Show 1200: Making Sense of Changing Nutritional Guidelines

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We've been told to avoid red meat. Then some study said the risk was minimal. What should we believe? This is the people's pharmacy with Terry. And Joe Graydon if experts can't agree about how to interpret Nutritional Studies House the public supposed to keep up with changing nutritional guidelines. It's not just read meter. Processed meat like Bacon are Rami. Some new research suggests that even poultry might pose a problem. Dr Aaron Carroll Helps US interpret risk. What should we worry about? And when should we relax Doctor Joann? Manson led the vital study which looked at the possible benefits from fish oil in Vitamin D. What did the data reveal coming up on the people's pharmacy making sense of confusing statistics? Welcome to the People's pharmacy. Terry Graydon Joe Graydon. Everyone knows that eating red meat is bad for you right except the data are surprisingly slippery a few months ago. Several articles suggested that meet might not be so bad after all recently. Another analysis showed a link between meat and cardiovascular disease for clarification we turn now to Dr Aaron Carroll Professor of Pediatrics and Associate Dean for Research Mentoring at Indiana University. School of Medicine. He's also director of the Center for Pediatric and Adolescent Comparative Effectiveness Research Dr Carols. Most recent book is the Bad Food Bible. How and why to eat simply welcome back to the People's pharmacy. Dr Aaron Carol. Thank you very much. Remmy Duck Carol. It seems as if food fights are the biggest controversy in medicine today. And you've written a really fascinating article in the New York Times as usual. The title meets bad for you exclamation mark. No it's not exclamation mark. How expert see different things in the data? Well tell us about this latest study about meat. It's got a lot of folks up in arms while there were a bunch of studies actually published Gosh it's gotta be like two couple months now ago in annals of internal medicine a group of researchers got together and tried to look at all of the evidence as to how meat affects health and they conducted a bunch of systematic reviews and Meta analyses. They looked at how diet with meat affect how they looked at how meat consumption and our mounts affect how they looked at relationships to death to cardiovascular outcomes death from those outcomes on the analyzed in a bunch of different ways and just what they found was that the actual evidence for a link between meat and health is small in absolute value and not of great quality with respect to the evidence and so based upon all of those studies. I think there were four of them. They wrote a set of recommendations and the recommendations basically came down to given that we know with great certainty about this link and the link appears to be very very small for most people. Most people can probably keep eating the same amount of meat that they have been eating for some time and as you can imagine that is quite controversial as it flies in the face of nearly every other recommendation from every other group. Which would argue that. We need to eat much less meat that meters associated with terrible outcomes including cancer including death including heart disease and that everybody needs to eat less meat and in most of those other sets of recommendations or guidelines from other groups red meat in particular and processed meat in double particular are seen as Particularly negative for health so eating for example a hotdog or Bacon. Oh my goodness what a sin. It just drives a lot of nutrition experts crazy. Yes quite sure that that the the links are real that the links are large and that if we could convince everyone to eat less bacon for example or eat less steak or a hamburger That we would see massive changes in the health of the population and so lots of groups are very angry at this new set of research and studies and took exception with it other groups supported it and thought it made you know quite good sense to to look literature and the researchers wet so Dr Carol. How can intelligent well educated people come to such different conclusions based on essentially the same bunch of data while we should? I say that you know. Even intelligent well-intentioned people can get quite passionate and tribal about arguments about these and that even when their intentions are good. And they believe that they're in the service of of Science and truth that they can become wedded to one side or the other in ways. That probably aren't productive but even with the best of intentions people are going to disagree on stuff like this. For a variety of reasons one is that we just only have a certain kind of evidence. The vast majority of research with respect to how do nutrients effect health is what we call observational research. Get a bunch of people together. We ask them what they've been eating for the last ten years we look at how healthy they are and then we try to correlate what they've been eating with health. The problem with that is numerous one is that it's incredibly hard to look at high risk outcomes because still in the scheme of things things like heart attacks and death in cancer are pretty rare. And so unless you're focusing on a very very high risk population do numbers of these bad outcomes that are current studies are pretty small and of course if you look at Irish populations that doesn't translate well to what happens to not Irish populations which is what recommendations are supposed to be written for secondly we because we have observational research. It's never going to be causal it's always going to be confounded and that means that you know people that eat a lot of let's say bacon might also tend to smoke might also tend to drink too much. Alcohol might tend to be poor might tend not to exercise. All of those things are certainly