fact that I need something in a certain price point, I need it to be really good, I need it to be exactly for what I'm doing, I need to get it pretty conveniently. And then also, on top of that, I need to care about what's its footprint? Where did they source the ingredients? You know? And then also is it fair trade? Is it... You know, are they using renewable energy? What's the packaging? It's a lot to hold, but I think the more you can be okay and accept that complexity and really try to make informed purchasing decisions, the farther where we're going to go.

And, luckily, we're already seeing real movement. You know, I think 70% of Americans are looking to see more from the companies they're doing from a study that came out last year. I mean, you look at the younger demographics, those numbers get even higher and they really are making their purchasing decisions based on the footprint and choices of the companies they purchase from. So I think the more we can all lean into that, the better.

Gazella: Yeah. I would agree. And I think that's great advice. So, in closing, why don't you go ahead and describe some of your short-term goals moving forward. Say, within the next year or 2, what is your organization want to accomplish in the near term?

Callahan: Yeah. Well, firstly, on the outreach side, we've got an incredible base of companies committed. We're at about 440, like I mentioned, I want us to get to 500 by March of 2020. That is my goal.

It really matters to keep that energy and momentum up, and so I'm looking to bring on new companies. We're really looking to actually move in to a lot of health and nutrition companies and we're going to be at a conference in a couple of weeks talking to them. And, you know, that's kind of a subsector of the industry that we really want more actively engaged, so that's the one thing. And then on the programming side and the work of it side, we're just over a year away from the 2020 elections. Giving our companies pathways toward active engagement on policy issues ahead of that election and getting them informed on what they can be seeking out on and supporting, is a real, real priority of mine. We're working with a great set of policy partners on that front to do that and that's something that we're going to really try to be doing a lot of over the next year.

Outside of that, I mentioned consumer engagement. We are launching a consumer engagement part of the project over the next year, where we're trying to actually create a common set of messages that companies are using to engage in dialogues with consumers. And also to raise awareness on specific issues. Like soil health, like food waste, packaging, and really try to create dynamic, fun, engaging conversations with consumers that are action-focused as well. So we're hoping to really get that off the ground in the next year as well.

And then our rooted community, the regenerative agriculture community that we have, we meet 4 to 6 times a year right now and going to be doing our first on-farm site visit over the next year as well. And I really hope we can be doing more of that, and constantly just trying to roadmap the business case for action. I think a lot of companies understand the altruistic and moral reasons to act, but when you back that up with saying that there are real business cases to be doing certain things like this, especially when you're working upstream in your supply chain with farmers who have very small margins and also really know... They know how best to manage their farms, and so when you have these conversations, what are the incentives we can provide and what data do we have to back that up?

So we're constantly looking to increase the amount of data that we have on that and to connect your companies to it to really help promote these practices within the industry. So, those are a few key priorities. I think, overall, we're also just trying to keep the energy and momentum up in the industry. Climate is a really complex issue with a lot of nuances and not a lot of clear black and white solutions that we can just easily adopt, and so the more we can get companies excited and motivated and willing to work together, which I think they increasingly are, the more opportunity we have to really see transformative change in how the industry at scale is really attacking some of these issues.

So that's my biggest hope. Is that we just keep the energy up, from as wide a group of stakeholders as possible, around focusing on climate and moving forward with real action.

Gazella: Well, those sound like some great goals and it sounds like you're going to be very busy in the coming couple of years.

Callahan: I think so. Yeah.

Gazella: Yeah. Well, I just want to congratulate you on creating the... Well, your founders creating he Climate Collaborative and your work as the director. I really applaud you. I think it's great work. It is lofty and it's huge, but it's so important.

So thank you so much for joining me today and telling us about your work. And I encourage our listeners to go and check out the Climate Collaborative, and thank you, Erin, for joining me today.

Callahan: Thank you so much.

Gazella: Have a great day.

Callahan: You too.

Oct 2, 2019

In this interview, Benton Bramwell, ND, discusses the unique Mediterranean herb Arum palaestinum. Listeners will learn about the traditional use of this herb, as well as current research that helps illuminate its modern-day clinical applications including oncology specifically. Synergy, safety, and dosage will also be discussed.

About the Expert

Benton Bramwell, ND, graduated from the National University of Naturopathic Medicine in 2002. He manages a private practice and also provides consulting services to food and dietary supplement industries in matters of scientific and regulatory affairs. He enjoys the wonderful outdoors, especially working the vegetable gardens with his family and going on bicycle rides that allow him to think and exercise at the same time.

About the Sponsor

Hyatt Life Sciences

Hyatt Life Sciences is Putting Science Behind the Tradition™
Headquartered in America’s heartland, Sterling, Kansas, Hyatt Life Sciences continually searches for unique botanical entities and combinations that have been used traditionally in their countries of origin for hundreds of years. Rather than depending only on tradition and legend as many nutraceutical companies do, scientists at Hyatt Life Sciences research, test, and evaluate each herb, root, and component to discover the scientific reason for the ingredient’s benefit. We offer products only after each ingredient has been thoroughly researched for benefit, safety, and purity. At Hyatt, we are committed to Putting Science Behind the Tradition™. Read more.

Transcript

Karolyn Gazella: Hello. I'm Karolyn Gazella, the publisher of the Natural Medicine Journal. Today, we're going to have an interesting discussion about the Mediterranean herb Arum palaestinum. My expert guest is Dr. Benton Bramwell. Before we begin, I'd like to thank the sponsor of this topic, Hyatt Life Sciences. Dr Bramwell, thank you for joining me.

Benton Bramwell, ND: Pleasure to be here, Karolyn.

Gazella: Well, let's start with the basics. Where does Arum palaestinum grow?

Bramwell: Great question. Arum palaestinum grows in the Mediterranean region and is particularly known and used in the Middle Eastern portion of the Mediterranean.

Gazella: Okay. Perfect.

Bramwell: Quite a history to it actually, Karolyn. It's been known in the region for actually, literally, thousands of years. In fact, it shows up on some drawings in ancient Egyptian temples. We believe it was probably brought to Egypt from Canaan in about 1440 BC. It's been there for a while.

Gazella: Yes. Yes. Also from a historical perspective, what conditions was it used traditionally for?

Bramwell: It appears from the historical literature that it's been used for many different kinds of conditions. Primarily for a treatment for cancer, historically, but also as a treatment for infections and open wounds, as a treatment for kidney stones, and even for a worm treatment in animals and humans. Also, it's a way to strengthen bones. This is one herb that has been used in a very diverse applications, perhaps not the least of which because it happens to also be a wonderful food. It made its way from food into medicine. Really that distinction as, of course, you know in a lot of places in the world, there really is no distinction, right? A lot of times the best medicines come from our feed. This is certainly a prime example of that.

Gazella: Yes, exactly. Let's fast forward to today. What are the main clinical applications of this botanical today?

Bramwell: Yes, we're still learning about that in terms of modern application, where it's going to be the best fit. We certainly continue to see it used clinically in the ways that has been used traditionally previously. That's in the Middle East. It's still used as a complimentary supportive adjunctive support for patients with cancer. It's also finding its way into skincare, and I think we're catching up, frankly, in the modern scientific age as to where it should be best used. I think we still have a lot to learn there, but we're learning as we go.

Gazella: That's a pretty diverse list of conditions that this herb can help with, which is kind of common with some botanicals. I'm assuming that's because there's a variety of mechanisms of action. Is that a correct assumption? Can you tell us exactly how this botanical works in the body?

Bramwell: Right. I can tell you what we're starting to see there and understand. There are a variety of mechanisms. Just for a minute, let's focus on where it might fit in terms of something that makes supportive sense for the patient with cancer. What we're seeing is that it may very well, at least in the in vitro models that we're seeing, it may very well help with the cellular process of apoptosis. That's the process by which a cell decides that it's time to basically do itself in. It's programmed cell death, right? There are some interesting mechanisms through proteins that are caspases. I think that we're going to continue to see the literature develop there quite a bit, but I think that's one important mechanism.

It's also important in terms of cell signaling by means of phosphorylation. There are many pathways in the cell which run off messenger systems based on phosphorylation. It seems that Arum palaestinum probably inhibits some of those pathways as well, or at least the compounds from. Those are several of the mechanisms that we see in play.

Gazella: Okay, good. I understand that there's a topical application of this plant. Can you tell us a little bit about the topical application and what that formulation actually looks like?

Bramwell: Yes, I can tell you a little bit about that. I'm glad to see that one coming forward. It's certainly in line with the traditional use. That product, Arumacil, it contains the Arum palaestinum extract, as well as dimethicone and petrolatum. The object there is to help protect the skin, give it a chance to heal, basically. I wouldn't be surprised, and I don't think the literature has necessarily caught up to us here, but one of the main categories of plant chemicals that we're talking about here are flavonoids. Flavonoids are known in the literature to have antiviral effects. Again, a little bit more to learn there, but I wouldn't be surprised at all to find this topical application of good use, clinically for people with cold sores and other minor skin irritations, frankly.

You're going to get a lot of antioxidant action from these compounds, as well as potentially some antiviral, although I think we need to learn more about them.

Gazella: Okay. That makes a lot of sense. From what I've read, this is a pretty complex botanical. It has a lot of different constituents. From the therapeutic perspective, what are some of the key active compounds in the plant?

Bramwell: Well, there are many actually. In the literature where I've spent some time, and from what we can find, there's about 180 phytochemicals that we can at least tentatively be identified at this point in time. Most of those, as I mentioned, are flavonoids of one kind or another. As I look at the list of what's been identified, some of those I would pull out would luteolin, which I think is going to prove to be very important from an anti-inflammatory point of view. That's certainly an active bioflavonoid, in particular, a class of flavonoids called flat bones. I think that's going to, doing the [inaudible 00:07:52] one of the important ones. But there are others as well. There are derivatives of rutin in there, and epicatechin. So I think those are all going to be important.

In addition to the flavonoids, there are also phenolic acids and derivatives of phenolic acids in here as well. Rosmarinic acid is one that pops out, and these are all compounds that I mentioning that when you look at the individual ingredient, it doesn't take you long to find in the literature that these individual ingredients, upwards of between 20 or 30 of them, have a little body of literature of their own, as to their anticarcinogenic potential.

And so, I think what we've got here among the flavonoids, the phenolic acids, and I should mention also some terpenoid derivatives, of course solic acids in there as well as some iridoid derivatives. When you put all those together, and each of them have an anticarcinogenic potential, the complexion of the botanical is one that seems well suited for its historical use.

Gazella: Yes. Especially when you consider a condition like cancer, which in and of itself is so complex. I'm fascinated by the fact that there are all these little compounds, and as you've mentioned, you could probably take one compound, do a scientific literature search and find data to support that one compound, but here we're talking about multiple compounds all within the same plant.

Bramwell: Well, that's exactly right. And actually some of the interesting work that's been done, one of the interesting approaches here is to take some of the compounds that occur in the plant naturally and make a fortified extract, if you will. So, that work's been done in vitro and in vivo and in several different places. They've taken out, for example, linolenic acid, beta sitosterol and isovanillin.

Those are items, constituents that you can get in a water extract of the plant and then made a fortified product from that... material. And when that material has been tested in the in vitro and animal models, it seems to perform superiorly to the raw extract, and I find that very interesting. It seems that Genzada Pharmaceuticals, Hyatt Life Sciences have done a very good job in the work that's been ongoing here showing an increased potential of this fortified extract approach.

Gazella: Yes, that sounds like some pretty cool science. I want to focus, in particular, on a 2018 study that was published in scientific reports. Now in that study, it compared to three different formulations and all of the formulations included Arum palaestinum. What were the results of that study? Tell us a little bit about that particular study and what the objective was and what the results were.

Bramwell: Right. So, this is an approach, again, where a fortified... a number of things were tested. One of the things that they tested was combination of the three plant extracts, Arum palaestinumcurcumin longa, which most people are familiar with turmeric, as well as another from the Middle East peganum harmala, sometimes known as Syrian rue.

So, those 3 botanicals were studied together and then various combinations of a fortified extract, or in one case, a chemical constituent from each of those was mixed together, and that actually looked the most potent as far as it's anticarcinogenic potential. And in that case, isovanillin, which you would find in the Arum palaestinum, was mixed with harmine, which you would find from the Syrian rue and also curcumin from the turmeric and all three of those plant chemicals were used together. And that actually seemed to have a very potent anticarcinogenic effect in the in vitro and in the animal models that we're studying here, in terms of looking at the invasive potential and proliferation, of the cancer cellulars models that we used.

And in this case, the researchers were looking at the head and neck squamous cell carcinoma, which is a very fast growing, aggressive kind of cancer. And, it does appear that the cells that were used here were very sensitive in these models, to that combination.

Gazella: So remind us, which combination then performed the best in this particular study?

Bramwell: Right. In this particular study, the combination of the three phytochemicals, so isovanillin, Arum palaestinum, and harming from the Syrian rue and curcumin from turmeric is what performed the best.

Gazella: Got it.

Bramwell: And again, they were able to show the effect on the molecular signaling cascades within the cell. So, there's some definite believable mechanisms of action here as to why the compounds would have the effect that they do. I think we're going to see a lot more about this one in the future as it becomes translated to human clinical studies.

Gazella: Right. Yes. Based on that study and other research, it sure seems like Arum palaestinum is best used in combination, potentially with other botanicals versus as a single botanical. Is that true? And if it is true, why is that?

Bramwell: That's an excellent question. I think that probably is the case, that either combination of the Arum palaestinium with other botanicals or even compounds, key compounds, from each of several important medicinal herbs. The question is why do we see this additive or even synergistic effect with these compounds or with the botanical blends that seems to manifest in the literature? I don't know all the reasons for that, but I rather think, given as complex as cancer is, being able to affect multiple pathways is probably the breadth of the attack against cancer cells, is probably why we're seeing that synergistic kind of benefit.

One way to attack something is with a very narrow focused approach. A deep attack. Another way is with a multitude of effects together. A nice, you know, cover all the bases. And I think that's potentially what we're seeing as this literature sort of declares itself here.

Gazella: And now what combination or what product, what Arum palaestinum product do you use in your clinical practice?

Bramwell: So right now what I'm using is the Afaya Plus and you can learn about that, consumers, patients, physicians can learn about that at the Hyatt Life Sciences website. But I think that that's the best product certainly than I've seen on the market at this point in time.

Gazella: Mm-hmm (affirmative) great. We'll also provide a link to the website too, so listeners can click right over. So, so far, there's been some compelling in vitro and in vivo and we all know that that's kind of the progression of research as we study these botanicals. What about human clinical trials?

Bramwell: That's the next step really, Karolyn, and I don't know when those are going to be published or what stage we're at, but we're definitely ripe for what would be called phase one and phase two clinical trials here. From what I can see in the literature.

Gazella: Are they underway? Phase one, is this phase one underway or is that still, are we still waiting for them?

Bramwell: I think we're still waiting for that, at this point in time. I hope to hear more about that in the near future. But at this point, following the literature and everything we see we like.

Gazella: Right.

Bramwell: And can't wait for the next human work to actually be published.

Gazella: Yes, I mean, the traditional use combined with the preliminary research sure does seem to be compelling. I'd like to talk a little bit about how it's used in oncology in particular. Do you look at this botanical as an adjuvant to be used with treatment or maybe after treatment? What's the clinical application when it comes to oncology?

Bramwell: Right. Well that's a very good question and because of where we are in the scientific process here, we're still early on. Although I think Hyatt Life Sciences, to be fair, has done much more work than many dietary supplement companies ever do. But we're not there yet in terms of knowing all we want to know. So at this point in time, I don't think anyone would responsibly say that this is a treatment for cancer. What we would say is, traditionally the syrup has been used by patients who have cancer. It's part of our herbal armamentarium historically, and it seems to make supportive sense.

And so, this would be something I would recommend while the patient is going through treatment. Although I tend to leave a space of time between conventional care and herbal therapies, just to make sure that the chemotherapy has time to do its work. So I would tend to leave three or four days, or at least one or two before and after a chemotherapy treatment. I think, from what I see in the literature, at least from the the Middle Eastern region where this is used quite heavily, when oncologists in that area are surveyed, they're not reporting anything really of concern as far as interactions go. But I would still leave a couple of days on either side of treatment, make sure the chemo gets in and does its job.

Gazella: Yes, that, Oh, go ahead.

Bramwell: No, you're fine.

Gazella: Well, I think that that's a good, prudent recommendation and I think that oncologists would agree with that. Now beyond oncology, is the herb safe? You talked about no interactions with chemotherapy that we know of, but are there any other interactions or contraindications that we should know about?

Bramwell: You know, not that we can see at this point in time. The only thing I would point out and highlight there, Karolyn, is that even in traditional use, where this has been used as a food, what's been known for a long time is that it's boiled. It's boiled several times in water and that water is decanted several times, taken off, in the preparation of the herb as a food. Or in this case, before it's a supplement. Don't know all the reasons for that, but part of the thinking has been there that there's a high amount of oxalates in the plant and in order to prevent toxicity, that's an important part of the plants preparation as a food/medicine. So, I would highlight that for you.

Gazella: Yes, that's interesting. Is there any kind of standardization with this botanical?

Bramwell: Yes, it could be standardized. But since we're in the process of learning all that's important about it, I think the closest thing to standardization is the work that was done several years ago with the fortified extract of isovanillin, linolenic acid and beta sitosterol . That complex looked quite promising. And if you wanted to standardize to something, that would be one way to do it, but I'm not aware of a totally standardized extract at this point without fortification, if that makes sense.

Gazella: Okay. Yes. Let's talk a little bit about dosage. So what dosage do you recommend and does that dosage change based on the clinical application or if it's for prevention versus treatment?

Bramwell: I would tend to be more aggressive with a patient who's using this as a supportive. Make it a supportive care during cancer. And the Afaya Plus, two capsules [inaudible 00:23:07] of that is going to give about 900 milligrams, of a combination of vanillin powder, tumeric powder, harmala powder, the Syrian rue and Arum palaestinum. I would tend to go at least two capsules, twice a day on that.

But again, when you're working with a patient with cancer, you're going to have to titrate the need, titrate the dosage that they can take. Some patients going through treatment have a difficult time getting food in. And one thing we always have to remember with a patient with cancer is that we want to feed them first. And we don't want capsules to take the place of food, and so it's going to depend on what the patient can tolerate. But I would start off with a two capsule b.i.d. kind of an approach. And if they can tolerate that well, even up to two capsules t.i.d. As a maintenance kind of thing, for general health, I could see taking a single or two capsules a day, single serving.

Gazella: Do you feel like it has a good application? Like for example, somebody, a patient who may be at high risk of developing a type of cancer. So as a way to kind of help reduce risk, do you feel like there's an application for that?

Bramwell: We don't really know at this point, but I would suspect so. There again, I'm not one to, I don't necessarily subscribe to the philosophy of more is always better. But I think it's something that I would carry in my mind. You know, if dad and grandfather both had prostate cancer and I want to take something and it's kind of a daily maintenance to keep as healthy as I can, to maintain that prostate tissue in a good state, I would think of serving of this a day would make a lot of sense.

Gazella: Okay, great. Now, we talked a lot about oncology, but we also mentioned skincare, infections, kidneys, bones, when you're looking at the clinical potential of this botanical and the clinical application of this botanical, does oncology bubble to the top over everything else?

Bramwell: I think it definitely does. In fact, there are many other applications that we've mentioned here. And we're going to learn more about those over time. I think this is something that naturopathic physicians and other integrated healthcare practitioners are going to learn about as they go. And that's okay, really. We're using something that's been in traditional use for a very long time. But it would be something that for other conditions like skincare, I would just try it clinically and see what we see with it. But I think the biggest, biggest application, Karolyn, is going to be oncology.

Gazella: Yes, I would agree based on what we've discussed today. For sure. Now, Bramwell, I'd like you to pull out your crystal ball and kind of look into the future as a clinician, what would you like to see happen with this botanical as it relates to oncology specifically?

Bramwell: Couple of things and I think already some progress has been made in terms of what formulations are the most effective, but I'd like to see a little bit more work in that regard, with various combinations. I think that we will see, in the next few years, based on what's already been done, phase one and phase two clinical trials. And I hope, based on what's done that that includes work in both patients with prostate cancer, as well as patients with head and neck squamous cell carcinoma and some of the other lines that have shown promise. I mean, there's been some work that's a promising in glioblastoma cell lines as well as lung cancer. So we'll see where it goes in humans first, I hope with patients with prostate cancer and patients with the head neck cancer especially. I also am intrigued, in that 2018 paper that you referenced, there was some work indicating that it may go very well in combination with Cisplatin.

Bramwell: Platinum chemotherapy is very commonly used in colon cancer treatment, as well as other cancers. And boy, if there would be something that would help the platinum chemotherapy be even more effective than it is, I think that would be a wonderful combination and as I kind of look to the future, that one comes to the front of my mind, Karolyn is, is this an adjunctive therapy that could actually make the conventional therapy a little more effective? And I would really hope that the future upcoming human work will really hone in on that and help to answer that question.

Gazella: Yes, and it would also be kind of interesting to see if this botanical could help reduce some of the side effects that come with conventional chemotherapy. I think that would be kind of an interesting... I'm curious as to why prostate and head and neck. I mean, head and neck, that's a tough one and I would love to see it be effective, but why are those two ones kind of standing out in your mind as to where this botanical may help?

Bramwell: Right. Well that's based on the work that's been done so far. So yes, there's going to be a great, great question. The 2018 work was primarily done in head and neck squamous cell carcinoma, and the work before that, in 2015 that was published, was quite focused on prostate cancer cells. So, it makes sense to build on what you have there.

But, you know what? Here's the great thing about Arum palaestinum, from everything I'm reading, it looks like the mechanisms of action, and there are multiple of them, could be applicable across many kinds of solid tumors. So this would be the kind of thing where you can build on your in vitro and animal work and human studies, but you might quickly branch out and other areas of exploration as well. It could be something that could be beneficial to many patients. We don't know yet, I don't think. But, when I read this literature, the question I asked myself is, could this be the next [00:30:30] ? Could Arum palaestinum be that botanical source for a cocktail of phytochemicals that really finds broader use and helps many patients live longer and much better lives. I hope so. Time will tell. Human data will certainly inform things from here, but what we see so far is it's highly encouraging and kudos to the Hyatt Life Sciences for getting this out there.

Gazella: Yes, I hope so as well. It sure sounds like there's a lot of potential here and we're going to definitely, The Natural Medicine Journal, will definitely be following this research on this interesting botanical, Arum palaestinum. Well, once again, thank you Bramwell, for joining me today and I'd also like to thank the sponsor of this topic, Hyatt Life Sciences. So, thank you for the interesting information, Bramwell, and I hope you have a great day.

Bramwell: Well, thank you, Karolyn. Pleasure to be with you.

Aug 22, 2019

Natural Medicine Journal publisher Karolyn A. Gazella talked with Kristie Ebi, PhD, from the Center for Health and the Global Environment with the University of Washington. The two discuss Ebi's research using new technology to model growing conditions as they will be in the coming decades if we don't curb climate change.

Aug 6, 2019

In this interview, Ronald Hoffman, MD, describes the scientific research associated with essential fatty acids, specifically omega-3 fats from fish oil. Hoffman touches on some of the controversial research and then focuses on the practical clinical applications that have been confirmed in the scientific literature. 

 

About the Expert

Ronald Hoffman, MD, is a physician in private practice of integrative medicine in New York City. He is a graduate of Columbia College and Albert Einstein College of Medicine. Since 1984, he has served as Medical Director of the Hoffman Center in Manhattan. Hoffman is past president of the American College for the Advancement of Medicine. Hoffman is the host of Intelligent Medicine, a nationally syndicated radio program, and he produces the daily Intelligent Medicine podcast. He is a Certified Nutrition Specialist and the author of several books, including How to Talk with Your Doctor (About Complementary and Alternative Medicine)

For more information, visit drhoffman.com.

About the Sponsor

Carlson Labs

Since 1965, Carlson Labs has produced fresh, pure, award-winning vitamins, minerals, fish oils, and other nutritional supplements. The company began with a single vitamin E product in Founder Susan Carlson’s small Chicago apartment and quickly grew to offer the most complete line of all-natural vitamin E supplements in the world.  In the early 1980s, we helped launch the omega-3 market in North America, importing our high-quality, great-tasting, sustainable fish oils from Norway. In 2009, we released a new marine oil sourced form an abundant species of calamari. Today, the next generation of Carlson leads the company—daughters Carilyn Anderson and Kirsten Carlson—and the innovations continue.

Carlson recently announced the opening of Carlson Healthy Oils, our new, state-of-the-art bottling facility in Søvik, Norway. Søvik is located near one of the busiest and most important fishing harbors in the north Atlantic, ensuring that only the finest, freshest fish oils are delivered to Carlson Healthy Oils for refining, distillation and bottling.

Transcript

Karolyn Gazella: Hello. I'm Karolyn Gazella, the publisher of the Natural Medicine Journal. Thank you for joining me today. Our topic is the utilization of essential fatty acids in clinical practice. And my guest is integrative health expert, Dr. Ronald Hoffman. Before we begin, I'd like to thank our sponsor Carlson Labs. And thank you Dr. Hoffman for joining me today.

Ronald Hoffman: Well, thanks for inviting me, Karolyn.

Gazella: Well, this is a great topic. And I know that you are consistently a food first clinician. So let's start with something very basic. How much fish does a patient have to eat each week to get the benefit of the omega-3 fats?

Hoffman: Well first, let me just say, this is a controversial topic. And especially when it comes to supplementation, but it's generally acknowledged that a fish is healthy. It's beneficial for a variety of reasons in particular for cardiovascular prevention. And usually the suggestion is that people consume 2 to 3 small to moderate portions of oily fish per week to obtain the optimal amount of omega-3s.

So, for example, a 6-ounce portion of wild salmon contains about 900 milligrams of the EPA, and about 1,000 milligrams of DHA. And 2 to 3 servings a week of salmon, in particular, in a setting where you have a low intake of omega-6, which competes with omega-3, would be adequate for most people. There's also some information that suggests that the omega-3s in fish are more bioavailable than the omega-3s that you get from a capsules where it's in isolated form. And there may be other compounds within fish, even certain fish peptides or proteins, which may have a beneficial effect. So you're getting kind of an all round benefit when you eat fish.

Gazella: That makes a lot of sense. Now I want you to remind us, you mentioned heart health, but can you remind us why these omega-3 fats are so important to human health?

Hoffman: Well, there there's so many ways. First of all, fish oil seems to have an anti-inflammatory effect. It works on tamping down pro-inflammatory pathways within the body. These so called eicosanoid pathways. And also, it has a lot to do with membrane fluidity. So fluid membranes help our blood vessels expand and contract, helps the ingress and egress of compounds into our cells, helps nerve transmission. And that may be why fish oils have what are called pleiotropic effects, which means that they work in a multiplicity of ways to help the body. Brain, heart, circulatory system, joints. There may be even an anticancer effect because of its ability to reduce inflammation, which is a trigger for cancer.

Gazella: Yeah. And I think sometimes when a substance such as fish oil and these essential fatty acids have multiple effects, and can do so much good on so many levels, there's almost a tendency to be a bit suspicious. But it seems—

Hoffman: Right. One of the "too good to be true" phenomenon. It sounds like a panacea. So that tends to induce a little bit of doubt.

Gazella: Exactly. So I think that that's when integrative doctors like yourself and our listeners look to the science. So I'd like to talk a little bit about the science as it relates to the practical use in clinical practice. So which conditions in clinical practice will positively and confidently be impacted by essential fatty acid consumption?

Hoffman: Well, let's start with the controversy, which is about cardiovascular health. And this really dates back to studies of Greenland Eskimos, which showed a near absence of cardiovascular disease. And so then that sort of triggered the gold rush for fish oil supplementation because they thought, well they consume so much of that stuff, this is going to protect the hearts of normal folks in the West.

Lately there's been a lot of blow back against that because, for example, the Cochrane Collaborative has ruled that there is no definitive evidence that fish oil supplementation has heart benefits. But I got to say I critique some of those conclusions because a lot of the studies that show no benefit from fish oil are done with very low doses of fish oil supplements, a capsule or 2 of fish oil of unclear quality.

Also, often when we test fish oil for cardiovascular disease, we have people really tanked up on medication. They're on aspirin, they're on statins. Maybe that will blunt the benefit of the fish oil. And also it may be that fish oil is very preventative against cardiovascular disease, and we'll see the benefits if we do a 20- or 30-year study. But if we take very sick people who are near end stage when it comes to cardiovascular outcomes, we're not going to see that taking a fish oil capsule to 2 is going to make a difference.

But the really exciting development on the fish oil front, and I got to give credit to the company that did this, Amarin, which is the maker of a pharmaceutical fish oil, has a come up with a study, the REDUCE-IT trial, which suggests that their very concentrated version of fish oil can reduce cardiovascular disease risks by 25%. Now they were very quick to say by no means does this suggest that fish oil pills are equivalent to our medication. But Vascepa is really concentrated EPA. And so it remains to be seen if supplementary fish oil has that robust effect. In many studies, it came up short.

Gazella: So let's stick with the cardiovascular effects. When you're talking about that Cochrane Collaborative, was that the study that came out late last year that you're talking about that was a bit controversial, and pretty widely publicized?

Hoffman: Right. And with kind of lurid headlines like there was an editorial in, I guess, it was Journal of the American Medical Association, which is "The Last Nail in the Coffin of Fish Oil." It's almost gleefully pouncing on the supplement industry saying that it doesn't work. But by the same token, I'm pretty sure that the self same journals are going to run ads for the Amarin product that's been validated by scientific research.

Another problem with some of these studies is when some of these studies compare fish oil to an inert placebo, which is olive oil. Well that may be a mistake. Because olive oil actually has cardiovascular benefits. And interestingly in the Amarin study, the REDUCE-IT trial, their placebo was mineral oil. And because you had to give a lot of of these refined fish oil capsules in the active group, you had to have a lot of mineral oil capsules. A lot of people were consuming a lot of mineral oil, which some people would say could actually be deleterious when it comes to a cardiovascular health and reducing the absorption of other critical nutrients.

So this is a very fraught area of discussion because some people say, well, fish oil doesn't make a difference. I would say that it may be different strokes for different folks. Some people who are very deficient in omega-3 would obtain a great deal of benefit. Other people are pretty tanked up on dietary fish consumption. So the benefit is not going to be that great. There may be some genetics involved. Also, it may be that if you're consuming a lot of omega-six fatty acids from seed oils, these are pervasive in our western diet. That may blunt the benefits of omega-3s because we look at the ratio of omega-3 to 6 as being an important determinant of health.

Gazella: Yeah, that's a good point. So I'd like to stick on the clinical applications here. There are a lot of doctors that I interview that actually think of fish oil or these essential fatty acids as foundational. And if their patients are not eating enough fish, and they're not getting enough of these in the diet, they automatically supplement even if there's no real clinical application. What's your view in your clinical practice? Do you supplement? When do you supplement? And for what conditions other than cardiovascular may you consider fish oil supplements?

Hoffman: I do believe in that, what you just stated. Which is I think that that's part of, if one's going to construct a [inaudible 00:09:43] series of 4 or 5 supplements that people should take, I think fish oil is right up there. I personally take fish oil. I have my family members taking fish oil. I have my patients taking fish oil. And it's kind of an insurance policy against lack of the requisite amount of fish oil that prevents a variety of diseases.

We see also benefits in pregnancy. A recent study showed that there was a preventive effect against preeclampsia of omega-3 supplementation. That's a bad pregnancy outcome. Also reduces the instance of premature births. There may be some benefits in terms of a kid's ultimate intellectual development, DHA, which is a constituent of fish oil. Docosahexaenoic acid is naturally present in breast milk. So it was only recently that US manufacturers joined the rest of the world in adding DHA to infant formulas. Long overdue.

Also in brain conditions. We look at a lot of neurodegenerative conditions where there's an inflammatory component. These include Alzheimer's, also depression. There are actually some very good studies looking at depression and omega-3 fatty acid administration. Certainly that would be an area of application. Autoimmune disorders, inflammatory disorders, dermatological conditions that are inflammatory, on and on it goes. There's so many different applications.

