Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2006; 11: 38
The aim of the study was to investigate endometrial safety by assessment of endometrial biopsies, and to investigate the tolerability and efficacy of the special extract CR BNO 1055 (Klimadynon).
Postmenopausal women (n = 400) suffering from estrogen deficiency related symptoms were enrolled into a prospective, open-label, multicentre study. Treatment duration (daily dosage corresponds to 40 mg of herbal drug) was 52 weeks. For probability of endometrial hyperplasia and more serious adverse endometrial outcome the point estimator and upper limit of 95% confidence were calculated. Descriptive statistics were used to assess the secondary endpoints.
Since no case of hyperplasia or more serious adverse endometrial outcome occurred (point estimate 0.0; upper limit of CI 0.011) endometrial safety has been proven. Endometrial thickness, which was measured by endovaginal ultrasonography, did not show an increase. The number and intensity of hot flushes were markedly decreased. The dropout rate was <10%. The overall tolerability was good.
The lack of endometrial proliferation and improvement of climacteric complaints as well as only few gynaecologic-organ related adverse events were reported after a treatment period of 1 year. The excellent benefit/risk ratio confirms that the treatment of climacteric complaints with Cimicifuga racemosa special extract BNO 1055 is safe and efficient.
The study was funded by Bionorica AG, Neumarkt, Germany.
