Description
Black cohosh (Actaea racemosa, Cimicifuga racemosa) is a medicinal plant belonging to the Ranunculacea family, originating from Eastern North America. Black cohosh rhizome is used primarily for menopausal symptoms, including hot flushes. Women with a history of breast cancer often experience menopausal symptoms as a result of cancer treatments, and thus this herb is of interest.
Efficacy
A systematic review of 14 randomized controlled trials (RCTs), 7 uncontrolled trials, and 5 observational studies and a subsequently published RCT have evaluated black cohosh for menopausal symptoms, cancer risk, and hormonal effects in women with a history of breast cancer.
The use of black cohosh either has no impact on risk of breast cancer or breast cancer recurrence, or decreases the risk of breast cancer and breast cancer recurrence. There is no evidence that black cohosh increases the risk of breast cancer or its recurrence.
The evidence for black cohosh on menopausal symptoms, particularly hot flushes, in women with a history of breast cancer is mixed. In open-label or uncontrolled trials black cohosh has been found to significantly reduce hot flushes and menopausal symptoms, but in RCTs when compared to placebo it has not been significantly better. Therefore, higher quality studies were less likely to find improvement.
Black cohosh does not affect circulating levels of oestradiol, follicle stimulating hormone (FSH) and luteinizing hormone (LH), and does not appear to exert any oestrogenic effects of body tissues including breast, endometrial, or vaginal.
Safety
Despite case reports of hepatotoxicity associated with use of black cohosh, results from clinical trials have found black cohosh to be safe and well tolerated.
Description
Black cohosh (Actaea racemosa, Cimicifuga racemosa, common names: bugbane, black snakeroot, rattle weed, Wanzenkraut) is a medicinal plant belonging to the Ranunculacea family. (Leach 2012) For medicinal purposes its rhizome or root are used. Black cohosh originates from eastern North America, and has been traditionally used by Native Americans and Europeans for women’s conditions such as chronic ovaritis and amenorrhoea (Anonymous 2003). It was first listed in the U.S. Pharmacopoeia in 1830 under the name “black snakeroot” (Blumenthal 2000). It has been widely used for more than 40 years in Europe and was introduced in Germany in the 1940s for the treatment of menopausal discomfort, dysmenorrhoea, and climacteric neurovegetative complaints. More recently, black cohosh has been used primarily as a therapy for menopausal symptoms such as hot flushes (Leach 2012).
Ingredients and quality requirements
The rhizome or root of black cohosh contains several active constituents including triterpene glycosides (acetin, cimicifugoside), fatty acids, caffeic acids, and isoflavones. Black cohosh is usually prepared as ethanolic or isopropranolic extracts, and standardized to 2.5%-5% tripterpene glycoside content (Leach 2012).
Indications
Black cohosh is most often used for menopausal symptoms including hot flushes, night sweats, sleep disturbance, and mood changes (Kligler 2003). It has also been used for dysmenorrhea and premenstrual syndrome (Fritz 2014). Women with breast cancer may be interested in Black cohosh, as breast cancer treatment often results in premature menopause or a worsening of menopausal symptoms due to anti-hormone therapies such as tamoxifen (Fritz 2014). Hormone replacement therapy (HRT) in breast cancer patients may not be appropriate because of evidence of a relationship between long-term use of HRT and increased risk of breast cancer (Roussow 2002), and potential stimulation of cancer growth by HRT (Schairer 2003). Herbal preparations such as black cohosh are used as by some as alternatives to HRT in the treatment of hot flushes (Graf 1996).
Application and dosage
Black cohosh is a dietary supplement, usually available as tablets. The most common dosage is 40mg daily of a standardized extract of black cohosh (usually standardized to 1mg or 2.5-5% triterpene glycosides) (Kligler 2003). Although 40mg daily is the most common dose, studies have used doses ranging from 40mg-160mg/day, administered from 4 weeks to 12 months (Leach 2012).