associated with bad outcomes and it might those might be the cause. It's very hard to tease out. What happens with one nutrient? Another problem is that while the relative risks can be high in fact the one that's often Mo- siders the processed meat serving process me to a will increase your risk of cancer by eighteen percent over the course of a lifetime. That's a relative risk that that means that compared to your old risk and went up eighteen percent but if you're starving risk was only two and a half percent then that eighteen percent increase musical from two and a half to three point two percent. That's not as big a deal as eighteen percent for most of these studies. The absolute potential risk increases are much smaller than that and so for an individual if the risk is only up by point five percent then then that means that if two hundred people make the change hundred and ninety nine will be unaffected. One will on the other hand. Some people argue. We should be looking at things at the population. Level that if we have a million people or two million people then that same risk increase might save ten thousand people. Of course one million nine hundred ninety thousand or unaffected but you know when we talk to individuals about what they should or should not eat. They care about their individual risk. A lot of people who are pushing some of these recommendations are much more focused on the population risk in the population level. That's not how individuals think on how people think and a final reason. I think the people will often good with good intentions. Really disagree about this has to do with you know. Should we take preferences into account? Some people really really like meat and it may be that they're willing to take that tiny absolute risk in exchange for getting the EAT. Lots of meat now. The counter to that is people will say well. We don't ask people if they like smoking. We unequivocally tell them smoking is terrible for you and you should never never never do it. But those things are not comparable. The the risk increase for smoking is on the order of like ten thousand percent or twenty thousand percent not eighteen percent and that's of course the relative risk people who smoke quite a bit will increase the risk of certain cancers by literally that amount ten thousand or twenty thousand percent when the risks are that high in that clear preferences shouldn't come into account but when they're small five ten fifteen percent in a relative risk and it might get infected probably arguably is reasonable to say that people should get choose. We take on risk every day. We drive we ski. We Scuba dive. All of those things are risky and yet we say it's okay because people adults can make decisions to take on risk if it's for things that they enjoy and for a lot of these things. The absolute risks are very small. Carol one of the challenges of course is that August organizations. You know the Food and Drug Administration the Centers for Disease Control and Prevention. The American College of Cardiology. The American Heart Association various organizations especially in the health field put out guidelines and one something is in a guideline. It's like if you're a doctor and you don't tell your patients not to eat meat. You will be spanked. You're not living up to the best practice of medicine. Tell us a little bit about you. Know moving from beliefs which is often where we start to guidelines even when the data changes. Well here's part of the problem is that they're eas- no one accepted methodology for producing a guideline in fact. Different organizations will often submit or produce. I should say guidelines on the same topic did come to different conclusions for that reason. Some organizations like the United States Preventive Services Task Force do have a much more rigorous methodology. Which is why a lot of the guidelines they put out come out with what is known as an eye rating like an a rating is like big effect. We're pretty certain. Listening to what we're saying. And A B rating might be smaller effect with certainty or perhaps a big effect with less certainty. But we're still pretty sure and then of course like a derating might be. Don't do this. There's there's just evidence not to do this. But a lot of recommendations get an eye rating meaning. We just don't know like we don't have adequate evidence to determine what to do. And for instance whether or not we should universally screen kids for autism which seems like a no brainer gets an eye rating from the US PS PF. Because they say we just don't have enough evidence to know what universal screening. We'll do so when it comes to something like should we eat a lot of meter. Not they'd probably say we don't really know the effect is small. It's not certain benefits and risks or even we just don't know what most organizations don't do that they wanna tell you to do or not to do something. And so they wind up coming out with with instructions. Even when we're not terribly sure and unfortunately this leads to reversals. For instance for decades certainly for years if not decades the USDA was telling people to limit how much cholesterol a day and it's only in the most recent set of guidelines that the evidence finally got up to them and they're like yeah cholesterol really non nutrient of concern. It turns out that what you eat in. Cholesterol is not the driver of cholesterol. So avoiding all those eggs probably didn't make much of a difference well but that's not what they said for decades for decades said. Oh my gosh you've got to limit your cholesterol. We gotTA BE EGG. Whites have to limit your shrimp. You gotta be really on the ball for this. There was never a hedge. There was never a well. We're just not sure the evidence it's always with certainty and unfortunately because I think organization speak with such certainty even when the evidence is only observational even potentially confounded even when