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Mainstream and Alternative Medicine: Converging Paths Require Common Standards

Posted on: Saturday, 22 January 2005, 06:00 CST

The health care practices subsumed under the title "complementary and alternative medicine" (CAM) are now a substantial and growing part of health care. In the United States, office visits to CAM providers now outnumber visits to primary care physicians (1). The U.S. population spends more than $30 billion on CAM each year (1). Despite patient interest, CAM has existed largely outside of the world of mainstream medicine until recently, and evaluative research on CAM practices has lagged behind research on conventional medicine. Now, CAM and mainstream medicine are on converging paths as research funds become available and health systems search beyond conventional medicine for ways to attract-and help-patients.

In recent years, the body of research on several widely used CAM methods has grown in size and quality, partly in response to the availability of research support from the National Center for Complementary and Integrative Medicine of the National Institutes of Health. According to this evidence, some CAM treatments are effective, as measured against conventional medical treatments or against placebo, and others are not. A series of articles in Annals included systematic reviews of the very substantial body of evidence for some CAM practices (2-4), and that body of evidence continues to grow (the 21 December 2004 issue of Annals contained reports of 3 randomized trials of CAM interventions).

Reflecting this growing body of evidence of effectiveness, but also stimulated by market forces, many clinical practices are offering CAM treatments or are facilitating referral to community CAM practices. Most medical schools offer CAM coursework. Insurance carriers and health maintenance organizations are increasingly covering some CAM practices. Despite these signs, CAM's emergence into the mainstream of medical practice is just beginning. We predict that the gap between CAM and conventional practice will narrow when the fields share a common approach to settling questions of clinical effectiveness.

The agenda for research in CAM has many questions of concern to clinicians. The most compelling question is which treatments work and which do not. A related question is how to identify the clinical findings that predict which patients will benefit more from CAM instead of, or in addition to, conventional treatment. With these and related questions in mind, leaders of the National Center for Complementary and Integrative Medicine asked the Institute of Medicine to convene a working committee to help define principles to guide the research agenda for CAM. We were chair and a member, respectively, of that committee. In this editorial, we focus on one central question addressed by the committee. Although our answer reflects the committee's conclusions (5), we alone are accountable for what we write in this editorial.

The Institute of Medicine committee's core recommendation is that "the same principles and standards of evidence of treatment effectiveness apply to all treatments, whether currently labeled as conventional medicine or CAM" (5). This recommendation implies that integration of CAM and conventional medicine will require investigators in both fields to use similar research methods whenever possible. To do otherwise would risk permanent second- class status for CAM interventions.

This core recommendation has an unwritten corollary: that the world of conventional medicine must take CAM seriously. Some physicians do not take CAM seriously, and others regard it with extreme distrust. They are concerned about its widespread use and increasing integration into mainstream medical practice, whereas others see these developments as an opportunity and a reason to subject CAM to the same standards of evidence as conventional medicine. The large number of published clinical trials and systematic reviews suggest that some researchers are taking CAM seriously.

CAM researchers will confront some very difficult clinical research design problems, starting with the broad spectrum of CAM interventions that need study. The term CAM covers a broad array of products, concepts, disciplines, and practices. Some interventions are physical and others are spiritual in concept. Some therapies are as impersonal as an antibiotic (for example, a pill that contains an herbal product). Others seem to depend on a unique provider-client dyadic relationship. Only a few CAM methods have a plausible biological basis. Indeed, a purely biological explanation for interventions with metaphysical elements seems unlikely. Some CAM interventions are well-defined and reproducible, have measurable end points, and target populations that we can define in conventional medical terms. Other interventions fail all of these tests that predict a successful clinical study. We conclude that a single research strategy will not fit all circumstances and all CAM interventions.

