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Some Climacteric Symptoms in Breast Cancer Patients Treated with Tamoxifen Improve in Open Study
Date 03-31-2011
HC# 031151-421
Keywords:
Black Cohosh (Actaea racemosa syn. Cimicifuga racemosa)
Breast Cancer
Tamoxifen
Re:  Some Climacteric Symptoms in Breast Cancer Patients Treated with Tamoxifen Improve in Open Study

Rostock M, Fischer J, Mumm A, Stammwitz U, Saller R, Bartsch HH. Black cohosh (Cimicifuga racemosa) in tamoxifen-treated breast cancer patients with climacteric complaints—a prospective observational study. Gynecol Endocrinol. Jan 13, 2011; [epub ahead of print]. doi: 10.3109/09513590.2010.538097.

Tamoxifen has been used for more than 30 years to treat breast cancer. It blocks the activity of estrogen, which sometimes promotes growth of breast cancer cells. The adverse side effects of tamoxifen are menopause-like symptoms. Many breast cancer therapies including tamoxifen induce climacteric-like complaints (i.e., night sweats and hot flashes) or aggravate pre-existing menopausal symptoms. Since estrogen substitution is not recommended, many patients with therapy-induced menopause symptoms turn to alternative therapies, such as black cohosh (Actaea racemosa syn. Cimicifuga racemosa), to treat the symptoms. Data demonstrating the efficacy of black cohosh in treating tamoxifen-associated climacteric complaints are inconclusive. The purpose of this prospective, observational study was to evaluate the dosage, effectiveness, and tolerability of an isopropanolic extract of black cohosh in patients with breast cancer treated with tamoxifen and suffering from climacteric complaints.

Inpatients (n = 50, aged 43-77 years) of the Department for Oncological Rehabilitation and Aftercare at the Tumor Biology Center at Albert-Ludwigs-University, Freiburg, Germany with primary breast cancer participated. They were all utilizing physiotherapy and psychological and physical training after primary cancer treatment. Included patients had not used black cohosh preparations within the last 3 months, had not been treated with antihormonal drugs other than tamoxifen, or were not presently being treated with concomitant chemo- or radiotherapy, though 87% had previously been treated with radiotherapy and 51% had received chemotherapy. Patients were instructed to take 40 mg/day black cohosh (Remifemin®; Schaper & Brümmer GmbH & Co. KG; Salzgitter, Germany) for 4 weeks. After 4 weeks, the patients could change the dose. The primary endpoint was the Menopause Rating Scale II (MRS), which is a self-assessment questionnaire that measures severity of 11 symptoms. Patients completed the MRS at baseline and after 1, 3, and 6 months of black cohosh treatment.

Twenty patients maintained the 40 mg/day dose for the entire 6 months. After the first 4 weeks, 15 patients increased their dose to 80 mg/day, 3 patients increased their dose to 60 mg/day, 2 patients reduced their dose to 20 mg/day, and 4 patients switched to a combination preparation of black cohosh extract and St. John's wort (Hypericum perforatum) extract (product and dose not reported). Fifteen dropped out before 6 months. Thirty patients wanted to continue the black cohosh treatment after the 6-month study.

At baseline, the mean overall MRS score was 17.6 ± 6.1, which corresponds with severe symptoms. At study end, the mean overall MRS score was 13.6 ± 6.5, which corresponds with moderate symptomatology. The improvement in mean overall severity of symptoms was statistically better at all time points compared with baseline (P < 0.001 for all). The most severe symptoms at baseline—hot flashes, sweating, and sleep disturbances—were most improved. Vegetative somatic complaints (i.e., exhaustion and irritability) and psychic complaints (i.e., depression and anxiety) were also significantly improved from baseline at all time points (P < 0.01 for all). There was no significant improvement in urogenital symptoms (i.e., vaginal dryness and bladder problems) or in joint and muscular discomfort.

Only 1 adverse event (nausea) was possibly related to the study medication. According to physicians' opinion, none of the other adverse side effects were causally related to black cohosh extract, but rather were related to the tamoxifen treatment. During the study, there was no tumor recurrence.

The authors hypothesize that previous studies that did not demonstrate efficacy in this population did not treat the patients long enough with black cohosh. They also believe that this study had a positive outcome because patients could individually optimize their therapy (increase or decrease the dose) based on treatment effect, in contrast to randomized, controlled studies that have fixed doses. An important limitation of this study is the lack of a placebo control group. It is difficult to prove efficacy without a control group. Another limitation is that the patients were in an inpatient rehabilitation program during the first 4 weeks, which could have contributed to the positive outcome. Nonetheless, based on the safety and efficacy the authors conclude that black cohosh is a therapeutic option for reducing the adverse side effects of tamoxifen. Whether via a placebo effect or true benefit, black cohosh treatment may increase tamoxifen-treatment adherence by reducing symptoms that may cause cancer patients to skip a dose.

—Heather S. Oliff, PhD