the absolute risks are very small that we get stuck in places where it's very difficult to reverse themselves and I think that's where a lot of organizations are finding themselves right now after a long time of arguing. We are certain you must do this. It's very hard to turn around and say we will all you're listening to Dr Aaron Carroll Professor of Pediatrics and Associate Dean for Research Mentoring at Indiana University School of Medicine? He directs the Center for Pediatric and Adolescent Comparative Effectiveness Research. His latest book is the Bad Food Bible. How Y to eat simple. After the break Dr Carol will explain the difference. Between Relative and absolute riffs. Let'S THE NNT. And why does it matter? We'll touch briefly on statins cholesterol and diet. What actually makes a difference between? You're listening to the People's pharmacy with Joe and Terry Graydon. The People's pharmacy podcast is sponsored. In part by Kaya -biotics K. A. Y. A. -Biotics offers the first probiotics which are both certified organic and Hypo allergenic. I'll probiotics are produced in Germany. Under laboratory conditions with high quality ingredients and under strict regulatory oversight the three available formulas are created for very specific purposes such as strengthening the immune system fighting east infections and helping with weight loss to learn more about Kaya -biotics probiotics and the important topic of gut health. You can visit their website. Kaya -BIOTICS DOT COM that's K. A. Y. A. -biotics dot com. Use the discount code people for ten dollars off your first purchase. Welcome back to the People's pharmacy. I'm Joe Graydon Terry Graydon. The People's pharmacy is brought to you in part by COCO via the maker of high potency. Cocoa flavonoids supplements that support cognitive and cardiovascular health more information at Koko via dot com also by verizon an analytical laboratory providing home health tests for hormones gut health and the microbiome online at V. E. R. I S. A. N. A. Dot Com to they were trying to make sense of changing nutritional guidelines. Our guest is Dr Aaron Carroll Professor of Pediatrics and Associate Dean for Research Mentoring at Indiana University School of Medicine. He directs the Center for Pediatric and Adolescent Comparative Effectiveness Research. He's a regular contributor to the New York Times upshot column and has written three books debunking medical miss. His latest is the bad food Bible. How and why to eat sinful. Dr Carol you have mentioned the difference between relative risk and absolute risk and a lot of other. Our other guests have also discussed this. But you know I I would have to say. Journalists are in part to blame and in a sense. You're a journalist. I mean you do right for the New York Times after all but you know if you're a journalist and say the relative risk is maybe a fifteen percent reduction or a fifteen percent increase. That sounds kind of sexy. That almost sounds like it means something whereas if you say. The absolute risk was point seven percent who cares. I mean it's like Nah didn't do much. Why should I pay attention to this article the headlines GOING TO BE BORING? So how do we basically change? Not just the health professionals approach because they do the same thing when it comes to medications but also the writers journalists and then hopefully the readers who really will begin to understand. Oh yeah that relative risk of seventeen percent. That doesn't tell me anything. Yeah I wish I could give you a good answer about one. This is going to happen because the cynical party says it will never have. I mean there's a reason that every advertisement that you see that every doctor trying to get you to do something and then every news story. C is always going to cite the relative risk. Because it's always going to be bigger and journalists and media people want clicks. They want views. They want people to read. And telling you that something is going to raise or lower by and large amount is always going to get more attention than that's really really really small and so almost every single story you will ever read. That seems to you to be frightening is going to be a relative risk now of course if you read the articles I write. I laser focused on the absolute risk. And I make this point over and over and over again because this is almost my biggest pet peeve but if there's a disease out there and it has a fifty percent chance of killing you and I reduce it to a twenty five percent chance of killing you with the pill. That's a fifty percent reduction in risky. But that's massive. I mean I dropped you from you know to win four to a one in four chance of dying. That's huge but if the risk of something killing you was point. Oh five percent and I reduced it two point. Oh two five percent that is also a fifty percent reduction but but affects almost nobody tens if not hundreds of thousands of people would have to take the bill before they would see a benefit and of course what we call them. Go ahead. Well I was GONNA say the latter scenario is more common. Oh yes I was GONNA say. Almost every drug you've ever taken is much more like the ladder. There's a there's a statistical the number needed treat. Basically you figure that out by taking a hundred and dividing it by the absolute risk reduction like how much absolutely risk doubt so in the first scenario if we went from fifty to twenty five percent. That's a twenty five risk reduction. One hundred divided by twenty five is four that means for every four people to take the pill one's going to get a benefit. That's amazing. Almost. Nothing in medicine works that way on the other hand. If the absolute risk reduction is let's say point one percent then creates a thousand thousand people have to take the pill for one person to see benefit and nine hundred ninety nine will not. That's almost everything we do in medicine. It's certainly almost everything we do. With