What is black cohosh?
Black cohosh (known as both Actaea racemosa and Cimicifuga racemosa), a member of the buttercup family, is a perennial plant that is native to North America. Other common names include black snakeroot, bugbane, bugwort, rattleroot, rattletop, rattleweed, and macrotys. Insects avoid it, which accounts for some of these common names.
What are common black cohosh preparations?
Extracts of black cohosh are standardized to 26-deoxyactein content (erroneously reported in the scientific literature as 27-deoxyactein ), a member of a group of chemicals known as saponins. Commercially available preparations of black cohosh usually contain 1 mg of total triterpene saponins (expressed as 26-deoxyactein) in each 20-mg dose of extract.
What are the historical uses of black cohosh?
What clinical studies have been done on black cohosh and its effect on menopausal symptoms?
A randomized, double-blind, placebo-controlled trial was done in breast cancer survivors because most of these women experience hot flashes and many use complementary or alternative remedies . The women were over age 18 and had completed breast cancer treatment at least 2 months before the trial; 85 women (69 of whom completed the trial) took one tablet of placebo or 40 mg/day of black cohosh (as 20 mg twice daily) for 2 months to determine the effect on hot flashes, excessive sweating, palpitations, headaches, poor sleep, depression, and irritability [J.S. Jacobson, Columbia University, written communication, 2002]. Fifty-nine subjects were using tamoxifen (an antiestrogen treatment for breast cancer); tamoxifen users were distributed almost equally between the treatment and control groups. The frequency and intensity of hot flashes decreased in both groups, with no statistical difference between the groups; excessive sweating decreased significantly more in the treatment group than the placebo group. Other symptoms improved equally in both groups, and scores on a health and well-being scale did not change significantly in either group.
A 24-week study in 60 women who had undergone hysterectomy but retained at least one ovary compared the effects of 8 mg/day of a black cohosh extract (as four 2-mg tablets daily; isopropanol extract version of Remifemin) with three estrogen regimens: estriol (1 mg/day), conjugated estrogens (1.25 mg/day), and estrogen-progestin therapy (one daily Trisequens® tablet containing 2 mg estradiol and 1 mg norethisterone acetate) . In all groups a modified Kupperman index measuring additional physical symptoms was significantly lower 4, 8, 12, and 24 weeks after treatment began. Black cohosh decreased symptoms similarly to the other treatments, but this study was not placebo controlled.
A randomized, double-blind, placebo-controlled trial in 80 menopausal women compared 8 mg/day of a black cohosh extract (as two 2-mg tablets of Remifemin twice daily) with placebo or conjugated estrogens (0.625 mg/day) . At 12 weeks, scores on the Kupperman index and the Hamilton anxiety scale were significantly lower in the treated groups than in the placebo group; the scores of participants using black cohosh were somewhat better than the scores of those receiving the estrogen treatment. This is one of the few studies in which hot flashes were scored separately from other symptoms. Daily hot flashes decreased from 4.9 to 0.7 in the black cohosh group, 5.2 to 3.2 in the estrogen group, and 5.1 to 3.1 in the placebo group.
A randomized, 12-week study of 55 menopausal women compared an ethanolic extract of black cohosh (40 drops twice daily) with conjugated estrogens (0.6 mg/day) or diazepam (2 mg/day) . Regardless of the treatment, all symptoms improved as measured by the Kupperman index, a depression scale, and an anxiety scale. However, this was not a blinded, placebo-controlled trial and diazepam is not a usual treatment for menopausal symptoms.
Although some study results suggest that black cohosh may help relieve menopausal symptoms, other study results do not. Studies of black cohosh have yielded conflicting data, in part because of lack of rigor in study design and short study duration (6 months or less). In addition, interpretation of these studies is complicated by the fact that different amounts of black cohosh from different sources were used in the various studies and their outcome measures were different. To provide more definitive evidence on the effects of black cohosh on menopausal symptoms, NCCAM is funding a 12-month, randomized, placebo-controlled study to determine whether treatment with black cohosh is effective in reducing the frequency and intensity of menopausal hot flashes. The study will also assess whether black cohosh reduces the frequency of other menopausal symptoms and improves quality of life. The study will examine the possible mechanisms of action of black cohosh. (Women who are interested in participating in the study, which is at Columbia University in New York City, can find out more at www.clinicaltrials.gov or 1-212-342-0110.)
