Randomized Trial of Black Cohosh for the Treatment of Hot Flashes Among Women With a History of Breast Cancer

Abstract

Black cohosh was not significantly more efficacious than placebo against most menopausal symptoms, including number and intensity of hot flashes. Our study illustrates the feasibility and value of standard clinical trial methodology in assessing the efficacy and safety of herbal agents.

Critical evaluation of the safety of Cimicifuga racemosa in menopause symptom relief

“…During the course of these clinical trials and observational studies, 5.4% of patients reported adverse events, 97% of which were minor and did not result in discontinuation of therapy. Of the three severe adverse events reported (one case of thrombophlebitis, in a patient suffering from varicosis; 29 one case of hysterectomy, recorded as an adverse event in a breast cancer survivor concurrently taking tamoxifen; 72 and one case of breast cancer recurrence, also in a breast cancer survivor concurrently taking tamoxifen 72 ), the clinical investigators were unable to ascribe causation to the Cimicifuga extract.…”

“…In their study, postmenopausal women treated with an isopropanolic Cimicifuga extract (136 mg crude drug per day) for 3 months showed no change in the endometrial thickness, monitored by transvaginal sonography, or in hormone levels (E 2 , LH, FSH, and prolactin). Similarly, Jacobson et al 72 found that Cimicifuga treatment did not significantly alter LH and FSH levels in breast cancer survivors as compared with placebo-treated breast cancer patients, nor did the extract induce cancerous regrowth of breast tissue. Likewise, a study of 50 women, including 5 breast cancer survivors, treated with 20 mg/day of a Cimicifuga extract for relief of hot flashes and night sweats found that mammography, pap smear, and vaginal ultrasound results were comparable to baseline over a 24-week period.…”

“…In a study of 34 women treated with Cimicifuga extracts (4 mg triterpene glycosides daily for 6 months) for relief of menopausal symptoms, no side effects were observed; however, 4 patients discontinued therapy in favor of HRT. 85 In a recent randomized clinical trial of 85 breast cancer survivors (59 of whom were concurrently receiving tamoxifen treatment) who were randomly assigned to isopropanolic Cimicifuga extract (20-mg tablet twice daily; n = 42) or placebo (n = 43) treatment groups, 72 eight minor adverse events (six in the Cimicifuga/tamoxifen group and two in the Cimicifuga/no tamoxifen Menopause, Vol. 10, No.…”

Dietary Supplement Use in Cancer Care: Help or Harm

“…Breast cancer patients, after completion of conventional therapy (59 on tamoxifen; 26 on no hormonal therapy), were enrolled in a randomized, placebo-controlled trial of 8 weeks duration [188]. Both groups (placebo and proprietary black cohosh extract of Remifemin, 40 mg per day) showed similar improvements in number and intensity of hot flashes.…”

Black Cohosh (Actaea racemosa, Cimicifuga racemosa) Behaves as a Mixed Competitive Ligand and Partial Agonist at the Human μ Opiate Receptor

“…A number of clinical trials have been carried out to examine the efficacy and safety of black cohosh (6)(7)(8)(9)(10)(11). Black cohosh appears to be effective in reducing hot flashes and depression, although more clinical evidence is still needed (12)(13)(14)(15)(16)(17).…”