respect to food and so we're asking thousands of people to change their diets forever knowing that maybe what may see a benefit and that all the others will not eat perfectly rational unreasonable for lots of people to say? I don't want to do it. It's just not worth I'd rather live. You know the way that I want to live unless the risk is really high now of course if the risk is really high if they're in a high risk group it's GonNa make a huge difference then of course it makes sense you know people have sealant. Disease should not eat gluten. We're not talking about a tiny absolutely risk reduction. We're talking about a massive risk reduction and that's real but for most healthy people reduce includes GonNa make almost no difference whatsoever and so therefore there's really not much reason to do it out decker. Cara one of the one of our favorite examples of absolute versus relative risk. Reduction comes out of an advertisement for I think it was for Zocor. No lipitor for lipitor. Okay and so this advertisement which I'm sure you have seen said you know. Thirty percent. Risk Reduction thirty six percent. Risk reduction sounded like a lot and what it came down to is over the course of five years. In the Placebo Group. Three people had a heart attack and in the Lipitor Group. Two people had a heart attack over the course of five years and that was thirty percent. Thirty three percent risk reduction it. It doesn't make lot sense does it. Well what if there were ten people in the study but there were thousands of and that's the point. It's really the absolute risk of matters. It'd go from thirty percents to twenty percents or did it go from you know point. Oh three percent two point. Oh Oh two percent those really really really different things but of course the news and the Drug Company everyone else is. GonNa call it. Oh an absolute relative risk reduction of about a third and that's it it's it can scare people who are people to put the behavior change but it's not an accurate representation representation of your individual benefit now. Well we're on the topic of cholesterol. A lot of people have been told and understand that. It's a bad thing to eat. Foods that are high in cholesterol. So so it's important. It's important to understand that you know the vast majority of the cholesterol in your body is actually made by your liver. Because of course cholesterol has a function. It helps moving things around in your body and so still people thought while people that eat a lot of cholesterol are going to have high cholesterol and they did some studies. They were observational in nature. That showed that perhaps people that it a lot of cholesterol had more associated with high slightly higher levels on the whole of cholesterol but then finally they got around to some randomized controlled trials and the actually also got around to doing some better research with the observational Peter. And they took people even people say with diabetes and they randomized them to. Hey you eat a couple eggs every day for months and you eat no for a month and then we'll check your cholesterol and then have you your diet and we'll wait another month. We'll check it again. And they found for the vast vast vast majority of people didn't matter that the cholesterol level was being produced by the body had nothing to do with how much cholesterol they were. Actually consuming and these studies are not new. A lot of them have been you know decades old and still it took until I think it was the two thousand fifteen guidelines for the. Usda to finally changed their tune and catch up with the science and say you know what we eating. Cholesterol is not that big a deal. It's there are lots of other things that are related to it. Some people think saturated fat might be related to it but actual cholesterol. The idea of eating eggs is not what drives you to have high cholesterol. But it's amazing that they still hasn't permeated people's consciousness. I can't tell you how many people are still looking trying to go to F beaters or two to other egg substitutes or eating eggs omelets which are a crime against nature and in order to try to reduce their their cholesterol. It just doesn't work. Ironically enough. I wrote about this a couple of years. I mean I think it was one of my first article in the New York. Times editor rose because my daughter loved eggs and really wanted their bags breakfast every day and my wife because the nurse practitioner was really against it and we were sort of like not arguing out of participating. Because I'm not sure this is a problem and that was really when I started digging into literature on that in our first book that I wrote on the certainly written a bunch of papers on it but and everyone is finally caught up. And now you know my daughter and my waste have eggs for breakfast most weekdays which also makes the dog. Rahab because he loves the scrambled eggs. But you know it took this kind of change even in my own household to to get even my own family members to understand that this. There's just no evidence for this. There just isn't an in fact there's evidence against it that that consuming cholesterol for most people doesn't make a big difference in even for the people that does it's an incredibly tiny absolute difference. Well you know Dr Carol. Even when a massive study comes out you know like the one in the annals of internal medicine about meat or even when studies come out and they go you know that saturated fat problem that everybody's been worried about for decades it it. It may not be as bad as we all think. Even when there's data people's behavior doesn't change much so once. The study has disappeared without a trace. Once it's out of the headlines once your article has sort of disappeared into the the Great Internet people are still told no more meat avoid saturated fat watch out for cholesterol. It's GonNa give you a heart attack and for sure. Don't eat