Gazella: Yeah. Now you mentioned DHA, and often when we think of omega-3s, we do think specifically of DHA and EPA. Now you mentioned the applications of DHA in terms of pregnancy and childbirth. So from a clinical perspective, is there a time when you look to one of these to be emphasized over the other? Can you expand on that a little bit more?

Hoffman: Yeah. And I wish there was a rocket science answer to that. And I've just looked long and hard into the literature over the past few years. And it appears that EPA may be more important as an anti-inflammatory. And many studies suggest it's good for the brain because it reduces inflammation. But also DHA plays a very important role in brain health. It's certainly important in neurodevelopment. Deficiency of DHA is associated with behavioral problems and intellectual problems in kids.

And so it really is unclear. And if someone says it's DHA or EPA as a definitive answer, I would say, walk away from that conclusion. They seem to work synergistically to support health. The question is sometimes ratio, sometimes in certain conditions we might go for more DHA, other conditions we might emphasize EPA. But it appears that they both play central roles, and sometimes in the very self same condition.

Gazella: Yeah. Now, before I leave the topic of the research, because we talked about the controversial negative research that came out late last year, and sometimes bubbles to the surface every now and then. It seems like, and I know you're in the scientific literature all the time, it seems like the more I look at the scientific literature, gosh, there's not a month that goes by where I don't read a new study on fish oil. So in general, are you pleased with the research that's coming out about these essential fatty acids?

Hoffman: Well, the last time I checked, there are at least 20 or 30,000 articles that support the benefits of fish oil for one or another health problem. So when some group like the Cochrane Collaborative comes out and says fish oil is worthless, I think it's a conclusion that ignores the vast amount of evidence that supports the benefits of fish oil.

So, it's not binary. I think that we can't overhype or overestimate the universal benefits of fish oil supplementation. And there are appropriate cautions when we look at some of these big studies. But still, I'm generally supportive of especially targeted use of omega-3 for specific conditions.

Gazella: So now let's dig into some practical aspects. If a patient can't get the omega-3s that they need from diet alone, what dosage or ratio of these fats are typically recommended as a dietary supplement?

Hoffman: Well again, it depends. So for example, for cardiovascular, I'm thinking if people have serious cardiovascular problems, they need higher doses. So that comes to us for the REDUCE-IT study that used 4,000 of EPA, pure EPA to reduce cardiovascular risk. So it kind of depends on what you're dealing with. To lower triglycerides, for example, you need pretty high doses, not just a pill a day, or even 2 pills a day. But for general supplementation, I suggest one of the potent formulations of omega-3 that delivers a high percentage of EPA-DHA per capsule. The 1,000 milligram capsules, not the little teensy tiny capsules, 1 capsule, twice daily for general prevention.

Gazella: So that's 1,000 milligrams twice daily for general. And then what's the upper dose for somebody who may be having cardiovascular issues? Did you say 4,000?

Hoffman: I would say 4,000 for somebody with cardiovascular issues. Now what we have to be a little careful because some people have bleeding tendencies, or who are on blood thinners. And I notice it's very individual because some people taking high doses of fish oil have no problem whatsoever. Others have more easy bruising, or some signs, nosebleeds, that suggest that that is thinning the blood inordinately.

Gazella: Right. And I agree-

Hoffman: And that's a good effect. Ultimately, from a cardiovascular disease standpoint, that's actually a good effect.

Gazella: Right. And I do agree with you, it's a highly individualized approach that each practitioner uses. What about contraindications and safety? Anything else that needs to be discussed regarding that?

Hoffman: There are some studies that suggest that because omega-3 fatty acids sort of tamp down the immune system, as in autoimmune diseases, I love using them in conditions like Lupus and rheumatoid arthritis, that very high doses might suppress the immune system to the point where people are more vulnerable to infections. But I've seen a couple of suggestions in studies that that can be a problem. But I haven't seen it as a practical situation. Just as a potential caution. I would look to that possibly.

Gastrointestinal symptoms limits its use because some people are prone to diarrhea. It's great for all sorts of ulcerative colitis, but that being a GI condition, it's sometimes hard to administer sufficient amounts to get a good effect.

Gazella: Yeah. And the autoimmune conditions kind of caught my attention. So did you say that you use higher doses in cases of autoimmunity?

Hoffman: I do. There are some studies that suggest that as much as 9,000 per day can be beneficial in ulcerative colitis, which is an autoimmune condition. But again, that too has been subject to question. Some study suggests that it's not as helpful as was once thought for UC. But I think it's just reducing the inflammatory cascade is very important in these diseases. So you can really sort of turn around.

It's like using this powerful immune modulators that really target parts of the immune system and knock them out. Well, they knocked the immune system out to the point, the pharmaceutical drugs, where people are vulnerable to infections. And fish oil may be sort of a more gentle immune modulator that kind of turns down the volume on an autoimmune reaction.

Gazella: Yeah. That's good information. So a big issue when it comes to fish oil supplementation is quality. I mean obviously quality is always a big issue. But it seems like it's even more important when it comes to fish oil in particular. Why is that?

Hoffman: Well, there're a lot of issues with the quality and storage of fish oil. Fish oil, as a polyunsaturated fat, is subject to rancidity. So freshness is a big issue. I would look to a big reputable brand that's been around for a long time. I would also look at third-party certification. There are various places that do that. One of them is called IFOS, which is the International Fish Oil Standard program.

There's also the USP and the NSF, the national standards, which give companies a validation that their product is pure and of good quality. You want to make sure there's no flavorings or colorings to bad artificial ingredients. Another issue is sustainability. There's this issue of overfishing the oceans. And one certification is offered by something called the Marine Stewardship Council. Which awards a certificate to companies that farm fish responsibly rather than devastating the environment.

Fish oil should have maybe a faintly fishy smell, but if it has sort of a bigger acrid taste or smell, that's likely that it's rancid. And the other thing is just the potency. You want to look at products that deliver the requisite amount of EPA DHA per capsule. And that has to do with the degree of concentration and molecular distillation that they undergo to deliver active ingredient rather than just fishy extract in a capsule.

You want to look at the presence of PCBs, or mercury. And there should be a purity guarantee. And especially when companies undertake a responsible self-testing, where they test batches of their material, and you can actually request their specs. You just email the company, or call a 800 number, and they can actually give you the specs on the product that you're taking, just to verify that you're not getting harmful amounts of mercury, or PCBs. So those are among the concerns. If you go to a place, and you find a bottle of fish oil, it's like $9.99 for 500 capsules, I mean, it's not very plausible that they're doing adequate quality control.

Gazella: Right. I think that that's a really good point. Now when you're talking about... I want to touch on some of these. Because you brought up a lot for practitioners to think about when it comes to them choosing a high-quality fish oil supplement. So when you're talking about that third-party certification, is that third party company the one that tests for mercury and purity, and things like that? Or is that something that's done in-house by the manufacturer?

Hoffman: I think it's actually responsible companies will test the material on receiving the material. First of all, they receive a big batch of fish oil before they encapsulate it. So they want to make sure that their supply chain is reliable. So they'll undertake pre-testing. They'll also sometimes do an audit. They'll say, "Let's take a bottle of this stuff at random, and let's do random testing and see if what comes out of the assembly line is fresh." I think they might do tests for lipid peroxides, but also free of contaminants.

So it's more expensive to do that. There's no question. But responsible companies that want to maintain a good reputation and deliver quality products undertake that. And that's actually a selling point for them because the consumer can feel they're reliable.

Gazella: Oh, I would agree. And I think for our listeners, they can get the specs of those random testing batches and the third party certification information, that all helps to know that they can—

Hoffman: There's a lot number. There's actually a lot number on the products so that people could say, "Well I have lot number 56328. Can you show me the spec sheet?" And your eyes glaze over when you see these spec sheets. But you can actually see the contamination is like 0.0000000... way below what the EPA, for example, Environmental Protection Agency, would consider a toxic exposure.

Gazella: Here's a random question. I was told once that if you have a fishy burp that that means the product is rancid.

Hoffman: No. I think that's a kind of a misconception. You can minimize the fishy burp in a couple of ways. One is to take what are called enteric capsules, but there's a trade off. A, they're more expensive, and B, they don't contain as much fish oil. Enteric means that they're coated so that they break down lower in your GI track. The fishy burp can be camouflaged also by lemon flavoring, or orange flavoring, or sometimes cherry flavoring.

And also to some extent the fishiness is associated with purity of the capsule. So products that are not highly distilled will have some... it's basically you're smelling the proteins, or the various residues that are not the active ingredient. But you can't really use that as an ironclad way of determining if the product you've taken is fresh or rancid.

Gazella: Yeah. That's what I was thinking as well.

Hoffman: I would not stand by that. And some people are highly sensitive to the smell or taste of fish oil. Some people have GERD or reflux. And they have an aftertaste of many things that they take in.

Gazella: Right. Yeah. Okay. So what's your view on krill oil versus fish oil? Do you have a preference one over the other? And if you do, why?

Hoffman: Well, okay. There's a lot of promotion of krill oil. And it's based on a couple of basic ideas. One is that while krill oil, the actual capsules may contain less fish oil, and some of the capsules are smaller. Those are usually easier to swallow, that's a selling point. That it's more bioavailable. I've looked at the studies that purport to show that and they're very few and far between. They're based on a small number of individuals. They don't really meet the threshold for demonstrating that the claims are really true, that you're going to get more into your system.

The other benefit is said to be that they contain astaxanthin, which is a good thing supposedly. It's an antioxidant. It's got benefits. If you want to take astaxanthin, take it in a separate pill, or just eat farmed salmon. Because farmed salmon is loaded with astaxanthin. It's what they use to make the flesh look red. So I'm not the biggest fan of krill oil. Plus there's also a sustainability issue. It's very aggressively farmed. It's a form of crustacean that supports the whale population. And it's a little worrisome that there a scooping up all the krill to feed a very, very hungry marketplace in Europe and the United States.

Gazella: Yeah, I would agree. I think that sustainability issue is really an important one. I also agree. I don't read nearly as many studies on krill oil as I do on fish oil. The issue of astaxanthin, is there even enough in krill oil to have a therapeutic effect?

Hoffman: Yeah. First of all, astaxanthin is one of those things that has purported benefits, and I think it's on my radar screen amongst beneficial supplements. But it doesn't have as much robust information to support it as some of the more tried and true things like curcumin, and omega-3 fatty acids, and vitamin D, and coenzyme Q10. I think those are real stayer players. And astaxanthin is a little bit in an intermediate stage of credibility.

Gazella: So what do you recommend for your vegetarian and vegan patients when it comes to essential fatty acid supplementation?

Hoffman: Well, they can, I mean there's a couple of ways to go. One is to take flaxseed oil, or to eat a lot of nuts like walnuts and flaxseeds that are rich in omega-3 precursors. But the problem is the human body, and it's variable in its genetic capability. Some people convert very readily, and other people don't convert very well at all.

So the solution then is to get vegan capsules. They're made from algae, and virtually every company that markets fish oils markets products for vegan users. The concentration of EPA and DHA is going to be a little less these. Most of these products skew more towards DHA than EPA because DHA predominates in algae as opposed to fish that you usually deliver more EPA than DHA. But you can go that that route.

I think it's particularly important for vegans to supplement. if you're going to go vegan, you got watch for B12, you got to watch for zinc, you have to watch for your omega-3s, and certainly iron. And then you can frequently be a vegan.

Gazella: Yeah, that makes a lot of sense. Now, we covered a lot today, but I want to make sure that we have covered everything associated with the utilization of essential fatty acids in clinical practice. What further advice can you give our listeners who are either using fish oil in their clinical practice, or want to use it differently, or want to use fish oil more in their clinical practice? What your bottom line advice to them?

Hoffman: Well, I got to say keep your eye on the specific studies that clearly demonstrate the benefits of fish oil. Look at the therapeutic uses of fish oil. I think kind of ignore some of the bold headlines like "The Final Nail in the Coffin of Fish Oil." That's a little overdramatic. That was a JAMA headline last year that gleefully pounced on a study that showed that fish oil didn't make much difference.

And also look to specific conditions. So for example, we're looking at concussions now. A very high dose fish oil in a protocol for concussions has been shown to be efficacious. So, there's 2 aspects. One is the general use. Yeah. Everybody should get some omega-3s. We should certainly eat fish, and perhaps supplement with some omega-3.

But also look at the targeted application of fish oil as a therapeutic agent, not just as a dietary constituent for prevention. But as a molecularly targeted therapeutic agent that deserves a place alongside with our commonly used drugs, medications. It's no coincidence that a companies are now making concentrated fish oil, and selling them as prescription drugs on the pharmaceutical marketplace.

Gazella: Yeah, I think that's great advice. Taking a look at this from a therapeutic targeted perspective in clinical practice I think is really important. I have to say following the research on fish oil, and EPA, and DHA is pretty exciting.

Hoffman: It's a little bit like a watching Djokovic play in the finals at Wimbledon, going back and forth.

Gazella: Exactly. I watched that match. It was incredible.

Hoffman: It's like, well, let's see. Who's on top? Yeah.

Gazella: Yeah. Well, as per usual Dr. Hoffman, this has been great. You've provided us with a lot of information that our listeners can use in their clinical practice. So I want to thank you for joining me. And I also want to, once again, thank our sponsor who is Carlson Labs. So thanks for joining me, Dr. Hoffman.

Hoffman: Thank you very much, Karolyn. Really enjoyed talking to you.

Gazella: Great. Have a wonderful day.

Hoffman: You take care.

Jul 2, 2019

In this interview Stephen Ashmead, MS, MBA, discusses mineral acid chelates and their functions. Listeners will understand the molecular characteristics and physiologic significance of chelated minerals. In addition to discussing mineral supplementation in general, Ashmead delves more deeply into the importance of magnesium and why magnesium chelate is the preferred form.

About the Expert

Stephen Ashmead

Stephen Ashmead, MS, MBA, is a senior fellow in research and development at Balchem Corporation. He has a master of science degree from the University of Utah in Nutrition Science and an MBA from Western Governors University. His area of specialty is in mineral amino acid chelates and their functions.

About the Sponsor

 

Balchem is a supplier of Albion Minerals—highly effective nutritional mineral forms that can be easily absorbed by the human body. These special organic molecules are known as mineral amino acid chelates; they are used in nutraceutical supplements and food fortification to provide complete organic mineral nutrition, giving consumers the greatest chance to absorb minerals for their best biological advantage.

Transcript

Karolyn Gazella: Hello, I'm Karolyn Gazella, the publisher of the Natural Medicine Journal. Today our topic is addressing the challenge of mineral supplementation in clinical practice. My guest is mineral expert, Stephen Ashmead. Before we begin, I'd like to thank the sponsor of this interview, who is Albion Minerals. Stephen, thank you so much for joining me today.

Stephen Ashmead: You're welcome. It's a pleasure to be here.

Gazella: Well, let's begin with the basics. Now why has it become so important to consider a mineral supplementation in clinical practice? Can't patients get everything they need from food alone?

Ashmead: In theory, yeah, you can get everything you need from food alone, but just our lifestyles, particularly here in the United States with our westernized diet, our agricultural practices. We typically don't consume enough of minerals and other micronutrients that we need in our diet, and so supplementation has become a way to deal with that.

Gazella: Right. So what are some of the challenges that clinicians face when it comes to mineral supplementation?

Ashmead: I think there are three main challenges that they face. The first one is just finding good formulations. There is a multitude of formulations that are out there that have micronutrients in it, and just trying to find the formulation that works the best for their patients or for their clients. That's challenge number one. Challenge number two is patient compliance. Some of the supplements, people don't want to take because it's too big. They're trying to swallow something that's too large. It causes gastric upset. They just don't feel it's working, so they just don't take it, or they have to take so many of them that it's difficult to do. I think patient compliance is challenge number two.

Then challenge number three is just impact of other nutrients. A classic example of this is iron bioavailability can be upregulated or downregulated just based upon what you do, what you consume. For example, if you take your iron supplement in the morning with your coffee or tea, you're probably not going to get as much out of it as if you took it with a glass of orange juice. I think those are three main challenges that clinicians face in trying to get minerals and mineral supplementation in with patients and their clients.

Gazella: Okay, so let's dig into these challenges. How do we overcome these challenges?

Ashmead: I think it's a multistep, multifactorial approach. The first one, in terms of finding good formulations, there are a couple of databases that are out there in the industry that can be utilized to screen and see what's out there. One is by the government with Office of Dietary Supplements, although that one probably isn't as much up to date. The other one is a new effort by the Council for Responsible Nutrition, where they are asking the members of their organization to post up their labels, and creating a database of those dietary supplements. I think that helps, trying to find and trying to screen what those are before you can recommend them to your clients. The other one is just trying to find supplements that have a history in their track record of being both efficacious as well as tolerable for your clients.

Then the third one, and probably almost as important, something that the clinicians can do themselves, is just educating their patients or clients on how to take these mineral supplements, how to incorporate them in the diet. Using our previous example, if they're prescribing an iron supplement, for whatever reason, or recommending an iron supplement for whatever reason, given them the education. Don't take this when you're drinking your coffee and your tea. You might look at what they do, and how their patients' lifestyle is, and make their recommendations based on that so they can get the most out of the supplements that they might be taking.

Gazella: Okay, that makes a lot of sense. Now I'd like to talk about... It seems like all of these things revolve around the quality of the product and the efficacy of the product. We have done a lot of articles and such on mineral chelates. I'd like to have us delve a little bit more into mineral chelates. First let's start with the research. Tell us a little bit about the research regarding the safety and efficacy of mineral chelates.

Ashmead: Sure. So there's been a lot of research that has been done both in clinical research as well as animal research, and even in agricultural research. There's been a lot of research done on how effective mineral chelates are. Albion has been doing research since 1965 on mineral chelates, and they have done safety studies. They've done tolerability studies. They've done bioavailability studies. They've done functional studies where bioavailability is a little hard to measure. They're just looking at the functional aspects on it. They've really done a lot of work just showing that these mineral chelates are safe, and an effective, and are very good sources of minerals.

Gazella: Perfect. Before we dig in a little bit further, how do you define a mineral chelate?

Ashmead: That's a good question. So a mineral chelate is a chemical structure. The chelate refers to a chemical structure, and what it is is there's a... I'm going to use a couple terms, and I'll explain what they mean. There is a term called the ligand, or ligand depending upon where you are in the country and what pronunciation you use. This is the entity that bonds to the mineral. When it bonds to the mineral it forms a ring structure. That ring structure is characterized by another term called heterocyclic. What that means is it just means that all the members of the ring, all the atoms in the ring, are not all the same. They're not all a carbon atom, or they're not all an oxygen, which makes sense. If you're trying to bind a mineral with something that's organic, then you're also going to be different than everything else anyway. It just makes sense. This is a chemical structure for a chelate, and that confers upon it some of the enhanced properties in terms of bioavailability, and safety, and tolerability.

Gazella: Right, so that's where I want to go next. What makes these mineral chelates more effective? What are some of the factors that make a nutritionally functional chelate effective?

Ashmead: That's a really good question because there are chelates out there that are very, very good chelators, but they're not really nutritionally functional. Some of our drugs are based upon chelates to be able to take metals out of the body if there's a toxic thing. They're not really designed to be bioavailable or nutritionally functional. They're designed to do something else. For a nutritionally functional chelate, I think there are a few things for consideration. First of all, in definition, is it's got to be a chelate. It's hard to have a nutritionally functional chelate if you really don't have a chelate to begin with.

Second one is it's got to be relatively small in size. What that is, there's some literature out there. Some stay it needs to be less than 800 Daltons. Some say it needs to be less than 1,000 Daltons. I don't know where that exact number is, but what it needs to be is it needs to be small enough so the body doesn't have to digest it before it can actually utilize it. If the body has to digest before it gets utilized, then you lose some of the benefits of it being chelated if you've got it digested before it can be used. I think it also needs to have stability constants that are effective. What do I mean by effective? We want it to be bound up tight enough by the chelate that it helps protect it and still has those properties. At the same time, we don't want it to be bound so tight that the body actually can't utilize the metal once it gets absorbed.

So where that is, it depends upon the ligand and the metal. It varies, but it's a real balancing act, just kind of hit a sweet spot between the two. Then the third thing, I think, is that your ligand, or the binding entity, really needs to be something that the body can use. I know that out in the literature there's a lot of talk about iron-EDTA chelates being utilized as good food fortificants, and EDTA chelates are really good chelators, but our body doesn't use EDTA. On the other side, amino acids, our body would use amino acids. It could utilize them in the energy cycle. It could use them for protein building depending upon the need of the body at that time. So that ligand, that binding entity, can also be used by the body. I think those four things are the things that really make up what a nutritionally functional chelate is.

Gazella: Can you talk a little bit more about the absorption issue? Will a practitioner know that a chelated mineral is better absorbed in the body versus a non-chelated mineral?

Ashmead: Yeah, there's certainly some research out there that would show that that is, but looking at a bottle of a mineral supplement, it's going to be really, really difficult to tell just because our labeling laws don't allow for that sort of information to be on there. There isn't enough information on those bottles to tell whether or not they've really got a chelate in there or not.

Gazella: Interesting.

Ashmead: It's interesting, yeah.

Gazella: Yeah.

Ashmead: Some of the things they need to do is, really, they need to look for a brand that has some trust and reliability built up and looking for indications that that brand in there. For example, with the Albion products, the Albion brand will be on the bottle. Companies such as ours and others who have built a brand are really protective of that brand to make sure, one, it's being used correctly, and two, that the product is actually in there.

Gazella: Right. So Albion makes chelated minerals that are ingredients that are in dietary supplements, correct?

Ashmead: Correct.

Gazella: So when the practitioner looks at the supplement that they're using, it will say that it's an Albion ingredient?

Ashmead: Yes.

Gazella: Okay, I see. So that's one way-

Ashmead: That's one way they can tell.

Gazella: Yeah, because you were talking about the fact that there are true chelates, and there are so-called chelates, and the so-called chelates are not functional. They should be avoided, basically, is what you're saying?

Ashmead: Correct.

Gazella: Okay, perfect. Is there anything else practitioners should look for other than that brand on the label? Anything else that comes to mind, or is that the primary thing to look for?

Ashmead: That's really the primary thing that they would look for because the label is going to tell them how much of the mineral is in there. It might list a source, but it doesn't have to list a source. They might be able to look at the ingredient list and see a source on there, but really looking for that brand name from an ingredient supplier who has built their reputation for an efficacious product, as Albion has done, is really the primary way that they can tell that they're getting a good product.

Gazella: Okay, great. Now before I leave the topic of chelates I have one more question. You mentioned that Albion has been doing research since 1965. Can it be assumed that a lot of the research on chelated minerals actually features the Albion chelated minerals? Is that a fair statement?

Ashmead: I would say that that is a fair statement. There is a lot of information out there. Albion has developed a lot of that information, developed a lot of the patents surrounding the chelated mineral products, not only for humans, but for animals and for plants as well. We have chelates for those entities as well.

Gazella: Okay, perfect. I think that's why looking for that brand is so important, because you don't want to buy a product that's using borrowed science, or hasn't been studied in the scientific literature. I think that's important to our practitioners. I'd like to switch gears. I'd like to talk about magnesium, because magnesium plays such a significant role in the human body. What forms of magnesium are presently on the market for practitioners to choose from?

Ashmead: Oh, goodness. There's a number of forms. Probably one of the most common ones is magnesium oxide. There's magnesium sulfate, magnesium citrate, lactate, magnesium phosphate. Albion provides a di-magnesium malate, a magnesium creatine... Excuse me, a magnesium creatine, and of course we supply amino acid chelates such as the magnesium bisglycinate chelate.

Gazella: So that's why I wanted to ask that question, because what's the preferred form of magnesium, and why do you feel it's the best form to choose? Because there are a lot of different forms, so what's preferred, and why is it best?

Ashmead: That's a loaded question because the other part of that is what is the intent? What are you trying to do with that magnesium? You're just trying to supply magnesium for supplementation? Then the next set of questions that have to be answered is, how is supplying that magnesium? Is it going to be in traditional capsule tablets? Is it going to be as a gummy? Is it going to be in a drink? I think the best magnesium that is selected depends upon some of those factors. For example, traditional capsules, tablets, they have finite volumes.

Depending upon how much that manufacturer wants to put in magnesium, that affects a little bit of what are the sources that they might use when they have to cram so much ingredient within a finite volume. You really can't expand that volume because the capsule shell is what the capsule shell is. It doesn't get any bigger, so it depends. Overall, I'm going to lean towards a magnesium bisglycinate chelate just because I believe that it's the most effective, one of the most tolerable, and certainly has a good record of safety and good record of use. So I'm going to lean towards that, but there are mitigating factors that might dictate something else.

Gazella: Okay, and you've mentioned the different delivery, capsules, tablets. Is the magnesium bisglycinate chelate... Can that be delivered across all of those vehicles, capsule, tablet, liquid, food, whatever?

Ashmead: Yes, and I'm going to qualify that just a little bit. It has certain properties in it, particularly you mentioned food. Sometimes food vehicles, depending upon the food vehicle, because that is a hugely complex area. Just think about the food that you eat each day, and how a mineral will taste in each of those foods is very, very different because they're such complex entities. So it may work in some foods. It may not work in other foods. I'm going to say yes, but I'm going to qualify it as well.

Gazella: Yeah, that sounds good. I think that's perfect. I'd like to talk a little bit about the technology associated with magnesium bisglycinate chelate. Now that technology has led to, according to what I've read, enhanced bioavailability, tolerability, and safety. Tell us more about that technology because it seems like that's pretty significant.

Ashmead: Yes, it is. So to talk a little bit about that technology, let me just back up just a little bit. When you think about your food that you consume every day, there are minerals in there and other micronutrients. For the most part, we tolerate that food extremely well. Now I'm not talking about likes and dislikes because if you want to talk about that, I really don't tolerate liver and onions really well.

Gazella: Me neither.

Ashmead: But in terms of just tolerability in terms of GI distress and things of that nature, for the most part, we tolerate our foods very well, and they have those minerals in there. Why do we tolerate it well from the foods? It's because nature packages those minerals up, typically with proteins. It might be with some nutrients, but their typically packaged up. I mean, it's not in there as salts like are commonly available, that we talked about with oxides, and sulfates, and so on of that nature. What the mineral chelates, bisglycinate chelates, and amino acid chelates do is they try to mimic how nature does it. They give the protection to the minerals to keep them from binding with other foods. They try to keep them from that binding, minimizes the amount of GI irritation. When we do that, we're mimicking a little bit what nature does. I think that's why these amino acid chelates, and in our specific example here the magnesium bisglycinate chelate, that's why it is efficacious, safe, and tolerable.

Gazella: What about the bioavailability issue? Is that correct, that it is more bioavailable?

Ashmead: Typically, yes, they are more bioavailable. Bioavailability is another complex issue that is dependent upon the body's need at the time. It may be dependent upon environmental issues such as what else is in the gut that can decrease bioavailability, and it often can depend upon genetics. If we're missing some of the necessary proteins and other enzymes to be able to handle some of our foods, then that's going to impact it. But comparing apples to apples, everything the same across the board, then yes, it provides for more bioavailability.

Gazella: So also comparing apples to apples, if I'm taking magnesium bisglycinate chelate, do I take the same amount as another form of magnesium? Is that apples to apples, or do I need to take less of the chelate?

Ashmead: That's a really good question. That's an interesting discussion. When you look at our labeling laws, it doesn't differentiate between the form. It's based upon the elemental amount of that micronutrient in there. A lot of consumers and a lot of perhaps clinicians are just looking at that number, which is totally appropriate because it's based upon RDIs that have been established by government entities, and that's totally appropriate. The question I think that's probably a little bit more appropriate is do I want to have or do I want to take a full RDI equivalency, or am I supplementing my diet, and do with less because I know I'm getting some in my diet? I think that's probably a more appropriate question versus trying to match bioavailability because, as I said before, bioavailability is such a complex issue that is very individualized. It's hard to make that general statement for the entire population.

Gazella: Yeah, that makes a lot of sense. Let's stay on the topic of tolerability just for a second. Now you mentioned GI irritation. Are there other symptoms of intolerability when it comes to magnesium, or is that the primary symptom of tolerability?

Ashmead: So magnesium has a well known reputation for causing GI distress, and it's typically manifested as diarrhea or laxation. You could also have gas, kind of a bloating feeling. Those are the principle ones for that. Some people may have an upset stomach, some nausea, with it as well. Again, particularly magnesium, some people are a little bit more sensitive than others. Why? I don't know. It's hard to look at a person and say, "Oh yes, you're magnesium sensitive," and the person sitting next to them, "No, you're not." There's no really way to look at that and tell, but the typical GI distress factors with magnesium are going to be laxation and gas.

Gazella: Yeah, that makes a lot of sense. It's good to know that the chelate form has better tolerability because I know in clinical practice our practitioners are running across that. Our practitioners are also very interested in research. I'd like to have you tell us a little bit more about the research specifically associated with magnesium bisglycinate chelate.

Ashmead: Okay, sure. Yes. Let me just describe some maybe perhaps more recent studies that have been performed on it. There was a study that was presented in 2016 at Experimental Biology meetings, and it was using an in vitro model, so they were growing cell. In this particular case, the cell model being utilized was a Caco-2 cell model, which is a human intestinal epithelial cell. It's very perfect for studying absorption. What they did in this particular study is they created a monolayer of cells. They applied various magnesium sources on what we would consider the luminal side, so the inside of the intestine, and look for magnesium coming through on the basolateral side, or coming through the cell and being exported out. They compared several different magnesium sources. They found that magnesium bisglycinate was significantly greater absorbed through those cells than magnesium oxide and magnesium citrate. So there's one study showing that we've got better absorption.

Another study that was done quite a number of years ago. Excuse me, sorry. This was done by a group out of Chicago. In this particular study, this was a human clinical trial, and they were looking at patients that had undergone ileal resection, so their intestinal system and absorption capabilities already been compromised through surgery. They were looking at whether or not the magnesium bisglycinate would help these patients out who are at risk for developing magnesium deficiency.

This study is interesting because this is one of the few ones on literature where they used isotopes of magnesium, stable isotopes of magnesium, so they could definitively determine that when they drew blood, and looking for magnesium in the blood, that it was definitely coming from the supplement that they gave them. What they found is those with the highest need, or the lowest levels of magnesium, absorb the magnesium bisglycinate much more effective than the inorganic magnesium oxide that they were comparing against. The interesting thing too is as a secondary endpoint that they were looking at in this study was tolerability, and they had very good tolerability from the magnesium bisglycinate as compared to the magnesium oxide. So there's one study.

Another study, and this one's really interesting. I like this study. I have four kids, and my wife has issues with cramping during pregnancy. There was a study that was done looking in pregnant women, and in the pregnant women, they were comparing the amount of leg cramps, particularly later in the pregnancy. They found that with the magnesium bisglycinate, not only did they have a significant reduction in the frequency of the leg cramps, but even when they did have leg cramps, and they asked them how intense those leg cramps were, there was a significant reduction in the intensity of leg cramps. So not only did they get fewer ones, but the ones they got were less intense than compared to those that were not getting the magnesium bisglycinate. Again, with that one there was really good tolerability. In fact, the patients preferred the magnesium bisglycinate over the other magnesium source because it was easier on their GI system.

Then another study just looking at tolerability. There was a study that we conducted where subjects were given a placebo, 300, 450, or 600 milligrams of magnesium. So we're going above the RDI. They were given that on a per day basis, and they were comparing GI and fecal consistency scores going across those doses. What we found there is that there really wasn't a significant difference between gastrointestinal upset of 600 milligrams of magnesium bisglycinate as compared to a placebo. Again, in terms of fecal consistency, there wasn't a decline in fecal consistency either, so we didn't have the laxation effect that you would typically see with magnesium sources. So that's some highlights and some studies.

Gazella: Yeah, I like the fact that the studies address these main issues of bioavailability and tolerability. The leg cramp study is awesome, and it's good that there's in vivo and human clinical trials. I think a lot of times our practitioners are definitely looking at those human trials when it comes to ingredients. So that's an important one as well.

Ashmead: It is. I-

Gazella: Oh, go ahead.