Remifemin is a proprietary commercial product (manufactured by Schaper & Brümmer, Salzgitter, Germany), which has been used in many clinical trials of black cohosh (Leach 2012). It is an isopropanolic extract of black cohosh standardised to contain 1 mg of triterpenes per 20 mg of extract (Piersen 2003). Another standardised ethanolic extract of black cohosh is BNO 1055 (Menofem®/Klimadynon®), BIONORICA, Neumarkt, Germany) (Popp 2003).
Mechanism of action
Proposed mechanisms of action include a central action on the hypothalamus, effects on neurotransmitter systems, a selective oestrogen receptor modulator (SERM)-like effect (Fritz 2014), and anti-proliferative effects on breast and prostate tumour cells (Walji 2007).
A direct effect on hormonal levels or oestrogenic receptor α (ERα) is unlikely, as several clinical studies have demonstrated no change in hormone levels (oestradiol, follicle stimulating hormone, FSH, and luteinizing hormone, LH) and no effect on oestrogen sensitive tissues with the use of black cohosh (Fritz 2014). However, black cohosh might possess SERM-like effects. Black cohosh stimulates bone formation, and thus may exert effect on oestrogen receptor β (ERβ) as opposed to the classical oestrogen receptor, which is ERα (Fritz 2014). ERβ is associated with anti-proliferative effects, which may explain the possible protective effect of this herb on breast cancer risk. (Fritz 2014) Preclinical studies have also demonstrated a potential anti-proliferative effect of black cohosh on breast and prostate tumour cells (Walji 2007).
Black cohosh may act on central receptors in the hypothalamus affecting the hypothalamic thermoregulatory centres, which may explain an effect on hot flushes. Finally, black cohosh may affect other signalling pathways including the dopaminergic and serotonergic systems. Specifically it may stimulate dopaminergic-2 receptors, and bind 5-HT7 receptors (Fritz 2014).
Legal issues
Black cohosh has been granted a traditional herbal registration by the Committee on Herbal Medicinal Products of the European Medicines Agency for the relief of symptoms of the menopause, such as hot flushes, night sweats, and temporary changes in mood (HMPC 2018). The European Directive on traditional herbal medicinal products allows herbal medicines to be registered as drugs if they have been used medicinally for at least 30 years (including at least 15 years within EU countries).(MHRA 2019)
All clinical research for black cohosh and cancer has been in breast cancer, and the majority of these studies are summarised in a 2014 systematic review (Fritz 2014), which reviewed black cohosh for use by pre- or postmenopausal breast cancer patients or those at risk of breast cancer. A total of 26 articles were included: 14 randomized controlled trials (RCTs), 7 uncontrolled trials, and 5 observational studies. The impact on risk of primary breast cancer or breast cancer recurrence, effect on hormones and oestrogen responsive tissues, and efficacy in treating menopausal symptoms following breast cancer treatment were assessed. Subsequently only one RCT of black cohosh in pre-menopausal women with a history of breast cancer has been identified (Wang 2019). There were no human studies of black cohosh for other cancer types identified. There are many studies of black cohosh in non-cancer populations, which will not be reviewed in detail but can be found in other systematic reviews (e.g. Leach 2012, Shams 2010). In general, the findings of black cohosh for menopausal symptoms are similar in general populations to those found in cancer populations.
Description of clinical studies
Anticancer effects
Three observational studies have evaluated the risk of breast primary breast cancer in women using black cohosh, and one observational study has evaluated the risk of breast cancer recurrence in women with a previous history. The studies had low to moderate risk of bias; however, given all studies were observational causation cannot be determined.
In the systematic review of black cohosh and breast cancer (Fritz 2014), two observational studies found no association between black cohosh use and risk of primary breast cancer, and one study found a reduced risk of primary breast cancer among postmenopausal women compared to non-users (adjusted odds ratio = 0.47, 95% confidence interval = 0.27-0.82). In women with a history of breast cancer, one observational study looked at recurrence risk and found a reduced risk of recurrence (adjusted hazard ratio = 0.75, 95% confidence interval = 0.63-0.89). The results could have been influenced by higher tamoxifen use in the black cohosh group compared to control (35.8% vs 24%), however it does indicate that a negative interaction between black cohosh and tamoxifen is unlikely. There is no evidence that black cohosh increases risk of breast cancer or its recurrence.