any salt that too. Yeah I well. Here's the thing I would say. There's there's both pessimism and optimism here. I think the pessimism comes from the fact that like we have not stopped having these arguments and we will continue to have these arguments. The optimism is. I don't think most people are listening. you'd have to live under a rock not know to know that lots of people think that eating meat is bad for you and most Americans I think have just stopped listening And the same thing I think is going to happen with salt. It's things are going to have with a variety of things because we continue in the sort of academic world to continue to argue about these things and then get upset when people refuse to listen. I'd argue that people are sort of acting rationally. They're hearing that. There's not certainty they're hearing that you know. Even if there's some relative risk reduction of population level that it for an individual it doesn't matter too much. They're hearing that you know. Everybody should change their behavior. But we're not necessarily sure if there's confounding so I don't know they might be acting rationally now. People who think this stuff is terrible for you. We'll tell you I'm doing everyone a disservice and that you know the fact that people aren't listening is a bad thing. I'm going to come down on the I think. In this case there's not nearly certainty or the absolute risk that that so many believe and therefore. It's quite rational that the people aren't listening. There's another area where people are really at the mercy of their health professionals in particular. They're cardiologists and in extra particular. Their interventional cardiologists so changing gears. Here for just a SEC. There has been a ongoing controversy for decades about the value of angioplasty and a stent in patients that have something called stable angina. And I'll let you tell our listeners. What that means. Because for years an interventional cardiologists would squirts some die into a catheter. That would go into the heart. And there'd be some blockage in coronary artery and the person had no symptoms and so the person has told your heart attack waiting to happen. You need a stent and you need it like yesterday and so a lot of stance. A lot of angioplasties have been done and a lot of Bypass surgery have been done over the last two or three decades to quote unquote prevent a heart attack. Well there was a study that kind of undermined that thinking and it was. You know a lot of controversy. A lot of cardiologists push back but then not long ago came another study the Big Kahuna of studies and once again it said You know medications and lifestyle changes are justice effective at preventing a heart attack or prolonging your life as having a stint place. So can you put this all into perspective? And how a patient who has told? You're a heart attack. Waiting to happen is supposed to react well. Part of the problem is that we recognize when it comes to medications entered the food and a lot of interventions that the placebo effect is a big deal that if people believe they're being treated that can have a massive effect on on their outcomes With respect to procedures. We rarely care or do that. Because we we just assume procedures work if we see a benefit. How could it be placebo effect? Nobody can will away a heart attack and so it or will away heart pain that can't happen and extending must work so the big study. That happened a couple of years. Ago was an actual randomized controlled trial where they had strict criteria for who who met stable angina and then they randomized them so half of them they basically threaded the catheter. All the way up there and then put in a stent and for half of them. They threatened the catheter. All up there and then did nothing. And they didn't tell the cardiologist and they didn't tell the patient whether or not they got stints and then they check them out weeks later and they couldn't tell which ones have the spencer not because they look they had the exact same outcome. That's horrifying because it means that the placebo effect is real. Even with respect to this the benefits people were seeing. Were not related to the stand. They were just chance or or placebo effect. And it's real now. Of course cardiologists. Were very angry about this because we put a lot of stents and they argued against the study about well the sense that I use only for sick patients and this and that but we know that lots of people are getting stamped to meet criteria for not doing and the more recent study confirmed. I mean again. We've seen that for some of these that that when we actually do placebo controlled randomized controlled trials that the benefits are not nearly as drastic as people think and. I don't want to just pick on cardiologists. This happens for lots procedures. My favorite one was in the early two thousands arthroscopic surgery for osteoarthritis of the knee was like the most common procedure done in the United States. And then they finally randomized controlled trial where they gave one third of the people arthroscopic surgery and one third of the people got. La's which is basically just wash out your neighbor sailing and one third of the people. They they made an incision twiddle their thumbs for twenty minutes sewed it up and told them they had arthroscopic surgery. And they all say outcomes today arthroscopic surgeries much less comet gluing for for deebo plastic for for certain fractures of the Vertebra a lot of these. When they finally put them down to randomized controlled trials. It turns out the procedures performed no better than a sham procedure or or just placebo effect and again are fine but we don't do really unfortunately well designed clinical trials for too many things and we just assume this stuff works and we assume it makes a big difference and then years later we find out we were wrong. Dr Carol we are almost out of time. What