An example of the need for flexibility in designing research is the randomized, controlled trial. The blinded randomized, controlled trial-the most powerful method for testing the effect of a medical intervention-is suitable for many CAM studies. We need trials that compare CAM, conventional therapy, and the combination of both practices. However, the blinded randomized, controlled trial may not be possible for interventions in which the therapeutic effect depends on a distinctive relationship between the provider and the patient. Clinical studies that measure the effect of these therapeutic relationships must account for the provider's role as an integral part of the intervention. Furthermore, the experimental design must preserve the CAM practice as it would be used in practice. Because patients' hopes and expectations may constitute part of the healing effect, studies should account for placebo or patient expectation effects. One approach to this goal is the preference trial, in which patients with strong preferences receive the therapy they want while patients who are in equipoise are randomly assigned to one treatment or the other. Study sections in agencies that fund CAM effectiveness research will need broad expertise in study design and open minds.

The culmination of clinical research is the accumulation of a cohesive body of high-quality evidence that support recommendations for practice. Many organizations use systematic reviews and meta- analyses to summarize the evidence for an expert guideline panel. Some professional organizations and payers, such as the American College of Physicians and the Blue Cross/Blue Shield Association, currently have rigorous methods for evaluating a body of evidence and linking it to recommendations for practice or for insurance coverage. Funding agencies must understand that a single study should not ordinarily drive clinical practice, and they should be willing to fund several studies of the same clinical problem. To obtain credible results, professional organizations of CAM practitioners must model their practice guideline programs after the most rigorous systematic programs, such as the U.S. Preventive Services Task Force (6).

The integration of CAM and conventional practice places several timeless ethical considerations, such as beneficence, nonmalfeasance, and patient autonomy, in a new light. We will need to understand how well conventional and CAM practitioners deal with these ethical imperatives. For example, beneficence implies that physicians should know and use proven benefits of CAM. Nonmalfeasance implies that they should know and avoid the risks associated with CAM. Do most primary care physicians know which CAM interventions are effective? Do they know the adverse effects of CAM interventions? Respect for patient autonomy may require the physician to stand by when a patient seeks CAM care with which the physician disagrees. Do physicians make appropriate referrals to CAM practitioners? Health professionals have a duty to seek help from colleagues when their patients need it. Therefore, CAM practitioners must recognize conditions that require conventional medical treatment and make appropriate referrals. Do CAM practitioners recognize these clinical conditions? Questions like these will help to define an agenda for research and for continuing professional education.

Ignoring CAM is not an option. The widespread use of CAM by patients is a mandate to the scientific community to improve our relatively weak scientific understanding of CAM practices. Moreover, health professionals have a duty to their patients to bring these 2 worlds of contemporary medical practice closer together. The path to this outcome begins with adopting the same standards of evidence.

References

1. Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, et al. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998;280:1569-75. [PMID: 9820257]

2. Kronenberg F, Fugh-Berman A. Complementary and alternative medicine for menopausal symptoms: a review of randomized, controlled trials. Ann Intern Med. 2002;137:805-13. [PMID: 12435217]

3. Ernst E. The risk-benefit profile of commonly used herbal therapies: Ginkgo, St. John's Wort, Ginseng, Echinacea, Saw Palmetto, and Kava. Ann Intern Med. 2002;136:42-53. [PM\ID: 11777363]

4. Gherkin DC, Sherman KJ, Deyo RA, Shekelle PG. A review of the evidence for the effectiveness, safety, and cost of acupuncture, massage therapy, and spinal manipulation for back pain. Ann Intern Med. 2003;138:898-906. [PMID: 12779300]

5. Institute of Medicine. Complementary and Alternative Medicine in the United States. Washington, DC: National Academy Pr; 2005 [In press].

6. Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow CD, Teutsch SM, et al. Current methods of the US Preventive Services Task Force: a review of the process. Am J Prev Med. 2001;20:21-35. [PMID: 11306229]

2005 American College of Physicians

Stuart Bondurant, MD

Georgetown University School of Medicine

Washington, DC 20057

Harold C. Sox, MD

Editor

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Customer Service, American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106.

Current author addresses are available at www.annals.org.

Ann Intern Med. 2005;142:149-150.

Copyright American College of Physicians Jan 18, 2005

Source: Annals of Internal Medicine

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