Efficacy and tolerability of the Black cohosh (Actaea racemosa) ethanolic extract BNO 1055 on climacteric complaints: A double-blind, placebo- and conjugated estrogens-controlled study.

摘要

OBJECTIVES: Aim of the present double-blind, randomized, placebo- and conjugated estrogens-controlled study was to assess efficacy and tolerability of BNO 1055, the ethanolic extract of Black cohosh (Actaea racemosa) in postmenopausal women suffering from estrogen deficiency symptoms. METHODS: Ninety-five women were treated for 12 weeks with either BNO 1055 (daily dose corresponds to 40mg of herbal drug), conjugated estrogens (CE, 0.6mg/day), or placebo. The menopause rating scale (MRS) assessed climacteric complaints. Sweating episodes and sleeping behavior were evaluated from a patient diary. The change from baseline of the MRS total score after 12 weeks was defined as the primary efficacy endpoint. Changes from baseline were also analyzed for secondary endpoints including three MRS subscores (major climacteric complaints, somatic complaints, mental score), sweating episodes, and sleeping behavior. Thirty-three women had to be excluded from the intention-to-treat analysis due to protocol violations. RESULTS: BNO 1055 and CE reduced all estrogen deficiency symptoms and improved sleep quality equipotentially. Due to the small sample size the trial was considered as pilot study. CONCLUSION: This double-blind, CE- and placebo-controlled study demonstrated that BNO 1055 is able to reduce estrogen deficiency symptoms in the same degree as conjugated estrogens. The tolerability was good. Therefore, BNO 1055 might be another treatment alternative for menopausal complaints.