message should our listeners. Take Home Today. I think that the best one is that it's totally reasonable to first of all ask your physician when they're prescribing a recommending. Something to you about. What's what's the wheel. Absolute effect I. Can you know that I should expect to see from this? The second I think that too often we only look at one side. We look at the benefits or we look at the harms not both sides of the story and with all of these. There are potential. Harm their potential downsides of making these changes even if those are joy and those should be measured against the absolute benefit. You might see or the absolute harm reduction. You might see from making a change or undergoing a procedure. And you've got to think about both Dr Aaron Carol. Thank you so much for talking with us on the People's pharmacy today anytime you've been listening to Dr Aaron Carroll Professor of Pediatrics and Associate Dean for Research Mentoring at Indiana University School of Medicine. He's also director of the Center for Pediatric and Adolescent Comparative Effectiveness Research. He has co authored three popular books. Debunking medical myths has a popular. Youtube show called healthcare triage and is a regular contributor to the New York. Times the upshot Dr Carols. Most recent book is the Bad Food Bible. How and why to eat centrally. After the break we'll talk with Dr Joann. Manson about the clinical trial. She led called vital. What questions were the scientists trying to answer? A randomized control. Trial like vital is considered a scientific gold standard. They examined both vitamin D. N. Fish Oil. What helped and how much what didn't help at all. You're listening to the People's pharmacy with Joe and Terry Graydon. This people's pharmacy podcast is brought to you in part by Verizon A- dot Com verizon lab offers home health tests that allow you to monitor your hormones and health conditions you can take control of the quantitative assessment of your health and learn about male and female hormone balance the stress Hormone Cortisol Leaky Gut. Gluten intolerance or your gut microbiome take a more active role in tracking your health and take twenty percent off your first order of a male intesting opportunity with the Discount Code People that's P. E. O. P. L. E. All upper case to learn more go to verizon dot com that's V. E. R. I S. A. N. A. DOT COM Welcome back to the People's pharmacy. I'm Terry Graydon. And I'm co Graydon. The People's pharmacy is brought to you. In part by COCO via offering plant based nutrients in the form of COQ. Au flavonoids for brain and heart health online at Koko via DOT COM and by Kaya -biotics probiotic products made in Germany from certified organic ingredients Ky. -biotics dot com. Many people. Think there's no science support. The use of supplements our next guest has been conducting well controlled large studies to examine that precise question. Doctor Joann. Manson is chief of the division of Preventive Medicine at Brigham and Women's Hospital. She's also professor of medicine and the Michael and Lee Bell Professor of Women's Health at Harvard Medical School Dr. Manson is the principal investigator of the vital trial. Welcome back to the People's pharmacy. Doctor Joann Manson great to be here. Thank you Dr. Manson. You are the principal investigator for the vital trial. Would you tell US briefly? What you and your colleagues were hoping to discover in this trial in how you went about it. So the Vitamin D. Omega three trial vital is now a completed a randomized clinical trial in more than twenty five thousand men and women nationwide in the United States looking at the effects of vitamin D supplements at a dose of two thousand. And I use a day and also omega. Three FATTY ACIDS EPA DHA fish oil at a dose of one gram -Oday in the prevention of cancer and cardiovascular disease where we were able to look at the independent of each of these supplements and we could look separately at vitamin D separately. It'll make us reason as well as their affects in combination and we treated the participants. They were the double blinded trial. They were taking study pills from a blister. Pack a calendar pack and the intervention went on for a little over five years and we recently published the findings and What we saw were some promising signals but overall no really clear cut Benefits of the Vitamin D. Or The Omega. Three fatty acids in preventing cancer or cardiovascular disease but what we Where we did see the promising signals were for the Omega threes. There was a suggestion that those who had low fish consumption at baseline those who came in eating less than the average amount of fish which was one and a half servings per week they did have a significant reduction in the primary endpoint of major cardiovascular events. Heart attacks strokes. Cd death and in the overall Trial we did. See a significant reduction in heart attack with the Omega threes. About Twenty eight percent reduction for Vitamin D. We saw a signal promising signal for reduction in cancer death that once we accounted for cancer. Latency that we we looked at those who had been in the trial for. Let's say two years. There was a statistically significant reduction in cancer death But we did not see a significant reduction in the primary cancer and point of Total invasive cancer so the results are complex but I would say both of the interventions voces supplements had promising signals. That we WANNA follow longer. We want to see if over time the benefits become more clear-cut or whether over time these benefits just appear to Should go away so long. Term Followup up is needed and At this at this point we're certainly not recommending that everyone in the world begin taking vitamin D. or Omega threes but but actually There are some subgroups who may benefit Those who have low fishing take may WANNA talk with their healthcare provider about taking a n Omega three supplements