OAM Commences $8 Million Investigation Into Alternative Therapies

Alternative Therapies Author: Joy McIntyre The National Institutes of Health's Office of Alternative Medicine (OAM) has begun what promises to be a long and controversial process of investigating a vast array of alternative treatments-including therapies such as Chinese herbs, binaural feedback, massage, and mind-body techniques-for efficacy against a wide range of health threats. Nearly $8 million in funds previously earmarked by Congress will go out over three years to eight research centers throughout the United States specializing in such treatment areas as pain; stroke and neurological conditions; women's ailments, from pregnancy to menopause; cancer; lower back pain; coronary problems; addictions; HIV and AIDS; asthma, allergy, and immunology; and aging. Similar funding of slightly more than $900,000 each for two additional centers was dispersed last year. The research supported by the awards, if confirming data from clinical trials are collected, may acknowledge some alternative techniques as useful, perhaps integrating them into mainstream medicine. "It's always been true that the 'mainstream' of today is the 'alternative' of the past," says OAM director Wayne Jonas. "That's how medicine and science have always progressed." A 'MAJOR ISSUE': James Gordon says it's important to find out whether alternative therapies work or not. "Because people are using these therapies, we have to find out whether these things work or not. It's a major public-health issue," adds James S. Gordon, a professor of psychiatry and family medicine at the Georgetown University School of Medicine and chairman of OAM's Program Advisory Council to NIH. The council, which provides input on allocation of funds and research methodology, recommended about 18 months ago that OAM fund a wide number of centers. Despite the public interest in nontraditional therapies, there are some individuals who decry what they see as a waste of precious resources for research on the frivolous. "The research [in alternative strategies] has been done. The probability of anything positive is so low compared to basic biological research or clinical research as to make it nearly absurd to pursue it," declares Wallace Sampson, board chairman of the National Council against Health Fraud, a nonprofit group that monitors alternative therapies in Loma Linda, Calif., and an oncologist at Valley Medical Center in San Jose, Calif., the teaching hospital for Stanford University. "The money should have been placed here-in basic research. There are young scientists out there who don't have jobs." Three-year grants were awarded to: the University of Virginia School of Nursing in Charlottesville for research on pain ($1,103,486); the Kessler Institute for Rehabilitation in West Orange, N.J., and the University of Medicine & Dentistry of New Jersey in Newark for studies of strokes and neurological conditions ($1,089,922); Columbia University College of Physicians and Surgeons for women's health research ($1,067,587); the University of Texas Health Science Center in Houston for cancer investigations ($1,040,585); Beth Israel Hospital, affiliated with Harvard Medical School, for research on coronary disease and lower back pain ($935,696); the University of Maryland School of Medicine in Baltimore for pain studies ($900,088); the University of California, Davis, for asthma, allergy, and immunology investigations ($899,021); and Stanford University for aging research ($864,150). Funded in September 1994 were Bastyr University in Seattle for HIV and AIDS studies ($920,000), and Minneapolis Medical Research Center for addiction research ($924,000). The centers are encouraged to partner with other agencies and foundations to broaden their acquisition of funds and the possibilities for studies. The research agendas established are anticipated to produce questions several years beyond the scope of the three-year grants, creating additional opportunities for investigators. According to researchers and OAM officials, the centers are expected to collaborate with outside organizations in their field of study in order to augment their funding with external grants, thus extending the impact and, possibly, the time line of the OAM funds. The first year of these projects is to be devoted to gathering data on what alternative practices are being used through searching databases of previous studies, surveying practitioners, and, in some cases, gathering information from patients and their families. Data will be collected on a wide variety of techniques, including mind-body strategies, binaural beat technology, acupuncture, acupressure, massage therapy, and homeopathic and herbal remedies. Then, in subsequent years, investigators will cull out those areas appearing most promising for research agendas. Pilot studies and clinical trials designed to validate-or repudiate-the use of various alternative techniques will follow. The grants come at a time when traditionalists are taking aim at alternative medicine for fueling what they consider to be dangerous anti-science sentiments, substituting belief for rigorously achieved scientific evidence (F. Hoke, The Scientist, July 10, 1995, page 1). "OAM is under heavy pressure to abandon the conventional methodology and instead substitute self-reported anecdotal evidence from practitioners, which from a scientific point of view is an absolute disaster," maintains Norman Levitt, a mathematician from Rutgers University in New Brunswick, N.J. Levitt is coauthor-with Paul Gross, University Professor of Life Science at the University of Virginia-of Higher Superstition: The Academic Left and Its Quarrels with Science (Johns Hopkins University Press, 1994). Levitt says he foresees dangers in publishing the results of data collection: "I would say don't