Supportive care
Menopausal symptoms
Four RCTs, two uncontrolled single-arm trials, and one observational study have evaluated the effect of black cohosh on menopausal symptoms in women with a history of breast cancer.
A 2014 Systematic review evaluated the effect of black cohosh on hot flushes and included evidence from three RCTs, two uncontrolled trials, and one observational study; the results were mixed (Fritz 2014). Improvements in hot flushes were reported for black cohosh in the two uncontrolled trials and the open-label RCT, but there was no significant benefit found in the two placebo-controlled RCTs or the cohort study. All studies used a black cohosh extract (most often Remifemin) at doses of 20-40mg daily for minimum 4-weeks. Study sizes ranged from 23 to 132 women who were pre or post-menopausal with a history of breast cancer, or high risk of breast cancer. All women were experiencing hot flushes at baseline, and many women were medicated with endocrine therapy such as tamoxifen or aromatase inhibitors. Given the two strongest studies, the placebo-controlled RCTs, found no benefit of black cohosh on hot flush severity or frequency, it may be possible that benefits found in other studies may be at least in part due to the placebo-effect. An open-label RCT published in 2019 evaluated the effect of Remifemin with Lutenizing hormone release hormone analogue (LHRH-a) and endocrine therapy (aromatase inhibitor or SERM) on menopausal symptoms. (Wang 2019) The study enrolled 85 pre/peri-menopausal women with a history of breast cancer, and randomized them to Remifemin 20mg twice daily for 12 weeks or control. The Kupperman Menopause Index (KMI) was used to evaluate symptoms, and was significantly lower in the Remifemin treated group compared to the control group at all time points (4-weeks, 8-weeks, and 12-weeks). At 12-weeks the KMI was 13.12 in the control group compared to 7.15 in the Remifemin group (p < 0.01). However, given this study had no placebo-control, the placebo-effect cannot be excluded.
Hormone levels
Eighteen trials (13 RCTs, 5 uncontrolled trials) have evaluated the effect of black cohosh on circulating hormones or effect on oestrogen-responsive tissues.
Seventeen trials (12 RCTs, 5 uncontrolled trials) reviewed in a systematic review of black cohosh showed no significant impact of black cohosh on circulating hormone levels or proliferation in oestrogen responsive tissues (Fritz 2014). Another open-label RCT found that the addition of Remifemin with LHRH-a and endocrine therapy had no effect on serum FSH, LH, or estradiol levels compared to LHRH-a and endocrine therapy alone (Wang 2019). Additionally, there was no difference in endometrial thickness, ovarian cysts, or uterine fibroids, however there was a higher incidence of cervical cysts in the Remifemin treated group (21.43% vs 4.65%, p = 0.02).
Adverse events
Black cohosh has a very good safety profile from published data. Two systematic reviews of black cohosh in cancer patients concluded that black cohosh has a good safety profile, with no significant adverse effects attributed to the use of the herb (Fritz 2014, Walji 2007). Another systematic review of black cohosh’s safety in general (not only cancer patients) retrieved 13 clinical trials involving more than 2,800 patients (Borrelli 2008). All trials indicate relative safety: 97% of all the reported adverse effects were minor, and the only severe ones were not deemed to be causally-related to black cohosh. This is in line with the findings of an earlier review (Huntley 2004). Recent clinical trials in general populations confirm these findings (Ross 2012, Bai 2009, Li 2011, Sun 2012). Minor adverse effects observed in clinical studies include nausea, vomiting, headaches, dizziness, mastalgia, and weight gain (Zava 1998, Huang 2011).