Ashmead: I was just going to mention too that with human clinical trials, particularly with magnesium, it's hard to find good clinical markers of magnesium. The typical gold standard right now is 24 hour urinary collection, which is really difficult to do, particularly in a clinical setting. A lot of times you're going to be looking at the functional mechanisms or functional outcomes such as was done with the pregnant women. Sometimes to get that really nitty gritty absorption data, you have to go outside of the human clinical model into an in vitro model.

Gazella: Okay. Now is there an average dosage? I know that you supply these ingredients to other manufacturers, so they determine how much they want to put in their formulation. Is the quantity of magnesium bisglycinate chelate, is it all over the board, or is there an average?

Ashmead: That's a good question, and it's difficult for me to answer that. I guess there is a little bit all over the board depending upon whether it's in a magnesium dose by itself, if it's with other ingredients, and how much of those other ingredients, what they're trying to do. I will say that from an RDA, RDI standpoint, typically what we're required and what we need is right around 400 milligrams, depending upon the country you're in. It might be a little less, might be a little more, but right around 400 milligrams a day.

Gazella: Perfect.

Ashmead: So looking for a supplement as a supplement, I'd probably recommend base upon that and try not to exceed that if you're supplementing your diet.

Gazella: Yeah, that makes a lot of sense. So as we mentioned, this is an ingredient that is found in products that are sold to healthcare professionals. Where can our listeners find the Albion chelated minerals, including this magnesium bisglycinate chelate that we've been talking about?

Ashmead: That's a good question. There are multiple dietary supplement products out there that incorporate them in. There are a couple of ways that I would recommend looking for them, trying to find them. First one is through our website at www.albionminerals.com/human-nutrition, and we have there a tab called Products and a program called Gold Medallion. In that area you will find some manufacturers that incorporate and use our minerals. Another way that you can do it that's probably as easy and maybe more appropriate to our lifestyle is go to amazon.com, and you type in Albion chelated minerals in your search term. It will bring up a variety of mineral products that incorporate Albion mineral products, including magnesium bisglycinate.

Gazella: Okay, that sounds good. I want our listeners to know that we are going to provide a link to albionminerals.com, so you can just click over and find the professional grade manufacturers who are incorporating these chelated minerals into their products. This has been a lot of great information. I would once again, of course, like to thank today's sponsor, Albion Minerals. And thank you, Stephen, for joining me and providing us with such great information today.

Ashmead: You're welcome. It's been my pleasure. It really has been.

Gazella: Great. Have a great day.

Ashmead: Okay, thank you. You, too.

Jun 4, 2019

In this podcast interview, we speak with neuroscientist and physician Leanna J. Standish, ND, PhD, LAc, FABNO, about her naturopathic oncology research. Standish has been involved in original research at Bastyr University since 1987, where she continues to teach and serve patients. We discuss the research she's currently working on—the Canadian US Integrative Oncology Study (CUSIOS)—and its focus on understanding how integrative oncology care affects outcomes for people with certain advanced cancers. In addition, we discuss the use of psychedelic drugs like psilocybin in cancer care—especially for people who have a history of trauma.

About the Expert

Leanna Standish

Leanna J. Standish, ND, PhD, LAc, FABNO, is a neuroscientist and physician living in Seattle. She has faculty appointments in the University of Washington School of Medicine Radiology Department, the University of Washington School of Public Health, and Bastyr University. She is working toward obtaining approvals to conduct ayahuasca clinical studies in the United States. She uses functional magnetic brain imaging to study brain-to-brain communication and the ‘entangled minds’ hypothesis. As a physician she specializes in naturopathic oncology, with special interest in the treatment of stage 4 cancer.

Standish earned her PhD in neuroscience/biopsychology from the University of Massachusetts in 1978, her ND from Bastyr University in 1991, an MS in acupuncture and Oriental medicine from Bastyr University in 1994, and became board-certified in naturopathic oncology in 2006.

Transcript

Tina Kaczor: Hello, I'm Tina Kaczor, Editor-in-Chief here at the Natural Medicine Journal. I'm talking today with Dr Leanna Standish about ongoing original research in naturopathic oncology. Dr Standish is a neuroscientist and naturopathic physician with a master's in acupuncture and Oriental medicine and board certification in naturopathic oncology. She's been involved in original research at Bastyr University since 1987, where she continues to teach and serve patients. Dr. Standish, thank you so much for joining me. I want to go-

Leanna Standish: Hi, can I just say hi to everybody and especially you, Dr Kazcor, and just express how delighted I am to talk to all of you.

Kaczor: Yes, and so yeah, it's very exciting to have you one on one to get to know a little bit of what's going on in the front lines of research specifically. What prompted this was your update at the recent oncology conference. The Oncology Association of Naturopathic Physicians had their annual conference in February where you spoke. I'd like you to kind of start at the beginning. What was really compelling is some of the research on both non-small and small cell lung cancer as well as breast cancer studies. So, if you could kind of update us about a little bit of what ... update us on what's going on with your research in those areas.

Standish: Yes. Well, since 2009 working at Bastyr University with Paul Anderson, we started collecting data on survival outcomes in our advanced cancer patients and have a big enough database that we can start summarizing survival outcomes, which is I think of great interest to both patients and their physicians. What we found, our first study was in breast cancer, stage 4 breast cancer, that our median overall survival in our patients, they were 54 consecutive women with breast cancer. The median overall survival is 47 months. When I first got those data, I was very upset because it means that half of my patients were dead at 47 months. But then I thought, well, how does that compare to other studies that were being published at the same time that we were doing our work? What we found is that the best study that we could find in terms of median overall survival in stage four breast cancer was an Abraxane trial that happened in the early part of the 2000s. Just getting some tea here, hold on.

That study showed a median overall survival of 36 months. So the conclusion to me was yeah, this is an uncontrolled study. The kinds of patients that we see are the kind of people that are very proactive. They may be survivors just in their very being, but in any sense that you can think about this, that those are pretty good results in advanced cancer. Then we did a similar study in advanced non-small cell lung cancer, and that was with 18 consecutive patients, stage 3 and 4, and the median overall survival there was 43 months. Then we surveyed the literature and did a systematic, I should say systematized review to find that the median overall survival for all the chemotherapy drug trials and even the new immunotherapies that were coming out in just the last say 5 years, the median overall survival of all those studies when averaged together was only 13.3 months. It's kind of astounding to me how poor results in advanced cancer continue to be.

That's the summary. Just one more thing I want to say is that this is why we started the Canadian and US study of integrative oncology outcomes. This is 12 clinics all over Canada and the United States that are doing what we call advanced naturopathic oncology, and we're tracking survival and treatment data from 400 people. That probably will be published, it will probably be at 2 years before that study is published.

Kaczor: Are there any intermediate points where you've looked at that data? Do we have any idea of what's gong on with that study?

Standish: Which study do you mean? CUSIOS?

Kaczor: Yeah, that last one you just mentioned, which I think you called-

Standish: Yeah, we called CUSIOS, so Canadian US Integrative Oncology Study. What we know is that we've been able to recruit. We're about 85% done recruiting the 400 patients. We have a good diversity of the patients that we recruited for, which was stage 4 breast cancer, stage 4 colorectal cancer, and stage 3 and 4 pancreatic cancer, and stage 3 and 4 ovarian cancer. We wanted to narrow our study to those 4 conditions. We're recruiting. We're able to collect death data, and the most exciting and problematic thing is what do you compare our naturopathic oncology survival data to? Here I've just talked about a breast cancer study, 53 women, their median overall survival is 47, but what does that mean? Compared to what?

Right now there is a tremendous amount of intellectual work going on at Bastyr University and also at Canadian College to figure out what the best statistical method is, and fortunately we've been able to collaborate with some very sophisticated big data scientist with statistical ability that have access to this marvelous database in Canada. We will be able to use the SEER database too, and what we're doing is trying to figure out how to match naturopathic oncology cancer patients to patients that are just like them in these registries and then watch them over time with the hard endpoint of date of death.

We're also of course very interested in quality of life. We're also interested of course in what therapies each patient got, not only what they were recommended, but also what therapies they received. For example we're tracking Dr Gurdev Parmar's clinic where they're doing locoregional hypothermia. Another clinic is using mistletoe therapy intensively. Another clinic, such as ours at the Ames Institute in Seattle, we're focusing now on the utilization of what's being called metabolic therapy, which is the idea of the cliché is starving cancer using FDA off label drugs that is all the rage these days, very interesting approach. We're using intravenous vitamin C along with chemotherapy. We've sort of abandoned the idea that as a monotherapy it does much. We're starting to explore the safe use of quercetin as a botanical medicine that really needs to be given intravenously to be bioavailable.

But I think the most important thing we're doing is taking seriously the idea that trauma, childhood trauma in particular, is a risk factor for development of cancer. And I'm referring of course to the famous ACEs study, Adverse Childhood Events study, that linked in a dose-dependent way the number of adverse childhood events like neglect, foster child, abandonment by parents, alcoholism, violence, etc., war, that the number of these events is correlated with the risk of cancer later in life. And so we at Ames Institute are saying well okay, if that is an important causal feature of why we get cancer, then let's get to that. We're using now psychedelic assisted psychotherapy to be able to do the deep work that is required to help people heal from posttraumatic stress disorder, which not only can come from childhood, but just the very experience of having cancer, being diagnosed with cancer, going through cancer treatment produces posttraumatic stress disorder.

What we're hoping is all these therapies combined are going to improve the median overall survival of our patients. That's what we're doing here in my clinic.

Kaczor: Tell me a little bit more about this. Is this low-dose psychedelics? I think we're talking about it here in Oregon from a state level. I think there's going to be actually some kind of referendum vote to see if we can legalize such things here, so I'm curious about this.

Standish: Yes. The initiative that will be happening in Oregon in 2020 is about permitting psychotherapists, certified licensed and fully trained psychotherapists, to utilize psilocybin in the treatment of posttraumatic stress disorder and also in end-of-life care. That's very exciting. But in the meantime, right now there are no legal psychedelic drugs available for physicians with 1 exception, and that is ketamine. Ketamine is a drug that comes from anesthesia. It's been very well studied as both an anesthetic, but in low doses, it produces a state of consciousness that some people would describe as psychedelic with a dissolution of the sense of self, a connection with higher realities, a connection with one's ancestry, an ability to do deep work in the presence of a physician and a nurse who are overseeing the treatment. What we've found is a 3-hour ketamine session that's led and facilitated in an excellent way can help enormously relieving the depression and the anxiety that is part of all of our lives, but especially if you've been diagnosed with cancer, and especially if you have the kind of trauma in your childhood that is a risk factor for cancer.

Kaczor: Is there already clinical data on the use of this?

Standish: On what? I'm sorry, clinical data on what?

Kaczor: On ketamine or psychedelics being used in this fashion.

Standish: No. What there is, this is translational science, and the reason I love naturopathic oncology is that we are people who take science and translate it into other domains of medicine. We know without a doubt now that the state of consciousness, emotional states and brain states associated with those emotional states, have direct effect on the autonomic nervous system, which has direct effects through a cascade of physiology and biochemistry that affects the behavior of cells in the tumor bed. And there's tons of work on that. Is there work on the use of psychedelics for healing cancer? No, but it will be coming, and I hope that we can show some leadership in that area here in Seattle because I think it's an extremely important area.

The reason psychedelics might be important too is that most of them have very strong serotonergic effects. What we've found in immunology is that the kinds of cells that are involved in the immunological response to cancer, T-cells in particular, are loaded with serotonin receptors. It is not a far stretch to imagine that one of our future immunotherapies will be psychedelics, and there's now kind of a rage around doing low dose psychedelics, all of which are considered by the drug enforcement agency to be controlled substances, but there's huge interest in this field. Most of us have probably seen Michael Pollan's new book How to Change Your Mind.

Kaczor: Yes, yeah. It's a fascinating read. It definitely had more data behind the use of it for emotional states than I had ever realized before reading that book. So let me ask you this because our listeners are often clinicians themselves. Sometimes they are the lay public. In any case, if people want to look further to see if they are appropriate to enter a study or they have patients that might be appropriate, because what I hear you saying is some of these tough-to-treat cancers, whether it's stage 4 disease or lung cancer in stages 3 and 4, they're tough to treat, and we all want to help our patients as best we can. So where would someone go to find you or one of the other 14 clinics involved in CUSIOS study? We'll put a link here with the podcast, but otherwise, where do we find you?

Standish: Oh, okay. Yes, please to go the Bastyr University website, and look at the research, and then look for CUSIOS [https://bastyr.edu/research/studies/canadianus-integrative-oncology-study-cusios-advanced-integrative-oncology]. Everything is updated there. It's also listed on the national NIH clinical trials .gov site, and all the clinics are listed there [https://clinicaltrials.gov/ct2/show/NCT02494037].

Kaczor: That's great, and I think what we have is more of a full whole-systems research, outcomes-based research is what I hear you saying. All of these are taking into account large plants, not single agents, which is why we often have weak data when we use single agents in our medicine. Kudos for mastering the complexity of figuring out how to get this data going and inform us.

Standish: Yeah, I think that one of our fundamental hypotheses is that natural medicines, those that are known and those that are not known yet, have a potential when they're used in the correct sequence and at the right time and in the right patient who has the right genetics and the right epigenetics at the time that you see them, that our therapies have a chance of really extending high quality life and making cancer into what we hoped for AIDS in the old days as a chronic manageable condition. I think that that day is coming, and we're certainly not there yet. That's for sure.

Kaczor: Yeah, yeah. I'm excited because I think that we can track the data much better than we have been able to, so that's certainly helps our cause as well. I thank you for carving out some time in your day and speaking with us today and updating us on what's going on. It's all very exciting, and thank you for all of your ongoing work.

Standish: Okay, thank you, Tina. Thanks, everybody. See you soon.

Jun 4, 2019

This podcast interview features integrative health expert Russell Jaffe, MD, PhD, CCN, who shares his philosophy about addressing men's health issues in clinical practice. Jaffe discusses hormonal balance, prostate health, gastrointestinal health, cardiovascular health, and inflammation.

About the Expert

Russell M. Jaffe, MD, PhD, is CEO and Chairman of PERQUE Integrative Health (PIH). He is considered one of the pioneers of integrative and regenerative medicine. Since inventing the world’s first single step amplified (ELISA) procedure in 1984, a process for measuring and monitoring all delayed allergies, Jaffe has continually sought new ways to help speed the transition from our current healthcare system’s symptom reactive model to a more functionally integrated, effective, and compassionate system. PIH is the outcome of years of Dr Jaffe’s scientific research. It brings to market 3 decades of rethinking safer, more effective, novel, and proprietary dietary supplements, supplement delivery systems, diagnostic testing, and validation studies.

About the Sponsor

Perque Integrative Health

PERQUE Integrative Health (PIH) is dedicated to speeding the transition from sickness care to healthful caring. Delivering novel, personalized health solutions, PIH gives physicians and their patients the tools needed to achieve sustained optimal wellness. Combining the best in functional, evidence-based testing with premium professional supplements and healthful lifestyle guides, PIH solutions deliver successful outcomes in even the toughest cases. If you are interested in delving more deeply into this and other integrative health topics, we invite you to join the PIH Academy.

Transcript

Karolyn Gazella: Hello, I'm Karolyn Gazella, the publisher of the Natural Medicine Journal. Thank you for joining me today. Our topic is men's health, and my guest is integrative health expert, Dr Russell Jaffe. Before we begin, I'd like to thank the sponsor of this topic, who is Perque Integrative Health. Dr Jaffe, thank you so much for joining me.

Russell Jaffe, MD, PhD, CCN: Thanks for the invitation.

Gazella: Well, before we dig into the specific health issues that men face, you believe in a philosophy first approach. I'm sorry, physiology first approach. What do you mean by-

Jaffe: The philosophy is physiology.

Gazella: Exactly.

Jaffe: So, that was appropriate. Yeah-

Gazella: So, what do you mean by that?

Jaffe: Right. It's a high level, brief, 2 words, physiology first. What we mean is, physiology before pharmacology. We mean physiology first because it seeks an upstream assessment of the causes of risk or symptoms, in contrast to most conventional care today, even holistic or not, that remains rooted in downstream symptom management. Physiology first uses global evidence to reduce risks and prevent people from falling into the river of disease. Physiology first uses nature's nutrients in supplements, with enhanced uptake and chaperone delivery, for safer, more effective, essential replenishments, items we must take in since our body doesn't make them.

Physiology first urges organic or biodynamic or locally grown sources of nutrient-dense whole foods, as minimally contaminated as possible. Physiology first focuses on underlying causes. For example, too little of essential needs being met, which are eating, drinking, thinking, doing—those are the 4 headline categories—rather than working back from symptom-reactive case management.

And finally, physiology first uses predictive biomarkers interpreted to their best outcome goal values. Now, this is a paradigm shift for many colleagues but we now can impersonalize predicted, proactive, primary prevention practices, save individuals probably a million a year just by applying physiology first.

Gazella: Yeah. Well, that's exciting so I'm glad that we went over that. Now in general, what should be on the radar of clinicians when it comes to addressing the special health needs of their male patients?

Jaffe: Yes, and here again, now that we've kind of gotten the hundred thousand–foot level, we start and recommend colleagues start with self assessment. This includes transit time, urine pH after rest, hydration, and a sea-cleans as overall global self assessments, very inexpensive. The individual does much of it themselves, brings it to the expert who interprets it so that we get a snapshot of the metabolic or metabolon/microbiome, the digestion and metabolism. You interpret that to best outcome goal values. You use that to inform and inspire and motivate people to put it in effort for the 6 to 7 weeks that it takes to change a habit of daily living and you can add years to life, years of quality life and life to years.

In people with chronic symptoms, well. Take a careful family history although family history is highly relevant if you have the same behavior and environmental factors. If you change your behavior, your habits, your environment, then your family history to a very large extent disappears into the midst of history. If there have been prior treatments and treatment failures, it's important to assess that. We use the predictive biomarkers to help people celebrate when they are at their best outcome goal value and take action when their risks increase.

Now, men and women at all ages need activity, at least 45 minutes a day of walking or equivalent. Sitting is the new smoking. Weight-bearing exercise or cardio exercise 2 or 3 days a week and knowing about it or preaching about it is one thing. It's when you actually do it. I'm glad to tell you that I had just enough glimpse of the consequences of not doing that I do what I'm recommending. Now we want to teach men to prepare for sleep, achieve restorative sleep, using physiology before pharmacology, using salt and soda baths, Epsom salts and baking soda, plus or minus aroma oil, essential oil. The baking soda alkalinizes and relaxes muscles in the pores of the skin, and the Epsom salts, which is magnesium sulfate, allows the magnesium to come in and that's often very helpful. We recommend that teaching people, particularly men who have sleep issues, about abdominal breathing and active meditation and green dichromatic light, along with nature's sources of serotonin and melatonin, which is tryptophan.

We ask about changes in urine stream flow and quality after urination. Is there any dribbling? How many times do they get up at night to urinate? And we make lifestyle suggestions tailored to the individual at their phase of life. We want to be proactive with prostate support nutrients, such as micellized soft gel that contains all of active saw palmetto, [inaudible 00:06:03], lycopene. Free lycopene, not just some ketchup. Hygeium, with 14 or 15% beta sitosterols. Urtica dioica, also known as stinging nettles. Zinc, in the picolinate form. And selenomethionine, selenium in the selenomethionine, healthier, safer form. And all of this micellized in pure pumpkin seed oil to enhance uptake in retention, to improve function. And we think people can be pleasantly surprised at how effective and synergistic the above prostate health support is, available in a single, easy-to-swallow soft gel.

Ask about adult beverages. If they consume more than 5 a week, provide comprehensive liver support and recommend a glass of water above the four quarts or four liters a day that humans need to avoid marginal dehydration—1 or 2 or 3 percent dehydrated is a big stress on every organ in your body. So this is, again, at a headline level, how our comprehensive approach actually works.

Gazella: Perfect. Now I'd like to kind of narrow our conversation and I want to stay on the prostate because you mentioned the prostate. So, what are the roles that testosterone plays when it comes to prostate health and men's health in general?

Jaffe: Right. Both men and women need testosterone. They need a balance of free and bound testosterone. They need good and not bad testosterone. Now, what does that mean? Well, you can measure in saliva or in plasma. The free and the bound, free and total testosterone. You can measure the dihydrotestosterone. You don't want much of that, maybe zero. You can measure oxidized testosterone. You want zero of that. And you want to enhance the good T, the good testosterone and reduce the bad T based on testing results because testosterone is needed for brain and muscle and organ and joint and bowel renewal and many other functions beyond just being a male hormone. You want to enhance healthy testosterone production through healthy microbiome and metabolon functions, especially the family of the central antioxidants. Vitamins, minerals, and cofactors that along with good hydration optimize your healthy testosterone, which is one of the vitality factors in the body and minimize the bad testosterone that causes everything from hair loss to loss of erections.

Gazella: Okay, perfect. So before we leave the prostate, remind us what the significance is of the PSA test.

Jaffe: That's a very important question and I think we're finally, after half a century in laboratory medicine and I've been following the issue all of that time. The PSA test is a measure of prostate repair. So, the PSA goes up if you have prostatitis. For example, if you just sit in your car too long and hold your urine in too long. And the PSA goes up in some but not all prostate cancers, and you can fractionate the PSA, free and bound, and that usually but not always helps distinguish the prostatitis from the cancer risk. If you had concern about the prostate and about PSA levels and have a biopsy, after a single biopsy—often there are multiple biopsies—the future PSA has no interpretable value that I know of except for population, but we're talking about 1 man at a time. And so many review articles that I have seen in the last few years say do other tests of prostate health and don't even do the PSA because if you don't need the test, you wouldn't do the test. If it's a question, it's a gray zone, that's exactly what the test is not very sensitive or specific.

Gazella: What about enlarged prostate?

Jaffe: The first thing I would do and have recommended for many years for enlarged prostate is to take that combination of prostate vitality factors and we have had men whose prostate was double or triple than usual size come back to that of a 40-year-old by following for about 6 months a program that includes the supplements that I recommended just a few minutes ago, along with eating foods that the man can digest, assimilate, and eliminate without immune burden, and that means the lymphocyte response assay test that measures T and B cell function and that then says eat this and don't eat that, take the supplement and don't take that, follow this mental and physical plan because in the 80,000 cases that we put in our database, we've evolved a very personalized approach to, say, prostate size.

Gazella: Okay, perfect. So, let's move on. What does it mean when a man wakes up with an erection or doesn't have an erection? Is that significant?

Jaffe: Oh, absolutely. The headline is that every healthy man should wake up in the morning with an erection. In essence, it's the quality control check of the distinctive male. Too often and very commonly, when a man does not wake up with an erection, that's a sign that they have pregnenolone steal, that they have high stress cortisol levels and low DHEA, which is the antistress hormone, usually with low free healthy testosterone, often with a sluggish thyroid and an exhausted adrenal gland, due to lack of adequate intake of the essential antioxidants, minerals, cofactors that are necessary. In addition to prostate health nutrients, I would recommend checking the thyroid, TSH, 3T3, 3T4. That can be done on a blood spot or in many different ways. But you must, by my recommendation, get the 3T3, 3T4, TSH all at the same time, and the healthy range for TSH is .5 to 2.5, not above. The usual range has too many unwell people. (Usual lab range.)

You want to check adrenal stress hormones, cortisol and DHEA at four times during one day. And at the same time, in the same saliva or plasma specimen, you can measure male and female hormones and their sources, their precursors to see if the body has learned a distress response that steals the healthy progesterone and pregnenolone and produces too much distress hormone cortisol and too little healthy male and female hormones. They come from the same source. You want to get both and in balance.

Now in regard to male sexual performance, there are natural solutions to erectile dysfunction. The following vitamins, minerals, and amino acids work as a team to improve the quality and duration of erections

  • B complex. One phrase is 'B complex is for boners'. Keep the urine sunshine yellow and feel the difference comprehensive B complex means.
  • C, it is ascorbate vitamin C, always fully buffered, fully reduced and we recommend based on the C cleanse, taking that amount is associated with healthier and the more robust erections.
  • Vitamin D is really a neuro hormone and it does a lot of things, including improving cell function and providing cell energy to sustain the generally sixfold increase in blood retention during an erection.
  • Then magnesium choline citrate. Magnesium is essential for a lot of different things, including a healthy sexual function, and choline citrate at the same time, say 220 mg of magnesium solves and a teaspoon of choline citrate. That enhances the uptake dramatically. It enhances the retention because it is an alkalinizing, rather than an acidifying source. Most magnesium solves and magnesium products have very low bioavailability and are in the acid form, which makes the magnesium run out almost as soon as it comes in.
  • And then last is L-citrulline and L-arginine, and these are 2 amino acids. They both enhance nitric oxide production inside cells, and when you take about a gram of L-citrulline and 500 mg of L-arginine 30 minutes before adult activities, most men notice the difference, especially men over 40. Foods that are rich in these amino acids include nuts, seeds, chickpeas, and other legumes, also known as garbanzos, and meats. Making an avocado and chickpea hummus with some mustard seeds or black and white sesame seeds added plus or minus some toasted pine nuts with fresh ground black peppers and your favored high-quality salt, that can blend into a nutritious, delicious, amorous and traditional food.

Gazella: That's great and it sounds yummy as well.

Jaffe: It is. It should be nutritious and delicious.

Gazella: Exactly, exactly. Well, let's now move onto the gastrointestinal tract. What should practitioners focus here when it comes to their male patients?

Jaffe: Well, in the 21st century it is a pretty fair assumption that the person sitting across a professional has mild digestion dysbiosis, some degree of atrophy known as enteropathy, a long transit time. Transit time should be 12 to 18 hours. We recommend doing that with charcoal. We have an online instruction if folks are interested because you want to assess what's called the microbiome, which is the digestive tract in its fullness, or the GNS, known as the gut nervous system, which is in constant conversation and communion with the reigning central nervous system.

And so we recommend focusing on a full complement of personalized native antioxidant, minerals, and cofactors in their safer higher uptake forms based on the assessments and the predictive biomarker tests that we recommend. We want to pay attention to hydration because even a little bit 1, 2, 3% dehydrated puts a stress on every part of the body. We want to have prebiotics. That is unprocessed fiber from diet or supplements, 40 to 100 grams a day. That's what Dennis Burkitt taught me and the most knowledgeable nutritionists that I know recommend that much fiber a day. Probiotics, 40 to 100 billion healthy by a mixed bacteria, bugs. Then synbiotics, which is really recycled glutamine to energize and repair the lining of the digestive tract. Then you want to eat what you can digest, assimilate, and eliminate without immune burden.

So, you've done some functional immunology testing like LRA, lymphocyte response assay. Take in no empty calories. You are sweet enough as you are. If you feed parasites and pathogens, fungi and yeast, they will grow. Improve the digestion, the microbiome and metabolon, the innate biological detoxification competencies and enhance your digestion by eating what you can digest, assimilate, and eliminate without activating your immune responses. We teach people to stop feeding the pathogens and they disappear as digestion improves, repairs improve, resilience is restored, and habits of daily living are improved.

Then you want to look at the secretory IgA if you're concerned about the interface between digestion and the body. It's called SIgA, secretory IgA. You can measure that in saliva. There should be protected mucins so that if partially digestive materials get near the wall of the body, they don't become foreign invaders if you have healthy mucins and healthy secretory IgA. And there are other elected protected digestive functions that healthy people have that are lost when people lack the essential nutrients or the essential minerals when their cellular metabolism becomes acidic, when their body is reaching out, calling out, actually crying out for repair enhancement essentials, things you have to take in that you can't make in the body.

So, we wanna taper or possibly discontinue medications that impair digestion. We want to use prebiotics, probiotics, and synbiotics, especially in people who have had antibiotics and other digestive-interfering medicines. We want to check transit time, should be 12 to 18 hours. When I have roast beets as a main part of my dinner, I expect to see red in the commode in the morning. But I can tell you after all these years when I see that red, my first thought is never, "Oh, I had beets last night" so that's why we use charcoal. Now, avoid fat-binding medications and supplements that reduce essential fat-soluble vitamin uptake. That's vitamins A, D, E and K. And you need bile from the liver to do that and for that you need phosphatidylcholine-rich foods and/or supplements, and we happen to micellize all of our soft gels with this PC, with this—not politically correct—phosphatidylcholine.

Now, many men have atrophy of their intestinal lining because of stress and toxin exposure and it's the 21st century, and maybe less than perfect eating, breathing, and drinking. So, getting the essential needed nutrients restored may mean intensive supplementation for a few months, followed by maintenance supplementation for a long, healthy life, and I personally plan to be dancing at 120 and I would like you to join me.

Gazella: That sounds perfect. So, you mentioned tests to assess the microbiome and you also mentioned secretory IgA. Are there other tests that you recommend in terms of assessing the microbiome?

Jaffe: Right. So, the transit time we talked about, it's one of the self-assessments, 1 of the 4. Then this SIgA, the secretory IgA, in saliva or serum, with the comprehensive lymphocyte response assay, if there's any indication that the person has shifted from elected protected mode into survival mode, which means all the protective and repair functions are down regulated, that's called chronic illness to happen, or hormone tests that include cortisol and DHEA at 4 different time points, male and female hormones can be measured in their precursors on the same saliva specimen. You can use plasma if you wish.

Adrenal and thyroid adaptogenic supplementation is recommended either based on clinical history or these test results. By all means include some way of determining how much ascorbate that person needs because ascorbate is the maternal antioxidant that sacrifices yourself that all others may be presode.

And then the magnesium with enhanced uptake choline citrate. The choline helps build acetylcholine, an important neurotransmitter and neurochemical. It also helps build the choline-rich biosalts that are more soluble and help get the thicker bile out of the gallbladder and into the digestive tract, where that helps emulsify fat to be taken up into the body. And then based on the urine pH, we would adjust how many doses of the magnesium choline citrate you take. Do a regular hydration assessment and when in doubt, what I recommend is that you have a carafe of water in front of you and a glass. If the glass is full you drink it and if it's empty you fill it, and you just keep doing that. And personally my goal is to go to the bathroom at least every couple of hours and then I cut down the amount of liquid I take in after 7 or 8 PM so then I'm not overhydrated when I go to bed. But underhydration is a much more common and unappreciated problem.

Monitor the breadth of our little chemicals, and this can give very interesting insights that are both diagnosis-specific of mild digestion dysbiosis enteropathies and so forth. But in addition that information often makes it very clear to the individual that this is true for them and not in general.

And the last is a zinc taste test. Developed by Harry Henken, you drop a zinc solution on the tongue. The people who need zinc can't taste it. The people who say the zinc tastes strong have enough. And it's a pretty good one-dollar type assessment of a critical mineral and specifically for men, men need lots of minerals but especially zinc. You lose about 25 mg per every ejaculation.

Gazella: Yeah, that's good. That makes a lot of sense. So, now it's time to discuss inflammation. Is inflammation really repair deficit and how does that change clinical practice? Remind us why that's such a big deal.

Jaffe: Right. Well, we started with the physiology-first concept. Now I'm a doubly board-certified pathologist. I know the 5 aspects of inflammation. I know it's taught as a fire to be fought, something that has to be suppressed with anti-inflammatories. And now I pause and say: Anything that starts with 'anti' is using pharmacology before physiology. Inflammation is repair deficit. What my pathology colleagues see as inflammation is the cumulative lack of repair when your immune defense and repair system is doing too much defensive work because of foreign invaders from the breath or the skin or the gut, and if you enhance the innate immune system's ability to repair, your infrastructure is reborn, your bones get rebuilt, your joints are renewed, your mood is better. Your ability to get restorative sleep and meaningful relationships all are improved when you recognize that repair deficit is an opportunity.

You use the hsCRP test as a predictive and validated biomarker. It's also an all-cause mortality, morbidity marker. The healthy goal value—and this is, again, where we have the reframing. I don't even look at the lab range because that includes too many unwell people. You know the goal value for this test, hsCRP, and it's less than 0.5. Ignore statistical lab ranges unless you're treating statistics, and knowing the best outcome goal value we add ascorbate based on the [inaudible 26:350, magnesium choline citrate based on the urine pH, and other similar kinds of monitoring so that the person gets more safely the forms that are more effective because of their enhanced uptake and retention and therefore the deficits get corrected more quickly.