vegetarian. Their algae-based forms of the Omega threes of the fish oil or EPA DHA and for Vitamin D. It's the signals. Were promising. There were no adverse effects. And so we're saying if you're already taking in two thousand and I use a day. There's an urgent need to stop based on the results of this trial. Manson please explain why this kind of research is so crucial to making determinations about what people should do what we call our. Ct's randomized control trials the gold standard and this is kind of the platinum standard because it went so long and it was so well controlled That compared to what we would perhaps referred to as epidemiological studies where we look at populations and they tell us what they're eating or what they're not eating so tell us the significance of this research. Place boy it is very important to have random association. The process of random station which is like flipping a coin. Everyone who enrolls in the trial is randomized either. The active or the placebo group by the computer. It's totally random. Ki- you know flip of a coin process. This ends up balancing out all the other risk factors for the point of interest especially in a trial. This large twenty five thousand plus we were able to have very similar distributions of cigarette. Smoking physical activity dietary factors. A history of high blood pressure diabetes cholesterol all of these variables balanced out between the active treatment group and the Placebo Group. Therefore any result that we saw we can feel reasonably confident especially for the primary and pre specified secondary endpoint due to the treatment itself and not to other factors when you're looking at people who choose to take supplements who who take for example a vitamin D supplement or fish oil supplement. Sometimes are there other factors? That can what we call confound the associations so people who take supplements maybe more health conscious they may be more likely to exercise or to follow a healthy diet or to be more compliant with medications that had prescribed for them such as high blood pressure treatments or statins for High Cholesterol. Other medications for high cholesterol. So sometimes you see a lower risk in those who are taking supplements but it's not a cause and effect relationship. We often say in epidemiology that correlation does not prove causation. There could be a lower risk correlated with Taking the supplements but the lower risk maybe due to other factors such as a people who take these supplements are more physically active but doing a randomized controlled. Trial takes care of that. I care of it. Took care of virtually all of those factors if the trial is large enough. Everything looks very similar in terms of other Factors risk factors lifestyle behaviors. They get balanced out by the randoms. Ation Process Dr Manson. I think a lot of people are confused about supplements because there have been a number of articles written in the last several years by health professionals. Who Say oh. Don't waste your money. It's just GonNa be expensive urine. These dietary supplements these vitamins. These minerals. They don't do anything or even fish oil or even fish oil for that matter. There've been studies that say is pretty much worthless and now we have this study which suggests that actually might in higher risk patients or people who aren't eating fish that they might see a reduction in heart attacks for example if we look back at one of those early Staten Studies involving lipitor used to be advertised that it lowered the risk of heart attack by around thirty to thirty three percent so relative risk reduction. Not that different from what you found yes for for heart attack itself. The results were quite similar to what scene with the staten? The overall for total cardiovascular events heart disease strokes ebd death the results have been more impressive for statins. However there's also some evidence from a what we call a. Meta analysis we just published a combination combining all of the different randomized trials. That have been done of the Omega threes and looked at whether there is a dose response relationship that there's a greater benefit in those who take the higher doses and there does appear to be a dose response so we're now interested in testing higher doses of the Omega threes which may confer greater risk reduction for both heart disease and stroke the dose that we tested did not have benefits for stroke but did have show a reduction. In the Coronary Heart Disease Outcomes now Dr Manson we we're looking today also the question of guidelines and how guidelines may be guided in fact by research and. I'm wondering if you have any thoughts about how the vital trial might contribute to guidelines about what we all should be doing. Well I seek that guidelines really need to start taking into account subgroups of the population who may benefit more than others very often especially in primary prevention the guidelines have been much broader. You know in general for the total population. Don't take this or do take that and very very few treatments are Preventive Mo. Modalities will ever pass that test that they will be of benefit to everyone in the population. Very very broadly. But I see that. The various experts and clinicians researchers looking closely at the vital findings will see that there is a clear signal that those who have low fish consumption had a reduction in their cardiovascular events in their heart disease events looked at separately and those who started out with higher intake did not and that guidelines could include recommendation specifically for people who have higher or lower intake of these nutrients from from the Diet. I think that that would be an important step forward We'll have to see if the guidelines will be modified but I think that there may also be an interest in seeing other trials of for example the Omega Three for CD Reduction. Because