Stating that health care should strive to be both comprehensive and evidence-based, a new report from the Institute of Medicine of the National Academies calls for conventional medical treatments and complementary and alternative treatments to be held to the same standards for demonstrating clinical effectiveness. The same general research principles should be followed in evaluating both types of treatments, although innovative methods to test some therapies may have to be devised, said the committee that wrote the report.
The committee noted in particular the escalating popularity of dietary supplements as well as the lack of consistency and quality in these products, which are an important component of several complementary and alternative approaches. Product inconsistency hinders health professionals' abilities to guide patients on the use of supplements and researchers' ability to study them. The report calls on Congress to work with stakeholders to amend the regulation of supplements to improve quality control and consumer protections and to create incentives for research on the efficacy of these products.
"Ideally, health care should be comprehensive, grounded in the best available scientific evidence, and centered on patients' needs and preferences," said committee chair Stuart Bondurant, interim executive vice president for health sciences and executive dean, Georgetown University Medical Center, Washington, D.C. "Health professionals and patients should have sufficient information about safety and efficacy to take advantage of all useful therapies, both conventional and complementary and alternative. To that end, we believe that the same research principles and standards for showing effectiveness should apply to both conventional and complementary and alternative treatments. And because evidence is a key element of prudent decision-making, we need to change the current regulation of dietary supplements in this country to encourage more studies of these widely used products and to ensure their quality," he said.
Written to assist the National Institutes of Health in developing research methods and setting priorities for evaluating products and approaches within complementary and alternative medicine (CAM), the report also assesses what is known about Americans' reliance on these therapies. Use of CAM is widespread among the U.S. public, with more than one-third of adults reporting that they have pursued some form of these treatments, which include products such as herbal remedies, techniques such as acupuncture, and schools of practice such as naturopathy. Fewer than 40 percent of CAM users have disclosed their use of such therapies to their physicians. More than half of physicians report that they would encourage patients to talk to them about using CAM and would refer them for treatments that fall into that category. However, much is still unknown about how and why people use these therapies in conjunction with or in lieu of conventional therapies.
A common set of methods and standards for generating and interpreting evidence is necessary if health care providers are to make informed decisions about the use of both conventional treatments and CAM. It has been argued that characteristics of CAM therapies -- such as customization of treatments, variations in how practitioners perform treatments, or the holistic nature of many of these practices -- make it difficult to apply traditional clinical studies to them. Randomized controlled trials (RCTs) are the gold standard for providing evidence of efficacy, the committee said, but other study designs can generate useful information on treatments that do not lend themselves to RCTs. Observational studies, case control studies, and studies that specifically measure patients' expectations, emotional states, and other self-healing processes can provide useful data. Some conventional treatments, such as psychotherapy, also have similar characteristics that make them incompatible with RCTs, but they have been successfully evaluated via other methods, the committee noted.
Because many CAM products and approaches have not undergone formal testing and because resources to conduct research are finite, the report outlined several criteria to help determine which CAM therapies to prioritize for study. These same criteria apply equally well to as-yet untested conventional treatments, the committee noted. They include the prevalence and severity of the target health condition; existing evidence that the therapy is effective or may have safety issues; whether there is a plausible biological mechanism by which the therapy might work or the likelihood that research will discover a mechanism; and the likelihood that research will yield unambiguous results. Inability to meet any one of the criteria should not necessarily exclude a therapy from consideration, the report says.