To investigate endometrial safety by assessment of endometrial biopsy samples and the tolerability and efficacy of the special Actaea or Cimicifuga racemosa extract (CR BNO 1055).
Four hundred postmenopausal women with symptoms related to estrogen deficiency were enrolled into a prospective, open-label, multinational, multicenter study. Treatment duration (daily dose corresponds to 40 mg of herbal drug) was 52 weeks. To determine the probability of endometrial hyperplasia and more serious adverse endometrial outcome, the point estimator and upper limit of 95% CI were calculated. Descriptive statistics was used to assess the secondary endpoints.
Endometrial safety has been proven because no case of hyperplasia or more serious adverse endometrial outcome occurred (point estimate: 0.0; upper limit of 95% CI: 0.011). 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 less than 10%. The overall tolerability was good.
The lack of endometrial proliferation and improvement of climacteric complaints as well as only few gynecologic organ-related adverse events are reported for the first time after a treatment period of 1 year. Due to the improved benefit:risk ratio, it must be assumed that the Cimicifuga racemosa special extract BNO 1055 is a safe alternative for treatment of climacteric complaints.
This endometrial safety study showed that treatment of postmenopausal women with the special black cohosh extract CR BNO 1055 does not stimulate endometrial proliferation nor increase the density of breast tissue as well as improved climacteric complaints. Due to the improved benefit:risk ratio, it is assumed that this herbal preparation is a safe alternative for the treatment of climacteric complaints.
From the 1Department of Obstetrics and Gynecology, Charles University Teaching Hospital, Prague, Czech Republic; 2Department of Gynecology, Clinic Nuremberg North, Nuremberg, Germany; 3Bionorica AG, Neumarkt, Germany; and 4Department of Clinical and Experimental Endocrinology, Georg-August University, Göttingen, Germany.
Received August 4, 2005; revised and accepted November 9, 2005.
Address correspondence to: Christoph Gorkow, DVM, Bionorica AG, Department of Medical Research, Kerschensteinerstr. 11-15, 92318 Neumarkt, Germany. E-mail: firstname.lastname@example.org.