An isopropanolic extract of black cohosh does not increase mammographic breast density or breast cell proliferation in postmenopausal women.
OBJECTIVE
The aim of this study was to determine the effects of the isopropanolic extract of black cohosh (Remifemin) on mammographic breast density and breast epithelial proliferation in healthy, naturally postmenopausal women with climacteric symptoms.


METHODS
This was a prospective, open, uncontrolled drug safety study in which baseline status was compared with status after 6 months of treatment by blinded observers. A total of 74 women were treated with 40 mg black cohosh daily, and 65 women completed the study. Mammograms were performed, and breast cells were collected by percutaneous fine needle aspiration biopsies at baseline and after 6 months. Mammographic density was quantified according to the Wolfe classification or a percentage scale. Breast cell proliferation was assessed using the Ki-67/MIB-1 monoclonal antibody. Safety was monitored by adverse event reporting, laboratory assessments, and measurement of the endometrium by vaginal ultrasound.


RESULTS
None of the women showed any increase in mammographic breast density. Furthermore, there was no increase in breast cell proliferation. The mean change +/- SD in proportion of Ki-67-positive cells was -0.5% +/- 2.4% (median, 0.0; 95% CI = -1.32 to 0.34) for paired samples. The mean change in endometrial thickness +/- SD was 0.0 +/- 0.9 mm (median, 0.0). A modest number of adverse events were possibly related to treatment, but none of these were serious. Laboratory findings and vital signs were normal.


CONCLUSIONS
The findings suggest that the isopropanolic extract of black cohosh does not cause adverse effects on breast tissue. Furthermore, our data do not indicate to any endometrial or general safety concerns during 6 months of treatment.
Hirschberg
Angelica Lindén
AL
Departments of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden. angelica.linden-hirschberg@karolinska.se
Edlund
Mans
M
Svane
Gunilla
G
Azavedo
Edward
E
Skoog
Lambert
L
von Schoultz
Bo
B
D019840:2-Propanol / Q000737:chemistry; D000368:Aged; D044963:Biopsy, Fine-Needle; D001940:Breast / Q000187:drug effects* / Q000473:pathology; D049109:Cell Proliferation / Q000187:drug effects*; D031885:Cimicifuga / Q000009:adverse effects* / Q000737:chemistry; D004717:Endometrium / Q000187:drug effects / Q000473:pathology; D005260:Female; D006801:Humans; D008327:Mammography; D008875:Middle Aged; D010936:Plant Extracts / Q000009:adverse effects* / Q000494:pharmacology; D017698:Postmenopause / Q000187:drug effects*; D011446:Prospective Studies; D016037:Single-Blind Method
D010936:Plant Extracts; D019840:2-Propanol