I mentioned hydration. I keep mentioning it only because every part of your body is healthier and more resilient and more able to repair when you take in healthy water, 4 liters a day or more of either mineral-rich, I happen to have well water but some mineral-rich water that's not contaminated and/or sparkling water. I happen to like Pellegrino but there's also Gerolsteiner and Apollinaris and actually every culture has a mineral-rich water known as a therapeutic or beneficial or health-promoting mineral water. So, you want to drink hard water, so water softeners are not recommended, at least not total home water softeners. If you want to soften the water in the pipes, I don't care, but your blood vessels are not pipes and now I care about the quality of the water that you take in.

Gazella: Perfect. So, I love your perspective about looking at repair deficit as an opportunity. Are there other ways to kind of take advantage of that opportunity to reduce oxidative stress and reign in inflammation?

Jaffe: Yes. And again, in a physiology-first point-of-view in regard to, say, blood fats. Cholesterol and triglycerides and blood fats and [inaudible 00:28:14]. If you keep the oxidation of those fats, if you keep oxidized cholesterol to zero, if you keep oxidized LDL to zero, because you're taking enough antioxidants and especially ascorbate. Now, the fat-related cardiovascular risks just went away. What remains is understanding your hemoglobin A1C, your hsCRP, your homocysteine, your LRA (lymphocyte response assay immune responses), your vitamin D, your first morning urine pH, your omega-3 index, and [inaudible 00:28:51]. Those are the eight predictive biomarker tests and we have online for folks to peruse and/or download or watch on YouTube discussions of why these eight predictive biomarkers cover all of that genetics, which is 92% of your lifetime quality of life and health. And yes, you can blame mom and dad for the other 8%, and yes transgenerational influences on RNA are a big scientific field but not yet ready to measure clinically. Live in the moment, do one thing at a time, practice gratitude and random acts of kindness, breathe abdominally for at least 5 minutes a day, and make enhance repair your practice and banish inflammation.

Gazella: That's perfect. It's a very integrative approach that includes lifestyle as well. I'd like to end with heart disease because heart disease remains the leading cause of death for men in the United States. So, what do you recommend when it comes to protecting heart health for male patients?

Jaffe: Yes, and as I think you know part of my primary research when I was in government service at the National Institutes of Health Clinical Center was collaborating with the Heart Institute on animal models of heart disease. Now, Paul Dudley White in the 1930s was a famous cardiologist. He helped invent the electrocardiogram. He taught when I was a young student that in the 1930s at Mass General Hospital in Boston, Massachusetts if they had 1 heart attack a year, they published the case. And yet 40 years after that, cardiovascular disease was the major killer of Western civilization. That's not a genetic change. It's too quick for genetics. A lot has to do with smoking and sitting, sedentary lifestyle, processing of foods, and all that goes with that.

Jaffe: So, cardiovascular disease. If your heart attacks you, if you have a clog in a blood vessel, an artery, if you have a stroke, you didn't pay attention to the upstream warnings that you would know about if you did the self-assessment, if you did the predictive biomarker tests because these change. Your risk goes up dramatically decades before catastrophe. And if you change your consumption and attitude, if you change the environmental toxin exposures and by the way 80% of the toxins that people have in their body are of recent exposure, and you can dramatically reduce that by certain simple lifestyle changes. Include 1 to 300 mg a day of micellized CoQ10 in 100% rice-brand oil, and no glycose. No antifreeze in your CoQ10. Keep the 8 predictive biomarkers at their best outcome goal value and when they are, when those 8 tests are at their best outcome goal value, you have a 99% chance of living 10+ years, even if you're 100 at that point, and my main teacher Buntey was 110 when he passed and as I mentioned before I plan to be dancing at 120 by following this lifestyle, and I urge anyone who is willing and interested to join me.

Gazella: That's perfect. Well, Dr Jaffe, we covered a lot today. Before I let you go, I'm just wondering if there's any final thoughts or anything else that you'd like to share with our listeners today.

Jaffe: Yes. In essence, the physiology-first, the epigenetics is 92% of your life quality has to do with consumption, which you eat and drink and how you think and what you do. Now whatever season of your life is as a man, that may be different. When you're young and immortal, that's one thing. As soon as you're beyond young and immortal, be prudent. Cardiovascular disease starts in teenage years. Cancer risks goes up dramatically when your innate anti-cancer mechanism is turned down because you're eating foods that are causing too much defense burden in your immune defense and repair system. So, just follow through on this physiology-first approach looking at your individual needs for personalized health promotion and put pay to chronic ill health.

Gazella: Perfect. Well, once again I'd like to thank today's sponsor, Perque Integrative Health, and Dr Jaffe I'd like to thank you for taking the time and sharing so much information with us today.

Jaffe: Well, thanks for inviting me and for making it such an enjoyable time. I hope the listeners will take away much that will be of value, and it's my pleasure.

Gazella: Well, thank you and I hope you have a great day.

Jaffe: You the same, Karolyn. Always a pleasure.

Gazella: Yes, it is. Bye-bye.

Jun 3, 2019

This article is part of the 2018 NMJ Oncology Special Issue. Download the full issue.

During this interview, Christopher Shade, PhD, discusses targeted nutrients to support restorative sleep in patients who are struggling with sleep issues. Shade focuses on the neurotransmitter gamma-aminobutyric acid (GABA), key botanicals, cannabidiol (CBD), and tetrahydrocannabinol (THC).

About the Expert

Christopher Shade, PhD

Christopher Shade, PhD, founder and CEO of Quicksilver Scientific, continues to be the driving force of development and innovation. Shade’s vast depth and breadth of knowledge, passion for healing, and intuitive understanding of chemistry and biology are reflected in Quicksilver Scientific’s well-designed detoxification protocols, unique supplement delivery systems, and patented mercury speciation test. Shade earned his PhD from the University of Illinois Urbana-Champaign and his undergraduate degree in Environmental Chemistry is from Lehigh University.

Shade is a recognized expert on mercury and liposomal delivery systems. He has lectured and trained doctors in the United States and internationally on the subject of mercury, heavy metals, and the human detoxification system. Shade's current focus is on the development of cutting-edge, lipid-based delivery systems for nutraceuticals, such as liposomes and micro-emulsion systems, to address the growing need of high-quality, affordable detoxification solutions.

About the Sponsor

Quicksilver

Quicksilver Scientific is a leading manufacturer of advanced nutritional systems with a focus on detoxification. We specialize in superior liposomal delivery systems and heavy metal testing to support optimal health. Our advanced liposomal supplements are highly absorbable, and support the body in the elimination of ubiquitous toxins, enabling you to achieve your genetic potential. At Quicksilver Scientific, we are passionate about health and well-being, and are committed to improving the lives of everyone we touch.

Learn more about Quicksilver Scientific LipoCalm.

 

 
May 21, 2019

To treat patients with sleep disturbances, it’s important to understand how neurotransmitters affect sleep and wakefulness. In this interview, NMJ’s Editor-in-Chief Tina Kaczor sat down with neurotransmitter expert and practicing naturopathic physician Robyn Kutka, ND, to learn more about how GABA, melatonin, histamine, acetylcholine, dopamine, serotonin and lesser-known neurotransmitters are involved in the circadian rhythm.

Kutka shared a wealth of clinically relevant knowledge about neurotransmitters, hormones, stress, and sleep that any practitioner who sees patients with sleep issues can put into practice.

 

About the Expert

Robyn Kutka, ND

Robyn Kutka, ND, is an expert in naturopathic medicine, hormones and menopause. She uses this knowledge, coupled with her laboratory medicine experience and the latest in scientific research, to develop customized treatment plans designed to address the cause of health concerns. Kutka received her medical education from the National University of Natural Medicine, where she trained as a general practitioner and tailored her studies to receive more focused training in the field of women’s health, completing a 3-year women’s health clinical internship. She has spent more than a decade educating women on the topics of sexual health and romance enhancement in their relationships and continues to advance her knowledge in the field, studying with the International Society for the Study of Women’s Sexual Health and the American Academy of Anti-Aging Medicine.

In addition to practicing at Inspire Your Health in Portland, Oregon, Kutka is the director of clinical services and lead staff physician at Labrix Clinical Services. She serves as an educational resource for providers across the world on the topic of hormone balancing and bioidentical hormones and has shared her knowledge by speaking for organizations including the American Academy of Anti-Aging Medicine, the Association for the Advancement of Restorative Medicine and the Integrative Healthcare Symposium. 

Transcript

Tina Kaczor, ND, FABNO: Hello, I'm Tina Kaczor, editor-in-chief here at the Natural Medicine Journal. I'm talking today about sleep and how various neurotransmitters are involved in the circadian pattern of wakefulness and sleep, and I'm talking with Doctor Robyn Kutka. Doctor Kutka is a practicing naturopathic physician in Portland, Oregon, with a focus on women's health, and in particular balancing hormones and neurotransmitters. Doctor Kutka, thank you so much for joining me.

Robyn Kutka, ND: Absolutely, thank you for having me. I'm excited for our topic today.

Kaczor: Me too, and I want to start with the most basic of questions, because we are diurnal beings, we are not nocturnal beings. My first question is basically what drives us to sleep at night?

Kutka: Great question. I think we think about our circadian rhythm, our circadian Process C, but it's actually a little bit more than that. When it comes to sleep, we have a couple of processes that work together to balance that out and promote our sleep patterns. So we have our Process C, which is our circadian process, that is mostly endogenous. So we think about our body temperature, our melatonin production, but it's adapted to our local environment and our external time cues, so things like daylight, timing of sleep, our timing of meals, work schedule, social interaction, so it can change based on those things.

But then the Process C is balanced with something called Process S, and think a lot of people aren't aware of that. That's our sleep homeostasis, our sleep pressure so to speak. It's this drive for sleep that builds as we wake and accumulates until we start our sleep, at which point it starts to decrease. When we have an imbalance in those 2 systems, that's where we start to see some sleep disruptions.

Kaczor: So when you say it's our drive for sleep, do you mean that's more of our habits and our lifestyle?

Kutka: No, it's more of an internal process regulated by things like some of our neurotransmitters. It's more of a biochemical process. I think a great example of disruption that maybe will help to explain it is when people drink alcohol. We drink alcohol and people think it's helping them sleep. What happens is it disrupts some of the chemical process of this Process S and actually shortens it at the end, and so we end up waking earlier. A lot of people will fall asleep nicely but then they wake up sooner than they want to and it's because we've disrupted our normal process with that.

Kaczor: Oh, okay. So yeah, let's dive right into that. What's going on with the ... What neurotransmitters, I should start there, are involved with sleep? I think the one thing we all know about is melatonin and perhaps serotonin by association, but what are the neurotransmitters involved in sleeping and wakefulness?

Kutka: Oh, definitely, there's several involved in sleeping and wakefulness and some I think we're really aware of and others are newer, they're things we don't typically think about. Just like all of our processes, it's a balance between our neurotransmitters that will help promote sleep. And so we have sleep promoters which are more of your inhibitory neurotransmitters, things like GABA and melatonin. GABA's probably your largest sleep promoter, and those are common to us. We know those, but then there's a couple others like adenosine and galanin that we probably aren't used to talking about.

When we think about wakefulness promoters that's more of our excitatory neurotransmitters, so histamine, acetylcholine, dopamine, serotonin like you mentioned. Serotonin's a little tricky. I think it can really be both a sleep promoter and wakefulness promoter, but then norepinephrine, epinephrine, and then one called orexin or hypocretin is another.

Kaczor: Okay, yeah, we'll definitely come back to the serotonin because that's definitely one that I can see how it can go both ways given what it looks like in the pathway and just feedback from patients from over the years. Let's talk about histamine some more, histamine as a neurotransmitter, because the reason I started here is because I think there's another kind of common knowledge out there, which is Benadryl puts you to sleep and Benadryl's an antihistamine, and so it's kind of nice to have that to hang our hats on, like we know an antihistamine puts us to sleep then histamine must keep us awake. So what's going on there?

Kutka: Yeah, I think you're right in that a lot of people are turning to the over the counter medications, most of which have the antihistamine in there and it's spot on. Histamine is probably our strongest contributor to arousal or staying awake. So using an antihistamine and really blocking that neurotransmitter can help promote sleepiness. But beyond that histamine, also plays a limited role in our muscle tone and control while we're sleeping as well. A lot of our major pharmacological treatments will actually work on histamine to promote sleep, not all but quite a few of them.

Kaczor: Okay, so yeah, let's circle back. Well I was going ask you this. Antihistamine diets are popular. So now they have someone who knows neurotransmitters well on the horn, I want to ask a question and that is, these antihistamine diets, are they helpful for people who have sleep issues, or are they linked at all to the histamine in the brain, or are we just talking more systemic?

Kutka: Great question. There aren't a lot of great placebo-controlled, double-blind studies out there using an antihistamine diet but people who have higher histamine levels, higher stress levels, things like that, there actually could be some breach of integrity to the blood-brain barrier. And so I do think it's worth trying, at least initially trying some form of antihistamine diet, and I'll get back to that. It's not necessarily because we're consuming so much histamine or we're making so much histamine. Maybe it's because we're not breaking our histamine down as well, you know, break down and testing first and seeing what neurotransmitters are dysregulated, but in somebody that for whatever reason has those higher levels of histamine, of course decreasing the amount of histamine that might be coming in per se could be beneficial.

That's more of beneficial I think too for people who are more sensitive to histamine from their foods and that's not going to be everybody. You know, there's a lot of, I don't want to use the hype but I'm going to, a lot of hype around the histamine food plans. I definitely have patients come in and say, "I'm sure I have a histamine intolerance." Well do we really have a histamine intolerance or maybe we have a variant in that enzyme in breaking it down, or maybe we have a nutrient deficiency so that enzyme isn't working at full capacity or as well as it could per se.

If we try a histamine or low histamine diet for people and it's working I wouldn't necessarily look at that as a histamine intolerance. It might be more diagnostic of that's the reason that's they're not sleeping but is it because, like I mentioned, not necessarily a histamine intolerance but maybe they need more of the nutrients to break it down to help support that enzyme.

Kaczor: Yeah, and I do want to get back around to testing but before we go there I just want to hit a couple more of these neurotransmitters that are wakefulness neurotransmitters like that serotonin that you mentioned, which I find interesting because a lot of people take a lot of supplements and drugs to increase their serotonin levels and those same folks can sometimes have sleep issues. How do we kind of tease this apart to know when serotonin should be supported and maybe shouldn't be pushed so heavily with substrates or cofactors?

Kutka: Well I do think that probably goes back to testing but also knowing where any implications that somebody might be lower in serotonin, I'm going to think about that in my postmenopausal women that might be a little lower in estrogen. That's one of estrogen's main roles is to promote serotonin. So if I know that, and I don't want to wait for testing maybe I'm just going to try it and try to get her some relief, you know, try promoting serotonin at that point and see if we can get some relief in the short term and then think about testing later so we don't have to wait for something.

But you're right, I think serotonin's a tricky one where too little and we're not going to get great sleep and too much and that could actually promote wakefulness and decrease our REM sleep. If we think about it, a lot of people will try 5-HTP and when we're giving 5-HTP, that serotonin precursor, we're almost always giving it to people before bed. So clinically I think well, if we give it to them and it helps that's a pretty good indication that they need that serotonin support and maybe melatonin support because, down the road serotonin becomes melatonin, but if we give it to them and it causes them to have more sleep disruptions or irritability on waking or something along those lines I think we've missed the mark there and it probably isn't serotonin that's the issue.

Kaczor: Yeah, so testing might flush that out? Is that what I kind of heard you start with? If they have a high serotonin and low melatonin then obviously there's a conversion issue?

Kutka: Yeah, that would be, I would think of that as a conversion issue or somebody with lower serotonin levels on their testing. Then we'd want to support that. Somebody with higher serotonin levels we probably wouldn't want to support that and that wouldn't really get us where we wanted to go.

Kaczor: Okay, and let me ask you this, is there a role for any of the other neurotransmitters to control the serotonin at all? Is there any play with the others that is involved with controlling the serotonin output into the synapse? Do you know what I'm saying?

Kutka: Oh, I do, yeah, absolutely. I think GABA in general will help to decrease the activity of our wakefulness promoters, so histamine, serotonin, norepinephrine. GABA's going to come in and kind of combat that, whether it's not necessarily decreasing serotonin per se but blocking serotonin messaging in different parts of the brain.

Kaczor: Okay.

Kutka: I think that's ... yeah, GABA's really huge across the board.

Kaczor: Yeah, yeah, GABA's kind of that mellow you out neurotransmitter, right? That's what we all associate with being calm and the Valium effect.

Kutka: Exactly.

Kaczor: All right, so let's move on to norepinephrine. There was something that you mentioned in a lecture that you did, and it was that ... You mentioned norepinephrine levels increase most when focused cognitive effort is interrupted. I kept repeating that line in my brain going, "Boy, focused cognitive effort is interrupted." So anytime you're ... I kind of wondered, I went straight to all of our interruptions on a given day, you know, our phone goes off or notifications come up on the computer. It's just such a very busy world that we live in now as far as long we have to concentrate on only one thing. Is that what you mean by that? Is that relevant even?

Kutka: Yeah, no, I think it is. We think of serotonin being elevated as we sustain our cognitive concentration but norepinephrine is going to raise as we interrupt it. So it's kind of ... I call it shiny goldfish syndrome. If you guys have watched Finding Nemo and Dory's all over the place. That's what we're thinking about. And so another way to look at that is our ADHD meds or ADD meds. They're working on norepinephrine and raising and sustaining those levels so that people can concentrate. So we're watching something, we get interrupted and move on to the next thing and we get this increase in norepinephrine. It's really, I think, in a way our body trying to maintain that focused concentration that's lacking there. And so disruption in that system makes it difficult and we see that sustained with medication but I think there's other ways we could do it certainly, but yes, I think you got out of it what I intended there.

Kaczor: Okay, good, good. So basically maybe turning off our phones while we eat or whatever, when we're just trying to concentrate on one thing maybe we should intentionally almost like horses, put blinders on, just kind of focus and not-

Kutka: Oh, absolutely. I think we can extract this really ... I was thinking about it in preparation for today and really we can even extrapolate that to this ... We see a huge lack of mindfulness in our culture and this idea of we're so busy. We go from one thing, to the next thing, to the next thing, and as we're doing that it's keeping us in more of the sympathetic versus our parasympathetic state, and this is really just another way of looking at it doing the same thing. We move from one thing to another, we're increasing those norepinephrine levels. We're in this fight or flight mode all the time, and then that's causing a disruption in some of our neurotransmitters, and we see that extrapolated into our patient base on all those things we do to help them with whether it's deep breathing or 10 minutes a day on their own, or any of the herbs or things that we might be doing. What we're really doing is trying to promote more time spent in that parasympathetic state so we can lower some of these excitatory neurotransmitters and things. So it goes beyond sleep for sure.

Kaczor: Mm-hmm, so what should dopamine be doing in the daytime and in the nighttime? Is there a rhythm for the dopamine, ideal rhythm for it like there is some of the others?

Kutka: Well it's another wakefulness promoter. It doesn't necessarily decrease toward bedtime or anything like you see in some of the others that we talked about, but when we have disturbances in dopamine you'll see some disturbances in sleep. So I tend to think about commonly we see disturbances in REM sleep in our Parkinson's patients or increased sleep disturbances in people with schizophrenia where dopamine is associated. It can definitely help control sleep and wake and as we wake up it actually down regulates melatonin. So I suppose it does have its own little rhythm there. It'll down regulate melatonin just before waking allowing us to wake up and get out of that sleep state.

Kaczor: Okay, so the other one you mentioned that I wasn't familiar with was orexin. What is orexin?

Kutka: It's actually, it's not newer per se but it's newer to us in medicine. It's only been really studied since the late '90s. It's another neuromodulator/neurotransmitter that helps coordinate sleep. When we don't have enough of it, it actually is associated more with narcolepsy. That's what they've studied it in quite a bit of so it's again a wakefulness promoter and it's influenced by a lot of our main energy factors, things like our monoamines, so serotonin, dopamine, norepinephrine, nutrients, blood sugars, leptin, ghrelin. So we extrapolate that out and see that it also coordinates our regulation of energy balance, and sleep, and wakefulness. Our newer medications, not so popular yet, actually work on this system. There's 2 different receptors for orexin. The newer pharmaceuticals, suvorexant, that's actually what's working on this. So it's not necessarily a hypnotic like some of the other medications that we use.

Kaczor: Okay, okay, yeah, and I saw those hypnotics just got an FDA warning for sleepwalking recently, last week I believe.

Kutka: Mm-hmm (affirmative).

Kaczor: Yeah, so yeah, if we can work around them that would be ideal, right, for folks who have sleepwalking issues.

Kutka: Yeah, absolutely.

Kaczor: All right, so we've been talking about all of those neurotransmitters and you had mentioned in your lecture glutamate and how it is involved as an excitatory neurotransmitter but I think it's also involved in GABA production as well. Can you give us a little review about glutamate and how we can either assess and/or balance that?

Kutka: Yeah, absolutely. So glutamate, like our other neurotransmitters, can be looked at in neurotransmitter testing. Not all can but glutamate can be. Glutamate actually becomes GABA when we're thinking about our cycles there. So when glutamate is too high and it's not converting properly to GABA we can actually see some of those insomnia symptoms or even difficulty falling asleep. And so having proper conversion so we have adequate GABA levels to promote sleep is important there.

Glutamate might raise because people are ... I have seen it raised because people are supplementing it or maybe it's in their protein powders and they're not converting it properly, but some people are more sensitive to our glutamic acids in foods, not all but some people are and that could also be what's raising it for people. If they have an issue, again, converting it or don't have the right cofactors to do that then we're going to see imbalances there that are going to promote more of our insomnia versus sleep patterns.

Kaczor: Okay. Let me ask you this because I know you've worked for laboratories in the past and you've looked at a lot of these various neurotransmitter tests results. Is it your opinion that cofactors in larger quantities push these pathways such that so if glutamate was high and GABA was presumed to be low, can we push these pathways just by giving the cofactors or is that not-

Kutka: No, I think that's a fair assessment. In a perfect world where all enzymes work properly without any variance or maybe we don't have any SNPs in them—it's a great environment with low inflammation, low pollution, low toxicity, as long as people aren't malnourished if we work on the cofactors I think we can get a lot of good benefit and good outcomes there but I would always think about making sure cofactors are repleted and optimal before I give any of the amino acid precursors or building blocks otherwise we won't be able to simulate them. And so I think you're right in what you're kind of saying here is that cofactors being the priority. One great example of that is vitamin D. We need vitamin D to make the vast majority of our neurotransmitters, especially serotonin and dopamine. Yeah, here in the Portland area we live in a part of the country where almost everybody's vitamin D is insufficient unless they're supplementing it. So it's a great example of making sure that we replete that before we start giving people building blocks.

Kaczor: Yeah, yeah, and it's an interesting difference between say repletion and mega dosing where you're giving intentionally large doses of P-5-P, Pyridoxal-5-Phosphate, or some other cofactor to make the neurotransmitters. I think that everyone should be aware that's there's a very big difference between those 2, repletion and basically nutraceutical dosing of large amounts of any kind of vitamin.

Kutka: Yeah, absolutely. I think that's a great comment there. The other thing I think about is iron deficiency. You know, we're working with both women and men can be iron insufficient but women in particular if they're menstruating quite often are insufficient in iron. Depending on what labs we're looking at reference ranges aren't going to show that. They're going to look "normal" when really they're considered iron deficient in that we work on repleting. Obviously wouldn't mega dose any iron or anything but repleting that before we give the amino acid precursors as well.

Kaczor: Yeah, that's a great point. Yeah, iron deficiency is pretty common in women's health, especially for cycling women. And it's so important for so many of these enzymes, isn't it, for these enzymes that create the neurotransmitters in the brain?

Kutka: Yeah, absolutely, for that initial step of conversion toward serotonin, toward dopamine. We need iron, we need vitamin D, we need B6, and actually biopterin, tetra biopterin, so we think about it as a methylation step as well.

Kaczor: Yeah, yeah, that's interesting because of course we think of fatigue as a low iron symptom but maybe sleep disturbance could be counted as a symptom as well or just any neurotransmitter disruption really.

Kutka: Yeah, absolutely.

Kaczor: Okay, so I have a question because I have a lot of women in my practice, especially if they're perimenopausal, postmenopausal, they tell me they have this wake in the night, say 1:00, 2:00, 3:00, and they've got a busy brain. One patient called it her monkey mind, turns on inexplicably. She starts worrying about stuff she knows she doesn't need to worry about but it kicks in and she can't turn it off and she can't get back to sleep of course because after that I'm guessing her cortisol kicks in and wakes her up, right?

Kutka: Mm-hmm (affirmative).

Kaczor: What's going on with these women who especially peri- and postmenopausally seem to have this middle of the night wakefulness and the brain just kind of kicks on and won't kick off?

Kutka: Yeah, great question. This is one of my favorite things to work with in practice because 97% of the time it's so easy to fix and get some really good symptom relief here. As we become perimenopausal we start having more anovulatory cycles and of course postmenopausally we're not cycling at all. So we have anovulatory cycles. We're not expecting that egg so then we don't have the tissue hanging around that would express a lot of progesterone.

Progesterone actually works at the GABA receptors, progesterone and its metabolite allopregnanolone. We have 2 different GABA receptors. So progesterone works at one and its metabolite works at the other. So as we become menopausal and we have much lower levels of progesterone overall, those GABA receptors aren't being stimulated as much as they have in the past. We talked about how important GABA is in that sleep promotion, probably the most important neurotransmitter we have there, and it's so calming. It's what things like most of our sleep medications and anxiolytics actually work at GABA receptors. And so for women in that period of life, their body's own anxiolytic has really decreased substantially.

When that happens they're going to have that what you called "monkey mind." They can't turn their mind off and they're thinking about all these things they know they don't need to think about. So as we promote, whether we're going to promote progesterone, or allopregnanolone, or utilize potentially some GABA. That's a tricky one because it's too large to cross the blood brain barrier but whatever we do, if we can promote working at those receptors they can get some excellent relief from their sleep symptoms.

Kaczor: So progesterone or allopregnanolone is usually how you would support those women through that process?

Kutka: Yeah, absolutely. Typically, when we swallow progesterone, we're straying from neurotransmitters a little bit, but when we swallow progesterone the vast majority of it, probably over 90%, is actually metabolized to allopregnanolone. So a tip for these women is to maybe utilize some oral progesterone or sublingual progesterone which will give them a little bit of progesterone and whatever is absorbed through the blood vessels under the tongue but what they swallow in their saliva will work like an oral progesterone. And so they'll get both progesterone and allopregnanolone at the GABA receptors. It can be so beneficial for sleep.

Kaczor: That's a great point because obviously a topical cream of progesterone is just not going to have that same effect.

Kutka: No, it's not, not for most women. Every now and then someone will get enough from that but that sublingual oral really helps, and what's really neat about that too is that it doesn't work as a hypnotic where a lot of the medications that work at those receptors work as hypnotics and they rob us from our deep restorative sleep that we need for muscle building, and hormone regulation, and things. Progesterone doesn't do that, and in studies with about 300 mg of oral progesterone they saw this return to sleep normalcy and the restorative sleep for the women who were suffering from it but it didn't negatively affect women who weren't suffering from insomnia when they took it. So it didn't make them excessively groggy or anything like that. There were no negative side effects with it.

Kaczor: And in interpreting the tests when you see them and women are taking that 300 mg of progesterone say orally, do you see any changes in downstream steroid synthesis? Do you see any more testosterone or anymore estrogens formed in those women?

Kutka: No, and I think 300 mg is probably higher than I would do. It's just what was in the study. But progesterone doesn't become estrogen, or testosterone, or anything like that. So we don't see any either increase in those. It also won't inhibit production of those. The pathways are so different, especially in our postmenopausal population, where they're making those hormones. So no negative or positive effects on other hormones really.

Kaczor: Okay, okay, and so we've mentioned the word testing several times during our talk today but I just ... There's a couple different types of patients, right? There's the ones who don't want to test, and there's people who want to test everything you can possibly test because they really want to see the objective information, and then there's the people in between where as a clinician you're like, "Well, let me just test a couple things and make sure I'm right," or you take a couple shots and you were wrong, and then you test. There's so many different ways of doing this. What I want to know is two-fold, one, what's the basic least amount of testing that's going to get you the most bang for your buck, because a lot of people are paying out of pocket, and then what would be on the flip side those folks who are just all in and they want to go no-holds-barred, they're just like, "Give me the whole package." What can you test and I'm talking saliva, urine, blood? What are the 2 routes to go as far as testing?

Kutka: Mm-hmm (affirmative), oh, great question. I think basic wise there's some serum, blood tests that we want to do really on the vast majority of people who are going to come in with some of these symptoms. At that point we're looking at nothing new but maybe looking at it with a new lens so to speak. So we're looking at somebody's ferritin, their vitamin D levels, we're looking at their CBC, and maybe B12, and folate to really get an idea of how they're using those really important cofactors here. Of course with sleep disturbances I'm thinking about potential thyroid imbalances too, so I would look at those in serum for people and that would be really my absolute minimum. Starting there, maybe doing some stress management techniques and repleting any nutrient deficiencies that we find, and optimizing I should say. I'm sure you and most of the listeners realize that our reference ranges aren't necessarily set to optimal for many things, and so we want to optimize those, not just make them look okay. Then they can better utilize and assimilate what else is going on in their body and whatever else we give them.

But then beyond that, we can look at neurotransmitters in urine, almost all of them. Acetylcholine we don't have a great assay for, some of those newer ones like orexin or adenosine we're not really monitoring that but our main ones that we know that promote sleep and wakefulness can be utilized in an easy spot urine test. It's super simple and the studies that we have on that correlated well to central spinal fluid. You know, yes, we're looking at full body levels there but it's still a reflection of the imbalances in the body and that is correlated well from the literature that we do have at this point correlating that.

And then, of course, from there if we wanted to get an idea on how we're breaking it down there's another test that will look at the metabolites of neurotransmitters. I don't use it a ton but for somebody who wanted to do absolutely everything, you know, we're looking at organic acid testing, and neurotransmitters, and all of their metabolites. But I would also think about hormones in these people as well, particularly our cortisol levels and finding any dysregulations in the HPA axis, so the brain telling the adrenals to work. Those imbalances with cortisol levels will absolutely lead to sleep disturbances and not just having elevated cortisol levels at night but even people with flat line or lower cortisol levels will actually be the ones that typically will report more nighttime wakenings than others.

But then we can look at sex hormone imbalances in our salivary testing as well and get a great look at all of the neuroendocrine influencers that can be resulting in sleep disturbances. That's really the imbalances there that we're seeing that's causing that, not necessarily one thing over the other but an imbalance of those sleep promoters and wakefulness promoters.

Kaczor: So would it be fair to say that if someone was testing hormones they're going a little bit more upstream because the hormones are having such a profound effect on neurotransmitters, so if they had to pick one or the other? Is that accurate?

Kutka: Yeah, I think that is pretty accurate but particularly in I think about it more in women in that period of postmenopausal group or even younger women who are having menstrual cycle disruptions because it's that estrogen promotes serotonin, it promotes dopamine; progesterone promotes GABA. And so our really big players are promoted by our main sex hormones. Yeah, I think that's a fair statement there for sure.

Kaczor: Okay, great. Well we didn't get in the HP axis so now we have something to talk about next time we have an interview. And of course this was great. I really appreciate your time and your expertise. Neurotransmitters can be a pretty confusing topic for a lot of folks so thank you for all the clinically relevant information.

Kutka: Yeah, absolutely. Thanks so much for having me. I hope that it helps with some patients' interactions in the future.

Kaczor: I'm sure it will and next time maybe we'll talk about the HPA axis, and sleep and wakefulness, and until then, take care.

Kutka: Thank you, you too.

May 1, 2019

Using content to connect with potential patients and grow a medical practice has become increasingly popular. Most practice owners are using some form of content to promote their business including a website, blogs, podcasts, social media posts, and/or email campaigns. In this podcast, the ethical ramifications of content marketing are explored with naturopathic physician and medical writer, Sarah Cook, ND.