most of the earlier trials were in populations that already had heart disease already had a history of cardiovascular disease. Vital was one of the very first trials to look at primary prevention people who already have a clinical cardiovascular event to see if Omega three supplements could prevent a first heart attack or I cardiovascular event so perhaps with an additional trial showing benefits of Omega threes maybe even greater benefits with a height with higher doses. And also this dose response in terms of if you start out with low intake of fish low intake of Omega threes. You may be more likely to benefit that could be enough to really influence the guidelines for only three supplementation and for Vitamin D. It's unlikely that there will be a change. A major change in the guidelines at this point because overall the results of the Vitamin D supplementation. Trials suggest that what has already been recommended by the Institute of Medicine now known as the National Academy of Medicine of six hundred to eight hundred. I use a day. Vitamin D That does seem to be enough for a bone health. Higher Doses have not clearly shown greater benefits and so far there isn't compelling evidence that higher doses will reduce cardiovascular disease or total cancer. There is a promising signal there for cancer deaths that needs to be explored further. I think there are a number of studies that can be done to delve more deeply into those findings but I don't think it will at this point. Lead to a change in the amount of vitamin D recommended. Said we did see safety of safety of today. Yeah I I'd like to pursue very briefly because we only have a minute or two left Dr Manson and that is the vitamin D. What I call it the anomaly. There's a lot of data to suggest that people who are low in Vitamin D. Perhaps because of where they live because perhaps they also use sunscreen religiously and so if they're naturally low in Vitamin D. There are a lot of consequences we we've seen epidemiological studies suggesting high blood pressure and arthritis and cancer. We down a long list of things that have been attributed to low vitamin D but unfortunately a lot of the clinical trials the randomized controlled. Trials have not shown dramatic benefits from supplementation. Why do you think that is well? I the low vitamin D disease. Associations are found. It's usually based on a blood marker for low vitamin D. And so it's you you. You can't be sure it's a cause and effect relationship so so people who have a low blood level of vitamin D do tend to have less time outdoors. They may be less physically active. They may have a less healthy diet. They may have underlying disease that interferes with Vitamin D. SYNTHESIS. It could be a marker for poor health. It's not necessarily cause and effect relationship that said we do know that's tremendously important to avoid vitamin D deficiency and. That's why for everyone. It's recommended to get at least six hundred to eight. Hundred is a day and if it can't be achieved from diet if people are not having for example fortified dairy products of the not having fish which can be high in vitamin A. or Mushrooms are foods that are that are sources of Vitamin D. Then they should take a supplement and I generally think one thousand to two thousand is a day is very reasonable. We documented safety over five years with two thousand. I use a day so if anyone has any concerns about whether they're getting enough from diet or having the foods that contain vitamin D. It's very reasonable to take a low to moderate dose supplement but avoid mega dosing because mega dosing. Getting above. Five thousand. Ten thousand. I use a day unless your clinician is recommending that specifically can be harmful doctor Joann. Manson thank you so much for talking with us on the People's pharmacy today. Thank you great thing here. You've been listening to Doctor Joann Manson. She's chief of the Division of Preventive Medicine at Brigham and Women's Hospital. She's also professor of medicine and the Michael and Lee Bell Professor of Women's Health at Harvard Medical School Dr. Manson is the principal investigator of the vital trial. We spoke earlier with Dr Aaron Carroll. He's professor of Pediatrics. And Associate Dean for Research Mentoring at Indiana University School of Medicine. He's also director of their center for Pediatric and Adolescent Comparative Effectiveness Research. Dr Carol Has Co authored. Three popular books debunking medical myths. He has a popular youtube show called healthcare triage and he's a regular contributor to the New York. Times the upshot his most recent book is the Bad Food Bible. How and why to eat simply Lynne Segal produced? Today's show our Dr Ski engineered Dave Graydon At. It's our interviews. People's pharmacy is produced at the studios of North Carolina Public Radio W. UNC. The People's pharmacy theme. Music is by J. Liederman. The People's pharmacy is brought to you in part by Verizon Analytical Laboratory providing home help test for hormones gut health and the microbiome online at V. E. R. I S. A. N. A. Dot Com and by Coco via maker of High Potency. Cocoa Flannel supplements that support cognitive and cardiovascular health more information that cocoa via dot com if you would like to purchase a CD of today's show or any other people's pharmacy broadcast. You can call eight hundred seven three two two three three four. Today's show is number one thousand two hundred. You can also find it online people's privacy dot com. When you visit our site you can share your thoughts about today's show. Have you found changes in nutritional guidelines confusing? Tell us about it at people's Pharmacy Dot Com. You can also sign up for free online newsletter or subscribe to the free podcast of the show. Never Miss Another episode in Durham North Carolina. I'm Joe Great and I'm Terry Haden. Thanks for listening. 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