The Reasons for Retraction

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Publications related to food habits are important if you’re in the weight loss field; I rely on them to help people achieve their weight loss goals. If the studies were poorly done, that’s unfortunate but behavioral science is an inexact science anyway. But if someone intentionally manipulated the data to get a specific outcome, that’s just not right. Let’s see what several scientists found when they examined Dr. Wansink’s data more closely. What were the problems?

It seems there were three. First, as I mentioned on Tuesday, he had a graduate volunteer continue to examine the data to come up with hypotheses that were significant. That means they organized the data differently and kept running statistical analyses until they came up with something that was statistically significant. As I said, that’s a no-no because of the potential of finding something by chance; you get the best answers to the questions you actually ask, so finding something by accident is not as valid among scientists.

Second, there were errors in the way data were displayed. The reviewers made a very big deal of granularity and how the means displayed weren’t possible. I’ll leave that to the people who specialize in statistics.

Finally, they accused him and his colleagues of plagiarism. If there were an absolute violation of science, that would be it.

But as you might expect, not everything is always as clear as people make it out to be, and I’ll explain that on Saturday. Until then, I would still keep the snacks out of sight and continue using that salad plate instead of a dinner plate in order to eat less.

What are you prepared to do today?

Dr. Chet

 

Reference: BMC Nutrition. doi.org/10.1186/s40795-017-0167-x.

 

Scientific Retractions

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One of my favorite observational scientists has been Dr. Brian Wansink, former Director of the Food and Brand Lab at Cornell University. I’ve written about his research and used it in presentations several times over the years. One of my favorite tips came from one of his studies: use a salad plate instead of a dinner plate. It cuts down on the food you take at one plate-full by about 25%.

That’s why I was dismayed when I read that several of his papers have been retracted from JAMA and other publications. There are many reasons why a paper can be retracted: problems with data and statistics, questionable research techniques, or unsubstantiated conclusions. Evidently, there was some of all of those accusations, which resulted in the papers being retracted.

Of course I had to check this out. What did he do? How did his papers become suspect to begin with? Who was involved in this process? I’ll answer part of the who right now. It was Wansink himself with a blog post talking about collecting data and then using multiple statistical analyses to get to a hypothesis in a couple of studies. That’s a very big no-no in science.

But due to the nature of his observational research, does it mean all of his work on relationships between habits and food is worthless? We’ll find out this week.

What are you prepared to do today?

Dr. Chet

 

Aspirin and Unintended Consequences

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We began the week considering a type of shortcut to health called biohacking. The polypill was a biohack to reduce the risk of CVD events, but there’s no research showing whether the polypill will ever prove to be effective. However, the results of the ASPREE trial may give us an idea whether the long-term trials should ever be attempted (1-3). Let’s take a look at the results of the ASPREE trial and the effects of an aspirin a day on healthy older adults.

In the first paper, the researchers evaluated the data to see if those who took the aspirin had less disability (1). In other words, did taking the aspirin convey benefits that reduced the risk of death, disability, or dementia? The data showed no differences between the aspirin and placebo group as it related to those outcomes.

In the second paper, the researchers examined the differences in all-cause mortality (2). What surprised the researchers was a slight increase in death from cancers in the group that took the aspirin; no specific type of cancer seemed to be impacted. Because aspirin has been shown to be beneficial in almost all other studies of cancer and mortality, the researchers said the results should be taken with a degree of caution.

In the final paper, researchers examined whether aspirin reduced the rate of CVD events and stroke (3) and found no difference, but the risk of hemorrhagic stroke was significantly higher in the aspirin group versus the placebo. This was the primary reason the study was terminated after five years.
 

The Problem

There were several problems with the study including the low adherence in both the aspirin and placebo group: if people didn’t take the pills, obviously that impacts the results. But the biggest question I have is a very simple one: who thought it was a good idea to give healthy people a medication every single day? Taking an aspirin for a headache or muscle ache is one thing. Taking it when you don’t need it is another.

The study demonstrated the logical fallacy of the polypill. “People won’t take care of themselves, so let’s put everyone on the medications that can reduce the risk of CVD.” No, let’s not. The results were unintended consequences that put the entire idea of biohacking into question.
 

