Comprehensive scientific review confirms the safety of black cohosh for menopausal women

July 15, 2003

July 15, 2003 - A report in the current issue of Menopause: Journal of the North American Menopause Society provides a 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) almost exactly one year after the startling revelation by the Women's Health Initiative that long-term, combination HRT can increase a woman's risk of breast cancer, heart attacks, stroke and blood clots.

"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. This evaluation is a review of evidence of the safety of black cohosh in humans, in contrast to a recent abstract presented this week at the American Association for Cancer Research (AACR), which studied the effects of black cohosh in mice with breast tumors. The AACR presentation described lab research that was exploratory in nature, requires further histological analysis to fully understand the results and used an animal model that a recently published paper determined needs more evaluation before it can be used to assess risk in humans.1

Design and Methods

The paper, entitled "Critical Evaluation of the Safety of Cimicifuga Racemosa in Menopause Symptom Relief," is the first to review all published literature pertaining to pre-clinical and clinical safety of various forms of Cimicifuga, as well as the FDA and World Health Organization adverse event reporting systems, monographs, compendia, internal unpublished data from a major manufacturer, foreign literature, and historical, anecdotal reports.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, utilized the isopropanolic extract of the herb, which is the formulation used in RemiFemin Menopause®. Many other black cohosh products use different extracts, which 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, has been shown in recent studies to have no effects on hormone levels or the growth of specific cell lines associated with some cancers. Unlike soy and red clover, which have weak estrogenic effects, RemiFemin is the only major alternative treatment for menopause symptoms that is non-estrogenic.

Human clinical trials, uncontrolled reports, and post-launch evaluations of over 2800 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.

Black cohosh (RemiFemin) can safely be taken continuously, twice a day, for six months at a time. After six months, women should reassess their symptoms and treatment needs as symptoms typically fluctuate throughout the multi-year menopausal process.

Background

RemiFemin Menopause, a unique extract of black cohosh (Cimicifuga racemosa), is the most studied herbal supplement for menopause symptoms, with more than 20 clinical trials and open clinical monitoring trials in physicians' practices. No significant drug interactions have been reported for RemiFemin in its over 40 years of worldwide use and adverse events have been limited to mild, temporary stomach upset. It is the #1 OB/GYN-recommended over-the-counter menopausal therapy.

In addition to the current Menopause article, there have been several recent reports confirming that black cohosh is safe, effective and non-estrogenic. A safety review of black cohosh in the January issue of Menopause supported the safety of black cohosh. A report in the November 2002 issue of Annals of Internal Medicine concluded that black cohosh is one of the only herbal remedies shown to be effective for menopausal symptoms, especially hot flashes. A controlled, double-blind, randomized trial published in the Journal of Women's Health and Gender-Based Medicine confirmed that the recommended dose of RemiFemin Menopause resulted in statistically significant improvements in menopausal symptoms without affecting hormone levels or affecting the growth of estrogen sensitive tissues (such as the vaginal cytology or breast). An article published in Breast Cancer Research and Treatment reported that RemiFemin does not have an estrogenic effect on estrogen-receptor positive human breast cancer cells.

RemiFemin is manufactured in Germany by Schaper & Brümmer and marketed in the United States by GlaxoSmithKline Consumer Healthcare. The product is widely available in U.S. supermarkets, pharmacies, drug store chains, discount department stores and health food stores nationwide.
-end-
Women can find more information about menopause symptom management and choosing herbals wisely at http://www.remifemin.com. The site provides women with interactive tools and information about menopause, about the most common treatments used for menopause symptoms and information on how to talk to their doctors about herbal therapies. The site also offers support materials, including an interactive journal, free product samples and menopause symptom tracker to help ensure the most complete relief.

GlaxoSmithKline Consumer Healthcare is one of the world's largest over-the-counter healthcare products companies and ranks second globally in sales of oral care products. Its more than 30 well-known products include such medicine cabinet staples as Abreva® cold sore treatment, Aquafresh® toothpastes and toothbrushes, Nicorette®, NicoDerm® CQ, Oxy®, Sensodyne® and Tums®.

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

For a full bibliography of research on RemiFemin, visit http://www.remifemin.com/professional.

(1) Pritchard JB, French JE, Davis BJ, Haseman JK. The role of transgenic mouse models in carcinogen identification. Environmental Health Perspectives 2003; 111(4): 444-54

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