Gail B. Mahady

Black cohosh (Actaea/Cimicifuga racemosa): review of the clinical data for safety and efficacy in menopausal symptoms.

Since the publication of the results of the Women’s Health Initiative that described the risks of hormone replacement therapy, many women are actively seeking alternative treatments for menopausal symptoms. Black cohosh (Actaea racemosa, syn. Cimicifuga racemosa) is one such alternative that has been used in the US for over 100 years. To date only two cimicifuga extracts have been tested clinically, and the current recommended dosage is 40–80 mg/day. Review of the published clinical data suggests that cimicifuga may be useful for the treatment of menopausal symptoms, such as hot flashes, profuse sweating, insomnia, and anxiety. However, the methodology used in most of the trials is poor and further clinical assessment of cimicifuga is needed. In terms of safety, transient adverse events such as nausea, vomiting, headaches, dizziness, mastalgia, and weight gain have been observed in clinical trials. A few cases of hepatotoxicity have been reported, but a direct association with the ingestion of cimicifuga has not been demonstrated. The most recent data suggest that cimicifuga is not estrogenic.

Response to Teschke et al.

Dear Editor, The review by Teschke et al.1 reanalyzed a selected group of 22 spontaneous reports from regulatory agencies for the causal relationship between the use of black cohosh–containing products and hepatotoxicity and concluded that an “updated” Council for International Organizations of Medical Sciences (CIOMS) scale should replace the liver-unspecific Naranjo scale. The “update” referred to by the author is not originated by the CIOMS but includes the authors’ modifications to the scale. On the basis of their new approach, the authors conclude that causality for black cohosh– mediated liver damage is “unlikely or excluded.” We would like to draw attention to some of the fundamental flaws with the authors’ analysis:

Research highlights from the UIC/NIH Center for Botanical Dietary Supplements Research for Women's Health: Black cohosh from the field to the clinic

In 1999, the Department of Medicinal Chemistry and Pharmacognosy at the College of Pharmacy, University of Illinois (UIC) at Chicago was funded to establish a Botanical Dietary Supplements Research Center from the National Institutes of Health (NIH). The emphasis of the UIC/NIH Center for Botanical Dietary Supplements Research (CBDSR) is botanical dietary supplements (BDS) for women’s health. The Center’s research has focused on BDS that may improve women’s health and quality of life, specifically in the areas of menopause, premenstrual syndrome, and persistent urinary tract infections. Center investigators have overcome many challenges associated with botanical dietary supplements research, including acquiring and identifying plant species for investigation, isolating and identifying active constituents, elucidating the mechanisms of action of these botanicals, and conducting Phase I and Phase II clinical studies. Black cohosh [Actaea racemosa L. (Ranunculaceae)] has been used as a model to illustrate the steps involved in taking a botanical dietary supplement from the field, all the way to clinical trials. Bioassays are described that were necessary to elucidate the pertinent biological studies of plant extracts and their mechanisms of action. The Center has used an innovative multidisciplinary approach to this type of research, and thus has been very successful in fulfilling its specific aims.

Herbal and Complementary Medicines Used for Women’s Health

Recent data suggest that the global herbal medicines market continues to increase, with estimates of annual sales as high as

Valerian extract and valerenic acid are partial agonists of the 5-HT5a receptor in vitro.

160 B USD. In the United States alone, almost 30 % of U.S. adults use herbal medicines, and of the

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11.5 billion spent annually on dietary supplements in the U.S., over half a billion dollars are spent on herbal products. Women continue to be the primary users of herbal supplements, and the use of these products to treat or prevent a wide array of ailments including the menopause, common cold, depression, and other non-life threatening medical conditions is on the rise. In terms of herbal medicines used by women, black cohosh, cranberry, dang gui, green tea, and ginseng are the most common worldwide. While the clinical data for efficacy are often equivocal for most herbal products with the exception of St. John’s wort, there are contraindications, drug interactions and some serious adverse events associated with the use of these products. Where no clinical efficacy has been proven but serious adverse events have been reported, the safety risk in negative (no benefit and potential safety risk), and thus such products should not be recommended.