Download the Guide

3 Ethical Pitfalls of Content Marketing

About the Expert

Sarah Cook, ND, is a medical writer and a copywriter for the integrative medical community. She holds a naturopathic doctorate degree from Southwest College of Naturopathic Medicine, a certificate in biomedical writing, a professional diploma in digital marketing, and she is a StoryBrand certified guide. Sarah writes website copy, email campaigns, e-books, and other marketing materials—helping clinicians and small business owners create authentic marketing messages to reach more of the people who need them most. Connect with Sarah at www.ndpen.com

Transcript

Karolyn Gazella: Hello, I'm Karolyn Gazella, the publisher of the Natural Medicine Journal. Using content as a way to connect with potential patients and grow your practice is an increasingly popular trend. Also called content marketing, most practice owners are using some form of content to promote their business. It may be a website, blog, podcast, social media posts, email campaigns. While it's true that content marketing can be extremely effective in growing your business, have you ever thought about what the ethical ramifications might be?

Today I'll be talking with Dr. Sarah Cook, who is a naturopathic doctor and seasoned medical writer. Dr. Cook has worked with us at the Natural Medicine Journal on many writing projects over the years. She also helps doctors with content creation and copywriting through her company, ND Pen. Dr. Cook is here to talk about the ethical pitfalls of content marketing. Thank you so much for joining me, Dr. Cook.

Sarah Cook: Thank you, Karolyn. I'm excited to be here.

Gazella: Well, before we dive into these ethical pitfalls, could you briefly tell us why you think this is such an important topic for clinicians to think about?

Cook: Absolutely. So, like you said, most clinicians are doing something with content. They're putting out content for their business, and most of them aren't really thinking about, "Well, how does this relate to ethics?" at all. And even if they thought about some of these things, they might not know where to go for information or really what precautions they should be taking. And I guess you asked why is it important, and I think it's really because it's just really too bad if they're well meaning clinicians, they're coming from a sincere place of wanting to put good information out to help people, and they make mistakes and just because they're not aware, and so then they end up with unexpected consequences. And so that's really what we want to avoid really just by creating awareness about it.

Gazella: Yeah, it's such a good point because I do agree; I think the clinicians are coming at it from the correct perspective. Now you mentioned unexpected consequences. What do you mean by unexpected consequences?

Cook: So, I mean, I can give a couple of examples of some things that I've seen happen. So for example, there was a doctor who I worked with to help him create his content for a while, and before I started working with him, he had been producing a blog, and one of his blogs, again, he just made a mistake. He found an image online that he thought went well with his blog and he posted that image along with that blog post, completely innocently, not trying to steal somebody else's content and not realizing that this image had a copyright and he was not supposed to use it. And ended up he got a letter in the mail for copyright infringement, and the thing is that the fines for copyright infringement, they're in the hundreds or even thousands of dollars, and so this is not a small thing.

So, one unexpected consequence certainly could be financial. And maybe even worse, I think the other thing to think about is your reputation. Really your reputation is on the line when you're putting content out for your business. And so I can share another example of where I recently saw this play out on social media, and essentially what happened was there was ... I try to stay out of the weeds on these things. I don't get involved, and so I don't have all the details on this, but essentially it was some sort of wellness practitioner, I think a nutritionist of some sort, was creating a lot of social posts and blogging about a concept that actually another better known physician who had written a book about this topic had really already coined these ideas and like I said, written a book about this specific concept, and this other practitioner essentially was promoting the same ideas using the same terminology and not giving credit to that original doctor who had come up with the ideas and had written the book about it.

And what happened, what I saw kind of play out on social media, was that people noticed and really her reputation was slammed for that. And I don't know, maybe ... We don't know. We can give her the benefit of the doubt. We don't know if she went intentionally stealing the ideas or if she just thought that she was putting helpful information out, but the mistake that she made was that she didn't give credit to the original person who came up with those ideas. So, I think that is really maybe even more important than the financial consequences is your reputation.

Gazella: Oh, I would agree. I think that's such a good point. I mean, your whole business model moving forward stands on your reputation, whether or not you get new patients, patient referrals, et cetera, so I would agree. I think that's critical, and I can see that the stakes are high. So what is your direct experience with the ethics of content marketing?

Cook: Yeah, so I mean, I can gratefully say that I haven't really personally suffered these consequences of making ethical mistakes. It doesn't mean I haven't made minor infringements. I'm sure I have, but I haven't been caught. But I've really just been forced to learn some of these concepts over the years of writing and creating content for the integrative medical community just really from being in the trenches and needing to.

So for example, you know very well, Karolyn, when we write anything for a dietary supplement company, we need to be extremely careful about the words that we use so that we don't make any claims that that supplement treats or prevents disease, right? And so that is one thing where writing for a dietary supplement company, they usually have their own lawyers, and they make sure that you're being compliant with your language, but even when I've worked with individual doctors where we might be writing a blog and they have a product that they really want people to know about, but it's a specific dietary supplement, and so now we're in the realm of where we have to be very careful about the words we use. And we can get more into this, but you can't talk about that supplement treating disease. You have to talk about it supporting the structure and the function of the body.

And so for one way, if there's clinicians listening to this and they're thinking, "Well, I'm blogging about this product," one thing I have done with doctors is like if you have any question, go to the company of that product and say, "Look, I'm writing this blog about this product. Is it okay how I'm wording this and what I'm saying?" I think it's always better to ask than to not exactly know if it's okay what you're doing.

So, working with supplement companies, working with doctors is certainly where I have just been in the trenches and having to figure this out as I go. I think the other area is when it comes to email marketing, so collecting people's email addresses, building an email list is huge now as part of content marketing, and the regulations just within the last year, there were sweeping changes in the regulations that actually change what you can ethically do with a person's email address. And so as those changes in regulations rolled out in this last year, any of my clients who I've been helping with their email list, we've had to figure out how to become compliant to these new regulations. So again, a lot of these things are not stuff you can necessarily just Google and find out. A lot of it, for me, has been learning as I go because I have to, and so that's really why I wanted to talk about this subject and make sure everyone else is informed.

Gazella: Yeah, it's such a good point, especially about emails, and it's interesting, I know we're going to talk about unsubstantiated claims, but I started out in the natural health industry in the early 1990s. It was like 1992. I became the marketing director of a very large supplement company, and within a couple of months after getting on the job, the company got into significant trouble with the FDA. Dozens of products had to be taken off the market. We had to change labels and literature, and I have to tell you, Dr. Cook, it was baptism by fire. I had to learn very quickly about structure/function claims, disease claims and how to write about products to keep the company safe. So, yeah, I think that that's such important topics. Now, I want to talk about-

Cook: Yeah, and I really believe, like you said, you then were like all of a sudden you have to learn structure/function. Well, it's like I also think we can learn from each other's mistakes, and so you and I have worked with structure/function a lot, so if we can share some pearls so that other people don't have to go through what we've been through.

Gazella: I know. It's so true, and I do like your advice about contacting the manufacturer because a clinician doesn't have the legal resources, but the larger manufacturers, they have a team of legal people that review content and make sure that the content is safe to publish, so I really like that piece of advice a lot.

Cook: And in my experience, they are happy to review an article if you're writing about their product because it helps them.

Gazella: Yeah, absolutely. And yeah, it's different when you're talking about a product specifically versus if you're talking generically about a nutrient or herb.

Cook: Yes. Yes, absolutely.

Gazella: You have to be a lot more careful. Yeah, lot, lot more careful when you're talking about a product specifically.

So, let's get to the ethical pitfalls of content marketing. What are some of the common pitfalls that you've seen?

Cook: So, I was thinking I would just highlight three so we keep this manageable here, so certainly copyright infringement would be one thing to talk about. Secondly, unsupported claims, which I can get into a bit more what I mean by that, but not being able to support what you say with evidence. And then the third thing, misuse of personal information, and that really comes into play when we're collecting people's email addresses and what we're allowed to do with that personal information. So I think those three things are probably a good place to start.

Gazella: Yeah. I would agree, those are perfect. So let's talk a little bit about that first pitfall. What advice do you have for clinicians to help them avoid copyright infringement?

Cook: Yeah, so honestly, this one probably is the easiest pitfall to avoid if you just have a little bit of awareness. But copyright applies to any content that somebody else has created, so it applies to words, images, videos, and it even applies to ideas, and so the example I gave of where the practitioner had been using these ideas from a book and not giving credit to the author of that book, she wasn't directly copying any paragraphs from that book, but she was copying the ideas, and it's something that's called derivative work. We use that word derivative where it's basically like she's deriving that content, and that is a form of copyright infringement that people might not realize. You don't have to directly copy the words to be infringing on their copyright.

So, derivative work is just something to keep in mind where ... I mean, the point is give credit to the person who came up with that idea in the first place. That's all you need to do. And that really goes across the board for any kind of a word. Any words, written content that you are using from somebody else, it's really just a matter of giving them credit, so either linking over to their website or linking over to wherever it was first published in a different article. Giving credit.

Images. Images are something to think about. Again, I gave that example of where the doctor didn't realize he shouldn't be using that image. You can't just go to Google images and use any image that comes up. Most of those would have a copyright on them, and here's the thing about images: it doesn't have to have that little copyright symbol on there. It doesn't have to have a watermark to be copyrighted. If somebody took the time to design that image on their own and put it on their website, by default, they own the copyright to that image, and you should not be using it without their permission.

So that's something to keep in mind about images, but probably the safest way to go about using images, I would say there's 2 categories of images that you can use without getting permission because you can always ask for permission, but of course that's a hassle, and probably for the most part you don't want to bother with trying to get permission to use somebody else's images. So, really the 2 types of images you can use would be either what's called royalty-free or images in the public domain. Now, I don't know if you want me to go into what's the difference between those, or what do you think, Karolyn?

Gazella: Sure. Let's just, yeah, let's touch on that.

Cook: Yeah, so royalty-free images, the free part doesn't necessarily mean they're free. You can buy these, so websites like iStock, you pay for it, but it's royalty-free meaning that you're getting a license to use it freely. And so some royalty-free images are paid for, like the iStock photos. Some royalty-free images are available for free at sites like Pixabay.com for example. But the point of being a royalty-free image is that they're granting you a license to use that image freely, and usually, I always would double check what the license agreement says, but for most of these, the license agreement says you can use this freely. You do not have to tell where you got it. The word is attribution. When you give credit, you do not have to give attribution. So you don't have to even document where it came from. Most of those licenses say that for royalty-free images.

And then the second category is images in the public domain. And so those are different in that they actually either never had a copyright on them or the copyright has expired, and so they're just in the public domain, again, for anybody to use freely, you do not have to give attribution. So some of the places that you would find those would be on like Wikipedia or it's called Wikimedia Commons, I believe. And that's a nice place if you're looking for more science kind of ... A lot of times you might want to draw a flowchart of the hormones from the hypothalamus down to the ovaries or something, right? That's not something you're probably going to find on iStock Photo, but you might find it in the public domain on like Wikimedia Commons for example.

Gazella: Yeah, that sounds pretty straightforward, and I'm glad that you went into that detail. Now, what about that second pitfall? This is the one that I'm really interested in hearing you talk about. What do you mean by making unsubstantiated claims? Can you give us some examples?

Cook: Yeah, so we can start with what we talked about when we're talking about specific dietary supplements. That's really just a matter of needing to use words that talk about how that supplement supports what we call structure/function of the body. So for example, if you're talking about a certain curcumin supplement, you can't say, "Oh, this treats pain and inflammation in arthritis." You have to just modify your wording and say something like, "Supports a healthy inflammatory response." And again, that is when you're talking about specific supplements, and I'm glad you brought up that if it is just you're generally talking about curcumin, you can be more free in your language.

However, it kind of brings me to the next point about supporting your claims, and that is even if you're just generally talking about curcumin, you shouldn't be making claims that you can't back up with evidence, and so either being able to link over to some study that supports what you're saying, if you're going to say curcumin really is great for knee pain or something, then you would want to be able to link to a study that showed that or be able to at least say, "Look, this is in my experience or what I have seen with my patients," and that's perfectly fine to use as evidence as long as you're clear that that's what you're basing this on, that's what you're basing your statement on.

So it's really all just about being transparent about if you're making a claim, being able to back it up with either research or your personal experience and just being open and honest about that.

Gazella: Yeah. That makes a lot of sense, and I think it's a great reminder.

Now let's move on to that third pitfall. What does misuse of personal information have to do with content marketing?

Cook: Okay, so this really gets into collection of email addresses, and so the thing is, this is a huge trend in content marketing is give away something free. So people call it all different things; they call it a freebie or a lead magnet or a lead generator, but they're giving away maybe like a free PDF download, and it used to be that you could give away this free, really valuable piece of content, and it was just assumed that when somebody put in their email address to download that guide, they're automatically put into your email list of subscribers, and they're going to start getting your regular emails like your e-newsletter or your promotions or anything.

And that actually used to be fine, and there's an email regulation called the CAN-SPAM Act, which has some items in place to make sure you don't spam people with mass emails, but it used to be very easy to be compliant with CAN-SPAM if you were using any regular kind of MailChimp or Constant Contact or any of those things, you were pretty much automatically compliant. It was just required things like having a little unsubscribe button at the bottom of every email.

But here's the thing is that just in the last year, so May of 2018, regulation went into effect in Europe called GDPR, and it totally changed this situation. So, quick disclaimer, I'm not a lawyer, so please, Karolyn, do not take anything I say as legal advice, Okay?

Gazella: That's a great disclaimer. I like it.

Cook: This is not legal advice.

Gazella: I'm going to make that same disclaimer. I'm not an attorney.

Cook: I am not an attorney, but in a broad sense, I think it's useful to understand what GDPR is about because it completely relates to ethically what we do with people's email addresses. So, I want to just broadly tell you what this is. Pretty much what GDPR says is that people should have a say in what you do with their personal information. So, it's really 2 things that we need email subscribers to give us, number 1 explicit consent to email them stuff, so they need to specifically say, "Yes, I want to be on your email list," and the second thing, granular consent. So it means you can't lump everything into a bucket anymore and say, "When you download this guide, you're also going on my general email list." They need to specifically check a box that says, "Yes, I want the guide, and yes, I want to be on your email list," so they need to specifically say they want to be there to be compliant with GDPR.

So, it doesn't mean ... We can still use freebies or lead magnets or whatever you want to call them. It's just a slight variation on how you create that form on your website to collect that email so that you'll be compliant.

Gazella: Yeah, that makes a lot of sense, and clinical practices are used to dealing with personal health information, so as long as they take that same care when dealing with the personal emails I think that ... And it can be confusing. A lot of this-

Cook: But wait. Can I say one more thing about ... I'm sorry. Excuse me.

Gazella: Uh-huh (affirmative).

Cook: One more thing I just want to mention because a lot of people might say, "Well, I'm a US-based business and GDPR is a European law, so it doesn't apply to me," but here is the thing is that GDPR, if somebody in Europe accesses your website, even if you're a US-based business, you need to be compliant with GDPR. And so if somebody sitting in a coffee shop in Madrid, Spain looks at your website and opts in for your guide for smoothies, then you're supposed to be GDPR compliant for that person. And so that ... Oh my gosh, email marketers are doing all different kinds of things, and some are getting really technical and monitoring like, "Oh, if somebody is in Europe and they're on my website, I'll show them the GDPR-compliant form, and if they're in New York and they look at it, I'll show them the noncompliant form."

So you can get into the weeds really fast here, but in my opinion, GDPR brings up an ethical issue that is people should have a say in what you do with their information, and if they want to be on your email list, you should get their permission for that.

Gazella: Yeah, I think that's a good general piece of advice, but I can also see where some of these issues might get a little complicated quickly. Where do you suggest people go for more information if they have additional questions?

Cook: So, that's a great question because I think I mentioned earlier a lot of these things, Google doesn't necessarily get you where he need to go. So, I actually put together a list of resources, at least from what I have, that I can share with your listeners, and so I just put together a resource guide. It has some things of where you can find royalty-free images or images in the public domain, linking over Copyright Alliance is actually an organization that just has really simple to understand information to understand copyright law. I have a link in that guide for where you can find FDA guidance on the structure/function language, and then of course some links to where you can learn more about GDPR.

So, I tried to put together just some things that I have found to be reliable and really useful in that guide, and so I think we're going to share that maybe in the show notes, but you can find it. It'll be on my website, which is NDPen.com/ethics.

Gazella: Yeah, and we'll also-

Cook: Oh, and by the way ... I keep cutting you off, Karolyn. I'm so sorry.

Gazella: Oh no, that's okay. Go ahead.

Cook: I am setting that up to be a GDPR compliant opt-in so that you can see an example of what that looks like, so you can just download the guide and that's it, or you can choose to be on my email list, but I will not just add you to my email list when you download the guide.

Gazella: Yeah, and we're also going to be linking to that guide. On this page of the podcast, there's going to be a link so our listeners can just click over. I mean, from a clinician standpoint, this might be something that you're going to want to share with your office manager or the people who are actually executing your marketing communication plan, your content marketing plan. So, yeah, thank you for doing that free guide for our listeners, Dr. Cook.

Now, I have a question here. With all of these ethical pitfalls, do you think that content marketing to grow a medical practice is worth the risk?

Cook: Yes, absolutely. Oh my gosh. I mean, here's the thing. The chances, if you are going about this from your heart, with good intentions, honestly the chances of getting in trouble for minor infractions of any of these things is so slim. It's so slim that you would ever get in trouble for anything, and yet the benefits of getting your content out there are massive. So, I mean really, if you're putting content out there, it's a way to really show your expertise, it's a way to get ... I mean, all of these integrative health practitioners, everyone has a unique message. Everyone's message is different. They have their own authentic voice and way of sharing it, and you get that out with your content. And really, yeah, creating content takes time, and you might hire some people to help you with all the parts and pieces, but it is a really effective way to promote your business without getting into a massive advertising budget.

So, I mean bottom line is like getting your content out gets you connected with people who need you the most; that's what it's about. It's about getting your message out there and helping people, and I really believe that that content marketing is a solid way to do that and really to just grow a thriving business.

Gazella: Yeah, I would agree with you. I have been a content publisher of integrative health information since the early 1990s, and I really feel that content is king. So, I have a love of quality content just as you do, Dr. Cook. I think that you brought up some really good points. It allows the practitioner to showcase his or her expertise. It can help you distinguish yourself from the competition. So for example, if you have areas of expertise or specialty areas that the doctor down the street doesn't have, you can showcase that, and you can actually target the patients that you want coming into your clinic. You can use content marketing as a referral tool.

There's so many great things about content marketing, and the fact that you highlighted, Dr. Cook, the fact that content marketing helps practitioners help people; it helps a ton of people, so it's not just the patients that they're seeing, it helps a broader audience, and I think that is very much in line from a vision standpoint for most of the practitioners, and that's probably true in the case of the practitioners that you're working with, that they have this mission; they're on a mission.

Cook: Yep. Absolutely.

Gazella: Yeah, I think that this is great. Well, this has been a lot of great information, and we are going to be submitting this podcast for continuing educational credits in the area of ethics, so thank you for helping us out it with that, Dr. Cook.

Cook: Awesome.

Gazella: And I hope you have a great day.

Cook: Thanks so much, Karolyn. You too.

Gazella: Bye-bye.

Cook: Bye.

Apr 2, 2019

During this interview Russell Jaffe, MD, PhD, CCN, will share his thoughts on how to safely and effectively enhance and protect bone health. Listeners will learn how acid-alkaline balance impacts bone health, as well as key nutrients that can help support bone density. 

About the Expert

Russell M. Jaffe, MD, PhD, is CEO and Chairman of PERQUE Integrative Health (PIH). He is considered one of the pioneers of integrative and regenerative medicine. Since inventing the world’s first single step amplified (ELISA) procedure in 1984, a process for measuring and monitoring all delayed allergies, Jaffe has continually sought new ways to help speed the transition from our current healthcare system’s symptom reactive model to a more functionally integrated, effective, and compassionate system. PIH is the outcome of years of Dr. Jaffe’s scientific research. It brings to market 3 decades of rethinking safer, more effective, novel, and proprietary dietary supplements, supplement delivery systems, diagnostic testing, and validation studies.

About the Sponsor

Perque Integrative Health

PERQUE Integrative Health (PIH) is dedicated to speeding the transition from sickness care to healthful caring. Delivering novel, personalized health solutions, PIH gives physicians and their patients the tools needed to achieve sustained optimal wellness. Combining the best in functional, evidence-based testing with premium professional supplements and healthful lifestyle guides, PIH solutions deliver successful outcomes in even the toughest cases.

Transcript

Karolyn Gazella: Hello, I'm Karolyn Gazella, the publisher of the Natural Medicine Journal. Thank you for joining me.

Today, we're talking about bone health with pioneering integrative health expert, Dr. Russell Jaffe. Before we being, I'd like to thank the sponsor of this podcast who is Perk Integrative Health. Dr. Jaffe, thank you so much for joining me today.

Russell M. Jaffe, MD, PhD: Thanks for the invitation.

Gazella: Well you know when we think of our bones, we often think of osteoporosis. Let's start there. How common is osteoporosis in particular?

Jaffe: Oh, far too common. Depending on how you make the measurements, somewhere between 50 and 100 million Americans are at risk. One in 4 women over the age of 40 will have a fracture of their bones due to the osteoporosis or osteopenia. Maybe 1 in 5 or 1 in 4 men, maybe more, the precision of diagnosis probably understates the issue. The point is that bones, whatever your birth date might be, your bones should be young.

Bones turn over every 10 years, which means no part of any bone that you or I have is more than 10 years old. Remember when we were 10 years old, we could jump around, we could leap around. I don't recommend behaving like a 10-year-old. What I'm saying is, your bones should be resilient, and flexible, and not brittle, and not being leeched by the stress and dietary choices of modern living.

Gazella: Yes. It's hard for me to even imagine a 10-year-old, but it would be fun to have bones like a 10-year-old, for sure.

Now is the DEXA scan still the gold standard for measuring bone density?

Jaffe: Yes. D-E-X-A, DEXA is the "gold standard" reference standard. There are other measures that are coming along. There's N-telopeptides which are a little hard to interpret. There are other measures, but to the best of my understanding, the expert experts in bone say that you can measure DEXA changes over 2years. My colleague, Susan Brown and I did an anecdotal prospective study with 11 people, 10 of whom had between 2% and 10% or 11% new bone growth, unprecedented new bone growth by following this approach to Alkaline Way bone health.

Gazella: Yes. How often do you recommend that patients get a DEXA scan?

Jaffe: Well, let me come at it 2 or 3 different ways. In regard to the usual and customary use of the DEXA scan, it's a 2-year waiting period. Now many doctors will do a DEXA after one year and try to compare, and interpolate, God bless. Other people will use other measures, including bone mineral protein and how much of that there is in say the urine.

You asked the right question, which is what is does the measure that almost everyone agrees, or that about which there is reasonable agreement and consensus. The answer there, DEXA. Until something better is really validated and yes, new things come along all the time, but I'm seeing a lot of them go 'cause as you know, my PhD was in collagen and elastin cross-linking, and how you regulate that. That was half a century ago and learned a lot since then. But collagen has a lot to do with bone health and bone turnover.

Then there's certain other unique characteristics contributed by the liver that allow the minerals, not just calcium, but all of the minerals that are necessary to align properly to form what we call a bone.

Gazella: When it comes to bone health, what do you mean when you say physiology before pharmacology?

Jaffe: Well I mean the fact that bone is piezoelectric, which means when you walk, when you move, actually stimulating tiny electrical flows that say to the bone rebuilding cells, the osteoblast and osteoclast, "Do your job." Moving is a good thing, at least 45 minutes a day of walking. Yes, sitting is the new smoking, but if you get up at least 5 minutes an hour, you can undo most of the adverse effects of cutting off your circulation when you sit in most chairs.

Now if you happen to have one of these recliner chairs or something like that, more power to you, but you still have to get up out of the chair. Walk for at 45 minutes a day. [inaudible 00:05:24], to the extent that he had a doctor was me, and [inaudible 00:05:29] very active now, they both agree. Now walking is a terrific way of human beings stimulating bone growth because of this "piezoelectric" or tiny electrical flow that nurtures and nourishes the bone. That's an example of physiology before pharmacology.

Gazella: A great example. When it comes to your integrative approach, I want to dig into certain aspects of how we can enhance or protect bone health. You often talk about the acid alkaline balance. How does acid alkaline balance impact bone health?

Jaffe: Well in essence when your diet or your environment contributes acid, your bones melt slowly away and sometimes not so slowly. On the other hand, when you have a mineral rich environment that bathes the cells and renews the cell's mineral buffering abilities, now you build new bone. We want to build new bone. We don't want to melt the existing bone.

Gazella: Right. That makes a lot of sense. Let's stay on this topic for a bit because I know that most of our listeners understand how to support the acid alkaline balance, but what are some of your foundational aspects when it comes to supporting proper acid alkaline balance?

Jaffe: Well as you know, we start with the self-assessments. The assessment we want to start with measuring the pH, that means how much acid or how much mineral is in your urine after 6 or more hours of rest. It's the one time of day when you get a meaningful measure in a non-evasive way of the cellular mineral status, 'cause after 6 hours, the fluid in the bladder equilibrates with the lining cells, and lining cells, if they need magnesium then they put the extra acid into the urine.

If it's below a pH value of 6.5, then you're too acid. You're deficient in minerals, particularly magnesium at the cellular level. You should take 2, 3, 4 more doses a day of magnesium, but enhanced uptake magnesium with choline citrate. It must be choline citrate, it cannot be choline bitartrate. Try to fool mother nature and she'll come back and slap you on the tush.

You want to enhance the uptake and chaperone delivery of magnesium based on [inaudible 00:08:14] chemistry, and for your listeners who are technical, these are inverted [inaudible 00:08:20] droplets. I really am a biochemist. What that means is tiny little droplets that are taken up by [inaudible 00:08:28], that easily enhance the uptake. In recent studies near 100% comes in and then goes to the cells that are [inaudible 00:08:37].

Gazella: You know it seems like bone broth has been the rage for a while now. What are your thoughts on bone broth as a way to boost bone nutrition?

Jaffe: Well I'm a big advocate for broth, but not bone broth. Why not bone broth? Bone broth turns out to be far too rich in glutamate, and why is it rich in glutamate? You wouldn't think there's much glutamate in bone, it's glycine, and proline, and something else. No.

What the industry calls bone broth includes skin, it includes things that have no other commercial value that are left after you "render" the animal, or the chicken, or the whatever, [inaudible 00:09:27] bone. Bone broth, no. But meat broth, vegetable broth, fish broth, broth you make at home, or broth that's organic or biodynamic, yes, yes, yes.

Broth is a very good source of minerals, and I mean vegetable broth, fish broth, meat broth if you want, but real meat made into a broth, which means you very slowly simmer it until it falls apart, and then you have more or less a broth, especially if you either whisk it or put it in a blender. Broth, yes. Bone broth, no.

Gazella: Okay, good. That's a good distinguishing factor. Now we also hear about MSM and hyaluronic acid for bones and joints. I'm wondering what you think about these 2 ingredients when it comes to bone health.

Jaffe: Well MSM is a sulfur source. Sulfur sources are very important in protecting and enhancing bone vitality and renewal. Now we recommend that physiology before pharmacology approach, which we use garlic, ginger, onions, brassica sprouts and eggs. G-G-O-B-E, garlic, ginger, onions, brassica sprouts. All sprouts are good, but broccoli sprouts, brassica sprouts especially, and eggs.

Why not MSM? 'Cause it's pharmacology. It is water soluble DMSO. DMSO makes you smell like a fish. Not a very healthy fish or a decomposing fish actually. MSM is a supplement that's been around for 20 plus years. It has a certain [inaudible 00:11:04] that comes and goes, but it's pharmacology. We want to start the physiology, the G-G-O-B-E, garlic, ginger, onions, brassica sprouts and eggs. Then if a particular practitioner feels that additional MSM is helpful, I think they make the final decision along with their client.

As you can hear from my comments, we want to use nature's pharmacy, which means you generally have to cook the food the way it's traditionally done. If you just chop up an onion, the cell walls will prevent you from getting the good stuff. But if you sauteed the union until it's clear, now you have a nutritious and delicious detoxifying physiologically helpful bone joint and vitality enhancing material that you can make into any broth you want. However, you want to eat the foods you can digest, assimilate and eliminate without immune burden. If your body reacts to one or more of the G-G-O-B-E foods, then substitute with the other 4.

Thomas Jefferson said they should be stables in the diet, not condiments. I'm a Jeffersonian democrat, which means I'm a grieving optimist. I believe that we should make these staples in our diet again.

Gazella: Yeah, that makes a lot of sense. What about hyaluronic acid?

Jaffe: I'm glad you asked that too. Hyaluronic acid is different. It is physiologic, so when you take ... I'm a pathologist, [inaudible 00:12:40] certified pathologist. When you look under a microscope at a joint, more than at bone, but at the joints you do see what are called water absorbing compression-friendly molecules, hyaluronic acid among them.

Hyaluronic acid goes back to the early '80s, when a Canadian company thought that this was going to be the answer to joint erosion, to the kind of bone-on-bone pain that very commonly occurs to people who haven't walked enough, and have sat too much, or have been on planes too much, as I have been from time to time. Hyaluronic acid has a medical application. It's an injection.

I think after you use nature's pharmacy, after you engage, when you eat and think, drink and do in a comprehensive and holistic way, that injections in hyaluronic acid in the right hands, in experienced hands, are an option. It does provide relief to some people for a period of time while other renewal should be engaged in.

Gazella: Okay, that makes a lot of sense. Now let's dig into some of your other go-to nutrients for healthy brains. I'm sorry, health ...

Jaffe: Bones.

Gazella: Bones. Yeah.

Jaffe: That applies to brains too.

Gazella: Yeah, yeah. That's good. When it comes to bones, what are some of the nutrients that you like to recommend?

Jaffe: Well in regard to the nutrients, there are over a dozen and a half. You can divide these into vitamins, minerals and co-factors. It's mostly about a family or a symphony of minerals. Remember a symphony has many different instruments, each of whom plays a slightly different tune. We recommend, in addition to vitamin K1 and K2, in addition to vitamin D3, we recommend biotin necessary for healthy bone. We recommend half a dozen forms of calcium, half a dozen forms of magnesium. Specialized bio available forms, low contaminant forms of zinc and magnesium, and chromium and selenium, methionine. Copper is the sebacate, iodine and iodide, you need both.

Boron, acid citrate, vanadium, which balances out blood sugar and chromium. Silica, but from horsetail. Stable strontium is the gluconate, and fiber, croscarmellose fiber to enhance the easing digestibility making it food-like. Those are the over 18, 19, 20 essential bone building nutrients. Now vitamin D should be the D3. There should be some vitamin C to keep everything reduced and happy.

Gazella: 'Cause this does seem like a big list. These all work synergistically?

Jaffe: And they're all essential. If you lack any one, your bones won't renew properly. It's amazing how many co-factors, how many minerals and necessary nutrients that allow for bone health. But Dr. Susan Brown and I published an article a decade ago, we're working on an update now, which basically says the more tonic, or soda, or acid beverage you consume, the more quickly your bones will dissolve, the more quickly your bones will melt away.

Then on the other hand, when you have a healthy traditional diet, rich in minerals, the Alkaline Way, the joy of living the Alkaline Way, documented by morning urine pH, keeping it in the 6 ½ to 7 ½ range, that's green rather than sandy color which is acid, or blue which is too alkaline, you want to keep it in the green zone. It's Goldilocks scenario. Not too much, not too little. Just right is just right.

Gazella: Now before I move on, I want to talk about this combination of vitamins, minerals and co-factors. Are these in one product? What will be ...

Jaffe: Oh, yes. This is what Dr. Brown and I used in our prospective study. When I say gaining 2% to 11% new bone, by DEXA in just 2 years, I'm saying people taking this formula and also following a healthy lifestyle of foods they can digest, assimilate and eliminate.

Gazella: Okay, great. What's the name of this product and what's the recommended dosage of this product?

Jaffe: Well the recommended dosage is 4 tabsules a day to build, 2 tabsules a day to maintain, 6 tabsules a day if you have osteopenia or osteoporosis.

