May 14, 2001 09:32 New Study Provides Perspective on Safety and Efficacy of Black Cohosh for Menopausal Symptoms in Breast Cancer Patients PITTSBURGH, May 14 /PRNewswire/ -- A study released today by Columbia University provides important information on the safety and efficacy of the herbal supplement black cohosh in treating menopausal symptoms in breast cancer patients, for whom hormone replacement therapy is contraindicated. This study found that taking black cohosh for two months had no effect on the level of hormones that may increase risk of recurrent cancer. "Safety information about alternative methods to relieve menopausal symptoms is important," said Judith S. Jacobson, DrPH, MBA, assistant professor of clinical public health at Columbia University's Joseph L. Mailman School of Public Health and lead author of the study. "We chose a particular preparation of black cohosh for the study because it has been extensively studied. The study demonstrates the value of standard clinical trials assessing this and other herbal agents." In the study, both those taking black cohosh and those in the placebo group achieved a 27% decrease in hot flashes. The black cohosh group reported significantly greater improvement than the placebo group in sweating, a common and often debilitating symptom of menopause. According to Mary Hardy, MD, an authority on women's health with Cedars-Sinai Integrative Medical Group in Los Angeles, "The hot flashes in women being treated for breast cancer may require a management strategy analogous to salvage therapy, where any relief is highly valuable." Previous placebo-controlled and open clinical monitoring trials with black cohosh in healthy women, as well as worldwide use over 40 years, have shown a 70% reduction in hot flashes and other symptoms in the majority of women after 12 weeks. Based on the divergence between previous findings on effectiveness in healthy women and the results of this study, additional research is necessary. The following study conditions may help explain the differences: -- Patients: The study included 85 breast cancer survivors (with 42 assigned to treatment with black cohosh). Fully a third were not in the normal age range for natural menopause symptoms. -- Influence of Tamoxifen: The majority of patients in the study were taking tamoxifen, the drug most widely prescribed for breast cancer patients. A frequent side effect of tamoxifen is menopausal symptoms, including hot flashes and excessive sweating. Many experts theorize that drug-induced and natural hot flashes differ in nature and severity. -- Duration: The study duration was only two months. Since labeling indicates black cohosh works to fully relieve symptoms in up to 12 weeks, a full result might not be expected in this eight-week study. In addition, placebo effects -- which often factor into pharmaceutical and herbal trials -- typically, wear off with time. A longer study may have picked up a difference between active and placebo groups. -- Dosing: The dose studied may not be sufficient for breast cancer patients taking tamoxifen. Studies are currently underway evaluating different doses, including a study at Columbia University's Rosenthal Center for Complementary and Alternative Medicine. "This study confirms that black cohosh is a safe alternative for women who cannot or choose not to take estrogen. Black cohosh caused no changes in female reproductive hormone levels," said Susan Love, MD, adjunct professor of surgery at University of California, Los Angeles and author of Dr. Susan Love's Breast Book. "Further research will help clarify its efficacy in breast cancer patients and survivors." An unprecedented number of American women are or will be entering menopause. There is growing interest in alternative therapies among women, including breast cancer survivors, to treat the disruptive symptoms associated with menopause naturally. "Choices to relieve the distressing physical and emotional symptoms of menopause are critical," added Dr. Hardy. "These study findings should be evaluated in the context of the totality of evidence on black cohosh and inform future research to help all women make informed choices." /PRNewswire -- May 14/