The Bottom Line

When it comes to health, there are no real shortcuts. Biohacking, while a cute contemporary term, is fool’s gold. Yes, you can use your time and resources more efficiently to improve your health, but there are no shortcuts.

There is also one other obvious conclusion. Healthy people shouldn’t take medication. I take an 81 mg aspirin every day because I have had a stent and my doctor told me to. But I don’t take a statin any more because I changed my diet and lifestyle to keep my cholesterol normal. I control my blood pressure with diet and exercise. I don’t take medications I don’t need.

If you’re willing to do all you can to avoid medications and you still need medication to help you out, do it. But don’t take them to avoid doing the work. There are unintended consequences of taking the easy way out.

What are you prepared to do today?

Dr. Chet

 

References:
1. DOI: 10.1056/NEJMoa1800722.
2. DOI: 10.1056/NEJMoa1803955.
3. DOI: 10.1056/NEJMoa1805819.

 

An Aspirin a Day

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In Tuesday’s Memo, I talked about biohacking. Specifically, I talked about the idea of having everyone over a certain age take a pill that can impact the risk factors for CVD: high blood pressure, cholesterol, high heart rate, and blood cell stickiness. The idea is that taking that single pill in low doses every day might help reduce CVD events such as strokes and heart attacks.

Researchers in Australia and the U.S. decided to test one component of the polypill: aspirin. The study was called the Aspirin in Reducing Events in the Elderly (ASPREE) trial. They recruited over 19,000 people 70 and older or 65 if they were Black or Hispanic in the U.S. They randomly assigned half the subjects to take 100 mg of enteric-coated aspirin while the other half got a similar looking placebo. The subjects were tracked for an average of 4.7 years. The researchers examined many variables including mortality and the incidence of disease.

The results were published in three separate papers in a recent issue of the New England Journal of Medicine. The study was terminated after five years by the primary funding organization, the National Institute on Aging. The results were not exactly what was hoped. We’ll get into the details on Saturday. If you’d like to read the studies, all are available online at the links in the references.

What are you prepared to do today?

Dr. Chet

 

References:
1. DOI: 10.1056/NEJMoa1800722.
2. DOI: 10.1056/NEJMoa1803955.
3. DOI: 10.1056/NEJMoa1805819.

 

A Look at Biohacking

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One of the terms that have evolved in the health and fitness field that I really dislike is biohacking. Whether related to fitness, nutrition, or supplementation, the implication is that there are shortcuts to get health benefits. I believe that we can do things that are a more efficient use of time but when it comes to your health, there are no shortcuts. If you want benefits, you have to put in the effort. This week, I’m going to give you an example of a reasonable idea that hasn’t proven to demonstrate the benefits that were expected.

The concept for the polypill was introduced 15 years ago. The purpose was to put together a group of medications that could help reduce the risk of cardiovascular disease (CVD) by giving it to everyone over 55. The polypill was modified over the years to include low doses of aspirin, a statin, beta-blocker, angiotensin-converting enzyme (ACE) inhibitor, diuretic, and folic acid or some combination of these medications. The idea was that putting all the medications together in a single pill would increase adherence, a significant issue when it comes to taking medications. By so doing, it would decrease the risk of CVD disease.

The polypill has not been put into use in the U.S. While there are some positive data from other countries, the clinical trials that have been done are not long enough to demonstrate reduction in mortality and CVD events. But a recent study on one component of that polypill shows that it may not be such a good idea for everyone. I’ll continue on Thursday.

What are you prepared to do today?

Dr. Chet

What We Can Learn from Kipchoge

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There are a couple of lessons that we can get from Eliud Kipchoge and his approach to setting the world record in the marathon. Let’s take a look at what he did to prepare to be called the best marathoner of all time.

He Knew It Was Possible

When I say he knew it was possible, I don’t mean a theoretical thing. He knew it because he had already run a marathon in 2:00:25, over a minute faster than his current world record. He ran it over a minute faster under controlled conditions on a track. It was not recognized as the world record because he used rotating pacers. That means that every so often, a fresh runner would join him to help him maintain pace. He did have pacers in his world record attempt, but they began the race with him and dropped back when they ran out of gas. He ran the last 11 miles alone and at a faster pace than his pacers helped him keep.