Gazella: Okay, so 4 per day, 2 per day. Then, I'm sorry, that was 6 per day if there is osteoporosis or osteopenia? Dr. Jaffe?

Jaffe: Oh, I'm back. Sorry.

Gazella: Okay, perfect. The dose for osteoporosis or osteopenia is 6 per day.

Jaffe: Yes, that would be 6 per day. What I would say would be 3 in the morning, 3 in the evening, so a twice a day dose of 3 tabsules, these are fully active, fully available, and they contain all of these different nutrients, each one of which is necessary, and together they form a symphony or a bone building team.

Gazella: Okay, perfect. Great. Now I want to switch gears a little bit. What's your view of bone morphogenic proteins and the long-term effect on bone status?

Jaffe: Well you're absolutely up to the minute. Bone morphogenic protein is being studied as we speak. It's promising, but we really don't, in my opinion yet, have enough information. What we know is it's built upon something called 2-Beta Coxatene, for those of you who are technical. This is bone mineral protein precursor.

Dr. Brown and I are, at this moment in time, encouraged by what we have heard about this. She and I are collecting information as we speak, and stay tuned for bone [inaudible 00:19:21], as they say.

Gazella: If we were going to look into the future when it comes to integrative health and bone support, bone building, is this where we're headed with the morphogenic proteins? Is this an exciting area?

Jaffe: Well yes, definitely an exciting area. The question is, how much do you need for each person because, as you can imagine, given that you started with a really healthy organic or biodynamic bone, and then you somehow got out of it, this magic complex, how much do you need, and how much does it cost, and how long will it take before you really confirm what is asserted by some clinicians based on their observations? The observations are encouraging, but stay tuned for the bulletin.

Gazella: Okay. Perfect. Now I want to dig into diet and lifestyle. I want to circle back with your G-G-O-B-E, the garlic, ginger, onions, brassica vegetables and eggs. Explain it again or in more detail as to why these 5 dietary items are foundational for you.

Jaffe: Right. They're foundational because in traditional societies they are sulfur rich. You can think of sulfur as a fire that burns away bad stuff and toxins. That's a metaphor, but biochemically it's not far from the case.

For those of you who are technical, they form thioethers. This makes compounds that would otherwise be free radical generating harmful compounds more water soluble and less harmful, so once they're complex, what these sulfur rich foods, or the sulfur in the foods, then they can be treated in urine, sweat and stool more safely and effectively, and it's been used for millennia in traditional societies. We just have rediscovered it in recent times.

Gazella: Perfect. Well I want to stay a little bit with eggs because I've done a lot of writing about eggs, and I had the belief that eggs have gotten a bad rap. I personally eat eggs almost every morning. Explain to us about why eggs got the bad rap, and why eggs are actually good for us. Just remind us of that.

Jaffe: Yes, eggs got a bad rap because Levy and Fredrickson had the idea of the diet-heart hypothesis that the amount of fat or cholesterol you ate was determinative or it actually determined how much blood fat you have. Now it turned out to not be the case, but Levy ran the Heart Institute and Fredrickson ran the NIH. They had the dominant ... in their time.

At that time, there was a man named Olson, and he pointed out that eggs are the perfect food when you combined the white and the yolk, when you make a gently coddled or gently cooked egg you have a near perfect food in regard to easy to digest, assimilate and eliminate for people that have healthy digestion.

Now implied in what you said, I think, is getting a healthy egg. My preference today are goose and duck eggs, or quail eggs because they haven't been messed with very much. If you put in front of me a biodynamic chicken egg, or a home harvested fresh egg, I'll be delighted. Commercial eggs I'm not so sure of. I'm concerned about what the chicken ate the got into the egg and that's what she wrote, as they say.

Gazella: I would have that same feeling as well. Let's talk a little bit about what we should not eat if we're trying to protect and enhance bone health. What do you tell your patients not to do from a dietary standpoint?

Jaffe: Well as you know, I don't have a private practice. I get to influence other doctors and their probable cases, but what I do recommend is stay alkaline. Stay alkaline means eat foods that are mineral rich, eat foods that are antioxidant rich, eat foods that are nutrient dense and rich, and you are sweet enough as you are, do not add sugar to your diet, do not use edible oils. I think edible oils is an oxymoron. What I mean by that is you avoid packaged goods, shipped foods, crisp foods, extruded foods, things that have been processed because processed means you lost the good stuff and you gained the bad stuff.

Do a makeover in your kitchen, eat the foods that are whole, eat more fruits and vegetables that are vying ripe. If you want to have healthy fat in your diet, have an avocado, a whole one. Once you separate the oil from the seed, you know, like the olive oil, once you separate the oil from the seed the protective material is now gone and what you have are dense calories. Fat are dense calories, but those fats, those edible oils are easily oxidized, damaged and rancid. Then they get masking agents to make sure that your tongue and your brain get addicted to wanting those rancid processed fats.

I don't think that's a good idea. I can tell you lots of reasons why [inaudible 00:25:15], who taught me about this in the early '80s, late '70, [inaudible 00:25:19], why Patty Deuster is so correct about these issues, but slowly we turned in regard to nutrition [inaudible 00:25:26].

Gazella: Let's talk a little bit about lifestyle factors. Now you mentioned movement and exercise in a scientific literature is so clear that that's protective of bone health. What about other lifestyle factors, like if we're looking at stress, or sleep, or just other things that we do? What do you tell your doctors to tell their patients?

Jaffe: Well what I learned from [inaudible 00:25:52] and the Dalai Lama was that afflictive responses, that is the traumas of early life or the traumas of daily living that contribute stress hormones, afflict us, they erode us, they reduce new bone formation. By the way, no one gains from any of that.

In the famous words of Bobby McFerrin, "Don't worry, be happy." I don't mean live by denial. What I mean is practice relaxation response. Know that your breath is a refuge and know that stress hormones only come out when you feel under attack. You may have heard about fight or flight, but there's also fortitude, there's also gaining the resilience to know that when you go to your breath, you can stay at ease even if everyone around you is hysterical. I can tell you from personal experience, in my family, if you didn't shout, no one paid any attention to you because everyone else was shouting. They just didn't know it.

Gazella: Yeah, that's true. The relaxation ... Stress is a big deal. What about sleep? I know often times, sleep and stress go hand in hand, and one can lead to the other, and vice versa. What's your philosophy on sleep?

Jaffe: Yes, my philosophy on sleep is that it's really important, restorative sleep, and how do I prepare for restorative sleep? Well I take a salt and soda bath. I put half to a cup of baking soda and Epsom salts in a warm tub of water, and get in for 20 minutes. First 5 minutes I breathe like a baby into my abdomen, the next 15 minutes I pray that my heart won't attack me, and whatever active mediation you want to do, then I get out and I dry off before I get into bed, and I stretch when I'm in bed before I fall asleep.

Then I might even ask myself a question that I would like my dreams to answer if I'm inclined to do that. [inaudible 00:28:03] dreaming myself. In the morning I wake up and I stretch. I got to bed early enough that I get up early enough that I don't need an alarm clock. There is no screen, there is no clock, there's no unnatural sound.

Occasionally I'm woken up by a wind chime or by a bird, but that's a nice thing to get woken up by. Then I stretch before I get out of bed, and then I get in the shower and I stretch when I'm in the shower, 'cause if you're not stretching a lot, you'll contract. Look at most old people, they slow down and contract. I am how you say old, but not that old, and I'm not yet contracted.

Gazella: That's a good thing.

Jaffe: That's a good thing. I'm working on it.

Gazella: It's perfect. What would you like to be the most important bone health message that our listeners of health care professionals receive today? What's the most important thing that you want to get across?

Jaffe: Most important is that bone health is a choice. It is about what you eat and drink, think and do. When you put it together in this proactive way, you have healthy bones for life. If you follow the "Conventions of modern living and pharmaceutical pill-based solutions," you end up slowing the loss but creating brittle, more fragile bones. In the famous words of Mel Brooks, the 2,000 Year Old Man, "Don't do that."

Gazella: Right. Yeah, the physiology before pharmacology, I think, is such an important message.

Well this has been very interesting, Dr. Jaffe. Once again, I would like to thank the sponsor of this topic, who is Perk Integrative Health. Dr. Jaffe, once again I'd like to thank you for joining me today.

Jaffe: Pleasure to be with you as always.

Gazella: Yes. Have a great day.

Jaffe: You have the same.

Mar 5, 2019

Research is confirming that there is a direct link between the gut and the brain. In this interview, probiotics expert Ross Pelton, RPh, will describe the research associated with probiotics and brain health. The focus of the interview is on cognition and mental health issues such as depression and anxiety and how probiotics may help patients with brain issues.

Approximate listen time is 31 minutes

About the Expert

Ross Pelton, RPh, CCN, is Essential Formula's director of science, in addition to being a practicing pharmacist, clinical nutritionist, and health educator in Southern Oregon. Pelton earned his bachelor of science in pharmacy from the University of Wisconsin. A certified clinical nutritionist, Pelton was named as 1 of the Top 50 Most Influential Pharmacists in the United States by American Druggist magazine for his work in natural medicine. Pelton teaches continuing education programs for healthcare professionals to use natural medicine and integrate it into their practices. He also has authored numerous books, including The Drug-Induced Nutrient Depletion Handbook, which is a gold-standard reference book for health practitioners.

About the Sponsor

Essential Formulas Incorporated (EFI) was established in 2000 as the sole US distributor of world-renowned microbiologist Dr. Iichiroh Ohhira’s award-winning probiotic dietary supplements and skin care products. Always an innovator, EFI introduced REG’ACTIV in 2015, containing ME-3, a probiotic catalyst that produces the “master’” oxidant glutathione inside the body's cells. A family-owned and operated business, EFI was founded on the philosophy of providing high-quality preventative, supportive, and comprehensive pro-health products for the entire family. EFI continues to flourish and grow through a strong company and product integrity and the knowledge that they’re providing scientifically proven products that positively impact the health and well-being of their customers.

Transcript

Karolyn Gazella: Hello, I'm Karolyn Gazella, the publisher of the Natural Medicine Journal. Today we're talking about the gut-brain axis and how probiotics can help with brain function, including mental health issues and cognition. Before we begin, I'd like to thank the sponsor of this topic who is Essential Formulas Incorporated. My guest is probiotics expert and registered pharmacists, Ross Pelton. Ross, thank you so much for joining me today.

Ross Pelton: Hi, Karolyn is really nice to be with you and your audience again. Appreciate it very much.

Gazella: Yeah, this is a really interesting subject. We've covered it a little bit in the Natural Medicine Journal, but I'm really anxious to kind of dig in a little bit more deeply with you. So let's just jump right in. How much do we know about the connection between what's going on in the gut and how that can influence the brain?

Pelton: Well, we're starting to learn a lot more about it and I would say that we're still in the infancy of this learning curve, but we now understand why we call the gut your second brain. There's an enormous amount of neurons in your gut. There's over a hundred million neurons and your probiotic bacteria and the compounds they produce, interact with those neurons in your gut and send signals to your brain up what's called the vagus nerve, and so that's how the gut communicates with the brain, through this super highway of nerves called the vagus nerve. It's the longest nerve in the body. What's really interesting to me, Karolyn, is that they've figured out that about 20% of the vagus nerves are sending information from the brain into the stomach or the gut. But 80% of these nerve fibers in the vagus nerve are sending information from the stomach to the brain. So the majority of this information, this communication between the gut and the brain is really the gut communicating with the brain.

Gazella: Wow. That's pretty cool. So let's talk a little bit about the scientific literature then. What does the scientific literature tell us about the link between the gut microbiome and mental health issues like depression and anxiety?

Pelton: That's getting to be a big topic also and there's a tremendous amount of work being done in that area. In the cover, on the cover of the magazine Psychology Today, in April, 2014 their lead article was the psychobiotic revolution, how your gut bacteria control and influence your emotions and your state of mind. So a mainstream journal, Psychology Today, is referring to what they call a psychobiotic revolution. There's more and more studies that are starting to tease out how this happens. One study I found that was very interesting, mice who were infected with a very small of a toxic bacteria called campylobacter, but it was such a small dose, it did not cause any immune system activation. So the body really didn't know it was there. There was no immune alarm reaction.

However, several tests revealed at the mice exhibited greater levels of depression and anxiety-like behavior. So the brain knows, even though the body wasn't responding with an immune reaction, the brain could tell that there was some bad bacteria, very small amount in the gut. In a human trial, it was chronic fatigue patients. It was a placebo controlled trial so some of the chronic fatigue patients were getting probiotics and some were getting a placebo and they did stool samples and they did a number of tests of depression and anxiety and the people taking probiotics were calmer, had less anxiety and claimed they were better able to cope, they got better sleep and they had fewer heart palpitations. So animal studies and human trials are also kind of combining to give us more and more information about this gut-brain communication.

Gazella: Great. Now what about other brain issues like cognition and concentration? Does the gut-brain axis cover those issues in the scientific literature as well?

Pelton: Well, it really does and it starts at birth and there's a real strong and important relationship between the early microbiome and child cognitive development. You find out that when children are born with a Cesarean birth, the mother has to give a C-section birth, then there's a difference in the microbiome. They've studied infants between C-section births and healthy natural vaginal births and they find out that the infants that are born via C-section for cognitive development through the ages of 4 through 9 is what this particular study looked at and they called it a cognitive gap. So it's just more information that's detailing that an infant's microbiome plays a real critical role in cognitive development.

Now, we're learning more and more about the relationship between microbiome and psychology and neuroscience and normally you'd think that the fields of psychology and microbiology are not really connected, but now they're starting to be strongly connected because we're finding out how strongly microbiology and the influence of your bacteria communicate with your brain and affect your mental, emotional states. So gut health affects mental health is the stronger and stronger message that's coming out from the scientific community.

Gazella: Yeah, it's really true. I have to tell you, there was an interesting study that I read while I trying to prepare for this interview and it was involving traumatic brain injury. Now, I understand that that connection is preliminary, but it's pretty promising to make the connection between traumatic brain injury and the gut. How can probiotics help someone who has experienced traumatic brain injury?

Pelton: Well, there's several studies that have been done on this now. The gut-brain axis is a communication between the gut and the brain and it's the nervous system that does the communication, and when you upset the nervous system, you're going to upset the communication between the gut and the brain. So the gut microbiome has a central role in this pathway of humidification and it's really altered. They find out that the gut microbiome is significantly altered following a brain injury. It reads to more inflammation in the central nervous system and that affects the brain. You get brain inflammation. So that's 1 of the studies that talked about this traumatic brain injury microbiome relationship.

In animal studies, it's not nice to talk about these studies because they do some nasty things to the animals, but that's the way we learn about a lot of these things. So they took some male rats and divided them into 2 groups. One group received a brain injury and the other didn't. But they looked at their microbiome before and after and they started a pre-traumatic brain injury incident and then they rechecked the microbiome in day 2, day 7, and day 14. They found that the mice that had received the traumatic brain injury, there was a definite significant change in the composition of their microbiome and it got worse as time went on. They started looking at the microbiome before the injury and then checked it at 2 hours after the injury and then 1 day, 3 days, and 7 days afterward. The change in the microbiome continued to worsen after that traumatic brain injury. So when we learn more about this, we see that the faster you can intervene, the more help that you can provide in this type of a situation.

Gazella: So the scientific literature is clear that in cases of brain function, mental health, like depression, anxiety, and even in cases of traumatic brain injury, that the gut microbiome is altered. Does the scientific literature tell us that a probiotic intervention can reverse, change or influence the gut microbiome in such a way that the brain will be positively influenced?

Pelton: Well, yes. That's what we're learning is that if you supply probiotics, you will change the gut and you change the electrical and chemical communication between the gut and the brain and you can influence the brain in positive ways. There's a number of researchers that are really documenting the changes in the brain from microbiome probiotic administration. There's a scientist by the name of [Christine Tillich 00:09:11] and she does brain imaging scans on people, these are human clinical trials. She had a group of women who had no previous gastrointestinal complaints and no previous psychiatric problems. She gave them probiotics twice a day for 2 weeks and she conducted functional MRI brain scan on these women and they were looking at the brain activity when the volunteers were viewing faces that contained different emotional expressions and they found changes in the brain regions that control the central processing of emotions and sensations.

So this is a placebo controlled trial. Some of the women who were taking something but wasn't a probiotic and then the other women had probiotics and the women that had probiotics, they found positive changes in the brain areas that process emotions and sensations. So really interesting work that's being done.

Gazella: Yeah. Very exciting to know that we have this intervention. Now, last year I read about a very small study that got some publicity and it was actually negative towards probiotics and it stated that probiotics can actually cause brain fog. I'm not sure if you had a chance to read that study or what's your take on this issue if it's come up in your pharmacy practice that probiotics can actually cause negative brain issues?

Pelton: Well, I'm familiar with that study and my take on that is that this has to do with SIBO, small intestinal bacterial overgrowth. When people have SIBO, then yes, probiotics can cause a problem because SIBO is a situation were bacteria that are normally resident in the large intestine and the colon have translocated. They backed up into the lower portion of the small intestine. So it's not necessarily bad bacteria, but it's just bacteria that are now in the wrong geographical location in the GI track. Those bacteria can digest the fibers in food and cause gas and bloating and a great deal of discomfort. They produce a compound called D-lactate and that can produce brain fog.

But the scientist that reported this, I think, really didn't report it correctly, or at least how I would like to report it because he's just saying that taking probiotics cause brain fog. Well, you have to understand that this is in SIBO and many people with SIBO should not be taking probiotics because the bacteria will digest the fibers and cause a great deal of gas and bloating and discomfort. So SIBO is a unique situation and needs to be dealt with separately.

Gazella: Yes. Now, that makes a lot of sense. I'm glad that you clarified that. So when it comes to using probiotics in clinical practice for brain health, do you recommend probiotics as a sole treatment or as a part of a more comprehensive protocol? How can clinicians best use probiotics in clinical practice for this particular application?

Pelton: Well, I'm always in favor of a more comprehensive approach to health, so I wouldn't advocate just probiotics. It's really important to understand how important a healthy diet is and exercise and good sleep. I also advocate a wide range of different types of nutritional supplements. But probiotics are 1 of the things I do recommend on a regular basis and it's kind of like insurance where you might not need it, but if you get in this situation where you need it, you're darn happy that you have it. I would say that there's certainly a range in how important probiotics are to people. Some people can maintain a microbiome when they're eating a healthy diet and they do pretty well long term and they might be less in need of probiotics on a regular basis.

But I would say the majority of Americans, in fact, I've got 1 study that said that 90% of adults and children in America do not consume the recommended amount of fiber in their daily diets and fiber is what feeds your good bacteria. So if you're not getting adequate fiber in your diet, then you're not supporting the growth of your microbiome and your need probiotics. But I really emphasize the people, Karolyn, probiotics alone are not enough. You have to feed your probiotics well, otherwise they won't thrive and survive. So it's a combination of a fiber rich diet with lots of fruits and vegetables, especially the multicolored vegetables. That fiber will feed your microbiome and promote growth and proliferation of a more diverse microbiome. So it's probiotics plus fiber in the diet.

Gazella: How do you counsel your patients about getting more fiber in the diet? Because I think you're right. I think that this is a big issue and the statistics are pretty clear that people aren't getting enough fiber and fiber and probiotics go hand in hand. How do you teach them to get more fiber in their diet?

Pelton: Well, I encourage people to Google my YouTube video. It's an 8-minute youtube video, just Google Ross, R-O-S-S, and and salad buzz, B-U-Z-Z. It is an 8-minute video that I teach people how to save a lot of time making salads. One of my theories is that people don't eat salads often enough because they're time consuming. But I teach to process all the vegetables all at once and then the secret to the whole process is squeeze a lemon over all of your processed vegetables and toss that lemon and lemon juice in your vegetables and the vitamin C in the lemon juice will preserve your precut vegetables. So I put it in a Tupperware and it stores easily for a week and then every night when my wife and I have our big salad, I take a handful of lettuce and a handful of vegetables that I've already processed and put some wild caught salmon on there. It takes me like a minute to make supper. So it's a way to get a wide range of vegetables because I've got about 14 different types of vegetables in my salad mix and it saves time in the process.

Gazella: Yeah, it's a great idea. I'm sure that practitioners may want to share that with their patients. So that's Ross salad buzz. Go ahead and search that. So now let's talk about probiotics. I mean, this is a field where there are a lot of different types of probiotic products. So what do you feel clinicians should look for when choosing a probiotic to recommend to their patients?

Pelton: Well, that's a really broad topic, Karolyn, and there's a lot to talk about there. Turns out that humans have somewhere between 500 and a thousand different species of bacteria in their GI track and we're just beginning to learn what these are and there's a wide range between your microbiome and my microbiome. But generally you want to have a strain that has been prepared well in manufacturing so they good shelf life. That's a critical factor whether or not they need to be refrigerated. But 1 thing I'd like to talk about is what I call the new frontier in microbiome science. This is the term postbiotic metabolites. Now, some of your listeners might not be aware of this term, but it's really in 1 of the most important new understandings about probiotic bacteria and the microbiome.

We're starting to learn that it's not so much the bacteria that are important, but it's the compounds they produce and we call these compounds postbiotic metabolites. So the process goes like this. You ingest fiber rich foods, your probiotic bacteria break down those fibers and produce secondary compounds that we call it postbiotic metabolites. These are the compounds that are the master health regulating compounds for the entire body. These postbiotic metabolites influence the functioning of every single organ system in the body, especially your immune system in your brain. I use the analogy of NASA's mission control center, controls our space flights. There's dozens and dozens of scientists and engineers but it's really the hundreds of computers making millions of decisions every second that guide and regulate our space flights.

So in my analogy, your probiotic bacteria are kind of like the scientists and engineers, but it's your postbiotic metabolites that are really doing all the work, controlling and regulating all the signals that are having an effect on virtually every single organ system in your body. So that's the real important message and the new frontier and the microbiome, learning what bacteria produce these compounds, what strains of bacteria are more efficient at producing some of these compounds and as we get farther into this whole topic, science will start to tell us what types of fibers and what types of food will primarily or preferentially feed different types of bacteria.

We know that diversity is important for a healthy microbiome and that means a wider range of different types of bacteria. The way to get a wider range of different types of bacteria is to consume a wider range of different types of fiber. So it's not just the quantity of fiber, it's also the the different diversity, different types of fiber is what's required to get a diverse microbiome.

Gazella: Now give us some examples of the postbiotic metabolites that are produced that are so important to our health.

Pelton: That's a big topic and I'm glad you've asked me because it's fascinating to me. Our probiotic bacteria are fascinating little chemical factories and so some of the postbiotic metabolites, all the B vitamins are produced by your probiotic bacteria. Several of the amino acids, they make a lot of the neurotransmitters and lactobacillus fermentum ME-3 produces glutathione. Some of the strains produce hydrogen peroxide, which is active against some of the things like Candida yeasts and short chain fatty acids are 1 of the big, most important categories that we know about. These short chain fatty acids are active against pathogens. They rebalance the acid base level. They have antiinflammatory activity. So that's why these postbiotic metabolites are so important because these are the compounds that have all the activity to regulate the microbiome ecosystem.

So again, it's not just the bacteria, it's all these compounds that they produced. These compounds are produced during fermentation. The bacteria ferment foods to get access to the fibers and then they change these fibers into these secondary metabolites, the postbiotic metabolites. So fermentation is the process that creates the postbiotic metabolites. For years, and in fact for centuries, fermented foods have been a primary way that we preserved foods and it's the postbiotic metabolites, especially the short chain fatty acids that are produced during fermentation that create an acidic environment to suppress the growth of pathogens. So that's how fermentation works and that's an important part of your immune system because in your gut, the bacteria go through fermentation process and produce these short chain fatty acids that will suppress the growth of pathogens.

Gazella: Yeah. When you're describing this, you're describing this combination of fiber plus bacteria. So you're actually describing more than a probiotic. You're describing more of a whole food extract or what's sometimes called a symbiotic. Is this where we're headed? It seems like there's not a lot of probiotic products that have fiber rich foods combined with the bacteria to create this whole food combination, which then creates the posts by attic metabolites. So it seems like this is unique.

Pelton: Well, you're right. Although you will see some probiotic products that have a prebiotic in them, like fructo-oligosaccharides or FOS. I mean, some of them had things like inulin in them. But keep in mind, we want to strive for a diversity of fibers and so these products just have one type of fiber or 1 or 2 types of fiber. A product that I'm very familiar with because I'm the scientific director with Essential Formulas is called Dr. Ohhira's Probiotics. They're made in a fermentation process. It takes years to produce the product. They have large fermentation vats where they start out with 12 strains of bacteria then they had dozens of different types of organically grown foods and the bacteria are given 3 to 5 years to break down and ferment all of these foods, and during the process they're producing a wide range of postbiotic metabolites and scientific research has determined that Dr. Ohhira's Probiotics contain over 400 different postbiotic metabolites.

So Dr. Ohhira's is really not primarily a probiotic. It's primarily delivering postbiotic metabolites directly and it's a much faster way of effecting change in the microbiome because if you just take probiotic bacteria, those bacteria, when they reached the gut have to find fibers and begin the process of breaking those fibers down and transforming them into the postbiotic metabolites. But Dr. Ohhira's is directly delivering these postbiotic metabolites so you get a really rapid microbiome restoration because they immediately, as soon as they hit the gut, they start to produce the antiinflammatory effects and accelerates the regrowth of healthy new cells that line the GI track. It's just a really unique fast way to create change and correct things like dysbiosis.

Gazella: So you mentioned that there are dozens of forwards in the Dr. Ohhira's product that are fermented and combined with the 12 strains. What are some of the types of foods that are in that product?

Pelton: They have a wide range of fruits and vegetables and mushrooms and seaweeds, all healthfully raised. They have different standards in Japan, so they're not what we would call organically grown by our standards because they just don't have those standards. But they're healthfully grown. They use pure spring water. There's no pesticides and insecticides and artificial fertilizer or anything, and they're allowed to grow naturally and then there are harvested at their peak of ripeness. So the nutritional content is at its peak and then they shred these foods and add them to the fermentation vats so that the bacteria can start to break them down and do the fermentation process that allows them to produce the postbiotic metabolites.

Gazella: Now you mentioned that you don't have to refrigerate Dr. Ohhira's. I mean, as a consumer, I actually find that really appealing, but some practitioners are pretty focused on the refrigerated probiotic products. Why don't you have to refrigerate Dr. Ohhira's?

Pelton: Well, Dr. Ohhira's, this fermentation process that I've spoken about, the bacteria learn to thrive and survive in the fermentation vats at room temperature. So they have adjusted to survive in a room temperature and then the capsule for Dr. Ohhira's Probiotics is a patented capsule design that's as hard in the harsh acidic environment in the stomach and then preferentially releases all the contents in the small intestines. So it's a user-friendly product where food is not an issue, it could be taken on an empty stomach or with food and refrigeration is also not an issue.

Gazella: Then what's the dosage of the Dr. Ohhira's if you're just going with regular maintenance and there's not really a therapeutic application? You just want to recommend it to your patient for optimal health.

Pelton: Sure. The recommended dose is 2 capsules daily on a ongoing regular basis.

Gazella: Perfect. So I'd like to talk a little bit about the future because it sounds like what you've just described with this whole food extract and this fermentation process at room temperature and the paste that's created and it's put into this special gel cap that can survive the stomach. It sounds like that we're headed to the future. So bring out your crystal ball and tell us 2 things. First of all, what does the future hold when it comes to probiotic research and advancement and then what does the future hold when it comes to this gut-brain axis and where we're headed with that?

Pelton: Okay. Well, I think that in the future we'll see more and more recognition of the benefits of these postbiotic metabolites. I think more companies will start to try to develop products so that they can directly deliver postbiotic metabolites. In fact, the pharmaceutical industry also sees the handwriting on the wall. I've looked at a number of different reports where pharmaceutical companies are starting to develop new products that contain postbiotic metabolites. The pharmaceutical industry realizes that rather than trying to develop more antibiotics, they can start to develop products that contain postbiotics and these new products will be less expensive to produce. They'll have fewer side effects because these are compounds that are naturally produced in the human body. So it's a new frontier for the pharmaceutical industry also. The postbiotic metabolites is a new frontier all the way around.

Your other part of your question is how do I see the whole industry of probiotics going? We'll continue to discover new strains of bacteria, but I think there will be more emphasis focused on trying to discover what are the compounds, these postbiotic metabolites, the different strains of bacteria produce. So it's not so much trying to just discover different strains of bacteria and name them, but what are these compounds that they're producing and which strains of bacteria are more effective at producing these compounds for us. I think we'll also get into in the future much more personalized microbiome understanding so that different people will react differently or more favorably to different types of probiotic products and even different types of postbiotic metabolites will probably be more effective and more important for different types of individuals with different types of problems.

Gazella: Yeah. I have to say that this does lend itself to that personalized medicine that practitioners and researchers are talking about. So I would agree. I think that's a great direction to go in. Now when it comes to the gut-brain axis, I know a lot of the research that we talked about today is a bit preliminary. Are you expecting to see some more formalized larger clinical trials, human trials, double-blind, randomized placebo-controlled trials in the area of mental health, potentially dementia, Alzheimer's, concentration, maybe chemo brain? I mean this is just such a big topic.

Pelton: Well, yes, Karolyn. That's another huge frontier for the microbiome. Some studies are calling the microbiome the missing link in the gut-brain axis and they're starting to focus more on the microbiome's role in the link between gastrointestinal health and mental health. So we'll see a lot of that happening in the future. I can share 1 study with your listeners that's really quite amazing that talks to the mental health issue and the relationship between the microbiome and mental health. Scientists started out with 2 strains of mice. One strain of mice is specifically bred to be highly timid and anxious and the second strain of mice are bred to be highly courageous, bold, and exploratory. So then the researchers just took the bacteria from the GI track of each strain of mice and implanted them into the opposite strain.

It completely reversed their behaviors, just by changing the bacteria and their microbiome, taking it from the bold, courageous exploratory mice and transplanting those gut bacteria into the strain that was timid and anxious. It just totally changed the behavior from being bold and exploratory to being timid and anxious and did the reverse in the opposite of mice. So fascinating information to see how just the gut bacteria have this direct influence on behavior and emotional activity and so forth. I'm sure we'll see many more studies in the future that are starting to unravel how this all works for us.

Gazella: Yeah, I would agree. This is going to be fun to keep an eye on and to follow because it's really exciting and it can really make a difference in patients' lives. So once again, I'd like to thank the sponsor of this topic was Essential Formulas Incorporated, of course, the distributors of Dr. Ohhira's Probiotics. Thank you, Ross, for providing us with such a great amount of interesting information for us to consider. Have a great day.

Pelton: Okay, Karolyn. Nice to be with your listeners. I want to just encourage everybody, every time you eat, you're feeding 100 trillion guests, so feed your probiotics well.

Gazella: Absolutely. That's great ending advice. Thank you.

Pelton: All right.

Feb 6, 2019

The Centers for Disease Control and Prevention has called insufficient sleep a public health epidemic. And yet, many of the commonly prescribed medications are not helping most patients. In this interview, John Neustadt, ND, explains why an integrative approach to treating insomnia provides a much more effective alternative to commonly used sleep medications.

 

About the Expert

John Neustadt, ND

John Neustadt, ND, received his naturopathic doctorate from Bastyr University. He was founder and medical director of Montana Integrative Medicine and founder and president of Nutritional Biochemistry, Inc. (NBI) and NBI Pharmaceuticals. He’s a medical expert for TAP Integrative, a nonprofit organization educating doctors about integrative medicine. He has published more than 100 research reviews and was recognized by Elsevier as a Top Ten Cited Author for his work.

Neustadt’s books include A Revolution in Health through Nutritional Biochemistry and the textbook Foundations and Applications of Medical Biochemistry in Clinical Practice. Neustadt is an editor of the textbook Laboratory Evaluations for Integrative and Functional Medicine (2d Edition). He was the first naturopathic doctor ever voted Best Doctor among all physicians in his area.

Neustadt received 15 Orphan Drug Designation by the US Food and Drug Administration for the use of natural products for the potential treatment of rare diseases.

About the Sponsor

Nutritional Biochemistry, Inc.

