Are Clinical Trials Misleading?

Written by Dr. Steve Chaney on . Posted in clinical trials

Is Most Of What You’ve Been Told About Vitamins Wrong?

Author: Dr. Stephen Chaney

 

man searching with magnifying glassI am a scientist and a professor. I taught medical students for 40 years. I believe in evidence based medicine. Why would I tell you that many of the clinical trials about the impact of individual nutrients on your health are misleading?

Let me start by sharing a story that I used to tell every new graduate student in my lab. The story goes like this: There is this drunk on the sidewalk, on his hands and knees under a lamppost, just groping around. A policeman comes up to him and says, “What are you doing?” The drunk says, “I’m looking for my housekeys.” The policeman gets down on his hands and knees and he looks too, and finally he says, “I can’t find them anywhere. Are you sure you lost them here?” To which the drunk relies, “Nope, I lost them over there, but the light’s better here.”

The point I was trying to make is that we can only do experiments where the light is good. But the questions we sometimes want to ask are over in the corner, where we can’t really shine the light on it directly. It’s often difficult to look in the right place and/or to ask the right questions.

That’s particularly the case with holistic approaches because holistic approaches, by their very nature, are multi-factorial. You have multiple variables that you’re trying to change at one time. For example, you might want to optimize weight, exercise, vitamins, minerals, and essential fatty acids if you’re trying to look at a healthy lifestyle.

But, in the 21st-century, studies generally focus on individual nutrients or individual drugs in an intervention, placebo-controlled trial. This is considered the “Gold Standard” for evidence based medicine. However, it’s very difficult to evaluate holistic approaches with that kind of study.

 

The Whole Is Greater Than The Parts

internationally renowned expert sessionOne of the examples that I love to use, because it really made an impression on me as a young scientist, occurred at an International Cancer Symposium I attended more than 30 years ago.

I attended a session in which an internationally renowned expert was giving his talk on colon cancer. He said, “I can show you, unequivocally, that colon cancer risk is significantly decreased by a lifestyle that includes a high-fiber diet, a low-fat diet, adequate calcium, adequate B-vitamins, exercise and weight control. But I can’t show you that any one of them, by themselves, is effective.”

The question that came to me as I heard him speak was: “What’s the message that a responsible scientist or responsible health professional should be giving to their patients or the people that they’re advising?” You’ve heard experts saying: “Don’t worry about the fat” “Don’t worry about calcium.” “Don’t worry about B-vitamins.” “Don’t worry about fiber.” “None of them can be shown to decrease the risk of colon cancer.”

Is that the message that we should be giving people? Or should we really be saying what that doctor said many years ago – that a lifestyle that includes all those things significantly decreases the risk of colon cancer?

 

Are Clinical Trials Misleading?

 

clinical trialsA recent paper about how to best evaluate the relationships between nutrition and disease (Shao et al, European Journal of Nutrition, DOI: 10.1007/s00394-017-1460-9) caught my attention. This paper, written by a team of 10 international experts, was a summary of key findings from a recent international meeting of the Council for Responsible Nutrition.

The paper started out by reviewing the strengths of clinical studies in which the effect of a single intervention on a health outcome is evaluated in a double-blind, placebo controlled clinical study; something they referred to as a reductionist approach.

  • A reductionist approach is ideal for evaluating the effect of drug candidates on disease outcomes. That is because:
    • Everyone in the study already has the disease.
    • The drug is meant to be used by itself.
    • It is easy to measure outcomes. The drug either has an effect on the disease, or it doesn’t.
  • A reductionist approach has also been valuable in defining the role of nutrients in preventing deficiency diseases. That is because, in the words of the authors:
    • “A simple cause-effect relationship exists between a particular nutrient and a specific deficiency disease.
    • Symptoms of a specific nutrient deficiency can be explained in terms of the role played by the respective nutrient.
    • Providing the nutrient in the diet can prevent, and in many cases, reverse, the deficiency disease.”

However, the authors went on to say that the use of the reductionist approach to study effect of nutrients on optimal health or holistic approaches to health often has led to misleading results. They characterized these studies as often “leading down a rabbit hole.”

