For many years Americans have quietly courted medical treatments and therapies outside of traditional allopathic and osteopathic medicine. Today, some form of complementary and alternative medicine (CAM) is embraced by nearly two in five adults nationally and CAM overall is one of the fastest growing health and wellness areas. The unabashed consumer interest has forced CAM to be seriously considered by the traditional medical establishment, which seeks to impose upon CAM scientific rigor and testing, and to be addressed by governmental research and regulatory agencies, which now must include CAM under their varied health-related missions.

CAM encompasses what some account to be over 300 heterogeneous disciplines, procedures and treatments not found in conventional medicine. Core to most CAM philosophies and practices are the notion of self-help, the relationship of mind, body and spirit, and an emphasis on prevention and healthy life styles. The National Institutes of Health (NIH) has classified CAM into seven major categories: mind-body interventions, alternative medical systems, lifestyle and disease, biologically-based therapies, manipulative and body-based systems, biofield medicine and bioelectromagnetics. Within most of these major categories fall practices already accepted and used in conventional medicine, such as psychotherapy, meditation and imagery; practices that overlap between CAM and conventional, such as placebos, dance therapy, and, potentially, acupuncture; and practices completely eschewed by conventional medicine, such as reiki, color therapy and reflexology.

That consumers are embracing CAM is well documented in a 1997 follow-up survey to a 1990 pioneering study, released in 1993, on the use of alternative therapies. The surveys were conducted by Drs. David Eisenberg and Roger Davis of the Center for Alternative Medicine Research and Education, Beth Israel Deaconess Medical Center. The 1997 study, published in November 1998 in the Journal of the American Medical Association (JAMA), found that 42 percent of the population has used at least one of the 16 alternative therapies defined in the survey, up from 34 percent in 1990. The largest increases were in herbal medicine, massage, megavitamins, self-help groups, folk remedies, energy healing and homeopathy. This corresponds to an estimated 47 percent increase in total visits to alternative medicine practitioners, from 427 million in 1990 to 629 million in 1997, thereby exceeding total visits to all U.S. primary care physicians. The 1997 survey noted an increase over the 1990 survey in the use of alternative therapies for treatment of an existing illness, as opposed to health promotion. Both surveys showed alternative therapies were used most frequently for chronic conditions, including back problems, anxiety, depression and headaches, in conjunction with conventional medicine. The 1997 study estimated that nearly 32 percent of individuals seeing a medical doctor for a principal condition also used an alternative therapy. In addition, of patients using alternative therapies, only 40 percent discussed their use of CAM with their medical doctor.

As CAM has grown in consumers and revenues, with the entire industry estimated at over $30 billion, insurers across the country are responding. According to Modern Healthcare, September 1998, the number of major insurers covering some form of CAM moved from two or three to 29 in a just a few years. This includes such carriers as San Francisco-based Blue Shield of California, Prudential, Blue Cross of California, Kaiser Permanente and Denver-based Blue Cross and Blue Shield. That many states are licensing or considering licensure of some CAM providers, such as chiropractors, acupuncturists and naturopaths, will facilitate incorporation of such providers into insurers’ networks and will likely increase the number of plans offering some coverage for alternative practices. According to Healthcare Trends Report, December 1998, interim data from a three-year project at Stanford University showed that most of the major national health plans were either working on or already had a complementary medicine product.

This pervasive utilization has forced conventional medicine to seriously consider CAM and opened the debate on how best to deal with this phenomenon. Historically, western conventional medicine has not recognized CAM as legitimate medical treatment. Critics stress that the use of science for understanding alternative medicine is frequently missing from such practices and evidence-based research on CAM is needed. As noted by Phil B. Fontanarosa, MD, and George D. Lundberg, MD, in a November 1998 JAMA editorial, "There is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking."

Some advocates of alternative medicine believe the scientific method is not applicable to many of their remedies. Furthermore, if a treatment is low risk, they contend the consumer does not have to be certain of the benefit in order to use it. Dr. William Wardell, executive director of the Covance Institute for Drug Development Studies in Princeton, N.J. states that the convergence of conventional and alternative medicine is a clash of cultures, noting that in conventional medicine ". . .The presumption is that drugs are ineffective and unsafe unless they are proven to be effective and safe. [CAM] philosophy has been the presumption that treatments are safe and effective unless proven otherwise."

A large portion of the public debate focuses on the use of herbal remedies, which, according to Eisenberg’s study, increased 380 percent between the 1990 and 1997 surveys. Much of this growth can be attributed to the 1994 Dietary Supplement Health and Education Act, which weakened the authority of the Food and Drug Administration (FDA) to regulate vitamins, herbal remedies and other products classified as dietary supplements. Under the Act, the FDA must prove a product unsafe before taking it off the market. Manufacturers, not required to standardize the contents of herbal products and allowed broad advertising and labeling freedom, placed products of unregulated content on the market with untested claims of efficacy and safety. Recently, large, reputable drug makers have entered into this profitable $3 billion market. While these manufacturers do not appear to be conducting efficacy studies, their well-established manufacturing and procurement processes may nonetheless improve the safety of such products by reducing the potential for contamination.

