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Korean Journal of Obstetrics & Gynecology 2007;50(2):306-313.
Published online February 1, 2007.
The short-term effect of black cohosh on vaginal atrophy and safety in postmenopausal women.
Dong Kyu Lee, Hyoung Moo Park, Byung Moon Kang, Jung Gu Kim, Byung Koo Yoon, Byoung Ick Lee, Soo Hyun Cho, Hoon Choe, Bum Hee Yu
1Department of Obstetrics and Gynecology, Chung-Ang University, Korea. hmpark@hananet.net
2Department of Obstetrics and Gynecology, Ulsan University, Korea.
3Department of Obstetrics and Gynecology, Seoul National University, Korea.
4Department of Obstetrics and Gynecology, College of Medicine, Sungkyunkwan University, Korea.
5Department of Obstetrics and Gynecology, Inha University, Korea.
6Department of Obstetrics and Gynecology, Hanyang University, Korea.
7Department of Obstetrics and Gynecology, Inje University, Seoul, Korea.
8Department of Psychiatry, College of Medicine, Sungkyunkwan University, Korea.
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.
Key Words: Black cohosh, Vaginal atrophy, Maturation value, Safety


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