Have you ever lost weight before or lowered your blood sugar? If you have, you know that it’s possible. Maybe your approach wasn’t sustainable or maintainable but if you did it once, you know you can do it. But it takes more than that.

He Got A Little Help

There were coaches, nutritionists, physical therapists, and a whole host of other people involved in getting him prepared. That’s essential. Your physician and other healthcare professionals can help fill that gap for you so you know how to do lose weight or lower your blood pressure responsibly. But the pacers were critical as they were with him on the course. They helped him get through at least half the race until his effort exceeded what they were capable of doing.

There are two ways this helps you in achieving a health goal. First, if you can find someone who is willing to help you on your journey by doing it with you, that can help you tremendously—and it helps them as well. We don’t care about world records; we care about achieving our health goals. You support others as they help you. Sometimes your support group doesn’t stick it out all the way.

That’s when you need to talk or listen to people who’ve already done it. It doesn’t have to be the same goal. It doesn’t even have to be in the same area. But we can all use encouragement in the form of hearing about how others achieved their goals.

The Bottom Line

Kipchoge is the greatest marathoner in the world. We can use what he did as inspiration but more importantly, we can take the lessons in how he did it to achieve our own health goals. Break it down to its simplest component. Rely on our past experience in achieving goals. Get a little help from our friends. Take those lessons and use them and you can change your health.

What are you prepared to do today?

Dr. Chet

Only Three Seconds Faster

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Eliud Kipchoge shattered the world record for the marathon by one minute, eighteen seconds. But breaking it down, that was about three seconds per mile faster. Sustaining that faster pace for the entire duration was an amazing physical feat but in its essence, it was three seconds per mile.

Let’s carry the logic to weight loss. If you want to lose 52 pounds in a year, that works out to one pound per week. One pound per week is 2.3 ounces per day. While the typical 3,500 calories in a pound of fat isn’t as precise as we’d like it to be, it’s close enough. That works out to be 503 calories per day. We either have to eat 500 fewer calories, burn 500 more calories, or some combination of both. That’s doable.

The key would be to be sustain that for 365 days in a year. Based on the best available research, we seem to do well until about week 10 of any type of diet you might try. That’s when we begin to return to former eating patterns—very slowly, but that’s when the plateaus and weight regain begin.

We could pick any health goal from lowering HbA1c to getting more flexible to reducing blood pressure and use the same approach. We need to know the variable that should be adjusted, from exercise and diet to taking supplements or medications regularly. We can break them all down to this: what do we need to do today?

What can help us sustain the effort once we know what we need to do? More lessons from the world record holder on Saturday.

What are you prepared to do today?

Dr. Chet

 

New World Record 2:01:39

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The marathon is 26.2 miles. If you’ve ever done one, you know what kind of effort it takes to just finish a marathon. For people who are better runners, qualifying for the Boston Marathon is a significant goal. It takes intense training to achieve that goal. This past weekend, a Kenyan named Eliud Kipchoge set a new world record for the marathon.

Set a world record? No. He shattered the world record by running it 1:18 faster in a time of 2:01:39. That’s an average pace of 4:38.4 per mile. For 26.2 miles! I run a half-mile loop in my neighborhood in about five minutes. To give you some perspective, he would complete over two laps in the time it takes for me to complete one.

While it’s an amazing physical achievement, what does it have to do with you and me and our health? In my opinion, a whole lot and that’s what I’m going to talk about the rest of the week. But for today, Kipchoge deserves our respect as the greatest marathoner in the world.

What are you prepared to do today?

Dr. Chet

 

Why I’ll Keep Taking My Probiotics

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One thing I try never to do is to take cheap shots at research studies. I’ve acknowledged that my expertise in the methodologies of microbiome analysis is limited. I think that these research groups did something unique in their approach to assessing the microbiome. That doesn’t prevent me from pointing out some obvious issues with the studies that could have impacted the outcomes.
 