Nutritional Biochemistry, Inc. (NBI) formulates and manufactures products that give results. Started by John Neustadt, ND, in 2006 when he couldn’t find formulas he needed to help his patients and family, NBI products solve 2 problems he was having. Existing products didn’t contain the dose or combination of nutrients used in clinical trials and actually shown to work. Equally frustrating, other companies would cite studies on their websites, but then use lower amounts of nutrients than what was used in the study, or use entirely different nutrients that weren’t supported by the research.

Neustadt’s latest creation is Sleep Relief. NBI’s Sleep Relief is a breakthrough in sleep technology. Its bi-phasic, time-release technology delivers NBI’s proprietary formula with clinically validated nutrients in two stages—a quick-release first stage and a slow-release second stage to help you gently fall asleep, stay asleep and wake refreshed and ready for your day. NBI's Osteo-K delivers the clinical dose of nutrients shown in more than 25 clinical trials to grow stronger bones and reduce fractures more than 80%.

NBI is and always has been a family-owned company. We don’t manufacture anything we wouldn’t take ourselves or give to our own family. No matter what we do, our promise to physicians using our products is to help their patients, and to customers purchasing directly from NBI, is uncompromising quality.

NBI is a name you can trust. But don’t take our word for it. Spend some time on our website, learn about our products, and educate yourself on the hundreds of research citations and studies that they’re based on.

Transcript

Karolyn Gazella: Hello. I'm Karolyn Gazella, publisher of the Natural Medicine Journal. Thank you so much for joining me. Today, our topic is the integrative approach to insomnia. During this interview, we will learn that insomnia is a significant problem for many patients that can have far reaching physical, mental and emotional health ramifications. We will also learn how to successfully treat this condition by using a combination of diet, lifestyle recommendations, and dietary supplements.

My expert guest today is Dr. John Neustadt. Dr. Neustadt received his naturopathic doctorate from Bastyr University and he was the founder and medical director of Montana Integrative Health.

Before we begin, I'd like to thank the sponsor of this topic who is Nutritional Biochemistry Incorporated, or NBI, manufacturers of high-quality dietary supplements for health care professionals.

Dr. Neustadt, thank you so much for joining me today.

John Neustadt, ND: Thank you for having me on.

Gazella: Well, so the Centers of Disease Control and Prevention calls lack of sleep a public health epidemic. Now, that seems pretty significant so today we're going to talk specifically about insomnia. How common is insomnia in particular?

Neustadt: Well, the CDC is absolutely correct. It is a public health epidemic. Up to 80% of people struggle at some point with what's considered transient insomnia, less than two weeks of duration and insomnia effects 10 to 15 percent of the general population.

In primary care settings, it's estimated that up to almost 70 percent of primary care patients have insomnia so it is incredibly common.

Gazella: Oh, yeah that is. So how does lack of sleep impact a patient's overall health from like a physical, mental, emotional standpoint?

Neustadt: It has devastating impacts. There are two ways to think of it. One is short-term impacts and the other are the long-term impacts. So, short term it can impact decreased job performance, impact social and family life by creating greater fatigue. I mean, just you're more tired during the day. Decreased mood and depression, increases in anxiety and stress. Decreased vigor and just not being able to cope with the demands of daily life and be able to complete tasks. That's only short term. Devastating just in the short term.

But in the long term, it can be a killer. There, if people are sleeping an average of less than six hours per night, it can increase the ... or decrease the quality of life at the same magnitude of a similar condition such as congestive heart failure and major depressive disorder. It's an early symptom for Alzheimer's Disease and Parkinson's Disease and Huntington's Disease and there's a sweet spot for sleeping of about eight hours. That research shows is the healthiest, and if you're sleeping less than six, or longer than nine hours, it increases your risk for diabetes, metabolic syndrome, and death and, in fact, for metabolic syndrome, there's a 45 percent increase in risk compared to people who are sleeping seven to eight hours a night.

Gazella: Wow, so yeah, so this is a very important topic for clinicians to have on their radar. So, when you're evaluating a patient with a sleep disorder such as insomnia, how do you approach the work up?

Neustadt: Well, insomnia's really a qualitative diagnosis. It's how are they ... how do they feel that they're sleeping? How do they feel that it's impacting their health? Now the DSM official diagnosis, there is a quantitative or a couple of quantitative aspects to that and that is it's occurring at least three nights per week, and present for at least three months. So understand the difference between transient insomnia, less than two weeks, versus the diagnosis, official diagnosis, needs to be going on for greater than three months.

So there's a huge discrepancy there and in time periods and clinically it's important to be aware of that because these detrimental and dangerous effects of insomnia and sleep deprivation definitely are occurring in shorter than three months period of time. They're happening pretty quickly if someone's not getting enough sleep and even over a few days the short term consequences.

And so what I ask people about is how many hours, on average, do they think they're sleeping a night? Do they have any difficulty with falling asleep or staying asleep called sleep phase delay or sleep phase advance? Are they waking refreshed in the morning? What's going on with them psychosocially? Are there any stresses going on at work or in relationships or financially that's increasing their anxiety and could be impacting their sleep? Are they are risk for any hormonal abnormalities or imbalances because the research is clear that low estrogen, low or high testosterone, elevated TSH, those are all things that can create insomnia. Abnormal progesterone, as well.

And then looking at medications because there are some medications that can impact sleep, as well.

Gazella: Yeah, let's talk about the medications that can impact sleep. What are some of those medications that can impact sleep?

Neustadt: Well, prednisone, that can cause hyper-arousal, or can cause somebody to not sleep, not be able to fall asleep, or have fragmented sleep. Beta-blockers, very common heart medications, can decrease melatonin production. So we know what the mechanism of action ... their interaction of sleep is they decrease melatonin and can cause poor sleep.

Some antidepressants, actually, can cause poor sleep. Antidepressants can, depending on the antidepressants, can either cause somebody to not be able to sleep enough or can cause hypersomnolence, somebody to be sleeping too much. So looking at those, looking up ... it's very easy to look up whatever medication they're taking quickly and see, besides the ones that I mentioned, could it be potentially interfering and impacting with their sleep.

Gazella: So I've been hearing about hyperarousal, or the hyperarousal hypothesis, which I find quite fascinating. What is the hyperarousal hypothesis and how can it affect what is recommended to patients?

Neustadt: Great question. So the hyperarousal hypothesis I like to refer to as "wired-but-tired." And it occurs to people typically who are under a lot of stress, they have elevated cortisol, and when they end up trying to fall asleep they just can't turn their mind off, or even if their mind isn't racing, they just can't calm down. Their body can't relax and settle into sleep. They're staring at the ceiling, it can cause fragmented sleep. And that wired-but-tired, again, typically occurs in people who are under chronic stress.

Gazella: Yeah. And you know the other day when you and I were talking as it related to the hyperarousal hypothesis, you were telling me about something else that was new to me and it was called social jet lag. Talk a little bit about social jet lag and the research associated with social jet lag.

Neustadt: I'm so happy you brought this up because I love this as well. Fitbit, that maker of the wearable tracking devices, and tracking people's sleep as well, they had access, because of their users, to over six billion data points of sleep. And they looked at those. And they looked at the data and determined that the biggest predictor of healthy sleep, restful sleep, is going to bed at about the same time every night. Basically training our body that it's bedtime, getting that routine.

Social jet lag occurs when people are going to bed at about the same time every night during the week but then the weekend comes. Friday night they go out, hang out with friends, stay out late. Saturday night maybe do the same thing, and then Sunday comes around and they try to go to bed again at their weekday, or their work week time, and they can't fall asleep. And essentially what they've done is it's as if they've flown to another time zone and their body thinks that it's not time to go to sleep yet. And they've induced their own jet lag called social jet lag.

And so one of the things that Fitbit found, and I think one of the most impactful things, is showing that getting that regular bedtime, being in that routine, going to bed at about the same time every night is one of the best things people can do for improving their sleep.

Gazella: And even on the weekend, and I'll tell, you, when you put this on my radar I, of course, had to do a little research and there's a lot of studies on this that actually show that the physical effects that you talked about with sleep deprivation earlier also occur with this social jet lag. So I think it's really important for clinicians to be aware of that. So thank you for bringing this to my attention.

So now doctors often prescribe benzodiazepine or benzodiazepine-like drugs to help patients sleep. What are some of the potential risks of these particular medications?

Neustadt: Well, the potential risks are very well documented and they increase risk for falling, dizziness, light-headedness, those risks are increased in people who are 60 years or older because their ability to metabolize the drug tends to decrease. And so because it increases the risk for falls and dizziness and light-headedness, it then increases the risk for fall-related injuries, such as osteoporotic fractures, such as concussions, such as death, even. But even beyond those risks associated with increased risks for falling, the research has shown that cancer risk is actually increased in people who take over about 132 doses of benzodiazepine a year. So that's even ... that's less than half of a year worth.

And in fact some of these risks are increased with very small and limited exposure. So you know from half a dose to 18 doses per year, the hazard risk for death is increased 3.6 times. 18 to 132 doses, the hazard risk for death increased 4.43 times in a study that looked at this. And for greater than 132 doses, it increases 5.32 times. That's 532 percent greater than somebody not taking these medications for death. And the research has shown to actually get one benefit, the number needed to treat, to have one patient benefit is 13 patients. But the number to treat to create harm is only 6 patients.

Gazella: Yeah, that's problematic. So what about the newer class of medications, like the orexin receptor antagonist Belsomra?

Neustadt: Belsomra came on the market in 2015, it's a schedule 4 drug and it's a CNS depressant. So, like other CNS depressants, like benzodiazepine, it can have similar adverse effects. Some of the benzodiazepine drugs like Lunesta or Ambien can also cause, like Belsomra, can cause daytime impairment including impaired driving skills, risk of falling asleep while driving, abnormal thinking and behavioral changes are part of the adverse events spectrum, including amnesia, anxiety, hallucinations, other neuropsychiatric symptoms, even complex behaviors like sleep-driving. I mean, you're driving while not fully awake, after taking the hypnotic. Or other complex behaviors have been documented, like preparing and eating food, making phone calls, or even having sex, without remembering it.

And so the drug has some serious risks, including worsening of depression and suicidal ideation, and the benefits of that, it can increase ... or the benefits of the medication, because all medication, it's a risk-reward calculation ... it can decrease sleep latency, that is, the amount of time to fall asleep by about eight to 10 minutes and increase sleep duration by 17 to 20 minutes.

So at the most beneficial end of that, maybe it's 30 extra minutes of sleep. But you get all of those risks associated with it.

Gazella: And are patients getting good sleep when they're on these prescription and over-counter medications? Are they getting good quality sleep?

Neustadt: Well, you raise a great point. That's one of the problems with all of these medications is they tend to increase sleep duration, sleep quantity, but they're not increasing sleep quality. They're not getting patients into that deep, restorative phrases of sleep, the slow-wave sleep, phase 3 and into phase 4, to get that good, restorative sleep.

So the quantity of the sleep may be increased but the quality has not been shown to be increased.

Gazella: So you've made a pretty compelling case that a more integrated, holistic approach is needed. And integrative practitioners often recommend melatonin for insomnia with their patients. Can you talk a little bit about melatonin and why for some patients, many even many patients, it may not be enough?

Neustadt: Melatonin is one of the first things I find that people with whom I speak, they've tried. They've reached for that. If they're going to try a natural product, they've reached for the melatonin, you know, first, almost universally.

The challenge with melatonin is that it's got a very short half life, 40 to 50 minutes. And so while melatonin is considered a circadian modulator, meaning it helps the body recognize day from night, and it is a natural hormone, a natural product that our body uses to help us fall asleep, it's not really used for sleep maintenance. And so when somebody takes melatonin to help them fall asleep, because it's got such a short half life, well 50 percent of the melatonin is eliminated from the body in less than an hour, so let's just be generous and say an hour for easy calculations. So common doses out there is a 3 mg dose. So in an hour, they've got a one and a half milligrams left. An hour later they've got .75 milligrams left. And on down.

And so 3, 4 hours later, essentially most of that melatonin is out of their body and they wake up again. I hear so often people who take melatonin, they end up waking up in the middle of the night, still. And so what do they do? Well, they might need more melatonin. And so they keep taking higher and higher doses until they're sleeping through the night and then they wake up feeling drugged in the morning. Groggy, hungover and it takes them hours to actually feel fully awake.

So the natural rhythm of melatonin in our body is that the rise in melatonin occurs around 10 PM and then it peaks at about 2 AM in the morning, and it declines at approximately 6 AM, it's declined back to baseline. And that makes sense because that's sort of the rhythm of when we start to fall asleep and when our body then starts to wake up. Of course melatonin is balanced with other hormones as well that the body is producing during sleep, but the immediate release of melatonin that people are taking is not mimicking the body's cycle of melatonin production during the night. And it's also not a complete solution because it's not dealing with the other phases of sleep, we're looking at the other hormones in sleep, GABA for example. Or the other variables that can impact sleep such as poor blood sugar. When blood sugar can drop, hormones are secreted like cortisol and epinephrine to increase the body's blood sugar and we wake up.

And so that's why melatonin for a lot of people doesn't work, because it's just not a complete enough solution.

Gazella: I think that's a really good point, that it's not a complete solution for many people and that's why you use such an integrative approach. So I'd like to really dig into your integrative approach, I'd like to talk about dietary supplements, diet, and other lifestyle factors. So as long as we're talking about melatonin, let's keep on that subject and talk about dietary supplements. Are there specific dietary supplements that you use in your clinical practice specifically for insomnia?

Neustadt: There are and it depends typically on the clinical picture. So for example if somebody has muscle aches or tight muscles that's keeping them from sleeping, magnesium can help, that can be a gentle muscle relaxant. If there's some anxiety that may keep them from sleep, well, glycine is an amino acid that's also an inhibitory neurotransmitter, that can be helpful. GABA also an inhibitory neurotransmitter used in the body available as a dietary supplement. That can be helpful. Botanical extracts such as alphianine increases alpha-wave production in the brain which is associated with calming, alert calmness. Then there are some sedative botanicals that can be helpful such as hops or skullcap, also called Scutellaria. And others.

So that's part of it and for potential, looking at decreasing the response to stress, I like using, if they're under a lot of stress, some adaptogenic herbs like ashwagandha, or jujube, magnolia bark extract. If there is vaso ... if there's an issue with hot flashes and perimenopause, pine back extract. There's a clinical trial on that showing that it improved sleep quality and sleep quantity.

And so I typically, you know, this monotherapy approach of one symptom, 1 pill, it really doesn't work when we're looking at complex pathologies like insomnia or many other chronic issues. And so I tend to like products that combine those different nutrients shown in clinical trials to work that target the underlying pathology, the underlying biochemical pathways at work and sleep and affected by insomnia in a time release or a biphasic time release delivery system because it more closely mimics the body's natural rhythm of the 2 major categories of your sleep. One is helping somebody fall asleep, you know how do we do that, and the other, over ... you know, the subsequent 6, 7 hours later after they've fallen asleep, how do we help them stay asleep?

And so that's how I conceptualize it and that's the overall approach with dietary supplements when they're indicated.

Gazella: So before I move on to diet, I know that you helped formulate and create a specific sleep supplement. I want you to tell me the name of that supplement but I also want you to tell me why you created it, because let's face it, there are a lot of sleep supplements in the market. So why did you want to create the supplement that you created?

Neustadt: So the name of the product is NBI's, my company, NBI's Sleep Relief is the name of the product. And I created it for a couple reasons.

One, just like all the products that I've created in NBI and formulated, I couldn't find the combination of nutrients or the dose and form of nutrients in a product shown in clinical trials to actually work. And I personally suffered from insomnia for years and years. And I tried a lot of different things. It wasn't helping me. I'd work with a lot of my patients trying to different things, having to dispense different bottles of products, in addition of course to working with diet and lifestyle and other psychosocial factors involved. And I couldn't find something that worked consistently.

And so I started digging into the sleep research, the pathophysiology of sleep, the clinical trials, what are the underlying mechanisms affecting sleep. And after over a year of research and formulating and working, trying over a dozen different combinations and doses, that's when I created Sleep Relief.

Gazella: Okay perfect, Sleep Relief. So now let's talk a little bit about diet. What are some of the things that you recommend to your patients when it comes to sleep, associated with diet that may not be on the radar of some practitioners?

Neustadt: So one of the big things that I see over and over is a lot of people have, may have acid reflux and they don't know about it. And because maybe it's not ... maybe they have a cough when they lay down, maybe they are just not aware that that's going on. And so evaluating for that because that can wake people up.

The other thing that I find with diet that's very important, and with acid reflux, you know, that can be diet related. There are 5 most common foods that can contribute to that and interrupt sleep, that's raw garlic and onion, chocolate, coffee, and citrus. Although other things can do it for other people. An infection can do that, H. Pylori can cause that as well. And then if they have a hernia, a hiatal hernia, that can cause it as well. So looking at that, looking at those underlying potential causes if that is involved.

The other thing is poor blood sugar control which I already mentioned. And one of the things I like to ask that can indicate if they might have poor blood sugar control is if they get that afternoon, postprandial tiredness. You know, about 3, 4 o'clock in the afternoon, a couple hours after lunch do they just get that energy slump. And that can be an indication that they're having a little bit of blood sugar control issues. Or are they waking up at the same time every night. Both of those questions can give clues.

And if that does seem to be involved, one thing that I love to try with patients ... it doesn't work very often but when it does, it's really a home run, and that is ask them to eat 8 to 10 grams of protein before bed. Protein's one of the best ways to regulate blood sugar. And so if they do that and it stabilizes their blood sugar and they then are sleeping through the night, well, again, it's a home run. I mean, there are no pills, no powders, it's just natural doing it with food and it also opens the door for even more discussions with helping them understand how they can improve their diet during the day to help, to eat, to promote ... to help them understand how they can eat, changes they can make to eat, the promote their health for the rest of their life.

Gazella: Yeah, those are some great suggestions when it comes to diet. Now let's talk a little bit about lifestyle. What are some things that may not be on the radar of some practitioners when it comes to lifestyle aspects?

Neustadt: So we talked about going to sleep at about the same time every night, that's really important. The other thing is ... and most practitioners, or hopefully all of them have heard of sleep hygiene. The research shows that about the 69 to 70 degrees for most people is the ideal temperature for sleep. Some people who, if they're in a relationship with their partner, they may like different temperatures may be most comfortable for them.

So there are wonderful things out there now, it's call the ChiliPad, that you can get, it's a pad you can put on your bed, where you can control the temperature on each side of the bed. So that can be really helpful.

Stress of course is a big issue in our society, a lot of people are under chronic stress, so anything that we can do to help people decrease their stress or better deal with stress is really important. And a fantastic study came out recently that showed that a lot of the impact of stress is not the actual event happening to us, it's how we view it. So if people view stress as a good thing, meaning "I gotta learn something from it and what can I take from this," the health impacts from stress are mitigated. If somebody sees a stressful event and they're internalizing it and they're not seeing it as a growth opportunity, then it magnifies the negative stress impacts.

So, A) getting them to just understand that mindset is really important, just when it comes to stress happening, and then what can they do to have more control over those events that may be causing them stress to decrease that stress. And that could mean creating healthy boundaries for themselves. That could mean doing any yoga or mind-body techniques. You know there's lots of things that we can offer to patients that can be incredibly, incredibly helpful.

Gazella: Yeah, I would agree. And now your approach focuses on diet, lifestyle, and dietary supplements. How important is it to focus on all 3? So some practitioners might be really focused on the person's diet, or some might be looking at their stress level, and some might be focused on just melatonin. Why is it so important to look at this from an integrative standpoint?

Neustadt: Well I think if we want to do the best job we possibly can for our patients and give them the best results, looking at it through a more integrative approach is important. And I like the approach of trying dietary supplements to give people benefit quickly. So if somebody is sleep deprived, it's gonna increase their tendency to reach for those comfort foods. I think we've probably all experienced that. And especially because what happens with insomnia and sleep deprivation, it decreases mood. It can cause depression. And sugary foods, for example, when we reach for those, it can increase our serotonin production and temporarily lift mood. But it causes this rollercoaster of insulin and blood sugar that's hard to get off of.

So just getting people sleep can help improve their mood. So I like the dietary supplement approach for triage to get them feeling better so they can make healthier decisions, have a more present mindset, be more proactive instead of reactive, while I'm working with them also on improving their diet. Transitioning to a healthier way of eating, which, the research has shown, unambiguously is the Mediterranean pattern of eating. And also stress reduction and exercise and those things as well.

Gazella: Yeah, I mean that all makes a lot of sense. And this is a very important topic and I want to thank you, Dr. Neustadt for a very interesting conversation and once again, I'd also thank today's sponsor, Nutritional Biochemistry Incorporated, or NBI. Thanks again, Dr. Neustadt, for joining me.

Neustadt: Thank you for the opportunity.

Gazella: Have a great day.

Neustadt: Thank you.

Gazella: I'd like to remind readers of the Natural Medicine Journal that we now offer free continuing education credits for naturopathic physicians. Our list of podcasts and research guides that have free CE credits is growing. For more information, just click the Continuing Education tab at the top of our Natural Medicine Journal website.

Feb 5, 2019

Statistics indicate that hearing loss is on the rise. In this interview, board certified otolaryngologist Dr. Ford D. Albritton IV describes the magnitude of the problem, as well as the research associated with key nutrients that can help reduce the risk of hearing loss. It's critical that all practitioners, not just hearing specialists, put this topic on their radar so they can help patients who already have hearing loss and those who are at risk.

 

About the Expert

Ford Albritton

Ford D Albritton IV, MD, FACS, is the director of sinus surgery at the Sinus and Respiratory Disease Center at the Texas Institute for Surgery. He has served as chairman of the board of directors at the Texas Institute for Surgery and chairman of the Department of Otolaryngology-Head & Neck Surgery at the Texas Health Presbyterian Hospital of Dallas. Innovation and creative solutions to long standing problems in his field have been a focus of his practice since completing his training at the Emory University School of Medicine. He holds patents in the fields of nutritional compounds for targeting prevention of sensorineural hearing loss based on research initiated in the early 2000s. He also holds patents and expertise in the field of sinus disease and surgery with several publications to his credit. He remains active in clinical research and has been requested as a lecturer on the subject for surgeons domestically and internationally. Current interest exists in linking dietary methods of hearing preservation to cognitive function maintenance in patients with hearing disability, defining intervention strategy, and establishing modes of prevention.

Transcript

Karolyn Gazella: Hello, I'm Karolyn Gazella, the publisher of the Natural Medicine Journal. Today we have a fascinating topic. We'll be talking about how certain nutrients can help reduce the risk of developing hearing loss, and we have the perfect expert to help us with this topic. Dr. Ford Albritton, IV is a board certified otolaryngologist with the Sinus and Respiratory Disease Center at the Texas Institute.

Dr. Albritton, thank you so much for joining me.

Ford Albritton, IV: It's my pleasure, Karolyn. Thanks for having me.

Gazella: Yeah. So, how common is hearing loss, and have we actually seen an increase over the past decade or so?

Albritton: Hearing loss is incredibly common, and it's been pretty consistent if we look at the prevalence. The National Institutes of Health actually has its own group that looks at communication disorders, and they estimate the prevalence of about 15% of residents in the US having a diagnosis of hearing loss, and currently that puts us at about 38 to 40 million.

And you asked the question has there been an increase, and it's sort of a tricky answer. Yes, there's been an increase, but so has the population increased. In 1971, that number was 13.2 million and basically one third the current number.

So, why are we seeing such an increase? Well, it's a combination of population growth and the basic dynamics of our population age. If we look at aging as a criteria for hearing loss, we can compare people that are between the ages of 45 and 54. Only about 2% of those people are going to have a diagnosis of hearing loss, but if we go up to 75 years or older, almost one half to two thirds of the population will be having a hearing loss diagnosis depending on the studies you look at. And the World Health Organization has currently estimated hearing loss at about 466 million, but by 2050 they do predict that number should hit 900 million.

So, there's certainly an increase, but it's tricky to say that that's because of something changing in the environment or our susceptibility is increasing, and their point of fact is a few years ago, pediatrics journals documented that adolescents were having an increased rate of hearing loss from comparing data between '94 and 2006. They reviewed that data again in 2010 and found that that was just simply a statistical error and that they had erroneously just compared two points of data instead of contiguous and that actually the rate of hearing loss has not increased in that age group.

Gazella: Okay, that's interesting. So, what is considered a normal hearing range, and at what range does there begin to be a problem?

Albritton: The way we measure hearing is using something called an audiogram or audiometry, and it measures sound intensity. The official measurement unit is called the decibel, which is a logarithmic measurement of sound intensity, and we define normal hearing as a threshold where a subject can recognize a presented tone at a specific frequency less than 20 decibels. So, if you're presented a tone at a low frequency or a high frequency and you can perceive it, recognize it at a sound energy level quieter or equal to 20 decibels, that's normal.

Furthermore, we use some tricks of averaging and statistics to have some simple ways of measuring. Like we will average two tones or three tones or pitches on the hearing test and come up with a number of sound intensity, and we consider anything less than 20 normal, and anything above 25 we start to believe is abnormal and probably would benefit from some sort of intervention.

Gazella: Okay, great. So, let's talk a little bit about risk factor. Who's at risk of developing hearing loss?

Albritton: Probably a number one factor is family history. So, genetics play a larger role than we really can appreciate at this point in our mapping of the human genome, but family history is probably the most important question we ask patients into mapping their risk for hearing loss.

The second one would be noise exposures, people with a high occupational noise exposure. OSHA measures that as greater than eight hours exposed at 90 decibels, so noise exposure at that rate can cause hearing loss.

And then drugs; certain chemotherapy agents, some antibiotics are notorious for being toxic to the inner ear. Certain infections; one of the great benefits of immunizations and the reason we recommend immunizations is to prevent some of these preventable causes of hearing loss. Maternal infection of mumps, measles, rubella, for instance, can have devastating consequences on a fetal ear development and could have consequent hearing loss.

And then finally, sort of our chronic illnesses, diabetes, hypertension, heart disease can compromise blood flow and health to the inner ear causing problems. Inflammatory conditions such as rheumatoid arthritis, certain inner ear inflammatory conditions can also cause problems.

So, it's a pretty broad area of the things that can cause hearing loss, but the biggest risk, again, being family history.

Gazella: So, when we think of hearing loss, it's understood that it obviously affects communication and how we communicate with each other, but does hearing loss have any physical impact on a patient's life?

Albritton: That's an interesting question, and I think that 20 years ago we probably would not have directly thought so. It obviously does affect sense of wellbeing and ability to interact with others, but it can affect a lot of other things.

An interesting study from last February demonstrated a correlation of hearing impairment severity and the incidence of fractures to the radial forearm, to the hip, to the spine, and it showed that patients with severe hearing impairment actually had an increased risk of fracture that was greater than the normal hearing group, and basically you had 1.4 to 1.6 greater risk of having one of those types of fracture from a fall if your hearing was severely affected. There's lots of further digging that needs to be explored such as severe hearing loss also contribute to injuries to the balance system. That's sort of outside the scope of the research at this time.

But really the most newsworthy research in the past decade is focused on the correlation of hearing loss, severity of the hearing loss, with cognitive impairment and dementia. In 2013, a paper out of Johns Hopkins authored by Dr. Lin out of their department of otolaryngology and his colleagues demonstrated in just under 2000 patients that patients with a pure-tone average, that's that average we discussed earlier, of several frequencies of over 25 decibels, they had rates in decline in their cognitive function testing that was 30% to 40% greater than their normal hearing peers. And not only that, there was a linear relation between the hearing loss severity and the degree of decrease in their cognitive function test scores.

So, that data really set off alarm bells, and health organizations throughout the world, the British health system, the French health system, Danes, Italians began looking at their population, and probably the most robust examination has been the English, many thousands of patients, have agreed with this information. They put a cognitive impairment risk of 1.6 times greater than normal hearing population with hearing impairment.

Interestingly, some of these studies took the next step and tried to assess, well, if we do something for the hearing, such as a hearing aid or a Cochlear implant, something that will restore hearing, does that make a difference in the cognitive impairment testing? And it actually does.

An Italian study was one of the preliminary studies to look at this, and they demonstrated that either a hearing aid or a Cochlear implant could actually reverse some of this cognitive impairment seen on the testing with improved scores. The French study was pretty astounding in terms of its result. Greater than 80% of their lowest scoring cognitive impairment patients tested, they showed improvement after the Cochlear implant, which was quite surprising.

So, there's a question as to how hearing loss, how is this leading to dementia? And I don't think we fully understand that yet, though there are some hypotheses, and Dr. Lin laid out about four of these. First one being is there some common physiologic pathway that's contributing to both brain damage and inner ear damage? Something like blood pressure elevations where we see some chronic ischemic changes to the brain on MRIs or diabetes or something along those lines.

The second theory is something called the cognitive load theory. Basically, it surmises that the effort of constantly trying to comprehend what is being heard takes memory resources, whether it be a neurotransmitter or other nutritive resources, and the chronicity and cumulative nature of this leads to issues and errors in ongoing brain function, the ability to maintain memories in an ongoing manner.

A third theory is that hearing loss may affect brain structure. We do know that in brains of patients without stimulation, stroke patients, et cetera, that there's certain areas of the brain that shrink, and it isn't necessarily that we lose cells there, but there are some changes in the simple [inaudible 00:11:38] of those cells and that hearing loss patients do appear to show some of those similar findings on their MRIs.

And then finally, social isolation. We know that social isolation happens with hearing loss, and we also know that social isolation is a known risk for cognitive impairment. One theory that a lot of fellow ENTs and otolaryngologists specializing in ear have known about since the '90s is that if we fit a patient with hearing aids earlier, they do better long term, and a large study in the VA looking at World War II veterans in the '90s established that patients that obtained hearing aids earlier did better with those hearing aids long term. They were able to accurately repeat words presented to them at a higher rate than their peers who had not obtained a hearing aid and had similar hearing test results. They would have basically the same level of hearing loss, but their ability to interpret speech was impaired, and the ability for the hearing aid to function with those patients was just suboptimal and were not able to get the same level of functionality from their hearing aid.

And what the theory was is that the stimulation of certain areas of the cortical brain kept those areas healthy and functioning and that the old use it or lose it hypothesis, the patients who weren't using it did not maintain that brain and it therefore degenerated, never to really fully improve.

This takes it to another level and seems to suggest that it's not just those areas of brain corresponding to speech recognition; it's rather the brain as a whole that is suffering from the lack of input.

Gazella: Yeah. Early intervention is always best, so that makes a lot of sense. Now, you mentioned social isolation. Are there other areas that are affected with hearing loss that negatively impact the quality of the life of the patient?

Albritton: Well, I'm sure that there are, and I'm sure that we're going to discover more, but I think the most obvious is isolation and its consequential potential for depression. People that can't hear, they eventually will isolate themselves in social situations because it just becomes too embarrassing or futile for them to continue trying to participate in a conversation they can't hear. And I think we all can appreciate what that feels like. If we've ever been to a noisy restaurant and we can't hear the conversation across the table or slightly away from us, we tend to withdraw. Imagine that for patients with significant hearing loss being a daily ongoing issue, and that ends up contributing to further self-isolation, but depression, and several studies have demonstrated that there is an increased incidence of associated depression with hearing loss.

Gazella: Yeah, that makes a lot of sense. Now, you mentioned genetics. So, what is the difference between hereditary hearing loss and age-related hearing loss?

Albritton: I would suggest that almost all forms of hearing loss that we attribute to age probably have some genetic component. As we look at just genetic programming for your resilience, your resilience of your skin, your eyes, your hair, your ears, all of those things are sort of pre-programmed, and most people accept multi-hit hypothesis to hearing loss. In other words, that it's not one thing; it's a multitude of things over time that lead to the cumulative and irreparable damage and that there are certain susceptibilities imparted by our genetics.

So, we would guess that most age-related hearing loss does have some genetic, if not total genetic, predisposition, and the fact that it's not 100% of patients over the age of 75 with hearing loss, rather one half to two thirds, sort of backs that up.

But in terms of congenital or hereditary hearing loss, there are certain conditions and syndromes which we know are hearing loss related, and we can diagnose those fairly young. It's the patients over the age of 40, 50, 60 that we're less able to determine. And there are some studies, though, that have looked at what we term age-related hearing loss and looked at their genetics and have identified some mutations that are fairly specific for a family group but not universally represented in other genomic studies, and they show up in certain areas of the gene pool where we know that genes dedicated to hearing messaging are present.

