The short-term effect of black cohosh on vaginal atrophy and safety in postmenopausal women / 대한산부인과학회지

ABSTRACT

OBJECTIVE: To evaluate the short-term therapeutic effect of black cohosh on vaginal atrophy and safety in postmenopausal women. METHODS: A total of 80 postmenopausal women having moderate to severe degree of climacteric symptoms were randomly allocated to receive black cohosh combined preparation (n=40) or placebo (n=40) daily for 12 weeks. Fifty eight subjects completed this clinical study. The effect of black cohosh on vaginal atrophy in postmenopausal women was evaluated by measuring Maturation Value. Maturation Value was determined from vaginal smear at 0 and 12 weeks of treatment. Safety assessment included vital signs, physical examinations, adverse events, and routine laboratory parameters (hematology, biochemistry and urinalysis). It was carried out at the beginning, and after 4, 8, 12 weeks of treatment. RESULTS: The mean (+/-standard deviation) Maturation Value decreased 0.18 (0.47+/-0.32 to 0.29+/-0.23) in black cohosh group and 0.13 (0.43+/-0.30 to 0.30+/-0.21) in placebo group. There was no statistical difference in change of Maturation Value from the baseline between the groups after 12 weeks. No serious adverse events were seen. Adverse events were observed in 7 (17.5%) patients in black cohosh group and 6 (15%) patients in placebo group. Prevalence of the adverse events did not differ statistically in the two treatment groups. No significant effects were seen on blood pressure, heart rate, body temperature, physical findings and laboratory values. Black cohosh was well tolerated. CONCLUSION: Black cohosh did not exert estrogenic effects on the vaginal atrophy but appears to be a safe alternative medicine for postmenopausal short-term use.