Black cohosh information, extract 40 mg for menopause symptoms, side effects and benefits, safety and side effects
Menopause herb and its benefits to reducing symptoms of hot flashes
October 30 2016

Black cohosh (cimicifuga racemosa), also known as snakeroot, bugbane and rattle weed, is native to eastern North America, and has historically been used by Native Americans for a variety of female conditions. It contains a variety of phytoestrogens. The German Comminssion E has approved it for the treatment of menopausal symptoms, premenstrual syndrome, and dysmenorrhea, however they recommend treatment be limited to 6 months.
Studies with black cohosh root have shown inconsistent results in reducing hot flashes in postmenopausal women. However, a survey of women done at the University of San Francisco indicated that women who use a combination of herbal remedies and estrogen were more satisfied in the outcome of their symptoms compared to women who used estrogen alone or herbs alone. The supplements used were black cohosh, ginkgo, and soy.
At this time there is debate in the herbal community regarding its role and effectiveness in treating female conditions. However, historically black cohosh has been used to treat some symptoms of menopause.

buy Black Cohosh Extract, 40 mg per pill, 90 Capsules – Natural Factors
Natural Support for Menopause Symptoms

Natural Factors Black Cohosh Extract capsules contain extract standardized to 2.5% triterpene glycosides. Containing valuable phytoestrogen, This botanical has been used for a number of feminine conditions and recently been recognized for its ability to support menopause symptoms naturally.

Suggested Usage, dosage:  1 black cohosh capsule, 1- 2 times per day preferably before meals or as directed by a health care professional.

Active ingredients, what is in it?
Black cohosh root contains triterine glycosides such as cimifugaside, 27-deoxyactein and actein.
Chaste berry contains several different substances, including flavonoids.

Side effects, safety, danger, bad effects
No major side effects have yet been reported in published trials.

Chemicals within this plant can protect against cellular DNA damage caused by reactive oxygen species by acting as antioxidants.

Breast enhancement
I’ve heard that black cohosh can aid in breast growth for males who are involved in cross dressing and are seeking to try to grow breasts. Is there a danger for males in taking this herb?
We are not aware of any research regarding breast growth in men with its use.

Cancer risk reduction
Dr. Timothy R. Rebbeck of the University of Pennsylvania School of Medicine in Philadelphia compared 949 women with breast cancer to 1,524 healthy controls. Women who reported taking black cohosh (5 percent of blacks and 2 percent of whites) were at 61 percent lower risk of breast cancer. Also, those who took an herbal preparation derived from black cohosh called Remifemin had a 53 percent lower risk of the disease. Previous studies have shown that it can block cell growth. The herb is also an antioxidant, and has been shown to have anti-estrogen effects as well. International Journal of Cancer, 2007.

When given to mice, it did not increase the risk of breast cancer, but in those that did develop it, the herb apparently made it more likely to spread.
Black cohosh has a non-estrogenic, or estrogen-antagonistic effect on human breast cancer cells. This leads to the conclusion that treatment may be a safe, natural remedy for menopausal symptoms in breast cancer.

Breast Cancer
Ethanolic extracts of black cohosh (Actaea racemosa) inhibit growth and estradiol synthesis from estrone sulphate in breast cancer cells.
Maturitas. 2006;
Extracts of black cohosh (Actaea racemosa) and soy are used as ‘natural’ alternatives to conventional hormone replacement therapy (HRT) and there is some evidence that soy may protect against breast cancer by inhibiting the production of active oestrogens. This study compares the action of ethanolic extracts of black cohosh and genistein on growth and enzyme activity in breast cancer cells. Black cohosh inhibited growth at the two highest doses tested, whilst genistein stimulated growth in the estrogen receptor positive  MCF-7 cells, but at high doses it inhibited growth in both cell lines. Black cohosh did not affect the conversion of androstenedione to estradiol and only the highest doses significantly inhibited the conversion of estrone to estradiol. In contrast, black cohosh induced a dose-dependent inhibition of the conversion of estrone sulphate to estradiol in both cell lines, whilst in human granulosa lutein (GL) cells enzyme activity was only inhibited at the highest dose of BC. Genistein had no significant effect on enzyme activity in breast cancer cells and like BC only the highest doses inhibited enzyme activity in human GL cells. In vivo genistein may have growth stimulatory effects on breast tissue but black cohosh not only inhibits growth but inhibits the conversion of estrone sulphate to active estradiol, considered by some, to be the preferred pathway of estradiol synthesis in breast tissue.

