In biomedical research, is the "gold standard" of controlled studies that analyze individual therapies the only way to get trustworthy results? That question is central to what has arguably become America's most profound public health development: the boom in complementary and alternative medicine (CAM).
That question also was pondered frequently at the fourth annual Comprehensive Cancer Care Conference recently in Arlington, Va. Cosponsored by the nonprofit Center for Mind-Body Medicine in Washington, D.C., and the University of Texas Medical School at Houston, the meeting drew an audience of more than 1,200 to hear about the inroads CAM is forging, and the roadblocks it is encountering, en route to the goal of acceptance by mainstream science.
"The reason there is as much interest in complementary medicine as there is, is not because of the science," according to James S. Gordon, a professor of psychiatry and family medicine at Georgetown University and founding director of the Center for Mind-Body Medicine. "The moving force has been us." He means the general public and practitioners have led the push. In terms of government-funded CAM research, Gordon believes that cancer is where the best progress has been made to date.
CAM's popularity is widespread, according to most estimates. For example, an oft-cited paper based on a national telephone survey of 2,055 adult Americans places CAM use at 42 percent.1 This extrapolates to 83 million people, who spend $27 billion out-of-pocket on such therapies. However, at least one large survey disputes such figures. A paper based on a written national survey of 16,068 adults shows that only about 8 percent use unconventional therapies.2 Regarding cancer, a survey of 453 outpatients reveals that 69 percent used CAM treatments, excluding spiritual practices and psychotherapy.3
Despite the generally strong evidence of public demand, CAM practitioners are aware that the skepticism of mainstream medical science is far from overcome. Harvard University medicine professor David S. Rosenthal wryly recalls the comment of a colleague upon hearing that he would be heading the Zakim Center for Integrated Therapies at the Dana Farber Cancer Institute in Boston: "Oh, Rosenthal. So now you're going to be giving antioxidants and enemas." By the same token, he remembers attending an American Cancer Society (ACS) meeting on "quackery." In following years, the meeting was titled "questionable methods," then it became "unproven therapies," before ACS finally adopted "CAM," with its emphasis on treatments that either complement or are alternatives to conventional ones. Now, he observes, a popular term is "integrated therapies" that are combined with mainstream modalities.
Burden of Proof
A major obstacle to integration of CAM into medical science is the burden of proof. CAM advocates seem to disagree on whether to focus on standard trials that test one intervention at a time, or to emphasize new trial designs that begin with "best case" scenarios taken from practices that use mainstream and CAM methods in combination. In the best case format, the effectiveness of certain modalities used together is first determined in the clinic, then tested in controlled trials as a group of treatments rather than singly. "CAM research can be just as good as non-CAM research, whether we study shark cartilage or [natural] angiogenesis inhibitors," Rosenthal declares.
Stanford University School of Medicine psychiatry and behavioral sciences professor David Spiegel affirms, "If we're going to be accepted by mainstream medicine, we have to use the tools of mainstream medicine, which is science." Spiegel, whose work concerns the effects of psychosocial treatment on cancer survival, adds that although all the answers won't be delivered by using conventional trial design, the established way of doing research must be respected.
Gordon agrees, but he also argues that the reductive study of isolated therapies is too slow and is irrelevant because CAM treatments are administered in combination. Research must be conducted on integrated approaches, as well as on treatments that are individualized, such as Chinese herbs prepared for a particular patient's needs. "This is crucial," he insists. "This may represent one of the most profound shifts. ... We're talking about a fundamental sea change in the way we look at medicine and health care."
"I don't think you can do evidence-based practice without doing effectiveness studies," comments Ian D. Coulter, principal investigator of the Southern California Evidence-Based Practice Center CAM project. It's one of 12 centers nationally that develop CAM "evidence reports" for the government. He conducts extensive patient records analysis, including interviews with clinicians, aimed at identifying best case models that warrant further study because of treatment results achieved. "We shouldn't be too apologetic that there are other ways of doing research," Coulter muses.
He advocates increased effort toward understanding what works in CAM practices, for what kinds of patients, and the qualities of effective physicians. Relatively few practitioners have participated since the best case series began in 1997, he acknowledges. Political factors are at stake, such as licensing issues, fear of prosecution, or ridicule by peers. Coulter, who was trained in economics and political science before embarking on a long career in CAM research, notes that the social sciences faced criticisms of lack of scientific rigor and responded with an array of methodologies and measures. He believes all science is, in part, political. "I think you have to build trust," he says of reluctant CAM therapists. "It's not the only issue, though. I think the other issue is that the magnitude of the task overwhelms them."
Jeffrey D. White, director of the National Cancer Institute's office of cancer complementary and alternative medicine, is working with NCCAM director Stephen E. Straus to uncover anecdotal evidence of useful CAM therapies and move them into clinical trials. "We're trying to develop a real dialogue with CAM practitioners," White declares.
Mary Ann Richardson, a program director at NCCAM, points out that the center has funded integrative medicine programs, but there's a catch: "You really need to show evidence [of effectiveness]. And it's difficult when you have a whole group of things." The trials that NCCAM funds extend from the preclinical phase to full-scale Phase III efforts, she adds. (See "CAM Cancer Research Grows").
Commission Highlights Self-Care
Gordon, who chairs the White House Commission on Complementary and Alternative Medicine Policy, decries the "homeopathic level" of funding for disease prevention. He says that wellness or self-care has become a major focus of the commission's work. Established last year by former President Bill Clinton, the commission issued a progress report in September and is charged with filing its final report by March 7, 2002. Recommendations are still being formulated, but Gordon says the commission is operating on principles that include: an emphasis on health promotion and a belief that self-care should be integral to the nation's health care system; respect for the body's self-healing capacities; attention to physical, mental, emotional, environmental, and spiritual impacts on health; and an appreciation of each patient's unique needs.
He also says the commission advocates increased information in lay language about CAM research findings. "The ultimate goal is to educate ourselves and other people, so we can discriminate between what makes sense and what doesn't." He adds, "We believe very strongly that there should be large-scale demonstration projects of CAM services, particularly for people of low income in community health center settings." Ultimately, he concludes, "We're talking about giving power back to the people who come for their health care."
1. D.M. Eisenberg et al., "Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey," Journal of the American Medical Association, 280:1569-75, 1998.
2. B.G. Druss and R.A. Rosenheck, "Association between use of unconventional therapies and conventional medical services," Journal of the American Medical Association, 282:651-6, 1999.
3. M.A. Richardson et al., "Complementary/alternative medicine use in a comprehensive cancer center and the implications for oncology," Journal of Clinical Oncology, 18:2505-14, 2000.
For More Information
National Center for Complementary and Alternative Medicine
White House Commission on Complementary and Alternative Medicine Policy