How does black cohosh work?
A compound recently identified in black cohosh-fukinolic acid-was shown to have estrogenic activity in vitro . Other active compounds appear to include triterpene glycosides (including actein and cimicifugoside), resins (including cimicifugin), and caffeic and isoferulic acids .
Effect on hormone levels
A study of 150 perimenopausal and postmenopausal women using two different doses of black cohosh (Remifemin tablets, 39 or 127.3 mg/day) found that 6 months of treatment caused no changes in LH, FSH, prolactin, estradiol, or sex-hormone-binding globulin . Another trial of black cohosh in women with breast cancer found small but insignificant changes in LH levels (in 18 subjects) and FSH levels (in 33 subjects) . In the third study, Remifemin (8 mg/day given as four 2-mg tablets) did not affect LH or FSH levels in 15 women who had undergone a hysterectomy who were part of a study comparing black cohosh with several estrogens .
The fourth study, which found an effect of black cohosh on LH levels, was a trial in 110 women with menopausal symptoms. Participants treated with Remifemin (8 mg/day) for 8 weeks had significantly lower average LH levels than did a control group (FSH levels were unchanged) . However, the report of this study does not include the participants' hormone levels before the study began, so the two groups may have had different LH levels initially.
In vitro studies used to examine the effect of black cohosh have given contradictory results. Black cohosh had no activity in estrogen receptor (ER) binding assays in Ishikawa (endometrial) and S30 (breast cancer) cell lines . It did not show potent ER binding activity; slightly enhanced the growth of ER-positive breast cancer cells (T47D) but was not tested on ER-negative cells . In another study black cohosh inhibited the growth of T47D (human breast cancer) cells . In ER-positive breast cancer cell line 435, black cohosh resulted in growth inhibition . In ER-positive breast cancer cell line MCF-7, it inhibited estradiol-induced stimulation of cell proliferation in one study  but isolated constituents of black cohosh increased proliferation in another .
Effect on the vagina
Effect on the uterus
When uterine weight of immature female mice and growth of ER-positive breast cancer cells (MCF-7) were used to measure the estrogenic effect of black cohosh, black cohosh caused an increase in uterine weight and growth of cancer cells in culture, which the authors said reflected an estrogenic effect . Black cohosh did not exhibit estrogenic effects in a study that measured uterine weight in immature mice and vaginal cell cornification (conversion of cells from columnar to squamous) in ovariectomized rats .
What is the regulatory status of black cohosh in the United States?
Can black cohosh be harmful?
A published case of acute hepatitis involved a 47-year-old woman who used black cohosh for symptoms of menopause . She received a liver transplant three weeks after she started taking the herb. The report indicated the dose of black cohosh did not exceed the dosage recommended on the package; but no other dosage information was provided. No other cause for liver disease was found.
Black cohosh usually has not been used for long periods, and published studies have followed women for only 6 months or less. Recently, a large study that followed postmenopausal women taking combined estrogen and progestin for an average of 5.2 years showed a small but significant increase in the risk of certain diseases, demonstrating the importance of long-term studies in revealing risks that may not be apparent in shorter studies . If black cohosh is estrogenic, long-term use may adversely affect uterine or breast tissue. No studies have been published on long-term safety in humans, particularly regarding abnormal stimulation of cells in the endometrium or breast.
There is a case report of neurological complications in a postterm baby after labor induction with a mixture of black cohosh and blue cohosh (Caullophylum thalictroides) during a home birth .
Other cases of adverse outcomes experienced by neonates born to women who reportedly used blue cohosh to induce labor have been published in peer-review journals [26,27].
Who should not take black cohosh?
What are some additional sources of information on black cohosh?