The Problems

The first issue was the lack of diet control in either study; diets vary between people, and that could have significantly impacted the results. The foods you eat can directly impact your microbiome for hours, and what the subjects ate the days before the sampling may have skewed the results. Before the study, they used a Food Frequency Questionnaire and determined there were no unique dietary issues that could have impacted the results, but not using a diet record during the entire 28-day study is curious. For the thousands of data points they did collect, they ignored the most basic.

What shocks me is that they knew better: these are the same laboratories that have shown both foods and synthetic additives can substantially impact the microbiome. Without studying the diet of the subjects, and only eight subjects at that, you don’t know who had a diet conducive to the restoration of the microbiome after antibiotics or not.

Second, they used a novel approach. They collected samples from the digestive system using endoscopic techniques in addition to the fecal samples typically collected. Very interesting, but they also used the typical colonoscopy prep which means no food and the complete cleansing of the colon. To their credit, they did test two subjects with and without the typical pre-colonoscopy prep and found few differences. Two subjects. I don’t need to say anything more. While the prep is not going to erase all the bacteria and other microbes, it will eliminate the food supply and could impact what bacteria are growing at the time of the sampling.

Third, they gave healthy people antibiotics; that may bear no resemblance to the microbiome of someone who has a serous infection. The best we can say is that taking antibiotics when you’re not sick may not be a good idea.

Finally, I’ve read research by this group in Israel before. They’re developing a weight loss program based on their microbiome research. It may have no relationship to these studies but it does demonstrate a willingness to monetize their research results, and that always raises my suspicions.

Sure enough, the purpose of these studies was to support a patent application. It may be for the collection technique or more likely, a test to ascertain what probiotics might benefit specific groups of people while healthy or with specific conditions. While they claim no conflicts of interest in the paper, I can’t think of a bigger one than this. While there’s nothing wrong with establishing tests and treatments based on your research, the procedures need to be tested in other laboratories before rushing to market. This strikes me as premature.
 

The Bottom Line

I think these two studies illustrate where we are with microbiome research: at the very beginning. They contribute to the body of knowledge but little else. Probiotics will impact everyone differently, and they may not be desirable for everyone under every condition. But unless we get a radical change in our diet that encourages the microbiome to grow healthy and strong, taking a probiotic every day is still a good idea. My family and I, including my grandson Riley, will continue taking our probiotics because nothing in this research raises any questions about the safety or potential everyday benefit of regularly taking a probiotic supplement, preferably with a prebiotic.

What are you prepared to do today?

Dr. Chet

 

References:
1. DOI:https://doi.org/10.1016/j.cell.2018.08.041.
2. DOI:https://doi.org/10.1016/j.cell.2018.08.047.

 

New Probiotics Research Results

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The methodology used in the two studies I’m reviewing is complicated. I mentioned the endoscopic biopsies on Tuesday (and a big thanks to the people who volunteered for an endoscopy); subsequent analysis of the actual microbiome utilizes very complex techniques. I’m not an expert in those techniques so I can’t assess the results the way I normally would, but here are the results published by the authors.

The first study examined the changes in the microbiome when subjects were given either a placebo or commercially available probiotic for 28 days. The most significant finding was that the results were highly specific to the individual. That’s no surprise for one reason: no two microbiomes are the same, even in people who live in the same household. That a probiotic with 11 different bacteria would have different effects on the 14 subjects in the intervention group is no surprise. Some showed no growth of any of the strains of the probiotic, while other subjects’ tests showed strains that took up residence.

The second study examined the effects of antibiotics when taken by healthy subjects under three conditions: no intervention (seven subjects), the commercially available probiotics used in the first study (eight subjects), and a self-donated fecal transplant (six subjects). They found that the microbiome of the subjects who took the probiotics was not restored to their pre-antibiotic state; the supplemental probiotics seemed to colonize, leading the authors to suggest that they impaired the re-colonization of the original microbiome. The microbiome of the other two groups seemed to recover.

Should we avoid probiotics as a result of these studies? I’m taking mine and explain why I’ll keep taking them on Saturday.

What are you prepared to do today?

Dr. Chet

 

References:
1. DOI:https://doi.org/10.1016/j.cell.2018.08.041.
2. DOI:https://doi.org/10.1016/j.cell.2018.08.047.