Following several case reports of hepatotoxicity with black cohosh use, several studies and reviews have evaluated this possible safety concern and none have confirmed these findings. (Fritz 2014, Walji 2007, Naser 2011). A systematic review published in 2008 by the Dietary Supplement Information Expert Committee of the US Pharmacopeia's Council of Experts on the hepatotoxicity found all the reports of liver damage were assigned possible causality, and none were of probable or certain causality (Mahady 2008). Many of the case reports were for combination products, and risk of adulteration and co-administration with known hepatotoxic drugs were possible confounders (Walji 2007). The eight most recent papers reviewing published case reports of possible black cohosh hepatotoxicity found a lack of causality for the herbal medicine in all cases (Teschke 2011a, Teschke 2011b, Firenzuoli 2011, Huang 2010, Teschke 2010, Teschke 2009a, Teschke 2009 b, Teschke 2009c). The 2014 systematic review of black cohosh in breast cancer did not systematically assess the impact of black cohosh on liver function but reported no impact on liver function or symptoms suggestive of impaired liver function among the studies the included in their review (Fritz 2014). A meta-analysis published in 2011 including five randomized double-blind clinical trials involving 1,117 women who were treated daily with black cohosh extract for 3 to 6 months evaluated liver function through levels of AST, ALT, and GGT enzymes. They found no evidence that black cohosh had any negative effect on liver function (Naser 2011). Ultimately, based on clinical trials it seems unlikely that black cohosh has any negative effect on liver function.
Contraindications
There are no known contraindications to black cohosh in the literature. There is insufficient evidence for use by pregnant or lactating women and thus use is not recommended (Dugoua 2006). Caution may be warranted for use in individuals with a pre-existing liver condition based on case reports described previously.
Interactions
Drug interactions with black cohosh have overall been deemed unlikely or very limited based on a 2017 review of herb-drug interactions (Asher 2017).
Several studies have evaluated the potential for black cohosh-drug interactions based on pharmacokinetic effects in healthy volunteers. One study administered a high dose of black cohosh (1090mg standardized to 0.2% triterpe glycosides) twice daily for 28-days to twelve volunteers, and used drug probes to evaluate the effect on a variety of CYP P450 enzymes (Gurley 2005). Black cohosh had no effect on CYP1A2, CYP2E1, or CYP3A4, but decreased CYP2D6 activity by 7%. This was deemed to be clinically insignificant given the small effect and the very high dose of black cohosh used. Another study administered 40mg black cohosh twice daily for 14 days, and found there was no effect on CYP3A4/5 activity (Gurley 2006a). Black cohosh is unlikely to affect Pgp given twice daily 20mg black cohosh for 14 days did not affect the pharmacokinetics of digoxin (Gurley 2006b). Lastly, one in vitro study suggested that black cohosh might affect OATP2B1 (Fuchikami 2006), which could reduce the effectiveness of amiodarone, fexofenadine, glyburide, and several statins, but clinical research is not available (Henneicke-von Zepelin 2007). Taken together, these studies suggest that black cohosh is unlikely to exert significant pharmacokinetic effects on medications.
Several studies (5 clinical trials, 1 observational study) have used black cohosh alongside tamoxifen or aromatase inhibitors (Fritz 2014, Wang 2019). The clinical trials did not report on long-term outcomes such as disease recurrence or overall survival. One observational study found that risk of breast cancer recurrence was 25% lower (HR 0.75, 95% CI 0.63-0.89) in those taking black cohosh, and 35.8% of people in the black cohosh group were on tamoxifen (Henneicke-von Zepelin 2007). This suggests that it is unlikely that black cohosh would decrease the effectiveness of tamoxifen. Additionally, given the pharmacokinetic data previously discussed, a clinically meaningful effect of black cohosh on CYP2D6 (metabolizes tamoxifen), or CYP3A4 (metabolizes aromatase inhibitors) is unlikely (Fritz 2014).
Warnings
A 2008 safety review by the Dietary Supplement Information Expert Committee (Mahady 2008), recommended that black cohosh products include a cautionary statement regarding liver health and possible hepatotoxicity. Health Canada similarly requires a statement to consult a healthcare provider if you have a liver disorder or develop symptoms of liver trouble (Health Canada 2018).
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Citation
Conte E, CAM Cancer Consortium. Black cohosh (Actaea racemosa) [online document], May 28, 2020.
Document history
Updated in May 2020 by Ellen Conte. Assessed as up to date in January 2019, March 2017, September 2013 by Barbara Wider. Updated in June 2012 and August 2009 by Jianping Liu, Xun Li and Guoyan Yang. Summary first published in March 2006, authored by Jianping Liu.
