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Complementary, Alternative Therapies Should Face Rigorous Testing, IOM Concludes

Charles Marwick

With the widespread and increasing use of complementary and alternative medicine (CAM), such practices should be held to the same standards for demonstrating clinical effectiveness as conventional medical treatments; studies of a therapy's effectiveness, safety, its role in health care, and the costs involved are needed, concludes a new report from the Institute of Medicine (IOM) of the National Academies.

"The report recommends, importantly, we think, that the same principles and standards of treatment effectiveness apply to all treatments," said Stuart Bondurant, M.D., of Georgetown University Medical Center in Washington, D.C., and chair of the committee that prepared the report.



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Stuart Bondurant

 
The report's authors gathered some statistics that speak to the skyrocketing popularity of CAM therapies: More than one-third of American adults routinely use CAM, spending in excess of $27 billion a year; 42% of Americans report that they have used at least one CAM therapy, but less than 40% tell their doctors; and in 1997, 629 million visits were made to CAM providers and 386 million to primary care doctors.

The report does not examine the use of CAM in specific diseases such as cancer. There have been very few national studies of CAM use by cancer patients, but the indications are that the use of CAM among cancer patients is similar to that in the general population, says Jeffrey D. White, M.D., the director of the National Cancer Institute's Office of Complementary and Alternative Medicine. Studies based in hospitals and cancer care facilities report that CAM use ranges from 25% to as high as 80% or more among cancer patients, he said. He added that the NCI agrees with the IOM report in calling for rigorous scientific evaluation of CAM therapies, and that, in fact, the agency funds a number of clinical trials to evaluate them.

The IOM report acknowledges that the rigorous evaluation of the safety and effectiveness of CAM therapies is easier said than done. Many of the characteristics of CAM treatments make it difficult or impossible to conduct the ideal randomized, controlled trials—the gold standard for determining efficacy. CAM practitioners have variable approaches, and there are customized treatments, treatment combinations, and hard-to-measure outcomes. Although these characteristics are not unique to CAM, they occur more frequently in CAM than in conventional therapies, the report states.

This means that "innovative methods of evaluation are needed," Bondurant said. The report suggested a number of approaches to determine efficacy, such as observational and cohort studies and case–control studies. Some system of prioritization is also needed to determine which therapies to evaluate. Such criteria could include the prevalence of the condition a therapy treats and whether it has a plausible mechanism of action and a substantial potential benefit.

The report also recommends that the 1994 Dietary Supplement Health and Education Act (DSHEA) be revised. The report made no specific suggested changes but called for stricter quality control, more accurate labeling, and improved enforcement against inaccurate and misleading health claims for dietary and herbal supplements. "Reliable and standardized products are needed if studies to determine safety and efficacy of dietary supplements are to be conducted," Bondurant added.

The American Herbal Products Association criticizes the recommendation. The 1994 legislation forbids misleading claims and requires accurate labeling, said the group's president, Michael McGuffin. He pointed out that the final notice implementing the law has not yet been published. "Why call for revising a law that has not yet been implemented?" he asked.

Stephen E. Straus, M.D., director of NIH's National Center for Complementary and Alternative Medicine, praised the report "as an achievement that elevates the discussion of CAM beyond the advocacy and skepticism that has long hampered the evaluation of CAM science. It will further the scientific investigation of this new field, increase its legitimacy as a research area, and ultimately improve public health."



             
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