National Center for Alternative Medicine Established

A physician asks, via the Internet, for help in locating a resource to evaluate possible interactions between herbal remedies and Western medications. A Stanford researcher surveys 1,035 randomly selected people and reports that 40% of them have used such alternative health care as chiropractic, acupuncture or homeopathy during the past year (Astin, 1998). A survey of U.S. medical schools indicates nearly two-thirds of those responding (64%) now offer courses that include alternative medicine (Wetzel et al., 1998).

Reacting to this growing interest in alternative and complementary health care, Congress recently passed legislation replacing the Office of Alternative Medicine (OAM) with the National Center for Complementary and Alternative Medicine (NCCAM). The change was included in the fiscal year (FY) 1999 Omnibus Appropriations Bill (S. 2440) signed recently by President Clinton.

"Establishment of the NCCAM and its appropriated budget of $50 million in fiscal year 1999 will provide greater autonomy to initiate research projects at a time when the public is increasingly interested in CAM [complementary and alternative medicine] therapies," said Harold E. Varmus, M.D., director of the National Institutes of Health (NIH), in a press statement. Last year, OAM's budget was $20 million.

As defined in the legislation, the purposes of the center "are the conduct and support of basic and applied research (including both intramural and extramural research), research training, the dissemination of health information, and other programs with respect to identifying, investigating and validating complementary and alternative treatment, diagnostic and prevention modalities, disciplines and systems."

Some of the areas classified as CAM, according to the center, include acupuncture, ayurveda, homeopathic medicine, electro-stimulation and neuromagnetic stimulation, nutritional supplements, herbal medicines, manual healing, art therapy, biofeedback, hypnotherapy, prayer therapy, yoga, and anti-oxidizing agents.

Varmus noted that a search is underway for a director of NCCAM. The new director, who is expected to be an expert in world-class clinical trials, will report directly to Varmus. "This [personnel selection] will ultimately lead to the expansion of clinical trials in this field," he said.

The change from an office to a center means that NCCAM will be able to fund its research grants and other projects directly. As OAM, it could only fund projects by collaborating with other institutes or outside agencies. Sen. Tom Harkin (D-Iowa), a co-author of the amendment to establish NCCAM, pointed out that the legislation also addressed another shortcoming of the current handling of research into alternative medicine.

"The hallmark of rigorous scientific review at NIH is the peer review process. However...there were no complementary or alternative medicine specialists on NIH peer review panels," Harkin said. Scientists with expertise in the particular CAM area to be studied are required by the new law to review projects. Harkin sees the center's creation as stimulating better and more effective health care for the nation.

"The only way to improve patients' access to the best treatments available is to create the body of scientific knowledge needed to ensure the development and review of safe and effective medicines and therapies," the senator said.

The multimillion dollar cost of obtaining U.S. Food and Drug Administration approval, according to Harkin, often "excludes from the review process all medical therapies not promoted by major corporations, or those that are nonpatentable or low-cost. Very few sponsors of alternative medicines and treatments have the resources to go through this process." Therefore, creation of the NCCAM, Harkin believes, will help assure improved and expanded rigorous scientific review of alternative and complementary therapies.

The NCCAM will be aided in its efforts by an 18-member advisory council and several ex-officio members. At least half the council members will include practitioners licensed in one or more of the major subsystems with which the center is concerned. At least three will represent the interests of consumers of CAM.

As a director for NCCAM is being sought, Wayne B. Jonas, M.D., former director of the OAM, has left to resume his research and teaching career as a medical officer with the U.S. Army. As reported in an NIH Record article (Greene, 1998), when Jonas became OAM director in 1995, the office was highly controversial.

"Its very existence generated considerable controversy and resistance from mainstream physicians and research scientists who felt that the presence of the OAM at the world's foremost biomedical institution lent credibility or endorsement to alternative medicine," the article said. The biggest change since the establishment of the OAM is in attitudes toward alternative medicine, said William R. Harlan, M.D., associate director for the Office of Disease Prevention. This office had administrative oversight of the OAM for two years.

"Conventional researchers and medical practitioners have become very interested in alternative medical approaches and in conducting research in this emerging field," he said. "It is now recognized that there are many CAM interventions that hold promise, but must first be tested in a scientific manner and proven to be effective for medical use.".

Research Centers

During Jonas' tenure, the OAM funded 13 research centers at universities and other institutions throughout the country; those centers are conducting some 50 research projects. Additionally, NCCAM has begun several major clinical trials in CAM; created a research database containing more than 100,000 citations on CAM topics; initiated a research training program; and established a clearinghouse to disseminate information to the public, media and health care professionals. The center also is a World Health Organization Collaborating Center for Traditional Medicine.

The 13 NCCAM-funded specialty research centers study complementary and alternative treatments for specific health conditions and populations. Three of the 13 centers were awarded grants last October. Over a five-year period, each will receive a total award of approximately $5 million. Grants were awarded to Thomas J. Kiresuk, Ph.D., principal investigator for the Addictions Research Center at the Minneapolis Medical Research Foundation; Steven F. Bolling, M.D., principal investigator for the Cardiovascular Disease Research Center at the University of Michigan Ann Arbor; and Fayez Ghishan, M.D., and Andrew Weil, M.D., for the Pediatrics Research Center at the University of Arizona Tucson.

