폐경기 여성에서 승마 물질의 비뇨기 위축과 부작용에 대한 효과
Effect of Black Cohosh on Genital Atrophy and Its Adverse Effect in Postmenopausal Women
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연구목적: 폐경기 여성에서 승마물질의 질 위축과 부작용에 대한 효과를 평가하기 위함이다. 연구재료 및 방법: 중등도에서 중증의 갱년기 증상을 가지고 있는 총 100명의 폐경기 여성을 무작위적으로 12주동안 매일 승마가 함유된 약제 (n = 50)를 받는 그룹과 대조군 (n = 50)을 받는 그룹에 배정하였다. 78명의 피실험자가 이 임상연구를 완료했다. 폐경기 여성에서의 질 위축에 대한 승마의 효과는 질 성숙 치를 측정함으로서 평가되었다. 질 성숙 치는 치료의 0주와 12주에 시행한 질 펴바름검사로 결정되었다. 안전성 평가는 활력징후, 이학적 검사, 부작용, 기본적인 검사실 지표 (혈액학적, 생화학적, 요분석)를 포함한다. 안정성 평가는 치료의 시작과 치료 4주, 8주 그리고 12주에 시행되었다. 결과: 평균 질 성숙 치는 승마 복용그룹에서 0.18 (0.48 ± 0.33-0.30± 0.24)로 감소하였고 대조군 그룹에서 0.13 (0.44 ± 0.31-0.31± 0.22)로 감소하였다. 12주 후에는 두 그룹에서 질 성숙 치의 변화가 기준치에서 통계적으로 차이가 없었다. 심각한 부작용은 나타나지 않았다. 부작용은 승마복용그룹에서 7명 (14%) 대조군 그룹에서 6명 (12%) 나타났다. 부작용의 이환율은 두 그룹에서 통계적으로 차이가 없었다. 혈압이나 심박수, 온도, 이학검사, 랩 수치에서 심각한 부작용은 나타나지 않았다. 승마복용그룹에서 내성을 보였다. 결론: 승마복용그룹에서 에스트로겐 효과에 의한 질 위축이 나타나지 않았으며 장기적 안정성과 적정용량에 대한 연구가 더 필요하다.
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.
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