Little Benefit Found In Black Cohosh For Menopause Symptoms Among Breast Cancer Survivors

(ASCO ABSTRACT No. 1593)

New York, NY - May 2001 -- An herbal remedy widely used to treat menopause symptoms, black cohosh, has little effect on these symptoms among breast cancer survivors, a study led by Columbia researchers has found. The study is the first randomized clinical trial of an herbal medicine for hot flashes in breast cancer patients. Black cohosh is a traditional Native American remedy. The study also adds to a growing body of systematic research on “alternative medicines,” controversial treatments not well established in modern Western medical practice. “What this study really shows is the need to conduct randomized trials for alternative medicines, the same way other medicines are investigated,” said Victor R. Grann, M.D., M.P.H., an author of the study. Dr. Grann is associate clinical professor of medicine and public health at the Herbert Irving Comprehensive Cancer Center of the Columbia University College of Physicians & Surgeons. The findings are to be presented May 13 at the annual meeting of the American Society for Clinical Oncology in San Francisco and published in the May 15 issue of the Journal of Clinical Oncology. Researchers believe the results are important to help patients put alternative treatments in perspective, given that growing numbers of patients are turning to these remedies. Cancer patients and survivors, in particular, have been frequent users of alternative therapies. A few alternative medicines have been shown to be effective and safe in controlled clinical trials. Most have not. “Because so many people, including patients with life-threatening diseases and those taking other medications, use complementary and alternative medicine, the research community has a responsibility to assess their efficacy and safety in these patient populations,” report the authors. “The largest segment of the cancer survivor community consists of breast cancer patients,” the authors added. “Nearly two-thirds of such patients report experiencing hot flashes.” The lead author is Judith S. Jacobson, Dr.P.H., M.B.A., assistant professor of clinical public health in the Mailman School of Public Health, and at Columbia’s Herbert Irving Comprehensive Cancer Center. The study assessed menopause symptoms in 85 breast cancer survivors. Half took black cohosh pills; half received a placebo, or inactive pill. For most symptoms, the outcomes were not statistically different between the groups. Both reported an average of about 27 percent fewer hot flashes, one of the most uncomfortable and common symptoms of menopause. This suggested the improvements were due to a placebo effect, in which patients often feel better simply because they are being treated. But excessive sweating, one of the seven menopausal symptoms studied improved with the herbal preparation. This was excessive sweating. “This finding may be due to chance, but unlike, for example, nervousness or headaches, sweating is directly related to the perception of heat and is also what many women find most unpleasant about hot flashes,” the authors said. The other menopausal symptoms studied were heart palpitations, headaches, poor sleep, depression, and irritability or nervousness. The researchers also found that the black cohosh pills are generally safe. Researchers are interested in therapies for menopause symptoms among breast cancer survivors because estrogen replacement may theoretically increase their risk of a cancer recurrence. Another common breast cancer treatment, Tamoxifen, also can trigger menopause-like symptoms. Black cohosh, whose scientific name is Cimicifuga racemosa, is native to the eastern United States and Canada. Native Americans have used it for menstrual, menopausal, and other conditions. Europeans also have used it for more than 50 years, particularly in Germany, where it is produced in precise pill formulations and regulators have issued favorable reports on its effectiveness. One limitation of the Columbia study was that it lasted only two months, the authors said; the researchers feared participants might drop out if they did not experience a benefit within that period. “It is possible that when used for a longer period of time, black cohosh may show greater efficacy relative to placebo, although our data show no strong indication of such a trend,” the authors said. Also, the study did not assess black cohosh’s use among healthy women. Such a study is under way at Columbia’s Rosenthal Center for Complimentary and Alternative Medicine. The just-finished study was supported by the American Cancer Society; the Sindab African American Breast Cancer Project; the Avon Foundation Breast Cancer Research and Care Program; the Breast Cancer Alliance; and a manufacturer of black cohosh pills, which supplied those used for the study.

####