publish even with strong cautions, because even if you have the most tentative indication and [a potentially] misleading indication, the popular press picks up that eating yogurt cures brain cancer. It's very irresponsible. I would say hold off until you have a scientific study." "The whole point of alternative medicine is that it's not scientific," counters David L. Goodstein, Frank J. Gilloon Distinguished Teaching and Service Professor and a vice provost at the California Institute of Technology. Though a traditionalist, he argues that the government must contend with alternative medicine as a political reality because of the sheer numbers of people using it. "There's no other way to go about that job other than to go out and listen to as many people as you can-even the crackpots," he says, suggesting that regulation may be the eventual result of investigation. There is now a plethora of alternative methods widely being practiced: A study published in 1993 in the New England Journal of Medicine (D.M. Eisenberg et al., 328:246-52, 1993) reported that one in three respondents used alternative therapies such as relaxation techniques, chiropractic, therapeutic massage, and special diets, making more visits to alternative practitioners than to U.S. primary-care physicians. Such techniques are most often used to treat back problems, headache, arthritis, pain, insomnia, depression, and anxiety. Because of the burgeoning number of alternative methods and their growing popularity and usage by individuals untrained in health care, those in the field say there are compelling reasons to first identify fertile areas for investigation before launching controlled studies. Program Advisory Council member Barrie Cassileth, a professor of family and community medicine at Duke University and an adjunct professor of medicine and oncology at the University of North Carolina, notes that the efficacy of alternative techniques is anecdotal. Yet, she contends, "If there were research showing that these things worked, they would be part of mainstream medicine." Cassileth, the author of several journal articles on the subject of alternative medicine (including B.R. Cassileth, Contemporary Oncology, 4:28-38, 1994; B.R. Cassileth, et al., N. Engl. J. Med., 324:1180-5, 1991; B.R. Cassileth et al., Annals of Internal Medicine, 101:105-12, 1984), says she supports the centers' role in promoting serious research. In November 2 remarks to a Washington, D.C., group of science writers, OAM director Jonas pledged to apply flexibility, creativity, and rigor to research into alternative medicine. "It will require the best of molecular and cellular biology, basic science research, surveys and epidemiological approaches, detailed case reports and best-case series, multi-disciplinary and cross-level research, randomized and placebo controlled trials, prospective parallel-outcome studies, cost-benefit evaluation, research summaries, meta-analyses, and direct comparisons of complex therapeutic systems," he said. "In all cases, the importance of objectivity, rigor, clarity of research goals, and the reduction of bias must be paramount." Yet, designing such studies with the appropriate rigorous methodology to promote confidence from all quarters in their results promises to be a challenge. "If you pray for an alcoholic and he stops drinking, how do you validate that isn't due to something other than prayer?" muses Geoffrey Chung, project manager for the grants at OAM and a director of extramural affairs. Chung indicates that those areas less easily validated may of necessity become less of a priority. However, Jonas tells The Scientist that part of his vision for the office includes investigating some strategies that may "require creative scientific solutions. We can't afford to ignore the subject just because it's more difficult to investigate," noting that serious research has been accomplished in difficult subject areas, such as psychotherapy. "The argument [by proponents of alternative medicine for why such rigorous studies have not been done] is always that constructing a study to find out what is going on is very difficult. I don't see why," counters Gross. "Constructing a study to find out what is going on is very expensive. Random double-blind clinical trials done under protocols taken seriously are hugely expensive. And that's why in the past we have not just gone ahead and investigated anything anyone says." DIFFICULTIES: Grantee Judith Stern of UC-Davis notes that some diseases are easier to study than others. Researchers in the field also point to difficulties. "Some diseases are easier to study than others: she either breathes or she doesn't," notes Judith S. Stern, a professor of nutrition and internal medicine and co-principal investigator of the grant in asthma, allergy and immunology to the University of California, Davis. With asthmatics, the results of touch therapies can be more quickly and clearly measured than with people with other conditions, such as cancer, Stern explains. "Let's say one's looking at massage, massage aimed at certain pressure points based on acupressure. We would encourage people to design a study that would take the patient and get a pretty stable baseline of peak flow [air expired] over a week or more, put in the treatment to measure peak flow again, stop the treatment and see if it returns to the previous peak." Another group of asthmatics might sit quietly or read a book. Principal investigators contacted at several centers say they have gathered statisticians and research methodologists to create a modern, scientific study design that will pass muster and produce believable results. At Columbia University College of Physicians and Surgeons, work at the center established under the OAM grant will focus on touch therapies and herbal remedies for the discomforts of women from