Hot flashes treatment and menopause
The results of studies evaluating black cohosh in the therapy of menopausal symptoms have not been consistent, but the majority of studies lean towards this herbal extract providing some sort of benefit, but certainly not in any way as powerful as estrogen itself. But estrogen has its risks, and, if needed, should be used at the lowest effective dose and hopefully not for very extended periods.

Hot flashes cause significant disturbances in postmenopausal women, including women with breast cancer. A pilot study was undertaken to evaluate the effectiveness of black cohosh in reducing hot flashes. Women who reported significant hot flashes (greater than 14 per week) were enrolled. The first week was a no-treatment baseline period, and therapy was given for the subsequent 4 weeks. Patients reported an average of 8 hot flashes per day during the baseline week. The reduction in mean daily hot flash frequency was 50%, while weekly hot flash scores were reduced 56% at completion of the study. Overall, patients reported less trouble with sleeping, less fatigue, and less abnormal sweating. No patients stopped therapy because of adverse effects or toxicity.

The Cimicifuga preparation BNO 1055 vs. conjugated estrogens in a double-blind placebo-controlled study: effects on menopause symptoms and bone markers.
Wuttke W, 2003.
Therapeutic effects of preparation CR BNO 1055 (Klimadynon / Menofem) on climacteric complaints, bone metabolism and endometrium were compared with those of conjugated estrogens (CE) and placebo. The question whether black cohosh contains substances with selective estrogen receptor modulator (SERM) activity will be investigated. Sixty-two evaluable postmenopausal women were included in the double-blind, randomized, multicentre study, and treated either with (black cohsoh 40 mg herbal drug, 0.6 mg CE, or matching placebo, for 3 months. Black cohosh proved to be equipotent to CE and superior to placebo in reducing climacteric complaints. BC had no effect on endometrial thickness, which was significantly increased by CE. Vaginal superficial cells were increased under CE and black cohosh treatment. The results concerning climacteric complaints and on bone metabolism indicate an equipotent effect of black cohosh in comparison to 0.6 mg CE per day. It is proposed that BC contains substances with SERM activity, i.e. with desired effects in the brain/hypothalamus, in the bone and in the vagina, but without exerting uterotrophic effects.

Cimicifuga racemosa for the treatment of hot flushes in women surviving breast cancer.
2003. Parque Humboldt, Prados del Este, Caracas, Venezuela.
To examine the effect of Cimicifuga racemosa (CR BNO 1055) on hot flushes caused by tamoxifen adjuvant therapy in young premenopausal breast cancer survivors. We accrued 136 breast cancer survivors aged 35-52 years. After treatment with segmental or total mastectomy, radiation therapy and adjuvant chemotherapy, participants were in open-label randomly assigned to receive tamoxifen 20 mg per day orally or tamoxifen (same dose and posology) plus black cohosh (Menofem / Klimadynon, corresponding to 20 mg of herbal drug). Duration of treatment was 5 years for tamoxifen, according to international standards for adjuvant therapies, and 12 months for black cohosh. The number and severity of hot flushes were reduced after intervention. Almost half of the patients of the intervention group were free of hot flushes, while severe hot flushes were reported by 24% of patients of intervention group and 73% of the usual-care group. The combined administration of tamoxifen plus black cohosh for a period of 12 months allowed satisfactory reduction in the number and severity of hot flushes.

Estrogen activity and as a phytoestrogen
Research with substances in black cohosh has not provided to us a complete understanding on what kind of estrogenic or anti-estrogenic activity this herb has.

Analysis of thirteen populations of black cohosh for formononetin.
Phytomedicine. 2002.
Black cohosh is a promising natural alternative to hormone replacement therapy for treating menopausal symptoms, but the mechanism of action is not understood. The clinical actions of this plant have been attributed to the isoflavonone formononetin. Others have since looked for formononetin, but have not detected it. We looked for formononetin in extracts of roots and rhizomes collected in thirteen locations in the eastern United States, including Maryland, New Jersey, New York, North Carolina, Pennsylvania, Virginia, and Tennessee. Formononetin was not detected in any of the thirteen plant populations examined.

