Black Cohosh - Get the Facts on Herbal Supplements

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  • 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.<a href="#hdng0">(More...)</a>



<a name="hdng0"></a>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). <a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> One placebo-controlled, double-blind trial of black cohosh showed estrogenic changes in vaginal epithelium of menopausal women, but another study of two Remifemin doses (39 or 127.3 mg/day) found that 6 months of treatment in perimenopausal and menopausal women caused no changes in vaginal cytology.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> 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 ).<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> 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.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a>

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.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> Jacobson JS, Troxel AB, Evans J, et al.: Randomized trial of black cohosh for the treatment of hot flashes among women with a history of breast cancer.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a>

The fourth study, which found an effect of black cohosh on LH levels, was a trial in 110 women with menopausal symptoms.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> 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.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> The National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health is funding a rigorous scientific study to determine whether treatment with black cohosh reduces the frequency and intensity of hot flashes, and other menopausal symptoms.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a>

In all groups a modified Kupperman index measuring additional physical symptoms was significantly lower at 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 href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> 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).<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> Liske E, Hanggi MD, Henneicke-von Zepelin HH, et al.: Physiological investigation of a unique extract of black cohosh (Cimicifugae racemosae rhizoma): a 6-month clinical study demonstrates no systemic estrogenic effect.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> 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.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> 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.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> Liu Z, Yang Z, Zhu M, Huo J: Estrogenicity of black cohosh (Cimicifuga racemosa) and its effect on estrogen receptor level in human breast cancer MCF-7 cells (in Chinese).<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> 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.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> In another study black cohosh inhibited the growth of T47D (human breast cancer) cells.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> 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.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> In ER-positive breast cancer cell line 435, black cohosh resulted in growth inhibition.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> The use of black cohosh during pregnancy has not been rigorously studied. It would be prudent for pregnant women not to take black cohosh unless they do so under the supervision of their health care provider. Women with breast cancer may want to avoid black cohosh until its effects on breast tissue are understood. Although black cohosh has not been reported to interact with any drugs or to influence laboratory tests, this has not been rigorously studied.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> Liver damage has been reported in a few individuals using black cohosh, but millions of people have taken the herb without apparent adverse health effects.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> Clinical trials comparing estrogens with black cohosh preparations have shown a low incidence of adverse effects associated with black cohosh; headaches, gastric complaints, heaviness in the legs, and weight problems were the main adverse effects noted.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> One commercial standardized black cohosh preparation is Remifemin, which contains black cohosh extract equivalent to 20 mg of root per tablet. The manufacturer changed the formulation of this preparation from a solution (root extracted with ethanol, 60% by volume ) to tablets (root extracted with isopropyl alcohol, 40% by volume), complicating the comparison of research results. Other preparations of black cohosh have been less well studied than Remifemin.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> 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.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> 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.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> 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 href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> Microscopically, vaginal cells look different after menopause because of decreased estrogen. Studies have been mixed on whether black cohosh affects vaginal epithelium.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> 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). 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.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> Black cohosh usually has not been used for long periods, and published studies have followed women for only 6 months or less.