pregnancy through menopause. In a study already under way with previous OAM funding, participants are currently being recruited to use a 12-herb mixture created by a professor at Beijing University to ease hot flashes in menopause. "If they work, one possible mechanism is that they have some estrogenic action. Plant estrogens are non-steroidal estrogens, a different structure than our body estrogen," explains Fredi Kronenberg, an assistant professor of physiology at Columbia and director of the Richard and Hinda Rosenthal Center for Alternative/Comprehensive Medicine, both in New York. The Columbia study is a double-blind, placebo-controlled crossover trial; prior approval of the herbal mixture was obtained from the endocrine metabolism division of the Food and Drug Administration. The willingness to include alternative methods in a treatment plan may be influenced by the severity or prognosis for the illness. For example, according to Jonas, half of all cancer patients use "unconventional practices." At the University of Texas, the center plans to investigate biopharmacologic remedies, such as the effects of herbs and natural products on cancers, possibly including iscador (a derivative of mistletoe currently undergoing trials in Europe), shark cartilage capsules, and herbal tea mixtures. "Cancer patients are using these therapies, and we need to evaluate the good ones. If there is bad stuff out there, we need to let people know because we need to inform the public,"says Mary Ann Richardson, grant co-principal investigator who has a doctorate of public health in preventive epidemiology at the University of Texas M.D. Anderson Cancer Center and School of Public Health in Houston. Richardson, who has two other grants from OAM, is co-investigator with Guy S. Parcel, director of the Center for Health Promotion Research and Development at the University of Texas Health Science Center. Exploration on the placebo effect is also on OAM's agenda. "Let's apply good science working alongside expert practitioners to figure out if and when these therapies do more good than harm. And if they do, is it because of the modality: because of the herb, the pressure point, or the belief in the herb or pressure point?" suggests David Eisenberg, a primary care internist and the director for alternative medical research at Beth Israel Hospital in Boston and an assistant professor of medicine at Harvard Medical School. ASSESSING THE PLACEBO EFFECT: Harvard's David Eisenberg notes that studying the placebo hypothesis is on the agenda of the OAM. Without the discovery of a physiological component, however, others point to placebo as the only explanation. "Since in almost all the cases we're talking about there is no compelling evidence of an understandable physiological process, if they work at all, it must work by the placebo effect," declares Gross. "With a nonsense science like acupuncture, if treatments seem to make people feel better, design a serious large-scale study on the placebo effect directly." DETRACTOR: U. Virginia's Paul Gross calls alternative therapies like acupuncture "a nonsense science." Yet one aspect of continuing research might be to determine what triggers the placebo effect and how to manage it. "If it is placebo effect, that's pretty strong medicine. That's one of the things that's of interest to us," counters Richardson. Even if the placebo effect is at work, how it works, for whom, and when may become part of a research agenda. "Placebo variability may be enormous," Eisenberg points out. As one person is tone deaf and the next can hear a song and immediately play it on the piano, individual differences may play a role in receptivity to alternative therapies, Eisenberg speculates. Thus, the placebo effect may work differently on different people. To use it effectively may require further understanding of individual differences. To that end, at the Center for the Study of Complementary and Alternative Therapies at the University of Virginia, work is proceeding on development of a psychosocial assessment tool, a standard personal information profile to define or describe individual differences, reports Ann Gill Taylor, a professor of nursing. The center plans to review the use of binaural beat therapies (whereby different frequencies are introduced into each ear, which is said to alter brain waves, inducing relaxation), energy healing, therapeutic touch, and other modalities for the relief of pain. Critics contend that positive results are the product of faulty studies or possibly placebo effect. "Placebos do not alter medical disease," says Sampson. But if a mechanism is not immediately apparent, others such as Georgetown's Gordon point out, traditional medicine employs some strategies-such as surgeries or even aspirin-"long before we know why it works." Is a double standard at work? "Most conventional therapies have not withstood randomized controlled trials which have been replicated at a number of sites. [Yet] that's the standard to which most alternative therapies are held," maintains Eisenberg. He adds that he agrees with the standard but urges that rigorous yardsticks also be applied to the latest lithotriptor or chemotherapeutic wonder drug. IN PROGRESS: Fredi Kronenberg is conducting a study of a 12-herb mixture to ease hot flashes in menopause. "Part of the goal is to find out which part of alternative medicine is worth integrating and to bring into good medicine remedies from wherever they come from," says Kronenberg. "Good scientists who want to see good research say open-mindedly, 'We're willing to look at this. We'll figure out a way to study it.' That, I think, is the best of science." Joy McIntyre is a freelance writer based in Philadelphia.

OAM Commences $8 Million Investigation Into Alternative Therapies

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