For example, the authors said: “In an effort to uncover the magic bullet, scientists inappropriately studied nutrients in a drug-like context. Unlike drugs, nutrients do not function in isolation and have beneficial effects on multiple tissues and organ systems.”

The authors concluded by saying that if we want to truly understand the role of nutrients on health outcomes, we need to focus on holistic studies in which the effect of multiple nutrients on multiple health outcomes are evaluated.

 

Clinical Trials That Have Mislead Us

 

I realize that the report I just described is conceptual. It’s difficult to wrap your mind around. To better understand how clinical trials employing a reductionist approach can often mislead us, let’s look at some specific examples comparing holistic studies to reductionist studies.

dash dietHealthy diets: Healthy diets have a significant impact on health, but it is not possible to show that individual components of those diets are beneficial: In previous issues of “Health Tips From the Professor,” I have discussed the Mediterranean and DASH diets. I have shared studies showing that the Mediterranean diet dramatically reduces the risk of heart disease, diabetes, cognitive decline, and some forms of cancer. However, you would be hard pressed to show that individual components of the Mediterranean diet have a significant impact on these health outcomes.

Similarly, the DASH diet is as effective as drugs at controlling blood pressure (Moore et al, Hypertension, 38: 155-158, 2001 ). Other than sodium restriction, you would also be hard pressed to show that the individual components of the DASH diet exert a significant effect on blood pressure.

Supplements That Are Going to Kill You: Individual nutrients can sometimes have adverse effects on your health. Those reports generate a lot of negative press, but the adverse effects usually disappear when those nutrients are consumed along with nutrients that complement their effect on whole body metabolism.

Here are two examples of the negative press that you may have heard about the dangers of supplementation, but what the studies actually showed is that a holistic approach to supplementation was superior to supplementation with individual supplements.

For example, there was something called the Iowa Women’s Health Study that got some negative press in 2011 (Mursu et al, Archives of Internal Medicine, 171:1625-1633, 2011). This is one of those studies that led to headlines saying: “Vitamins can kill you.”

The study did show a slight increase in mortality in people who consumed high-dose vitamin B6 or high-dose folic acid by themselves. But in that same study, people who were taking high-dose B complex containing both B6 and folic acid in balance had no increase in mortality.

Another example is vitamin E and prostate cancer. You probably saw the headlines, which said: “Vitamin E increases the risk of prostate cancer.” Those headlines were based on a study published in the Journal of American Medical Association in 2011 (J Klein et al, Journal of the American Medical Association, 306: 1549-1556, 2011). However, in that same study the people who were taking vitamin E and selenium (two nutrients that work together synergistically) had no increase in cancer risk.

There is a good biochemical rationale for those results. Vitamin E converts some reactive oxygen species to peroxides, which are quite dangerous themselves. Selenium is part of an enzyme that converts peroxides to water. Together, vitamin E and selenium convert reactive oxygen species (free radicals) to something that is completely harmless. By itself, vitamin E does only half the job.

Holistic Approaches to Supplementation: The same appears to be true if you look at holistic approaches to supplementation rather than holistic approach to supplementationsupplementing with individual nutrients. A study done by Dr. Gladys Block and published in Nutrition Journal in 2007 (Block et al, Nutrition Journal 2007,6:30 doi: 10.1186/1475-2891-6-30) looked at a holistic approach to supplementation for the very first time.

She compared people who were taking multiple supplements, typically a multivitamin, extra antioxidants, extra B vitamins, carotenoids, fish oil and probiotics; people who were taking only a multivitamin; and people who were using no supplements whatsoever over a 20-year period.

The results were dramatic. The holistic supplement users had one-third the prevalence of angina, heart attacks and congestive heart failure and one-quarter the prevalence of diabetes compared to the other two groups. In contrast, reductionist studies looking at the effect of those nutrients individually have generally been inconclusive.

So just like a holistic approach to health, a holistic approach to supplementation appears to be superior to using individual supplements. This is a small study, but it is an example of the kinds of studies that need to be done in the future, if we are to truly understand the role of holistic approaches for optimizing our health.

