Publication Details

Approximately one-third of adults in the United States use complementary and alternative medicine (CAM) yet less than 40 percent disclose such use to their physician and other health care providers. Women are more likely than men to use CAM therapies; use appears to increase as education level increases; use patterns vary by race, depending on the type of CAM therapy considered; and those who use CAM generally use more than one CAM modality and do so in combination with conventional medical care (Barnes et al., 2004; Eisenberg et al., 1998; Mackenzie et al., 2003; Ni et al., 2002; Wolsko et al., 2002; Wootton and Sparber, 2001). Some forms of CAM are being incorporated into services provided by hospitals; covered by health maintenance organizations; delivered in conventional medical practitioners' offices; and taught in medical, nursing, and other health professions schools. Insurance coverage of CAM therapies is increasing and integrative medicine centers and clinics are being established.

What do patients and health professionals need to know to make good decisions about the use of health care interventions, including CAM? Of primary importance is determining that they are safe and effective. Cost-benefit and cost-effectiveness may be important to both the individual and to society. In this report, the committee has recommended that the same principles and standards of evidence of treatment effectiveness apply to all treatments, with the understanding that certain characteristics of some CAMs and some conventional medical interventions make it difficult or impossible to conduct standard randomized controlled trials. For these therapies, innovative methods of evaluation are needed as are measures and standards for the generation and interpretation of evidence.

The committee believes that it is necessary and desirable to use a variety of study designs to research CAM therapies. Given the limited funding, the committee suggests that the following criteria be used when considering the CAM therapies to be selected for testing. No intervention will meet all criteria, and a therapy should not be excluded from consideration because it does not meet any one particular criterion, for example, biological plausibility.

  • A biologically plausible mechanism for the intervention exists, recognizing that the science base on which plausibility is judged is a work in progress and that potential science bases for some CAM therapies have not been well studied scientifically.
  • Research could plausibly lead to the discovery of biological mechanisms of disease or treatment effect.
  • The condition is highly prevalent (e.g., diabetes mellitus).
  • The condition causes a heavy burden of suffering.
  • The potential benefit is great.
  • Some evidence that the intervention is effective already exists.
  • Some evidence that there are safety concerns exists.
  • Research design is feasible and likely to yield an unambiguous result.
  • The target condition or the intervention is important enough to have been detected by existing population surveillance mechanisms.

Ideally, potential new treatments go through a series of scientific challenges that, if met, lead to acceptance of the test or treatment and integration into clinical practice. Many CAM therapies and many conventional medical therapies, however, are already in widespread use without such validation. The committee therefore concluded that, in addition to research aimed at determining efficacy and uncovering mechanisms of action, research aimed at investigating what is occurring in practice (that is, effectiveness) is also needed. This report proposes that such research be conducted within a research framework with four major components: practice-based research networks, a sentinel surveillance system, CAM research centers, and input from national surveys.

To ensure that research reflects as much as possible the actual ways in which CAM therapies are practiced, it is important to have CAM practitioners involved. However, most CAM practitioners do not have research training. CAM institutions focus primarily on training for practice; research training is rarely a part of CAM curricula. Investments in such training are crucial.

The widespread use of CAM therapies has implications not only for research but also for the education of conventional health care professionals. Health care professionals need to be informed about CAM and knowledgeable enough to discuss with their patients the CAM therapies that their patients are using or thinking of using. However, there are no guidelines for what should be taught, and there is great variation in the content and the methods currently in use. Suggestions for what to teach frequently emphasize critical thinking and evaluation of therapies as well as understanding of different belief systems. Although the content and organization of an individual educational program on CAM will vary from institution to institution, it is important for the health care professions schools to incorporate sufficient information about CAM into their curricula to enable licensed health care professionals to competently advise their patients about CAM. Furthermore, advances in understanding and applying CAM that derive from basic or clinical research should be incorporated into the pre-professional and continuing education programs of all relevant health professionals.

The committee chose to examine more closely the area of dietary supplements because they not only are a prominent part of American popular health culture but also present unique regulatory, safety, and efficacy challenges to consumers, researchers, and practitioners. The committee is concerned about the quality of dietary supplements in the United States. There is little product reliability (Raloff, 2003). Reliable and standardized products are necessary for the conduct of research on safety and efficacy as well as consumer protection, and the committee recommends that the U.S. Congress amend the Dietary Supplement Health and Education Act of 1994 (DSHEA) to require the appropriate reliability of dietary supplements.

The committee believes that the goal should be to provide comprehensive care that is based on the 10 rules outlined in the Institute of Medicine report Crossing the Quality Chasm (IOM, 2001). A comprehensive system uses the best available scientific evidence on benefits and harm, recognizes the importance of compassion and caring, encourages patients to share in decision making about their therapeutic options, and promotes choices in care that can include CAM therapies when appropriate. Scientific inquiry into little understood or unproven ideas, no matter whether they are from CAM or conventional medical sources, can lead to new information that in turn can lead to improvements in care for the public.

Health care is in the midst of an exciting time of discovery, a time when an evidence-based approach to health care delivery brings opportunities for the incorporation of the best options from all sources of care, be it conventional medicine or CAM. The challenge is to avoid parochial bias and to approach each possibility with an appropriate degree of skepticism or belief. Only then will it be possible to ensure that informed, reasoned, and knowledge-based decisions are being made.


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