Menopause symptoms
The combination of black cohosh and
St Johns wort reduces the physical and psychological symptoms of menopause. St. John’s wort is used to treat mild to moderate depression, while women have taken black cohosh for menopausal complaints. To see if a fixed combination of the herbal medicines could benefit women with depression and menopausal symptoms, researchers studied 300 women. Of these women, half took the combination formula, while the other half took placebo pills. After four months, women who took the two-herb combination showed a 50 percent reduction in symptoms such as hot flashes and sweating, compared to 20 percent for those on placebo. The women who were on the herbs also had much better mood. The improvement in menopausal symptoms was similar to that seen among women taking hormone therapy for three months. Source: Obstetrics & Gynecology, February 2006.
Comments: Treating menopausal symptoms effectively with few side effects is not easy. Estrogen works but it has potential long term side effects. Only half of the women benefited from the herbal combination, but that’s better than nothing. Be a little careful with St. John’s wort since the effects can accumulate after several days and you may need to take less with time. If you get insomnia, you may be taking too much.

Osteoporosis, no benefit
Exercise may help older women maintain their bone density, but adding the supplement black cohosh to the routine does not bring any extra benefits. Investigators found that among 128 postmenopausal women they studied for one year, those who were randomly assigned to regularly exercise generally maintained their bone density. In contrast, women who got only light, infrequent exercise showed a decline in their bone density, on average. But while exercise appeared to help women hang on to their bone mass, the herb black cohosh showed no added effects. Among exercisers, those who were randomly assigned to take the supplement each day showed no bone-density advantage after one year. Menopause, 2010.

Seizures, epilepsy
My client has general seizures for approx 30 years, I heard that a herb called black cohosh works what do you think?
We have not seen human research regarding the use of this herb as an effective treatment for seizure disorders.

Do black cohosh herbs improve sexual interest and pleasure as does the herb tongkat ali?
We have reviewed herbs used for menopause and have not come across any mention of it as an aphrodisiac herb.

Dosage and availability
Black cohosh is sold either by itself, or combined with other herbs and nutrients. The dosage of the extract used in the majority of clinical studies has  been based on the level of a key marker, 27-deoxyactein. The recommended dosage for the relief of menopausal symptoms is one tablet of 20 mg taken twice daily, or one 40 mg capsule daily, with benefits hopefully seen in one to three months.

Interactions with other herbs
I have menopause and use black cohosh herbal extract and wanted to know if this herb interacts with an aphrodisiac pill I want to try called yohimbe herb?
This is a mild herb that should not interact in a strong way with other herbs.

I am post menopausal and take black cohosh herb, and was wondering if there were any obvious side effects when a woman with post menopause uses black cohosh alternative therapy along with a natural treatment for libido using tribulus terrestris extract.
These two herbs should be safe to use if the libido herb is kept at a low dosage.

Availability by herbal suppliers
Black cohosh extract is sold in a number of concentrations and extract potencies including 2.5 percent triterpene glycosides.

Botanical information
Actaea racemosa or Cimicifuga racemosa is a member of the buttercup family (Ranunculaceae) and is native to the Eastern United States. The roots and rhizomes (lateral roots) of the herb have a long history of traditional use by native American tribes to deal with genitourinary complaints in women. An isopropanolic extract of black cohosh ( Remifemin ) has been used in German clinical practice since the mid-1950s with safe and effective results, and black cohosh preparations have been approved by the German government as safe and effective nonprescription medications for treatment of menopausal symptoms. In the past few years it has become increasingly popular as the most widely-used natural alternative to hormone replacement therapy. The herb’s popularity with middle-aged women and gynecologists grew significantly after the summer of 2002 when a large-scale government-sponsored clinical trial on HRT was halted prematurely after evidence that HRT was responsible for an increase in cancer and cardiovascular disease in menopausal women. Black cohosh preparations ranked eighth of all single-herb supplements sold in mainstream retail outlets in 2005.