 

The Bottom Line

Studies in which the effect of a single intervention on health outcomes is evaluated in a double-blind, placebo-controlled clinical study is considered the “Gold Standard” for evidence based medicine. A recent report has questioned the value of this kind of study in defining the impact of holistic approaches on health outcomes.

  • The authors concluded that the “Gold Standard” of clinical studies, which they referred to as a reductionist approach:
    • Was ideal for evaluating the effect of drugs on preventing or treating diseases.
    • Has been well suited for evaluating the role of individual nutrients in preventing deficiency diseases.
    • Was not well suited for evaluating the role of holistic approaches on health outcomes.
    • Was not well suited for evaluating the role of nutrients for promoting optimal health.
  • The authors concluded by saying that if we want to truly understand the role of nutrients on health outcomes, we need to focus on holistic studies in which the effect of multiple nutrients on multiple health outcomes are evaluated.
  • I shared three examples illustrating cases in which holistic approaches were more accurate than reductionist studies:
    • Healthy diets have a significant impact on health, but it is not possible to show that that individual components of those diets are beneficial.
    • Individual nutrients can sometimes have adverse effects on your health, but the adverse effects disappear when those nutrients are consumed along with nutrients that complement their effect(s) on whole body metabolism.
    • A holistic approach to supplementation can have a significant, beneficial effect on health outcomes, but it is difficult to show any benefit from individual nutrients included in that holistic approach to supplementation.
  • For more details, read the article above.

 

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure or prevent any disease.

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Comments (2)

  • Alayne Campbell

    |

    Very informative, A good yardstick to measure by.

    How do I get a copy of your suggestions for those on kemotherapy?

    Reply

    • Dr. Steve Chaney

      |

      Dear Alayne,
      I am not a medical doctor, so I do not comment on specific medical cases. If you are talking about nutritional supplements, a general rule of thumb is to space supplements and chemotherapy drugs so that they are not present in the bloodstream at the same time. This usually involves a day or two window on either side of chemotherapy during which supplements are not taken. For more specific recommendations, consult your doctor and/or your pharmacist.
      Dr. Chaney

      Reply

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Latest Article

What Is The Planetary Diet?

Posted May 21, 2019 by Dr. Steve Chaney

Is Your Diet Destroying The Planet?

Author: Dr. Stephen Chaney

 

Earth Day has come and gone, but you are still committed to saving the planet. You save energy. You recycle. You drive an electric car. But is your diet destroying the planet?

This is not a new question, but a recent commission of international scientists has conducted a comprehensive study into our diet and its effect on our health and our environment. Their report (W. Willet et al, The Lancet, 393, issue 10170, 447-492, 2019 ) serves as a dire warning of what will happen if we don’t change our ways. I touched on this report briefly in a previous issue of “Health Tips From The Professor,” What Is The Flexitarian Diet , but this topic is important enough that it deserves an issue all its own.

The commission carefully evaluated diet and food production methods and asked three questions:

  • Are they good for us?
  • Are they good for the planet?
  • Are they sustainable? Will they be able to meet the needs of the projected population of 10 billion people in 2050 without degrading our environment.

The commission described the typical American diet as a “lose-lose diet.” It is bad for our health. It is bad for the planet. And it is not sustainable.

In its place they carefully designed their version of a primarily plant-based diet they called a “win-win diet.”  It is good for our health. It is good for the planet. And, it is sustainable.

In their publication they refer to their diet as the “universal healthy reference diet” (What else would you expect from a committee?). However, it has become popularly known as the “Planetary Diet.”

I have spoken before about the importance of a primarily plant-based diet for our health. In that context it is a personal choice. It is optional.

However, this report is a wake-up call. It puts a primarily plant-based diet in an entirely different context. It is essential for the survival of our planet. It is no longer optional.

If you care about global warming…If you care about saving our planet, there is no other choice.

How Was The Study Done?

The study (W. Willet et al, The Lancet, 393, issue 10170, 447-492, 2019 ) was the report of the EAT-Lancet Commission on Healthy Diets from Sustainable Food Systems. This Commission convened 30 of the top experts from across the globe to prepare a science-based evaluation of the effect of diet on both health and sustainable food production through the year 2050. The Commission included world class experts on healthy diets, agricultural methods, climate change, and earth sciences. The Commission reviewed 356 published studies in preparing their report.

