| most of the clinical studies on black cohosh have been conducted using remifemin®, a standardized oral formulation developed by the firm schaper & brümmer (1995, 1997). remifemin tablets are standardized to 1 mg triterpene glycosides calculated as 27-deoxyactein per tablet; the recommended dose had been 2 tablets twice daily until 1996, when the company reduced the recommended dose to 1 tablet/wice daily. this change in recommended dosage is based on an unpublished study that claims safety and equal efficacy in the treatment of menopausal symptoms with the smaller dose (schaper & brŸmmer 1997). in a recent review of cimicifuga racemosa research, liske (1998) states that the therapeutic efficacy of the commercial extract is not attributable to hormonal (estrogenic) effects. the latest remifemin brochure (schaper and brümmer 1997) makes no claims regarding any estrogenic effects, such as increased vaginal epithelium thickness or alteration in hormone levels, including prolactin, estrogen, progesterone, fsh and notably, lh attributable to the product. a previous clinical study had demonstrated a decline in lh attibuted to remifemin® at the formerly recommended higher dose (duker et al. 1991). perimenopausal symptoms; double-blind, randomized; remifemin® tablets.
The makers of Remifemin® (Schaper & Brümmer 1997), describe a multi-center (4), controlled, randomized, double-blind clinical study of 152 patients with neurovegetative, climacteric complaints in pre- or postmenopause. All patients entering the study had a Kupperman menopause index of >20, indicating that they all suffered at least a moderate degree of menopausal complaints. The women, aged 43-60 years, were given either 2 tablets/2X/day or 1 tablet/2X/day for 3 months. No placebo was used in the experimental design, but the patients were administered 1 of 2 doses according to to a double-blind, randomized protocol.. Examination took place before treatment commenced and at 2, 4, 8 weeks and at the study's conclusion. Efficacy was measured using the Kupperman menopause index, Self-assessment Depression Scale (SDS), the Clinical Global Impressions scale (CGI), vaginal cytology indexes, and hormone status (leutenizing hormone (LH), follicle stimulating hormone (FSH), estradiol 17 beta (E2), prolactin (Prl), sex hormone binding globulin (SHBG) levels). A summary of outcomes showed a statistically significant decrease in the Kupperman index and SDS depression scale under treatment with Remifemin, at both dose levels. Efficacy was rated as "good" or "very good" by both doctors and patients in about 80% of the cases. The treatments at both dose ranges were rated as well-tolerated by 95% of the women, and 92% by their doctors. The company reports "no conspicuous changes" in vaginal cytology parameters or in the course of hormone concentrations for treatments at both dose levels. Although no details are given on adverse effects, they report no serious adverse events or clinically toxicological effects were seen (Shaper & Brümmer 1997).
A randomized, double-blind study was conducted with 80 female volunteers with menopausal symptoms (Stoll, 1987). Patients received Remifemin®, (2 x 1mg tablets, b.i.d.), or conjugated estrogens (0.625 mg) or placebo for 12 weeks. Remifemin® treated patients showed a significant increase in proliferation of vaginal epithelium compared to estrogens and placebo, and significant improvements of somatic and psychological parameters (Kupperman menopausal Index, Hamilton Anxiety Scale) compared to estrogen and placebo. No clear improvements were seen in the placebo group.
Perimenopausal Symptoms; Open-label, Randomized; Remifemin® Tablets.
An open study was conducted on 50 female patients with severe menopausal symptoms, who converted from an estrogen injection regime to oral Remifemin®, (2 x 1mg tablets, 2X/day), with additional hormonal injections given in cases of severe complaints (Pethö, 1987). Over the course of the study (6 months), clear improvements were observed in symptoms as measured by the Menopausal index (reduction from 17.6 to 9.2, p<0.001). Over half (56%) of the patients required no further hormone injections; additional hormone injections were needed in only 18% of the patients. Side effects were minimal and well-tolerated, with 82% of the patients reporting the success of the Remifemin¨ therapy as "good" or "very good."
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