Comprehensive Scientific Review Confirms Safety of Black Cohosh
for Menopausal Women.
PA, 15 July 2003
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.
paper supports the growing body of evidence on the safety of black
cohosh, an herb used by Native Americans for centuries," 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. "The findings should reassure the increasing number of
women, who cannot or choose not to take HRT that safe options exist
to treat their menopausal symptoms."
evaluation by Dr. Low Dog 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.
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 black cohosh, 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internal unpublished data from a major manufacturer, foreign literature,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.
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.
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.
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 treatment with black cohosh.
The report notes that, though low overall, adverse events associated
with black cohosh may be dependent on the specific herbal preparation.
advise patients to rely on a trusted manufacturer and avoid combination
products, whose safety has not been studied," Dr. Low Dog added.
cohosh 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.
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. Adverse events have been limited to mild, temporary stomach
upset. It is the #1 OB/GYN-recommended over-the-counter menopausal
addition to the current Menopause article, several recent
reports have confirmed that black cohosh is safe, effective and
safety review of black cohosh in the January issue of Menopause
supported the safety of black cohosh.
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.
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).
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.
is manufactured in Germany by Schaper & Brummer 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. For a full bibliography of research on RemiFemin®,