 

Is Your Diet Destroying The Planet?

When they looked at the effect of food production on the environment, the Commission concluded:

  • “Strong evidence indicates that food production is among the largest drivers of global environmental change.” Specifically, the commission reported:
  • Agriculture occupies 40% of global land (58% of that is for pasture use).
  • Food production is responsible for 30% of global greenhouse gas emissions and 70% of freshwater use.
  • Conversion of natural ecosystems to croplands and pastures is the largest factor causing species to be threatened with extinction. Specifically, 80% of extinction threats to mammals and bird species are due to agricultural practices.
  • Overuse and misuse of nitrogen and phosphorous in fertilizers causes eutrophication. In case you are wondering, eutrophication is defined as the process by which a body of water becomes enriched in dissolved nutrients (such as phosphates from commercial fertilizer) that stimulate the growth of algae and other aquatic plant life, usually resulting in the depletion of dissolved oxygen. This creates dead zones in lakes and coastal regions where fish and other marine organisms cannot survive.
  • About 60% of world fish stocks are fully fished and more than 30% are overfished. Because of this, catch by global marine fisheries has been declining since 1996.
  • “Reaching the Paris Agreement of limiting global warming…is not possible by only decarbonizing the global energy systems. Transformation to healthy diets from sustainable food systems is essential to achieving the Paris Agreement.”
  • The world’s population is expected to increase to 10 billion by 2050. The current system of food production is unsustainable.

When they looked at the effect of the foods we eat on the environment, the Commission concluded:

  • Beef and lamb are the biggest contributors to greenhouse gas emissions and land use.
  • The concern about land use is obvious because of the large amount of pasture land required to raise cattle and sheep.
  • The concern about greenhouse gas emissions is because cattle and sheep are ruminants. They not only breathe out CO2, but they also release methane into the atmosphere from fermentation in their rumens of the food they eat. Methane is a potent greenhouse gas, and it persists in the atmosphere 25 times longer than CO2. The single most important thing we can do as individuals to reduce greenhouse gas emissions is to eat less beef and lamb. [Note: grass fed cattle produce more greenhouse gas emissions than cattle raised on corn because they require 3 years to bring to market rather than 2 years.]
  • In terms of energy use beef, lamb, pork, chicken, dairy and eggs all require much more energy to produce than any of the plant foods.
  • In terms of eutrophication, beef, lamb, and pork, all cause much more eutrophication than any plant food. Dairy and eggs cause more eutrophication than any plant food except fruits.
  • In contrast, plant crops reduce greenhouse gas emissions by removing CO2 from the atmosphere.

 

What Is The Planetary Diet?

In the words of the Commission: “[The Planetary Diet] largely consists of vegetables, fruits, whole grains, legumes, nuts, and unsaturated oils. It includes a low to moderate amount of seafood, poultry, and eggs. It includes no or a very low amount of red meat, processed meat, sugar, refined grains, and starchy vegetables.”

When described in that fashion it sounds very much like other healthy diets such as semi-vegetarian, Mediterranean, DASH, and Flexitarian. However, what truly distinguishes it from the other diets is the restrictions placed on the non-plant portion of the diet to make it both environmentally friendly and sustainable. Here is a more detailed description of the diet:

  • It starts with a vegetarian diet. Vegetables, fruits, beans, nuts, soy foods, and whole grains are the foundation of the diet.
  • It allows the option of adding one serving of dairy a day (It turns out that cows produce much less greenhouse emissions per serving of dairy than per serving of beef. That’s because cows take several years to mature before they can be converted to meat, and they are emitting greenhouse gases the entire time).
  • It allows the option of adding one 3 oz serving of fish or poultry or one egg per day.
  • It allows the option of swapping seafood, poultry, or egg for a 3 oz serving of red meat no more than once a week. If you want a 12 oz steak, that would be no more than once a month.

This is obviously very different from the way most Americans currently eat. According to the Commission:

  • “This would require greater than 50% reduction in consumption of unhealthy foods, such as red meat and sugar, and greater than 100% increase in the consumption of healthy foods, such as nuts, fruits, vegetables, and legumes.”
  • “In addition to the benefits for the environment, “dietary changes from current diets to healthy diets are likely to substantially benefit human health, averting about 10.8-11.6 million deaths per year globally.”

