Abstract
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 40 mg of herbal drug), conjugated estrogens (CE, 0.6 mg/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.
Keywords
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Article info
Publication history
Published online: July 20, 2006
Identification
Copyright
© 2006 Elsevier Ireland Ltd. Published by Elsevier Inc. All rights reserved.