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> 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-reviewed journals.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> In vitro studies used to examine the effect of black cohosh have given contradictory results.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> No human studies have adequately evaluated the effect of black cohosh on uterine endometrium.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> While studies of black cohosh have not provided scientific evidence to show that the herb causes liver damage, one country has added a warning to the label of all products containing black cohosh, stating that it may cause harm to the liver of some individuals and should not be used without medical supervision.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> 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.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> In 2001, the American College of Obstetricians and Gynecologists stated, primarily on the basis of consensus and expert opinion, that black cohosh may be helpful in the short term (6 months or less) for women with vasomotor symptoms of menopause.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> 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 <a href="http://www.clinicaltrials.gov/">www.clinicaltrials.gov</a> or 1-212-342-0110.)<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> The study will also assess whether black cohosh reduces the frequency of other menopausal symptoms and improves quality of life.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> Although some study results suggest that black cohosh may help relieve menopausal symptoms, other study results do not.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> Black cohosh is used primarily for hot flashes and other menopausal symptoms.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> Black cohosh was used in North American Indian medicine for malaise, gynecological disorders, kidney disorders, malaria, rheumatism, and sore throat. It was also used for colds, cough, constipation, hives, and backache and to induce lactation.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> If black cohosh is estrogenic, long-term use may adversely affect uterine or breast tissue.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> Although preliminary evidence is encouraging, the currently available data are not sufficient to support a recommendation on the use of black cohosh for menopausal symptoms.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> This fact sheet provides an overview of the use of black cohosh for menopausal symptoms.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> A number of studies using various designs have been conducted to determine whether black cohosh affects menopausal symptoms.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> 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.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> The possibility that black cohosh exhibits estrogenic activity has been studied but the evidence is contradictory.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> The report indicated the dose of black cohosh did not exceed the dosage recommended on the package; but no other dosage information was provided.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> Gruenwald J: Standardized black cohosh (Cimicifuga) extract clinical monograph.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> In the United States, black cohosh is sold as a dietary supplement, and dietary supplements are regulated as foods, not drugs.<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank" [1]</a> Black cohosh can cause headaches and stomach discomfort. In clinical trials comparing the effects of the herb and those of estrogens, a low number of side effects were reported, such as headaches, gastric complaints, heaviness in the legs, and weight problems.<a href="http://nccam.nih.gov/health/blackcohosh/" TARGET="_blank" [2]</a> No interactions have been reported between black cohosh and prescription medicines.<a href="http://nccam.nih.gov/health/blackcohosh/" TARGET="_blank" [2]</a> Black cohosh has a history of use for rheumatism (arthritis and muscle pain), but has been used more recently to treat hot flashes, night sweats, vaginal dryness, and other symptoms that can occur during menopause.<a href="http://nccam.nih.gov/health/blackcohosh/" TARGET="_blank" [2]</a> There are not enough reliable data to determine whether black cohosh is effective for rheumatism or other uses.<a href="http://nccam.nih.gov/health/blackcohosh/" TARGET="_blank" [2]</a> NCCAM is funding studies to determine whether black cohosh reduces the frequency and intensity of hot flashes and other menopausal symptoms.<a href="http://nccam.nih.gov/health/blackcohosh/" TARGET="_blank" [2]</a> Study results are mixed on whether black cohosh effectively relieves menopausal symptoms.<a href="http://nccam.nih.gov/health/blackcohosh/" TARGET="_blank" [2]</a> Black cohosh has recently been linked to a few cases of hepatitis (inflammation of the liver), but it is not clear whether black cohosh caused the problem. It is not clear if black cohosh is safe for women who have had breast cancer or for pregnant women.<a href="http://nccam.nih.gov/health/blackcohosh/" TARGET="_blank" [2]</a> The underground stems and roots of black cohosh are commonly used fresh or dried to make strong teas (infusions), capsules, solid extracts used in pills, or liquid extracts (tinctures).<a href="http://nccam.nih.gov/health/blackcohosh/" TARGET="_blank" [2]</a> Black cohosh has also been used for menstrual irregularities and premenstrual syndrome, and to induce labor.<a href="http://nccam.nih.gov/health/blackcohosh/" TARGET="_blank" [2]</a>

