Uncovering the Truth

Abstract

Finding the truth is important. In the field of lifestyle medicine the randomized controlled trial has significant limitations. Physicians and patients need to know the truth about the healthy lifestyle changes and their ability to prevent and reverse disease. To meet this challenge, the American College of Lifestyle Medicine has established a committee of experts (HEaLM), under the leadership of David Katz to create a level of evidence construct for ranking lifestyle medicine evidence that includes evidence from basic science and epidemiologic trials. This tool will be used by the new Expert Lifestyle Medicine Panel to create guidelines and standards of practice.

‘In the field of medicine, the truth needs to be both understood and acted on in order to bring the health and healing that both our patients and we desire.’

I clearly remember the first day of medical school as the dean calmly told our matriculating class that through our medical training we would be taught many things, but it was likely that only 50% of it would be true. The problem, as he expressed it to us, was that our professors did not know, indeed, could not know which half was true and which was false. How true this turned out to be! Things we counted on just did not turn out to be true when tested in the crucible of the scientific process. Maybe you, too, have been through at least some of these “transitions.” Beta-blockers and not digitalis are better for congestive heart failure. Peptic ulcer disease is not caused primarily by stress and best treated with a bland diet—it is caused by Helicobacter pylori, which one probably picked up as a child, and it can be treated successfully with an antibiotic regime. Lumpectomy is as good as radical mastectomy for breast cancer treatment. And now, the challenge of finding truth marches onward as we unwrap the powerful effect of lifestyle and environmental epigenetic effects on the expression of our unique and individual genes, or grapple with the potential effects of the gut biome on obesity or autoimmune disease, or depression, or a host of other conditions. We still have so much to understand, so much truth to grasp.

In the field of medicine, the truth needs to be both understood and acted on in order to bring the health and healing that both our patients and we desire. The good news is that we have the scientific process in which to crucible our theories. It has served us well through the years. The scientific process with hypotheses, observation, measurement, intervention, statistical analysis, and debate has made many things plain and brought a multitude of benefits to our lives.

The bad news about the scientific process is that it is slow, cumbersome, and expensive. It takes commitment, time, and money to really find out the truth about any given subject. But success has brought more success, and each truth we learn enables us to be more efficient and, over time, preserves resources. It seems that the knowledge of truth is increasing at a greater than linear rate.

As good as a placebo-controlled randomized trial is at nailing down truth, it has significant weaknesses, especially in the area of understanding the long-term effects of lifestyle choices. ¹ Coerced diet and/or “lifestyle” trials in humans have been tried in the past. Examples include Dr Rose’s protein studies on prisoners in the 1950s: These gave us significant information on the essential amino acids unique to humans as well as clarifying actual protein needs through nitrogen balance studies at the lower end of human requirements. ² But they were unethical. And none can forget some of the Nazi experiments on the ability of the human body to function at physical extremes as an example of an ethical catastrophe in the name of science. Fortunately for the human race these are now considered unacceptable. Ethics has placed a welcome and necessary limit on what science can do to understand human physiology and identify treatment interventions. And so, there remains no ethical way to randomly assign human individuals different behaviors to test how those behaviors play out in mortality and morbidity.

This leaves us with a dilemma. How can we understand and use truths that are unapproachable with the “gold standard” of randomized-controlled trials? The randomized-controlled trial seems best applied to technology and drugs (or at least substances that can be put in pills). But the effect of lifestyle choices on disease, health, and wellness are not easily addressed using these methods, for ethical, financial, and other reasons. Especially in evaluating the long-term effects of lifestyle behaviors and treatments. Yet truth waits definitive discovery and practical application. Both we and our patients need to know.

Clinicians are in need of an appropriate construct through which to view the evidence that we have on any of the multitude of lifestyle-related truths, not yet fully “proved,” in such a way as to ethically render them clinically useful. We need to be able to recognize lifestyle behaviors with a high probability for being beneficial. Ideally, we should be able to recognize a growing level of evidence so we can appropriately recommend that which might be considered by some to be drastic lifestyle treatments for individuals suffering from lifestyle-caused diseases. Basic science evidence, good-quality epidemiologic studies, natural experiments, and randomized-controlled trials should all have their place in arriving at a measure of certainty as to the strength and weight of evidence.

Recognizing this need, the American College of Lifestyle Medicine has asked a special group of esteemed professionals in the area of evidence-based medicine, headed by our immediate past president, Dr David Katz, to review the variety of systems now in use for evaluating levels of evidence and create an easy to use rating system for lifestyle medicine clinical questions. The group, referred to as the Hierarchies of Evidence Applied to Lifestyle Medicine (HEaLM) Taskforce, is independent and given full freedom to create the best measurement tool possible. Two PhD graduate students have been funded to help with the heavy lifting of the project and the groundwork is being done as I write. A white paper is expected in early 2017 with the hope that it will be published in a major medical journal soon after. It is anticipated that the group will disband once its work is complete and the feedback from the greater medical/scientific community is analyzed and appropriately incorporated into the plan.

Once the tool is created, the job of applying it to the available evidence begins. The American College of Lifestyle Medicine, in conjunction with the American Board of Lifestyle Medicine, are facilitating the creation of an Expert Lifestyle Medicine Panel (ELMP) to use the evidence evaluation tool created by the HEaLM taskforce to analyze and grade the available evidence on a variety of lifestyle medicine treatment modalities. This will be an ongoing, independent committee that is likely to grow as it is ramped up to include those with expertise in managing different lifestyle diseases and treatment protocols. The ELMP will publish best-practice guidelines for lifestyle-oriented practice. John Kelly, the first president of the American College of Lifestyle Medicine, has accepted the chairmanship of this committee. His first job will be to work with a small group of selected expert lifestyle researchers to develop a separate corporate entity with vision and mission, charter, bylaws, and board. Until the entity is fully functioning with budget and staff, the American College of Lifestyle Medicine will provide significant support.

For those of us committed to knowing the truth about how best to apply lifestyle medicine principles in practice, these developments come as very good news. Our goal is to soon have an easy to understand, evidenced-based system for evaluating “truth” in the health field that goes beyond randomized-controlled trials. In the spring (and following) of 2018 we should begin to see practice guidelines in the major areas of lifestyle medicine treatments.

It is American College of Lifestyle Medicine’s goal to increase the credibility and effectiveness of the lifestyle medicine community. The ELMP will give practitioners a set of guidelines and be a professional support organization helping legitimize and standardize treatment practices. This will allow the practitioner to better identify and propagate the truth while avoiding the pitfalls of alternative medicine. It is our job to showcase lifestyle medicine in its true light: as scientifically sound, and deserving of a prominent place in the “House of Medicine.” And that is the truth.