Acceptance of CAM into the mainstream will always be linked to data and greater efforts to provide health care professionals with clinically relevant, scientific information continue. A pioneering edition of JAMA in November 1998 released studies of six randomized clinical trials evaluating six diverse alternative medicine therapies, including chiropractic spinal manipulation and Chinese herbal medicine. Additional studies were released during the same month in the nine American Medical Association Archives journals. In September 1998, the New England Journal of Medicine (NEJM) published a study, conducted by researchers at the University of Medicine and Dentistry of New Jersey, on the Clinical and Biological Activity of an Estrogenic Herbal Combination (PC-SPES) in Prostate Cancer. PC-SPES is a commercially available combination of eight herbs. Authors of the article were: Robert S. DiPaola, M.D.,  Huayan Zhang, M.D., George H. Lambert, M.D., Robert Meeker, B.S., Edward Licitra, Ph.D., Mohamed M. Rafi, Ph.D., Bao Ting Zhu, Ph.D., Heidi Spaulding, R.N., Susan Goodin, Pharm.D., Michel B. Toledano, M.D., William N. Hait, M.D., Ph.D., and Michael A. Gallo, Ph.D. [From the Departments of Medicine (R.S.D., E.L., M.M.R., B.T.Z., H.S., S.G., W.N.H., M.A.G.), Pediatrics (H.Z., G.H.L.), and Pharmacology (W.N.H.), Robert Wood Johnson Medical School; the Cancer Institute of New Jersey (R.S.D., G.H.L., R.M., E.L., M.M.R., B.T.Z., H.S., S.G., W.N.H., M.A.G.); and the Environmental and Occupational Health Sciences Institute, (H.Z., G.H.L., R.M., B.T.Z., M.B.T., M.A.G.).]

Observers on both sides of the CAM debate acknowledge that without proprietary incentives for most CAM practices or products, the financing of evidence-based CAM research is not likely to come from the private sector. In 1998, Congress elevated the status of its Office of Alternative Medicine (OAM), established in 1992, to the National Center for Complementary and Alternative Medicine (NCCAM) and boosted its budget from $2 million to $50 million. The growth of this office provides a national funding stream and visible platform for research in CAM. NCCAM will provide funding to ten research centers across the nation to evaluate alternative treatments for many chronic health conditions. The centers, each with a specific clinical focus and based at such medical institutions as the University of Virginia, University of California-Davis, Stanford, University of Texas, Columbia University and Kessler Institute for Rehabilitation, are designed to allow alternative medicine practitioners and research scientists to evaluate promising alternative medical practices in a scientifically rigorous manner. The Kessler-UMDNJ Center for Research in Complementary and Alternative Medicine for Stroke and Neurological Disorders was established in 1995 in conjunction with the OAM. The mission of this center is primarily educational and research-oriented, including assessing CAM techniques in this field, educating CAM practitioners in data collection and research, and supporting collaborative training and research. The synthesis of conventional and alternative practices, as seen in these centers, has recently been termed "integrative medicine."

The public interest in and academic debate of CAM is also beginning to shape medical education. Practitioners indicate they desire training in the use of CAM and information on its benefits and risks to better respond to their patients. For example, in 1996 the American Academy of Family Physicians surveyed its members and found that more than one-third felt they needed training in CAM.

To fill the gap in CAM training, a large number of programs have started in medical schools across the country, including programs for current physicians and physicians in training. In the September 2, 1998 JAMA, a study reported the results of the 1997 and 1998 Annual Medical School Questionnaire Part II, distributed by the Liaison Committee on Medical Education. Although no medical school reported offering a separate required course in complementary health care practices, medical schools covering CAM as part of a required course increased to 63 in 1998 (from 46 in 1997) and those offering a separate elective course increased to 54 (from 47 in 1997). A 1997 survey by the Association of American Medical Colleges found that approximately 75 percent of the 125 U.S. medical schools were offering instruction in CAM as part of required courses. Yet, as noted in the JAMA article, current instruction varies greatly; few schools reported content structured around evidence-based curriculum or including critical reading of existing research or epidemiological studies.

The importance of including CAM in medical education was cited by Drs. Fontanarosa and Lundberg in their JAMA editorial: "We believe that physicians should become more knowledgeable about alternative medicine and increase their understanding of the possible benefits and limitations of alternative therapies. By doing so, physicians will be able to serve as more useful sources of information for their patients and advise them appropriately."

Vivian H. Lubin
Vice President for Planning