Efficacy and safety of isopropanolic black cohosh extract for climacteric symptoms.
OBJECTIVE
Several clinical studies suggest that black cohosh may be effective in climacteric complaints. However, evidence of its efficacy based on current quality standards has been limited.


METHODS
This randomized, multicenter, double-blind clinical trial compared the efficacy and tolerability of the isopropanolic black cohosh extract in the treatment of climacteric complaints compared with placebo. A total of 304 patients were randomly allocated to receive tablets corresponding to 40 mg drug or matching placebo daily for 12 weeks. The primary efficacy measure was the change from baseline on the Menopause Rating Scale I; secondary measures included changes in its subscores and safety variables.


RESULTS
Patient groups did not differ in baseline characteristics. The isopropanolic black cohosh extract was more effective than placebo (P < .001) depending on time from symptom onset (P = .014) and follicle-stimulating hormone level (P = .011). The effect size was 0.03 to 0.05 Menopause Rating Scale units which is similar to recent hormone replacement therapy study results (0.036 Menopause Rating Scale units) and may therefore be considered clinically relevant. Women in the early climacteric phase benefited more than in the late phase. The hot flush subscore was the most effective measure of the isopropanolic black cohosh extract's efficacy. There were no relevant group differences in adverse events, laboratory findings, or tolerability.


CONCLUSIONS
This isopropanolic extract of black cohosh root stock is effective in relieving climacteric symptoms, especially in early climacteric women.
Osmers
Ruediger
R
Hildesheim General Hospital Department of Obstetrics and Gynecology, Hildesheim, Germany. frauenklinik@stk-hildesheim.de
Friede
Michael
M
Liske
Eckehard
E
Schnitker
Joerg
J
Freudenstein
Johannes
J
Henneicke-von Zepelin
Hans-Heinrich
HH
D000368:Aged; D031885:Cimicifuga; D002979:Climacteric / Q000187:drug effects* / Q000502:physiology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008593:Menopause / Q000187:drug effects / Q000502:physiology; D008875:Middle Aged; D017060:Patient Satisfaction; D048789:Phytoestrogens / Q000627:therapeutic use; D008517:Phytotherapy / Q000379:methods*; D010936:Plant Extracts / Q000627:therapeutic use*; D011336:Probability; D012016:Reference Values; D018570:Risk Assessment; D016896:Treatment Outcome
D048789:Phytoestrogens; D010936:Plant Extracts; C073419:Remifemin