First-time proof of endometrial safety of the special black cohosh extract (Actaea or Cimicifuga racemosa extract) CR BNO 1055.
OBJECTIVE
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).


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Raus
Karel
K
Department of Obstetrics and Gynecology, Charles University Teaching Hospital, Prague, Czech Republic.
Brucker
Cosima
C
Gorkow
Christoph
C
Wuttke
Wolfgang
W
D000284:Administration, Oral; D001794:Blood Pressure; D001835:Body Weight; D015519:Bone Density; D031885:Cimicifuga; D018153:Czech Republic; D004717:Endometrium / Q000187:drug effects* / Q000473:pathology; D015914:Estrogen Replacement Therapy; D005260:Female; D005858:Germany; D006339:Heart Rate; D006801:Humans; D042361:Mammary Glands, Human / Q000187:drug effects; D008875:Middle Aged; D048789:Phytoestrogens / Q000008:administration & dosage / Q000494:pharmacology* / Q000627:therapeutic use; D010936:Plant Extracts / Q000008:administration & dosage / Q000494:pharmacology* / Q000627:therapeutic use; D017698:Postmenopause; D011446:Prospective Studies
D048789:Phytoestrogens; D010936:Plant Extracts