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Black Cohosh Alleviates Menopausal Symptoms Induced by GnRH-a Therapy for Endometriosis
Date 06-15-2015
HC# 121456-522
Keywords:
Black Cohosh (Actaea racemosa syn. Cimicifuga racemosa, Ranunculaceae)
Menopausal Symptoms
Endometriosis

Chen J, Gao H, Li Q, et al. Efficacy and safety of Remifemin on peri-menopausal symptoms induced by post-operative GnRH-a therapy for endometriosis: A randomized study versus tibolone. Med Sci Monit. 2014;20:1950-1957.

Endometriosis is an estrogen-dependent gynecological disorder characterized by infertility and pain during menstruation, sexual intercourse, bowel movement, and urination. Conventional therapy typically involves surgery followed by treatment with ovarian suppressive agents such as oral contraceptive pills or gonadotropin-releasing hormone agonists (GnRH-a). GnRH-a reduce estrogen levels, and consequently the patient may experience decreased quality of life due to perimenopausal symptoms such as hot flashes and sexual hypoactivity. To counter these unwanted side effects, patients are often prescribed hormone "add-back" therapy; however, hormone replacement therapy (HRT) increases the risk of cardiovascular disease, liver damage, and cancer. Black cohosh (Actaea racemosa syn. Cimicifuga racemosa, Ranunculaceae) rhizome has been shown to ameliorate menopausal symptoms and does not have estrogenic properties. The purpose of this prospective, randomized, controlled study was to evaluate the effect of black cohosh (Remifemin®; Schaper & Brümmer GmbH & Co. KG; Salzgitter, Germany; distributed in the US by Enzymatic Therapy, Inc.; Green Bay, Wisconsin) compared to tibolone (a synthetic steroid hormone that acts as a Selective Tissue Estrogenic Activity Regulator [STEAR]) on perimenopausal symptoms induced by postoperative GnRH-a therapy for endometriosis.

Patients (n=116, mean age 28.5 years) receiving GnRH-a treatment after endometriosis surgery participated in this study conducted at the Third Affiliated Hospital of Suzhou University; Suzhou, China. Exclusion criteria were liver damage, severe diabetes, hypertension, thromboembolic disease or thrombophilia, and use of hormones or other anti-perimenopause medicine. "Patients who discontinued therapy within the 12-week period, used hormonal drugs in the first 4 weeks, took non-hormonal drugs (including nutrition) or ate food that might interfere with symptoms, or used any hypnotic, sedative, or antidepressant drugs, were all removed from the statistical analysis."

A study flow chart showing treatment groups and follow-up details is missing. From the context of the paper, however, it is clear that 1 week after laparoscopic ovarian cyst removal surgery, all patients were treated with the first GnRH-a injection (3.6 mg goserelin [Zoladex®] injection). In total, patients received 3 injections. At the same time as the first GnRH-a injection, patients began the study medications. They received either Remifemin (40 mg drug/day) or tibolone (2.5 mg/day) for 12 weeks. At baseline, 4, 8, and 12 weeks after the first GnRH-a injection, menopausal symptoms were quantified using the Kupperman Menopausal Index (KMI), and hot flash score was recorded. At baseline and after 12 weeks, liver and renal function, serum lipids, serum sex hormones, and endometrial thickness were measured.

At baseline, there were no significant differences between the 2 treatment groups in demographic characteristics. In both groups, there was a significant increase (P˂0.05) compared to baseline in KMI scores and hot flash/sweating scores after GnRH-a therapy. KMI scores and hot flash/sweating scores then decreased over time in both groups. At 4, 8, and 12 weeks after GnRH-a therapy, there were no significant differences between the Remifemin and tibolone groups' KMI scores, hot flash frequency, or measures of endometrial thickness.

As expected, 17β-estradiol (E2), follicle-stimulating hormone (FSH), and luteinizing hormone (LH) levels decreased in both groups after the GnRH-a injections. After 12 weeks of treatment, the Remifemin group had significantly lower E2 and significantly higher FSH and LH levels compared to the tibolone group (P<0.05). In agreement with the results of other studies, these findings indicate that Remifemin does not have an estrogen-like effect.

In regard to safety, there was no significant change compared with baseline for measures of liver function, renal function, or serum lipids in either group. The incidence of adverse events was significantly lower in the Remifemin group than in the tibolone group (P<0.05). It is noteworthy that the incidences of vaginal bleeding or spotting and breast distending pain were significantly lower in the Remifemin group than in the tibolone group (P<0.05).

The authors confirmed that "the present results add to knowledge about use of herbal remedies in add-back therapy practice, from both the clinical and the safety point of view. The positive action of Remifemin on peri-menopausal symptoms induced by GnRH-a injection was confirmed in this study. It is important to stress that the Remifemin treatment used in this study does not affect liver function, renal function, lipid profile, or hormonal levels, and was well-tolerated by almost all EMS [endometriosis] women recruited. Our results demonstrate that Remifemin (20 mg bid [twice a day]) may be considered a consistent and safe 'add-back' option to counteract specific peri-menopausal symptoms induced by post-operative GnRH-a in clinical practice." In comparison with tibolone, the incidence of adverse effects with Remifemin was lower. Therefore, Remifemin is potentially a safe option for treatment of patients who are concerned about the cancer risk of estrogen use. The authors recommend, however, further research of longer duration with larger sample sizes.

—Heather S. Oliff, PhD