Scientific review confirms safety of black cohosh for menopausal women

Scientific review confirms safety of black cohosh for menopausal women

(University of New Mexico-August 6, 2003)

A report in the journal Menopause provides reassurance of the safety of black cohosh (Cimicifuga racemosa) as a treatment for women experiencing menopausal symptoms.

The finding is based on the most comprehensive review of black cohosh safety data to date and provides welcome news for women seeking alternatives to hormone replacement therapy (HRT).

"This paper should reassure health professionals that they can safely recommend black cohosh to their menopausal patients who cannot or choose not to take HRT," said lead author Tieraona Low Dog, MD, clinical assistant professor at the University of New Mexico Department of Family and Community Medicine and advisor to the NIH Center for Complementary and Alternative Medicine. "Well-studied, non-estrogenic symptom management alternatives help address individual women's symptoms, health profile, and personal preferences."

The comprehensive evaluation published in Menopause included pre-clinical and clinical research in estrogen-sensitive populations, including women at risk for breast cancer and breast cancer survivors, as well as human cell lines most relevant to breast cancer. The evaluation is a review of evidence of the safety of black cohosh in humans, in contrast to a study presented in July 2003 at the American Association for Cancer Research (AACR), which studied the effects of black cohosh in mice with breast tumors.

The paper is the first to review all published literature pertaining to pre-clinical and clinical safety of various forms of Cimicifuga, as well as the U.S. Food and Drug Administration and World Health Organization adverse event reporting systems, monographs, compendia, internal unpublished data from a major manufacturer, foreign literature, and historical, anecdotal reports. The majority of the research that has been conducted, and is reviewed in this article, used the isopropanolic extract of the herb. Many other black cohosh products use different extracts that have not been as well studied.

"As menopausal women increasingly turn to alternatives, scientific evaluation of the safety and efficacy of the products is very important," said Margery Gass, MD, professor of Clinical Obstetrics and Gynecology at the University of Cincinnati College of Medicine and president of the North American Menopause Society.

In addition, the most studied commercially available formulation, RemiFemin Menopause (GlaxoSmithKline Consumer Healthcare), has been shown in recent studies to have no effects on hormone levels or the growth of specific cell lines associated with some cancers, according to the pharmaceutical company. Unlike soy and red clover, which have weak estrogenic effects, RemiFemin is the only major alternative treatment for menopause symptoms that is non-estrogenic, the company says.

Human clinical trials, uncontrolled reports, and post-launch evaluations of over 2,800 patients demonstrate a low incidence of adverse events with black cohosh (5.4%). Of the reported adverse events, 97% were minor and did not result in discontinuation of therapy, and the only severe events were not attributed to Cimicifuga treatment. The report notes that, though low overall, adverse events associated with black cohosh may be dependent on the specific herbal preparation.

"I advise patients to rely on a trusted manufacturer and avoid combination products, whose safety has not been studied," Dr. Low Dog added. This article was prepared by Biotech Week editors from staff and other reports.