Steve Mister, President and CEO of the Council for Responsible Nutrition, called upon scientific colleagues during this May's symposium to consider alternative methods for studying nutrition and the effects of dietary supplements.
This year's symposium, The Workshop, drew scientists and medical practitioners from across the country to discuss new research in the field of nutrition. While the current model for testing the health effects of particular nutrients and nutritional supplements utilizes randomized clinical trials (RCTs) and evidence-based medicine (EBM), the same methods employed to test the efficacy of pharmaceutical drugs, Mr. Mister urged scientists to consider approaches that may be more reflective of the complex nature of nutrients.
"(I) recognize (the) scientific rigor or RCTs...but we can't ignore all other research -- case-control and cohort studies, and other epidemiological data...(that) may be just as rigorous for proving hypotheses as well as developing them."
The repercussions of these seemingly simple statements may be huge for the natural health, healthcare, and health insurance industries. The entire country, from Texas, to California, to New York would be dramatically impacted by national organizations', such as the American Medical Association's, acceptance of data from studies other than the standard RCTs and EBM. Evidence integrated from observational studies focusing on nutritional supplements may eventually allow for the prescription of nutrients and supplements to, at least in part, officially treat certain conditions.
Texas, with its high levels of chronic diseases such as diabetes, and its fight against the growing epidemic of obesity, may particularly stand to benefit. Imagine a diabetic patient walking into a medical clinic in Dallas, Houston, Austin, or any other part of the state, and receiving supplements, along with other drugs, to treat the condition.
Some of the main differences between pharmaceutical drugs and nutritional supplements lies in the complex nature of nutrients, which interact with multiple tissues and body systems on multiple levels, and are often interdependent. For instance, research suggests that calcium supplements may have a greater effect when taken with vitamin D. RCTs isolate one or two compounds, at a single dose, for a few years at a time at best, and collect the data independently from other substances (such as nutrients) the subject may be ingesting.
Chronic diseases take years to develop, and perhaps years in order for nutrients or other natural supplements to have an effect. It is not possible to isolate single compounds within nutrients, test and analyze them over only a few months or years, and exclusively use data that has a clear, direct connection with those compounds. To isolate and test every active compound in even the most simple of natural remedies, such as garlic, would literally take decades, and would still probably miss very important pieces of evidence.
To discount observational studies simply because they are not confirmed by a clinical trial may also be dangerous. Too many variables affect the outcome of nutritional studies, many of which cannot be controlled, and perhaps should not be controlled, to collect the most accurate data. Such evidence may take longer to sift through in order to find cause and effect, particularly considering nutrients' symbiotic relationship with other compounds and hormones, but finding accurate answers would be worth it.
Many others at The Workshop agreed that a single research approach, like RCTs, may not be suitable for such a complex task. In contrast to pharmaceutical drugs, "nutrients have beneficial effects on multiple body tissues, and interact in a dynamic fashion with other nutrients," said Jeffrey Blumberg, Ph.D., of the Friedman School of Nutrition Science and Policy at Tufts University.
Robert C. Hearney, M.D., of Creighton University's Osteoporosis Research Center: "(Scientists) ...have eagerly embraced an evidence-based medicine approach without checking to see if it fits nutrition context." He went on to say that RCTs impose constraints ill-suited to testing nutrients and vitamins.
According to these scientists, observational studies may, in fact, be a better method for collecting data on dietary and nutritional supplements, supported by RCTs and EBM. Observational studies can better represent typical populations, typical behaviors, and how food and supplements are, in reality, used. Observational studies also bypass an important ethical dilemma: it's simply not conscience to deprive a subject of a vital nutrient, just to see which tissues are affected and how.
Many nationally-recognized organizations already use observational and experimental studies for data collection. The Institute of Medicine's (IOM) Dietary Reference Intakes, or DRIs, are based on data collected from observational and experimental studies. The Dietary Guidelines for Americans, developed by the U.S. Department of Agriculture (USDA), uses primarily clinical trials and observational studies, including cross-sectional, case-controlled, and cohort studies.
This new attitude is welcomed by the natural health community, which has been arguing the same point for years. Specific nutrients, foods, and herbs do, in fact, have a marked effect on many diseases and conditions, but precisely how most of them work is still a mystery. It's the observational, and other methods of study, that confirm this.
For instance, herbal formulas created by practitioners of Traditional Chinese Medicine are often extremely complex, and, in order to work to their best advantage, are tailored to each individual. Few specific compounds can, as of yet, be isolated and linked with one particular effect with any accuracy, but practitioners have recorded volumes upon volumes of "anecdotal" data over thousands of years stating that they work. Viral counts have been known to go down, the efficacy of immune systems have increased, and discomfort and disease all but eliminated in certain cases.
Similarly, acupuncture -- a process Chinese medical practitioners articulate as a method for clearing energy paths, called meridians, and a treatment articulated by Western medical practitioners as a method used to release certain natural compounds and reduce inflammation -- is an approved therapy for Carpal Tunnel Syndrome. We don't know precisely how it works, but somehow it just does. To discount such evidence simply because the data cannot be properly collected and analyzed through RCTs would not only be foolish, but would also deprive patients of receiving a possibly effective treatment.
So, if such research approaches are already accepted by national institutes, why are they not used more often? Part of it, simply and unfortunately, is money. Makers of dietary supplements are not allowed to claim their products treat or cure any disease. This provides less incentive for those with greater financial resources to fund such projects. Even if they were to find strong evidence that certain supplements do, in fact, treat and/or cure disease, they would not be allowed to advertise it.
The American public is growing more accepting of data collected through methods other than the traditional RCTs and EBM, however, as evidenced by the growing herbal, organic foods, and natural health care industries. Several universities across the country, in fact, now offer accredited, post-graduate, four-year degrees in Chinese and naturopathic medicine, much like graduate degrees in allopathic medicine (which produce M.D.s). With policies of open communication and integration, these two schools of thought, with their different research methods, may accomplish more medically in this era than ever before.
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