Press release by Enzymatic Therapy, Inc.
GREEN BAY, Wis., 2006 — Over 90 research papers, 15 published studies and 50 years of usage by women worldwide show that Remifemin is effective for alleviating menopausal symptoms including hot flashes, night sweats and occasional mood swings. Although research published in the Annals of Internal Medicine 2006 concluded that the type of black cohosh used in this study is ineffective for treating menopause-related symptoms, the study did not use the proprietary Remifemin black cohosh. Dr. Eckehard Liske, Director of the International Medical Department, Shaper & Brummer GmbH, Salzgitter, Germany says, “Remifemin is produced using a proprietary isopropanolic extraction method which yields a more complete spectrum of active compounds than other extraction methods. The body of published research demonstrates consistent positive results, unlike other black cohosh extracts.” “Multiple randomized controlled trials clearly show the benefits of Remifemin in relieving the symptoms of menopause,” explained Dr. Liske. “The most recent study by Osmers (2005) found a statistically relevant effect in relieving menopausal symptoms including hot flashes. This study was reviewed by the North American Menopause Society and given the highest level of validation. Remifemin is a safe and effective intervention for the relief of hot flashes and other vasomotor symptoms associated with menopause.” Remifemin comprises a proprietary, standardized extract (uniform dosage) of pure black cohosh root called RemiSure. It is an OB/GYN-recommended non-prescription menopausal therapy. The German E Commission has approved the use of 40 mg/day for 6 months for relief of menopausal symptoms, as well as for premenstrual syndrome (PMS) and dysmenorrhea. “Remifemin black cohosh is clearly the world’s most clinically tested black cohosh product,” said Mark Blumenthal, Founder and Executive Director of the American Botanical Council. “At least 15 clinical trials demonstrate the safety and efficacy of the product, manufactured according to the latest GMPs by Shaper & Brummer GmbH, a highly respected German phytomedicine company with over 50 years of experience in manufacturing and testing.
Comments: More research will be needed to figure out whether black cohosh is effective for menopausal symptoms and whether there are differences between different brands.