The remaining 10 centers focus on such clinical conditions as asthma, allergy and immunology; HIV and AIDS; cancer; pain; stroke, spinal cord injury, traumatic brain injury and other neurological disorders; the more general issues of aging; women's health (e.g., pregnancy, menstrual-related disorders, menopausal problems and breast cancer); chronic medical conditions (e.g., low back pain, ischemic heart disease); and chiropractic (Table).

"Chiropractic is the third largest doctorate health care profession in the United States with approximately one in 15 Americans seeing chiropractors yearly," Jonas said in a recent statement. "However, there is insufficient scientific data to address the safety and efficacy of this treatment for many musculoskeletal disorders, including chronic pain."

Consequently, in March 1998, the OAM and the National Institute of Arthritis and Musculoskeletal and Skin Disease awarded a $2.7 million grant to the Consortial Center for Chiropractic Research (CCCR), a group of chiropractic colleges and institutions headquartered at Palmer College of Chiropractic in Davenport, Iowa. In addition to establishing a research infrastructure, the CCCR will also examine the potential effectiveness of chiropractic therapies and provide technical assistance to chiropractic investigators in developing individual research-initiated projects.

The OAM also has jointly supported several large clinical trials with NIH's institutes and centers. One example is the three-year study, in cooperation with the National Institute of Mental Health and the Office of Dietary Supplements, on St. John's wort (Hypericum perforatum) for clinical depression. This three-year study will include 336 patients with major depression who will be randomly assigned to one of three treatment arms for an eight-week trial. One-third of the patients will receive a uniform dose (900 mg daily) of St. John's wort, another third will be given placebo and the final third will take a selective serotonin reuptake inhibitor. Study participants who respond positively will be followed for another 18 weeks. The goal of the follow-up is to determine if patients given St. John's wort have fewer relapses than patients given placebo. The study is being conducted at Duke University, and patient recruitment has just begun..

Preliminary Studies

Some of the NCCAM/OAM-funded projects have already added to the scientific literature and influenced clinical care.

In 1997, the OAM joined with the NIH Office of Medical Applications of Research to sponsor a consensus development conference on acupuncture. A 12-member panel concluded that there is clear evidence that needle acupuncture treatment is effective for postoperative and chemotherapy nausea and vomiting, nausea related to pregnancy as well as postoperative dental pain (PT March, 1998).

In 1993, the center began to cofund exploratory pilot projects to identify promising areas of future research. Thirty awards were made that year, and another 12 in 1994. A database of final report research data from OAM grants made in FY 1993 and 1994 is available at the following Web site: <http://altmed.od.nih.gov/nccam/cgi-bin/research/form.cgi>. Objectives, design, outcome measures, results and conclusions are cited for 23 studies. Here are some examples:

Acupuncture: Researchers from the University of Arizona Tucson sought to determine if the effectiveness of acupuncture in alleviating unipolar depression in women is sufficient to warrant a larger clinical trial. Following treatment specifically designed for depression, 64% of women (n=33) experienced full remission. "Based on the results of [a] small sample, acupuncture appears to provide significant symptom relief at a rate comparable to standard treatments such as psychotherapy or pharmacotherapy," the researchers concluded.

Energy therapy: Researchers at the Menninger Clinic looked at whether energy therapy could potentially treat, and produce cost-saving and reduced side effects for, basal cell carcinoma. Two bioenergy healers moved their hands (without touching) approximately one to two inches over the client's head and body. Treatment took place 30 minutes every other day for five days. All patients had tumors photographed and digitized for computer analysis. Four patients showed tumor reduction or elimination confirmed by these photographs during the three-week treatment period. All other patients either showed no effect or the results were equivocal. Static electrical surges of up to 28 volts and 54 volts were measured on the bodies of the two healers while they were engaged in energetic therapy. Based on their fingertips, the researchers concluded that "the findings of significant effects were modest, need replication with better standardization of camera-client distances and the use of color film, and a longer treatment period."

Massage therapy: Researchers from the University of Virginia School of Medicine conducted a controlled trial of the effectiveness of therapeutic massage as an adjunct to standard medical care. Patient volunteers scheduled for abdominal hysterectomy surgery were randomly assigned to receive either standard postsurgical care plus a daily 45-minute therapeutic massage or standard care alone. The researchers found that "cortisol was substantially lower and more often found to be within the normal range by the fifth postoperative day for the massage group relative to the controls...and the massage group used less patient-controlled analgesia." However, they did not find any significant differences between the two groups in use of oral narcotic painkillers or nonsteroidal anti-inflammatory drugs. No additional medical services were used by the massage treatment group during the four-week posthospital period, but five of the 15 standard-care patients required additional physician visits. The investigators concluded "therapeutic massage appears to promote recovery from surgery by reducing subjective tension and enhancing parasympathetic response."

In FY 1998, NCCAM-sponsored research included evaluating the efficacy of acupuncture for back pain, pilot studies of St. John's wort in juvenile depression and self-transcendence in breast cancer support groups.

As the NCCAM continues its work, Jonas has some practical advice for his successor: "Understand that biases abound in these areas. Opinions are often extreme-both pro and con. However, you must go with the research evidence, even if the topic is unpopular or the area is stigmatized."

References:

References

1.

Astin JA (1998), Why patients use alternative medicine: results of a national study. JAMA 279(19):1548-1553.

2.

Greene A (1998), OAM's director leaves after three years of service. NIH Record Dec. 30.

3.

Wetzel MS, Eisenberg DM, Kaptchuk TJ (1998), Courses involving complementary and alternative medicine at US medical schools. JAMA 280(9):784-787.