So, there's probably a multitude of issues with mutations over our family histories that does lead to the age-related hearing loss, so I would look at them mostly in the same way.

Gazella: Yeah. It'll be interesting to see how that research kind of plays out from an epigenetic standpoint.

Now, there's early evidence showing that antioxidants, specifically beta-carotene, vitamins A, C, and E and magnesium can be protective. Tell us about that research.

Albritton: Sure. I want to add one more little point to the last question as it'll tie into this. We do know that insulin-like growth factor 1 is something that's important in our homeostasis and our ability to fight off reactive oxygen species or free radicals, and some studies have demonstrated that this decreases with age, and some other studies have taken it a step further and looked at does this have a role in some of the age-related hearing loss, and it does appear to have some role in that.

So, it's been a natural thing for antioxidants to have been targeted as a potential therapeutic arm against the aging of the ear. You mentioned vitamin A, C, E, magnesium, and I would caution drawing conclusions to these individual compounds at this time because the data is really all over the place.

There are numerous studies in mice that have demonstrated some general improvements using a group of different antioxidants versus control groups. Some of those antioxidants include things like cysteine or acetylcarnitine. Longitudinal studies, though, looking at humans with vitamins A, E, C, B12, folate have showed different results. For instance, in men, they didn't find any difference with any of those vitamins used except in men over the age of 60 they did note that folate may have given some protective benefit. In women, they found that vitamin A and folate also helped not necessarily an age dependent result, but this is interesting; vitamin C, which has been shown to be helpful in some animal models, was actually harmful and actually worsened things in some women studies.

We know that folate is an effective cofactor. We know that it helps balance out homocysteine levels, which can protect ischemic vascular damage, so that makes sense to us that it would work. The roles of vitamin C are just straight antioxidant properties, so that suggests that there's something more than just straight antioxidant benefits.

One interesting study in Finland that was done about 10 years ago, and they call it the disco study, and it wasn't a very large study; about 20 people were given either an antioxidant vitamin or a placebo. They had their hearing tested before a night exposed to loud music and then they had their hearing tested short term and long term afterwards, and they definitively showed that the group with the antioxidants had less impact from the noise exposure than the control group.

Gazella: That's interesting. I like they called it the disco study. That speaks to the era or the timing of that study, I think. So, when we're talking about studies, the research that I read I believe also included magnesium. What would be the connection with magnesium and why would magnesium help our ears? Am I correct? Was magnesium a part of that study?

Albritton: Magnesium's a part in several of these studies, and magnesium and the metals probably have a bigger role in enzymatic cofactor, enzymes that can control either the release of certain natural antioxidants or enzymes that have some role in keeping a biochemical process in its favorable state as opposed to going to its unfavorable state. Those metals are essential to these enzymes functioning theoretically, and yes, in some military studies, the use of magnesium has been shown to be effective.

Gazella: Now, you mentioned a lot of nutrients, A, C, E, just talked about magnesium. Is the combination of nutrients important and are there other nutrients that you wish researchers would be looking at?

Albritton: Now, you're getting to what my interest is. I think yes. I think very much there is combination therapy that makes a difference. I think we're still trying to figure out what that precisely is.

There are a host of readily available organic compounds that are something we may have picked up through ethnobotany or traditional Chinese medicine or just from the vitamin industry at large, but we have found that several of these compounds do appear to help in the protection of the inner ear, the heart, the kidney, et cetera.

One of those is N-acetylcysteine in rat models, which has proven to be effective at protecting the outer hair cells of the inner ear, and one of the methods we think it works is just by scavenging the free radicals, but it does turn on the body's natural production of glutathione synthesis. So, it doesn't just target the free radicals with its own ability to neutralize them. It actually turns on the body's ability to keep producing those free radical fighters.

But there's something else that goes on. It seems to regulate the nitric oxide in the inner ear, and one of the things that nitric oxide can do is, depending on its concentrations, it can trigger a cell to commit cell suicide. We call that apoptosis. In damage that may be sublethal, damage that shouldn't cause a cell to destroy itself, sometimes that misregulation allows the nitric oxide to get so high that it ends up allowing that cell to die. And as you may or may not know, these cells can't regenerate at this time, and so that regulation of the nitric oxide is one unexpected benefit of the N-acetylcysteine.

And that's something we see in several other compounds. Some compounds, for instance ... I'm just going to give you a brief list. Resveratrol. We know resveratrol as a miracle compound that has some anti-aging properties in animals, turns on some anti-aging genes, but we found in several studies that it has a highly effective role in reducing inner ear damage in animal studies. It has not been studied in humans to date. We believe that's a real key chemical.

CoQ10 has been also very effective in guinea pig models. We know that the mitochondria stabilization appears to be important, and CoQ10 is important in the function of our energy production in the mitochondria. Replacement does appear to have beneficial effects.

One independent observation as I see patients in my office all the time with a balance disorder that we can attribute to a medication being used for their high cholesterol, and a class of medications HMG-CoA reductase inhibitors, such as the statin drugs, are notorious for depleting the body's natural production of CoQ10. So, replacement of that in patients has helped with balance preservation, and anything that helps balance preservation we can assume is also working in other areas of the inner ear as well.

There are a number of elements and compounds that we discussed. We put together in 2006 a group of compounds we thought were going to be important that included the resveratrol, the N-acetylcysteine, N-acetyl-carnitine, alpha lipoic acid, green tea extracts, flavonoids from citrus, the CoQ10, B complex, and the trace minerals such as selenium, manganese, magnesium, and have found that to be effective in some pilot studies that we have performed on patients with their hearing loss showing some actual improvement in their hearing using the compound versus not using the compounds.

We've not had the opportunity yet to complete a double blinded study at this time, but there is certain promise with this. I think the holy grail is a compound that would be able to be taken on a daily basis that would offer protective benefits to the whole body, not just the inner ear.

Gazella: Right, and when you're talking about protection, you're even talking about protection in a patient that has some hearing loss; that it can also work in that patient population.

Albritton: Yes. In fact, our pilot study really only targeted patients with hearing loss. We compared patients that had many years of hearing loss, and we had multiple hearing tests on them and then started therapy with them and measured several hearing tests on the medication, were able to compare their hearing test pre and post, and were able to make those comparisons based on a preexisting condition. And so we did see some improvements in patients with existing hearing loss.

Gazella: What about reversal? Is that on the radar or is that a little bit too pie in the sky to actually reverse damage, to have a hearing be regained?

Albritton: There's research being done in terms of hair cell regeneration. That's several decades away at best. That, if it does prove possible, would reverse it.

Now, in terms of nutritional therapy, that's an unknown. We don't have the data yet to determine that. I think it is promising that we can see improvements in cognitive function with hearing aids and with Cochlear implants, but we can't know that by correcting some of the metabolic issues or protecting the interior from damage from its own physiologic stressors or noise exposures whether that's going to actually reverse the hearing loss that has occurred. I think that's probably pretty hopeful on our parts, but never rule anything out.

Gazella: Yeah. Yeah, that's for sure. Now, given how common hearing loss is, it's likely that the readers of our journal have patients in their practice who are at risk. So, in addition to the nutrients that you mentioned, what else should doctors be recommending to their patients to help protect hearing?

Albritton: I think first and foremost is recognize how common of a condition this is and screen for it. Ask patients, "Have you had any problems hearing? Has your spouse indicated that you may be having trouble hearing you?" It's interesting that spouses tend to be the ones that send patients for hearing tests more often than the patient seeks testing on their own. And it's a known fact that only one in five patients with hearing loss is going to seek help for it on their own typically. It can take 10 years or so before patients seek help for the symptoms.

So, it can lay dormant, it can be hiding and be attributed to mumbling or volume not being turned up loud enough before a patient truly begins to embrace there may be a problem they need to evaluate.

Refer patients for hearing tests if there is a presumed hearing loss or if there's a family history of hearing loss. Any patient that is on those medications, chemotherapy drugs, certain types of antibiotics, those patients should be monitored.

One other thing that I think is very important and I think most practitioners are very good about doing, but let's remind them that noise exposure can be prevented. If you can't prevent the noise exposure, then protect yourself from it and that people that have hobbies or occupational risks should be wearing some degree of hearing protection, and just like smoking cessation's important for us to counsel, the use and adoption of protective devices should be something we continually discuss at our meetings with these patients.

Gazella: Yeah, it's such a good point that you bring up that one in five seek help on their own and a lot just kind of let it go, let it go, and yet early detection, the earlier it's caught, the better off they'll be. So, I'm so glad that we're putting this on the radar of the doctors who are reading our journal. This has been very interesting, and I really appreciate you for joining me today.

Albritton: Well, thank you. It's been a pleasure.

Gazella: Have a great day.

Albritton: You as well.

Jan 2, 2019

When it comes to testing, you can always count on a lively debate about how to best identify food sensitivity and intolerance. In this interview we review recent clinical and mechanistic research on the ALCAT test, including studies conducted by Yale School of Medicine and other institutions. In addition, general advice will be given about how food testing can help integrative practitioners create personalized diets for health and performance for their patients.

About the Expert

Roger Deutsch

Roger Deutsch is the CEO of Cell Science Systems, where he oversees research and general management. He has been involved with all aspects of the development of ALCAT technology for 34 years. He previously studied psychology at the State University of New York, Purchase and Chinese medicine at the International College of Oriental Medicine in the United Kingdom. He is coauthor of the book, Your Hidden Food Allergies Are Making You Fat, and has lectured in more than 25 countries on the topics of food, inflammation, and the aging process. He is deeply involved in supporting free education for impoverished girls and free healthcare in rural India.

About the Sponsor

Cell Science Systems

Cell Science Systems, Corp (CSS) is a CLIA licensed lab and an FDA registered medical device establishment that has developed the ALCAT test for food and chemical sensitivities, as well as GI function assays, telomere length assessments, molecular diagnostics, and this month will also be launching cellular tests for the assessment of functional micronutrient deficiencies and antioxidant status. CSS received the company of the year award in 2016 for Food Intolerance Testing, North America, by Frost & Sullivan.

The ALCAT test has been clinically validated in research at the Yale School of Medicine, where mechanistic studies were also conducted. Those studies have led to new discoveries regarding the pathogenic mechanisms underlying food sensitivities.

CSS will continue to participate in industry grant–funded, cross-border, translational research that focuses on the role of food-induced release of DNA and its role in pathology. CSS is located in Deerfield Beach, FL, and also operates a wholly owned subsidiary lab in Potsdam, Germany.

Transcript

Karolyn Gazella: Hello. I'm Karolyn Gazella, the publisher of the Natural Medicine Journal. Today, our topic is Identifying Food Sensitivity and Intolerance. I'd like to thank Cell Science Systems, who is the sponsor of this topic. My guest is Roger Deutsch, who is one of the pioneers in the field of food and chemical sensitivity testing. Roger, thank you so much for joining me.

Roger Deutsch: Thank you, Karolyn. Pleasure to be here.

Gazella: Well, historically, it's been kind of challenging to identify food sensitivities and intolerances in patients. Generally speaking, I'm just wondering, why is that? Does the research you've participated in offer any new understandings?

Deutsch: Yeah, the research that I've been involved in certainly does offer a lot of new understandings. Just to put this in context, and just to repeat, I'm sure most people are very clear on this distinction between allergy and intolerance. Just for sake of brief review, the term allergy was coined by a physician named von Pirquet in 1906 to denote an altered reaction. Then there was quite a bit of debate amongst allergists in Europe during the '20s and '30s as to what should be included in that definition of an altered reaction.

At the end of the day, they settled on including only those types of reactions that induced an immediate symptom onset, because those are more definable. Just through some research in the '30s where they transferred serum from an allergic patient to a non-allergic patient and then scratch test the area where the serum transfer took place, and they would induce the wheal-and-flare. They knew that there was some factor in the serum that caused allergy. They didn't know what it was. They called it reagent. Then, years later, in 1969, they found out reagent was IgE. Then they found out all the events that were preceding the IgE molecule and then how the IgE molecule bound to mast cells and then cross linked, which caused degranulation and release of histamine and medium symptoms and so forth.

Later, interestingly, they found out that's the same pathway the body uses to protect against infections with worms. So they called that allergen. Of course, worms are large compared to a cell, so when the immune system has to combat such a big pathogen, it's a very dramatic reaction, so there's a very dramatic release of histamine. The symptom onset, then, is very dramatic and very rapid. Then that being as clear as it was, by contrast, intolerances or sensitivities due to an enzyme deficiency or some other part of the immune system, the innate immune system underlining a sensitivity was more difficult because the symptom onset wasn't immediate. The linkage between cause and effect was ambiguous, obscure, and the pathway was unknown, so what do you look for?

A lot of different things were proposed. Before too long, people proposed looking at the white blood cell. In the 1950s, an allergist in El Paso named Black reported his usage of looking at white blood cells through a microscope, being challenged with an allergen and seeing morphological changes that then were correlated with clinical symptoms. Then that work got picked by some researchers from Washington University named, gosh. I forgot what their name is. I don't know. It will come to me later, but anyway, they gave it the name cytotoxic test. They published about three or four papers, and it became very popular and broadly used. There was a lot of political upheaval because it's something that came on that proposed a solution to a lot of problems. People don't like huge paradigm shifts, so it fell a little bit by the wayside.

We knew that there was a white blood cell component to the thing, which is logical. The immune system would underline an immune reaction. It's no mystery. When we came along, we thought, "Look. The allergists don't like the cytotoxic test." Bryan was the name, William and Marian Bryan brought out the cytotoxic testing. Allergists get upset about it, because it maybe changes the paradigm in ways they were afraid of. It was subjective, because it required a technician to look at cells under a microscope and make a judgment call as to whether or not there was a reaction. We came along in that period of time, in the mid-'80s and applied electronic instrumentation to the measurement of the cells and introduced some other standards, better controls over the allergen presentation and used the computer to interpret the degree of change in the white blood cells. We went along quite a long time observing and making the clear association that when the white blood cells would expand or degranulate or didn't become [inaudible 00:05:48], now we know undergo apoptosis or necrosis or pyroptosis, there was good clinical correlation.

We did studies in the late '80s with people who were pioneers, and had backgrounds in research and drug companies even that were interested in this field. We found that when you had an ALCAT, the name of our technology was ALCAT. When you had an ALCAT positive and if you challenged the person with the food that was positive under double blind conditions, you would get correlation about 80% of the time. When there was an ALCAT negative, you would get correlation, in other words, no clinical response from a double blind challenge, about 85% of the time. That was good clinical validation. It was building the mechanism. If you fast forward to earlier this year and last year, there had been a number of clinical studies in between, of course, but we gave the technology to be investigated to some very smart people at Yale School of Medicine.

They did a clinical study that they know how to do, a randomized, controlled, double blind, placebo-controlled trial, feeding patients either a diet that was based on the ALCAT test, eliminating positive foods or placebo group, and nobody knew who was in what group except the one coordinator who didn't tell until the end, a placebo diet based on an ALCAT test where they kept the positive foods in. They just looked at change in symptom scores over time. They saw a huge difference between the people following the true experimental diet versus the ones following the placebo. Then they looked at some chemistries. They actually banked serum at the beginning of the study, knowing that retrospectively, they'd see who had done well. Then they could go and evaluate what might have happened amongst that population that had a strong response.

They did find that, out of about 1,200 or so peptides and proteins that they assayed, that neutrophil elastase would drip precipitously in those people. Clearly, the neutrophil seemed to have some effect. They went on and did some look into what's happening inside the cell, and which subtypes of leukocytes were most involved. They did immunological studies using flow psychometry and they found that eosinophils were activated most of the time. Neutrophil elastase was being released, so obviously, there was some orchestration between these two classes of granulocytes, but the other thing they found, which is very interesting, is that there was greater release of DNA from the cells that had reacted in a positive way than there were, excuse me, reacted to a food that was tested as positive versus when there was no food in that sample or an ALCAT-negative food. Somehow, the positive reaction would induce the peripheral leukocytes to undergo some sort of process that would result in the release of toxic mediums like neutrophil elastase and others, but would also cause a release of cellular DNA.

That's an interesting finding, because over the last few years, most people are not familiar with this yet, but common sense tells you DNA doesn't belong outside the cells. It belongs either nicely tucked away in a eukaryotic cell in the nuclei or in the mitochondria. When it gets out, it can cause problems. We could talk all day about how it gets out, but there's some very smart research from Max Planck Institute, which shows that these neutrophils and macrophages and other granulocytes use, as a strategy to kill pathogens, something called ETosis. When it applied to neutrophils, it's called NETosis. Even after this cell has released free radicals, then it's to try and defend against invaders. Even though the cell is dead, a lot of the nuclear material, the histones, the DNA, merge with granules and the toxic mediators inside and the plasma membranes and the internal membranes and strip out, form these nets. That can trap pathogens, and the DNA is toxic, and kills them.

That's occurring, but if too much of this goes on and the body's mechanism for cleaning up the mess, which is mostly DNA's want, and you have the persistence of this toxic DNA in the circulation, excuse me. It causes all sorts of problems, like metabolic problems, like lupus, like arthritis, and even cancer. It's a new area of medicine, so it's interesting. We've found that the ALCAT predicts the foods that trigger the release of DNA. Now we have the next step ahead of us, using a grant that we received from one of the larger industry players, we're going to characterize the nature of the DNA that's released, because the nuance here is that if the DNA is methylated, it's not toxic. If the DNA is unmethylated, it is very toxic. We want to look at that. The expectation is that we'll find that it is mostly unmethylated, because the release of DNA is kind of chaotic and not controlled.

Gazella: That is fascinating. I have you tell you, you're talking about the 2018 study that was published in Alternative and Complementary Therapies?

Deutsch: No, this study was, it came out Yale.

Gazella: It was earlier this year?

Deutsch: Yeah, I can't remember the actual name of the journal right off the top of my head.

Gazella: Okay.

Deutsch: If people go on to CellScienceSystems.com, there are a couple of papers from Yale. The first one I spoke of was a clinical paper. That was published in EMJ Gastroenterology. The other one was another nice, international journal.

Gazella: Great. I do want to talk about the study that was published in Alternative and Complementary Therapies, but I want to stay on this topic that you just introduced, because honestly, it's fascinating to me. I think our readers will find it fascinating as well. Right now, can we draw clinical conclusions that ALCAT can be used to predict which foods might increase the release of potential unmethylated DNA, or is that down the road? Is that a clinical application right now, or is that something that is down the road?

Deutsch: I think the clinical utility has been established a long time ago from the studies from back in the late '80s where they did these double blind and placebo-controlled oral challenges very carefully and found overall efficacy of the test at 84-plus percent. There's been other studies, one that you just mentioned that also came out in last month's Complementary and Alternative Medicine with some work done at University of Northern Illinois. There, of course, they found some other pathways and some other mechanisms. They found that Serum Amyloid A, which is reflective of overall body inflammation, also drops precipitously in people who have clinical improvement when they alter diet based on ALCAT, much more so than control groups, where you have blinded sham diets being implemented.

Another validation just came out last week. This was on European Society of Clinical Nutrition and Metabolism. There was a group from the University of Pavia, which is northern Italy. The University itself was established in the 900s or the 800s. It's a very old institution, very well-respected in Europe. They found that with respect to gluten, isolated gluten, the 33-mer peptide that you can buy from chemical companies that are used in a lot of tests, some tests, and gluten-containing grains, wheat, oats, barley and rye, that the ALCAT test and double blinded placebo-controlled oral challenges with gluten and grains was also very highly correlated. They proposed, at the University, that ALCAT actually be used as a new diagnostic criterion for non-celiac gluten sensitivity.

Gazella: Yeah. There's a lot of solid research showing the clinical efficacy of using the ALCAT test. That's what I'm hearing from you regarding the research that's been done up to this point.

Deutsch: Yep. It's pretty clear.

Gazella: Great. Good. I want to step back a little bit. How common are sensitivities and intolerances to specific foods?

Deutsch: That's always a challenging question, because we don't have a clear-cut definition. Intolerances are generally induced by a lack of an enzyme to break down some component of a food, and we have an adverse reaction that may not be that severe, so lactase deficiency can induce lactose intolerance. If you bring those in, but then you get into the more nuanced types of intolerances where there's a chemical that is naturally occurring in a food or could be added in processing where the person lacks the enzyme to break down that toxin. Again, keeping in mind that all plants produce natural toxins in order to defend against pests. Nowadays, I think we see the inability of individuals to break down some of those toxins and the innate immune system comes into play, because we're increasingly depleting and compromising our ability to detoxify. Again, because of some overall changes in diet and how food is produced, the industrialization of farming and so forth.

You might find that because the body is not as efficient as it should be, breaking down a toxin the food with which the person has not had, through his ancestry, the development of those detoxification pathways, that if they have a little bit, it's okay. If they have too much, it becomes a problem or if it's the wrong time of year and there's too many other co-factors or they visited Mexico and have a disruption in their diet, then they have more of an issue with it. It's not as clear-cut as, say, an allergy where just a few molecules of the offending substance can trigger a very dramatic response. It actually gets amplified by things like Substance P in the body and spreads out, because it's a whole different pathway and a whole different animal entirely. It depends how you want to try and define these intolerances and sensitivities.

People fluctuate, depending on season, detoxification pathways, intestinal permeability, overall level of health, cofactors and so forth. If you are comfortable with a generalization, I'd say that it's very rare. We have found some, but we've had to look hard. It's very rare to find a person who doesn't have any sensitivities or intolerances. In how many? Again, it depends how you operationally define them, but it's highly relevant. It underlies a lot of inflammatory problems, metabolic syndrome and all the health issues that can come from that. It's extremely common, but I don't want to put a number on it, because we're all guessing.

Gazella: Yeah. That's interesting. It's rare to find someone who doesn't have a sensitivity or an intolerances. That's a pretty big statement. I'd like to talk specifically about celiac disease and non-celiac gluten sensitivity. Tell us about testing regarding those issues.

Deutsch: Celiac disease is an autoimmune disorder where cytotoxic T lymphocytes attack the enterocytes in the small intestine. In order for that to happen, the T lymphocytes have to recognize the allergen or trigger. The trigger, it's not really an allergen. The trigger is gluten. It's presented to the T lymphocyte by an antigen-presenting cell, mostly dendritic cells, which absorb the trigger, break down the peptides internally and lysosomes, transport it by an MHCT molecule to the surface where if there are T cells that recognize that complex, will become activated and may lead to celiac. Celiac depends upon the ability of the T lymphocytes to recognize the combination of that MHCT molecule with the gluten and gliadin peptides. If you're not genetically, if you don't have the genes to produce that specific variation of an MHCT molecule, you can not get celiac disease, so the tests for those genes, which are human leukocyte antigen GA DQ2.5 and H. They're very easy to test through PCR. We also do that testing. That test has phenomenal negative predictability. If you don't have those genes, you cannot get celiac.

However, you could still have an adverse reaction to gluten, which is not mediated by the T lymphocytes and that pathway, but it is a function of the innate immune system, which means neutrophils, eosinophils, mostly neutrophils. That's what we call non-celiac gluten sensitivity. That's what they studied in Pavia and found that the ALCAT test is measuring the activation of the granulocytes, which are mostly peripheral granulocytes, mostly neutrophils. The same thing was seen years ago with Fezzano and Stroup, working with the people at NIH in leukocyte biology labs where they challenged with gluten in experimental animals in transgenic mice whose neutrophils would glow when they became activated. They saw all this activation. It's the same pathway, but it goes further in those people who are genetically predisposed. If you go past the first lines of defense of the innate immune system and reach into the specific immune systems, T lymphocyte population becoming active, that causes the real problem.

Gazella: I see. ALCAT is actually effective for both food sensitivity and food allergy.

Deutsch: I wouldn't say it's effective for food allergy, because I wouldn't call celiac disease really a food allergy, because there's no IBE molecule. Again, the allergists only like to use the word allergy when there's IgE involved or there's an immediate symptom onset. Here, you do have other immunological reactions, more like a Type 4 reaction, whereas an allergy, in the Gell and Coombs system, is a Type 1 reaction. ALCAT will let you know whether you're going to have a problem with gluten. Exactly how that problem will manifest will depend upon many factors, your genetics and also your microenvironment, your ecology in your gut. The ALCAT will tell you both those issues, but not what we call a true food allergy with a Type 1 type of reaction.

Gazella: Right, okay. Good point. Good clarification. Let's dig into that 2018 study that was published in the Journal of Alternative and Complementary Therapies. Can you describe the objective, the method, and the outcomes of that study?

Deutsch: Going from memory, I don't have that in front of me. It was basically, again, a double-blinded, randomized trial looking for improvement in symptoms that are typically related to sensitivities, food sensitivities. We were looking at various inflammatory conditions where the control diet was, again, a sham diet where foods were taken out, but they were not ALCAT test positive foods. The test subject didn't know that their new diet instructions were excluding ALCAT test positive foods or ALCAT negative things. Then just looking at the outcomes and some biomarkers, and specifically Serum Amyloid A and body composition. There were differences seen that were pretty distinct between the two groups. There was a much greater improvement in the symptoms in the report, which is also on our website. It was, again, the University of Northern Illinois.

Dr Lukaszuk led the research project, showed that there was much greater reduction in symptoms amongst the people who were following the ALCAT test and the significance was significantly high. It wasn't something that could have happened as a function of [inaudible 00:26:01]. There was a very sharp drop in Serum Amyloid A, which a lot of people are beginning to look at more than high-sensitivity C-reactive proteins as an indicator of total body inflammation. It puts together a nice picture of that. Biochemistry is changing. The new system is less reactive and people are improving body composition and reducing their symptoms.

Gazella: Yeah. It sounds like you've got some great research going on, but I'd like to talk a little bit about the future. Can you tell us about cellular technology for identification of functional nutritional deficiencies?

Deutsch: One of my favorite topics. I used to live in Austin for 14 years. During that time, there was a lab. There was a charitable organization named the Clayton Foundation that backed a researcher of Experimental Biology Department, University of Texas in Austin named William Shive. William Shive was a protégé of a gentleman who wrote the book in the 1950s called Biochemical Individuality. That book basically explained that we're all quite different, and his experience was that he went in. Prior to the 1950s, he went in for a surgery the night before. They gave him morphine to help him sleep, and it kept him awake all night. That kind of reaction caused him to think over about how we're all a little bit different. A paradoxical reaction like that was quite pronounced. He did a lot of research just in animals and humans, looking at how we're different, and extended that concept to the idea that nutritional needs are also unique.

In the 1970s, a group basically challenged, recognized that we needed, as a profession, to have a test for nutritional deficiencies that took into account individuality. William Shive was proposed as the person to help develop it because of his knowledge in the field. He got backing from the Clayton Foundation. The Clayton Foundation, by the way, was a gentleman named Clayton who was in partnership with MD Anderson there in New Orleans. They would support research in nutrition and cancer. One of the things they did was to try and recycle the funding. As soon as something was developed, they would try and commercialize and monetize it, license it out, and recycle those funds for new things, because philanthropists want to see more and more benefit happen.

I got to know Dr Shive, and he was doing his evaluations in using the classical way of looking at lymphocyte proliferation, using incorporation of radioactive [inaudible 00:29:27] into the DNA and then extracting that after five days and measuring radioactivity and therefore inferring how much new DNA there was, what DNA synthesis levels occurred and being able to infer growth of lymphocytes, which we spoke about before. When they were stimulated by a mitogen, where a mitogen could be a plant lectin like phytohemagglutinin, which would universally induced EMD cells to multiply. Remembering here what I was speaking to you about the difference between gluten sensitivity and celiac disease. Celiac disease is, again, involving T lymphocytes, meaning it's a function of the specific immune system, so only certain T lymphocytes will recognize a pathogen's peptides being presented to it, and others won't, which is why it's not really a great test for looking at particular allergies because there's too much background noise. 99% of lymphocytes don't react to a pathogen, but 1% of them do.

After an infection or during an infection, a small number of lymphocytes that recognize the pathogen will divide in the circulation and in the lymphatics and multiply themselves, which is obviously not something that granulocytes to. He's stimulating lymphocytes with a mitogen. You want them to divide, because the ability of these cells to divide and clone rapidly enables you to produce the antibodies and the lymphocytes that will kill the pathogens. What they need to divide are nutrients. If you stimulate them, and they divide very slowly, you might look at adding nutrients into the culture. There was research done on that in the 1930s where people would take mold spores and radiate them and see that they no longer would divide. Then they one by one added back specific nutrients to see what would restore metabolic machinery. In fact, a group from the University of Chicago got a Nobel prize for that in 1958, so the idea was out there that lymphocyte proliferation could be a good marker for measuring a functional response to changing nutrients in a culture.

My early discussions with Dr Shive were, "Dr Shive, the concept is great, but why are you using this old-fashioned method that involves radioactivity if you want to count cells?" Use a cell counter. He agreed. We started to do some work together. Unfortunately, Dr. Shive passed away, but I always was fascinated by that area, and continued to work on it for maybe 15 or 20 years, looking at using cell counters to measure lymphocyte response when stimulated with a mitogen when you alter the culture medium to add another nutrient, one by one. If you found that the adding of the nutrient induced a more robust lymphocyte proliferative response, you can infer that for whatever reason functionally, that nutrient was not at optimal levels, and there should be repletion of that nutrient through foods that contain it or even supplementation.

After many years, we kind of looked at that, but we thought that even a cell counter, we're in the cell counter manufacturing business. Some people don't know it, but we're a CLIA lab, and we do these tests, but we also build cell counters and sizers that are used in our tests, because we want them to do very specific things. We found that there were other methods that we looked at that could be done more rapidly and more simply, and correlated with the cell counts. We've been validating that over the last couple of years, and we're actually going to release that testing this month, in January, to look at the levels of improvement of specific immune function when you add specific micronutrients to cell cultures. We're also looking at doing the same kind of testing under conditions of oxidative stress to see which antioxidants improve the survival of the cells when there is an oxidative stress situation going on.

Gazella: That's awesome. There's a lot of integrative practitioners who are interested in that type of personalized medicine. When you say it's available in January, is it clinically available to practitioners in January?

Deutsch: Yes.

Gazella: Awesome. That's great.

Deutsch: Yeah, we're making it available.

Gazella: I have one final question. I've been researching Cell Science Systems, and it seems like it's not just about delivering a test for your company. It's about helping clinicians personalize the diet for their patients, but then providing support regarding compliance and sustainability. Why is that so important to your company?

Deutsch: Our company is here to help. I've done this for coming on 34 years now, and I had health problems in my earlier years. I worked through it. I was an athlete as a kid and all that, played on teams and all that, but I had bad allergies. Finally, when I was in my 20s, with the help of some naturopaths in Australia, figured out that my issues were basically diet-driven. I got interested in this field. I know how, from firsthand experience, what a problem it can be if you don't know that you're eating something which causes your eczema, your respiratory problems, your fatigue, your arthritis, your migraines, so on and so forth. I want to do everything possible to have an impact. I know that's the way most people in the naturopathic community are as well. We've created some tools to help educate patients, to help them comply, to help them understand how to substitute certain things, to be able to take an ALCAT test result and have it reflect into a several-hundred-page personalized book of recipes, and then just make this all available.

We created an educational course, which actually, we'll have to go to the Naturopathic Societies and see if they'll accredit it, but we have accreditation for this from the dietitians and nurse practitioners, so it's a course that we offer. Again, we're going to present this to the naturopaths. It costs $199. Then when people go through that, then they can purchase from us these meal planning tools and other things for their patients. We're going to put a lot of this online, so it'll be very convenient, at our website for this purpose, called GutHealthPartners.org, and just make compliance a lot easier so people stick with it and get the benefits. That's what we're doing.

Gazella: That's great. We also have a lot of dietitian and nurse practitioners who are readers of the Natural Medicine Journal, so I'm sure that they'll appreciate that. That sounds like a wonderful mission for your company. This has been very interesting. Thank you again, Roger, for joining me today. Once again, I'd also like to thank our sponsor, of course, Cell Science Systems. Have a great day, Roger.

Deutsch: Thanks. Thanks for having me, Karolyn.

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