American Botanical Council Clarifies Clinical Trial results and interpretation
2006 – A clinical trial testing the popular herb black cohosh is inconsistent with the positive outcomes for treating menopause symptoms seen in the majority of published clinical trials, says the American Botanical Council. “The medical literature contains many controlled and uncontrolled trials that support the efficacy of the two leading black cohosh preparations for treating menopause symptoms,” said Mark Blumenthal, founder and executive director of ABC, the leading herbal nonprofit research and education organization. Numerous herb experts cautioned that this trial must be seen in context of the entire body of clinical research on black cohosh. According to Mary Hardy, MD, a physician in Los Angeles who has been researching herbal dietary supplements for over a decade, and an expert on black cohosh clinical trials, “This study should not be considered the definitive study on black cohosh. These results should be placed in the context of all of the black cohosh trials — many of which have shown efficacy for other commercially available products. Gail Mahady, PhD, an associate professor of pharmacognosy at the University of Illinois, said, “Since 2003 there have been about 10 clinical studies on black cohosh published and all were positive.” Dr. Mahady, one of the principal authors of the black cohosh monograph for the World Health Organization, has reviewed these trials in several journal publications. She added, “Thus, one negative study does not neutralize all of the other 10 positive trials.” Dr. Mahady is also currently a co-investigator on an ongoing black cohosh trial funded by the National Institutes of Health (NIH) and the National Center for Complementary and Alternative Medicine (NCCAM) which also funded the recently-published trial. The year-long trial did not show any significant benefit in reducing hot flashes or night sweats for two different black cohosh preparations — one a black cohosh extract and the other black cohosh with other herbs added — or a combination of the black cohosh/herbal mixture with an enhanced soy diet. (The authors acknowledged that it was difficult to ensure compliance of the added soy diet for an entire year.) One group of women in the trial used conventional hormone replacement therapy (HRT) but this treatment was terminated after researchers in another trial on HRT discovered adverse cardiovascular and cancer effects associated with the conventional hormones in 2002. Called the Herbal Alternatives for Menopause Trial (HALT), the study, published in the Annals of Internal Medicine on December 19, was a one-year, randomized, double-blind, placebo-controlled, 5-arm trial. Researchers at the Center for Health Studies in Seattle assigned 351 women aged 45 to 55 to one of 5 different groups (arms): (1) a black cohosh extract (CimiPure, produced by Pure World Inc. of Hackensack, NJ), (2) a multi-herb pill with black cohosh and 9 other ingredients* (Progyne, Progena, Albuquerque, NM), (3) the same multi-herb pill plus counseling to ensure the increased consumption of dietary soy, (4) conventional hormone replacement therapy (estrogen with or without progestin; this was terminated before the other arms when the Women’s Health Initiative trials were prematurely halted in 2002 due to observations that HRT actually increased the incidence of cardiovascular disease and cancer), (5) a placebo (dummy pill). The lead researcher was Katherine M. Newton, PhD, of the Group Health Center for Health Studies, Seattle, and the University of Washington, and colleagues. The trial was funded by the National Institute on Aging (NIA) and NCCAM. Criteria for inclusion of the women in this trial consisted of at least 2 or more vasomotor symptoms per day (e.g., hot flashes, night sweats, etc.). Although this study appears to be the longest placebo-controlled trial on black cohosh and one of the largest, there are still some potentially serious limitations, which the trial authors have acknowledged. By dividing the total number of women into 5 groups (arms) to test 4 different therapies (including HRT) against placebo, the number of women in each group drops to a point where the statistical significance of the outcomes (whether positive or negative) are greatly diminished. The trial had set a criteria for inclusion at a minimum of 2 hot flashes per day, a relatively low level at which reductions are more difficult to produce and/or monitor in a trial like this (although the actual median level was actually 6). In a corresponding editorial Carol M. Magione, MD, MSPH of the David Geffen School of Medicine in Los Angeles wrote, “Black cohosh is not effective.” – basically relying on this trial as the sole arbiter of the efficacy of black cohosh. Dr. Mangione’s conclusion contrasts with other randomized controlled trials (RCTs) that have shown measurable efficacy for the two most well-researched black cohosh preparations (e.g., Remifemin® and Klymadynon®, both from Germany). At least 15 clinical trials attest to the efficacy of Remifemin (Schaper and Bruemmer, Salzgitten, Germany, imported by Enzymatic Therapy, Green Bay, WI) and 6 do so for Klymadynon (Bionorica, Neumarkt, Germany, imported by Bionorica USA, Eugene, OR). Another question about the study was raised by Francis Brinker, ND, of the University of Arizona Program for Integrative Wellness and author of several highly-regarded reference books on herbal medicine, including Herb Contraindications & Drug Interactions 3d ed. Dr. Brinker states, “I do not have a problem with acknowledging the negative outcome, but I reject the extrapolation of the results to all forms of black cohosh products. The more medical (and herbal) minds are challenged on this sort of lazy assumption, the sooner they’ll recognize legitimate distinctions among various herbal preparations and their effects. Not all products from the same herb are created equal, so we shouldn’t blame, say, Peter Cohosh for the failings of Paul Cohosh (or reward Peter for Paul’s success), unless there is some good evidence for bioequivalency” — the ability to show that one preparation has the same physiological effect as another. That has not been demonstrated in this trial, so it is not possible to extend the results of this trial to other clinically tested black cohosh products. Dr. Brinker also commented that the extract studied in this trial was a daily dose of 160 mg of a 70% ethanolic extract, whereas the positive studies with Remifemin tablets used 40 mg daily of a 40% isopropanolic extract. Eckehard Liske, PhD, research director at Schaper & Bruemmer, the German company that manufacturers and markets Remifemin, the most clinically-researched black cohosh product, observed that the black cohosh product used in this trial did not appear to have met stability testing that should have been required of any herbal substance that was being employed for a 12-month trial. “The primary packaging does not protect the study medication as well as a blister packaging,” he wrote. This was acknowledged by the trial authors in their writing that they were not able to detect several characteristic [chemical] marker substances. Thus, this absence of blistered medication, according to Dr. Liske, suggests a possible instability of the study medication (i.e., the black cohosh extract may have degraded in some manner over time).