Black cohosh with or without St. John's wort for symptom-specific climacteric treatment--results of a large-scale, controlled, observational study.
نویسندگان
چکیده
OBJECTIVES To evaluate usage pattern, effectiveness and safety of Black cohosh alone or in fixed combination with St. John's wort on menopausal symptoms in general clinical practice. METHOD Prospective, controlled open-label observational study of 6141 women at 1287 outpatient gynecologists in Germany. Subjects were treated with recommended doses of study therapies, with treatment chosen by the participating physicians. Patients were followed up for 6 months, optionally 12 months. The primary effectiveness variable was Menopause Rating Scale (MRS) subscore PSYCHE at Month 3 evaluated by ANCOVA. RESULTS The treatment groups were comparable at baseline, excepting the main MRS score and the PSYCHE score (monotherapy: 0.31+/-0.22; combination therapy: 0.42+/-0.23). Reductions from baseline were seen with both regimens for all variables. The changes in the primary variable remained significantly different between groups (p<0.001) when adjusted for differences at baseline with the combination therapy being superior: from 0.37 (adjusted) to 0.25 (95% CI: 0.24-0.25) and 0.23 (95% CI: 0.22-0.23) at Month 3 in the monotherapy and combination-therapy groups, respectively. The improvement by both therapies was maintained at 6 and 12 months. The rate of possibly treatment-related adverse events was 0.16%, all non-serious. CONCLUSION The results support the effectiveness and tolerability profiles of two Black cohosh-based therapies for menopausal symptoms in general practice. They were used differentially: the monotherapy for neurovegetative symptoms, the combination for patients with more pronounced mood complaints. The fixed combination of Black cohosh and St. John's wort was superior to Black cohosh alone in alleviating climacteric mood symptoms.
منابع مشابه
Black cohosh and St. John's wort for climacteric complaints: a randomized trial.
OBJECTIVE To investigate the efficacy of the fixed combination of black cohosh (Cimicifuga racemosa) and St. John's wort (Hypericum perforatum) extracts in women with climacteric complaints with a pronounced psychological component. METHODS In this double-blind randomized placebo-control study, 301 women experiencing climacteric complaints with psychological symptoms were treated with ethanol...
متن کاملBlack Cohosh and St. John's Wort (GYNO-Plus®) for Climacteric Symptoms
PURPOSE This study was conducted to investigate the efficacy of black cohosh (Cimicifuga racemosa) and St. John's wort (Hypericum perforatum) in women with climacteric symptoms, and to assess their effects on vaginal atrophy, hormone levels, and lipid profiles. MATERIALS AND METHODS In this double-blind randomized, placebo-controlled, multicenter study, 89 peri- or postmenopausal women experi...
متن کاملبررسی مقایسه ای تاثیر علف چای و گل ساعتی بر شدت گرگرفتگی و بی خوابی زنان یائسه
Introduction: Because of being assosciated with changes and complications, menopause is a critical and sensitive period. Its common symptom include: vasomotor signs, psychologic changes and sleep disorders, witch could influence on work, social tasks, quality of life and the sense of wellbeing. Usually Hormon replacement Therapy(HRT) is thr treatment option that is assosciated with side effec...
متن کاملEfficacy and safety of isopropanolic black cohosh extract for climacteric symptoms.
OBJECTIVE Several clinical studies suggest that black cohosh may be effective in climacteric complaints. However, evidence of its efficacy based on current quality standards has been limited. METHODS This randomized, multicenter, double-blind clinical trial compared the efficacy and tolerability of the isopropanolic black cohosh extract in the treatment of climacteric complaints compared with...
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ورودعنوان ژورنال:
- Maturitas
دوره 57 4 شماره
صفحات -
تاریخ انتشار 2007