Integrative Medicine: Solid Evidence is Key
By Jim Daniels, CEO, CortControl LLC
In recent years, we’ve heard more and more talk of “integrative medicine,” a treatment approach that combines traditional medicines and evidence-supported alternative remedies in order to treat the whole person, not just a disease.
Also known as “holistic medicine,” “complementary medicine,” or “complementary and alternative medicine” (CAM), this approach—once considered “fringe”—has quickly made its way into the medical mainstream. For example, surveys conducted for the American Hospital Association show that the number of U.S. hospitals offering complementary therapies has grown dramatically, up from 9% in 1998 to 42% in 2011. And, to promote integrative medicine throughout North America, more than 60 academic and professional medical centers in the U.S., Canada, and Mexico have formed the Consortium of Academic Health Centers for Integrative Medicine. Among these are the centers at Harvard, Yale, Stanford, Duke, USC, and the University of Michigan.
Doctors’ Lingering Doubts
Although integrative medicine is now practiced more widely than ever, many doctors continue to have lingering concerns about it. In one hospital survey, for example, 44% of respondents listed “physician resistance” as one of the three main barriers to adopting integrative medicine programs.
One reason numerous doctors cite for their hesitation is the lack of scientific evidence. “I worry that people are making claims in the context of scientific medicine that they cannot really justify,” Dr. Tom Delbanco of Harvard Medical School has stated. “There have been few rigorously controlled, scientifically sound studies in the area.”
Solid Evidence Is the Critical Component
Regardless of how different doctors view integrative medicine, virtually all agree on the importance of meticulous scientific research and solid evidence:
• Was the testing controlled and double-blind?
• Was the sample group representative?
• Were biases built into the test procedure?
• Were the conclusions appropriately drawn from the data, and not overstated?
• If a mean result is stated, what is the confidence interval for that mean?
• What is the probability that a difference is due to chance?
It’s absolutely reasonable to ask such questions, and, when there is a compelling scientific basis for a particular integrative therapy, doctors will consider it.
Unfortunately, though, much of the discussion on integrative therapies thus far has focused on treatments such as herbs or meditation, where there is often little or no hard evidence to substantiate claims of effectiveness.
Considering the Medical Foods Option
Doctors who demand evidence also have another option: the integrated category of medical foods. Still unfamiliar to many in health care, these are dietary products developed specifically for the management of diseases and other health conditions. They are not substitutes for drugs and other traditional medical treatments but rather part of an integrative medical approach that safely and effectively addresses diseases and other conditions. And—of utmost importance—they must undergo rigorous scientific testing and secure FDA approval before they can even be made available to doctors or other health care providers.
That’s right. Before introduction, FDA scientists—under SSA (Substantial Scientific Agreement) guidelines—evaluate each medical food, judging the test methodology, data, and conclusions. Classical analytical methods are required. And, if the proposed product doesn’t demonstrate its value, it cannot be offered as a medical food. Period.
To learn more about medical foods, check out the Medical Foods Guidance Documents and Regulatory Information page on the FDA’s website or go to MedicalFoods.com.
Although it is quickly coming into the medical mainstream, integrative medicine is still a relatively new treatment approach. As such, it offers both great promise and reason for skepticism. The challenge, of course, is to separate the effective options from the ineffective or even harmful ones. The best place to start this process is to look at those options that have proven their value in rigorous scientific testing—options such as medical foods.
James Daniels is the CEO of CortControl, which develops and markets GlutrasolTM, a patent-pending medical food for the treatment of such indications as infertility, vaccine enhancement, diabetes, depression, breast cancer, heart disease, sleep disorders, and Alzheimer’s disease.