What Else Did The Commission Recommend?

In addition to changes in our diets, the Commission also recommended several changes in the way food is produced. Here are a few of them.

  • Reduce greenhouse gas emissions from the fuel used to transport food to market.
  • Reduce food losses and waste by at least 50%.
  • Make radical improvements in the efficiency of fertilizer and water use. In terms of fertilizer, the change would be two-fold:
    • In developed countries, reduce fertilizer use and put in place systems to capture runoff and recycle the phosphorous.
    • In third world countries, make fertilizer more available so that crop yields can be increased, something the Commission refer to as eliminating the “yield gap” between third world and developed countries.
  • Stop the expansion of new agricultural land use into natural ecosystems and put in place policies aimed at restoring and re-foresting degraded land.
  • Manage the world’s oceans effectively to ensure that fish stocks are used responsibly and global aquaculture (fish farm) production is expanded sustainability.

What we can do: While most of these are government level policies, we can contribute to the first three by reducing personal food waste and purchasing organic produce locally whenever possible.

What Does This Mean For You?

If you are a vegan, you are probably asking why the Commission did not recommend a completely plant-based diet. The answer is that a vegan diet is perfect for the health of our planet. However, the Commission wanted to make a diet that was as consumer-friendly as possible and still meet their goals of a healthy, environmentally friendly, and sustainable diet.

If you are eating a typical American diet or one of the fad diets that encourage meat consumption, you are probably wondering how you can ever make such drastic changes to your diet. The answer is “one step at a time.”  If you have read my books “Slaying The Food Myths” or “Slaying the Supplement Myths,”  you know that my wife and I did not change our diet overnight. Our diet evolved to something very close to the Planetary Diet over a period of years.

The Commission also purposely designed the Planetary Diet so that you “never have to say never” to your favorite foods. Three ounces of red meat a week does not sound like much, but it allows you a juicy steak once a month.

Sometimes you just need to develop a new mindset. As I shared in my books, my father prided himself on grilling the perfect steak. I love steaks, but I decided to set a few parameters. I don’t waste my red meat calories on anything besides filet mignon at a fine restaurant. It must be a special occasion, and someone else must be buying. That limits it to 2-3 times a year. I still get to enjoy good steak, and I stay well within the parameters of the Planetary diet.

Develop your strategy for enjoying some of your favorite foods within the parameters of the Planetary Diet and have fun with it.

The Bottom Line

 

Is your diet destroying the planet? This is not a new question, but a recent commission of international scientists has conducted a comprehensive study into our diet and its effect on our health and our environment. Their report serves as a dire warning of what will happen to us and our planet if we don’t change our ways.

The Commission carefully evaluated diet and food production methods and asked three questions:

  • Are they good for us?
  • Are they good for the planet?
  • Are they sustainable? Will they be able to meet the needs of the projected population of 10 billion people in 2050 without degrading our environment.

The Commission described the typical American diet as a “lose-lose diet.”  It is bad for our health. It is bad for the planet. And it is not sustainable.

In its place they carefully designed their version of a primarily plant-based diet they called a “win-win diet.”  It is good for our health. It is good for the planet. And, it is sustainable.

In their publication they refer to their diet as the “universal healthy reference diet” (What else would you expect from a committee?). However, it has become popularly known as the “Planetary Diet.”

The Planetary Diet is similar to other healthy diets such as semi-vegetarian, Mediterranean, DASH, and Flexitarian. However, what truly distinguishes it from the other diets is the restrictions placed on the non-plant portion of the diet to make it both environmentally friendly and sustainable (for details, read the article above).

I have spoken before about the importance of a primarily plant-based diet for our health. In that context it is a personal choice. It is optional.

However, this report is a wake-up call. It puts a primarily plant-based diet in an entirely different context. It is essential for the survival of our planet. It is no longer optional.

If you care about global warming…If you care about saving our planet, there is no other choice.

For more details read the article above.

 

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure or prevent any disease.

 

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