Effect of Black Cohosh on Genital Atrophy and Its Adverse Effect in Postmenopausal Women / 대한폐경학회지

ABSTRACT

OBJECTIVES: It is to evaluate the effect of black cohosh on genital atrophy and its adverse effect in postmenopausal women. METHODS: A total of 100 postmenopausal women having moderate to severe degree of climacteric symptoms were randomly allocated to receive black cohosh combined proparation (n = 50) or placebo (n = 50) daily for 12 weeks. A total of seventy eight subjects completed the study. The effect of black cohosh on vaginal atrophy was evaluated by measuring Maturation value (MV). MV 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. Assessments were carried out at the beginning, and after 4, 8, and 12 weeks of treatment. RESULTS: The mean (+/- standard deviation) MV decreased 0.18 (0.48 +/- 0.33 to 0.30 +/- 0.24) in the black cohosh group and 0.13 (0.44 +/- 0.31 to 0.31 +/- 0.22) in the placebo group. There was no statistical difference between the groups. But adverse events were observed in 7 (14%) patients in the black cohosh group and 6 (12%) patients in the placebo group, without statistical significance. No significant effects were observed 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 with regards to vaginal atrophy. Further studies on the long-term safety and the appropriate doses of cohosh are needed.