While the mechanism of action of black cohosh is not completely understood, it appears to act as a selective estrogen receptor modulator. In vitro, this preparation has been shown to induce cell cycle arrest and caspase-dependent apoptosis of estrogen-sensitive breast cancer cells.<a href="http://www.cancer.gov/Templates/drugdictionary.aspx?CdrID=302635" TARGET="_blank" [3]</a> In order to further assess the range of black cohosh abundance and harvest potential across western North Carolina, the Nantahala National Forest was selected for the study site in 2002.<a href="http://www.nps.gov/plants/medicinal/pubs/2002bcohosh.htm" TARGET="_blank" [4]</a> Black cohosh was harvested (either lightly or heavily) from 16 plots replicating the harvesting intensity initiated in 2001 in the Pisgah National Forest.<a href="http://www.nps.gov/plants/medicinal/pubs/2002bcohosh.htm" TARGET="_blank" [4]</a> The group's focus for 2002 was to continue the assessment of sustainable harvest levels of black cohosh ( Cimcifuga racemosa ).<a href="http://www.nps.gov/plants/medicinal/pubs/2002bcohosh.htm" TARGET="_blank" [4]</a> The third annual census of black cohosh in western North Carolina took place in 2002 on September 9th and 10th. As in previous years a diverse group of individuals including members of the Plant Conservation Committee of the Medicinal Plant Working Group helped to make this a successful project.<a href="http://www.nps.gov/plants/medicinal/pubs/2002bcohosh.htm" TARGET="_blank" [4]</a> The preliminary data suggest indicate that bloodroot is neither as abundant (occurring in 191 plots versus 343 plots) nor as dense (average density of less than 1% cover compared to an average of 4.9%) as black cohosh.<a href="http://www.nps.gov/plants/medicinal/pubs/2002bcohosh.htm" TARGET="_blank" [4]</a> Like black cohosh, the species has been found to be an excellent indicator for ginseng ( Panax quinquefolius ) since it also occurs in greater numbers in calcium rich habitats. Bloodroot is most conspicuous in the early spring when its bright white petals emerge, even before the leaves. While the undulate orbiculate leaves are also distinctive, they are not as conspicuous since numerous other taller herbs typically overshadow them.<a href="http://www.nps.gov/plants/medicinal/pubs/2002bcohosh.htm" TARGET="_blank" [4]</a> Bloodroot has a distribution broader than black cohosh with occurrences in 5 Canadian provinces and thirty-eight states (Natureserve Explorer 2003).<a href="http://www.nps.gov/plants/medicinal/pubs/2002bcohosh.htm" TARGET="_blank" [4]</a>

Bloodroot is currently being harvested primarily as a cattle feed supplement (antibiotic) to prevent scours. It is principally being exported to Germany, where the industry is projecting annual harvest totals exceeding 25 metric tons. Bloodroot occurs in similar habitat, mesic deciduous hardwood forest, to black and yellow cohosh throughout its very broad range.<a href="http://www.nps.gov/plants/medicinal/pubs/2002bcohosh.htm" TARGET="_blank" [4]</a> One of the objectives next year is to assess and recount the black and yellow cohosh plots harvested in 2001 on the Pisgah National Forests. Another goal is to harvest some bloodroot.<a href="http://www.nps.gov/plants/medicinal/pubs/2002bcohosh.htm" TARGET="_blank" [4]</a>

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1. <a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank">Black Cohosh</a>
<a href="http://ods.od.nih.gov/factsheets/blackcohosh.asp" TARGET="_blank">http://ods.od.nih.gov/factsheets/blackcohosh.asp</a>

2. <a href="http://nccam.nih.gov/health/blackcohosh/" TARGET="_blank">Black Cohosh (Actaea racemosa, Cimicifuga racemosa) [NCCAM Herbs at a Glance]</a>
<a href="http://nccam.nih.gov/health/blackcohosh/" TARGET="_blank">http://nccam.nih.gov/health/blackcohosh/</a>

3. <a href="http://www.cancer.gov/Templates/drugdictionary.aspx?CdrID=302635" TARGET="_blank">Definition of black cohosh - National Cancer Institute Drug Dictionary</a>
<a href="http://www.cancer.gov/Templates/drugdictionary.aspx?CdrID=302635" TARGET="_blank">http://www.cancer.gov/Templates/drugdictionary.aspx?CdrID=302635</a>

4. <a href="http://www.nps.gov/plants/medicinal/pubs/2002bcohosh.htm" TARGET="_blank">MPWG: Black Cohosh (Cimcifuga racemosa) Harvest monitoring 2002</a>
<a href="http://www.nps.gov/plants/medicinal/pubs/2002bcohosh.htm" TARGET="_blank">http://www.nps.gov/plants/medicinal/pubs/2002bcohosh.htm</a>

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