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갱년 및 폐경 후 여성의 안면홍조에 대한 침 치료 다기관 임상연구 : 수행보고 및 방법론적 교훈

Methodologic Lessons Learned from Multicenter, Randomized, Controlled Clinical Trial of Acupuncture for Hot Flashes in Peri- and Postmenopausal Women

이명수|김형준|이진무|정희정|최선미|김동일|윤현민|황덕상|강경원|김건형
대한한방부인과학회 (The Society Of Oriental Obstetrics & Gynecology)|2010.02|대한한방부인과학회지 (The Journal of Oriental Obstetrics ＆ Gynecology)|제23권 제1호|pp. 42-52

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참고문헌

키워드

AcupunctureHot flashesMulticenter clinical trialMenopausal symptomVasomotor symptomPragmatic trial
주제분류한의학

초록

Purpose: This report aims to administer methodologic issues around recently- conducted multicenter study for evaluating the effects of acupuncture on menopausal hot flashes and discuss practical issues for further implementation of acupuncture clinical trial for hot flashes. Methods: Study process were mentioned, and issues related to avoiding risk of bias, designing appropriate control group, optimal outcome measurement, potential different effects of menopausal status on study outcomes, and suggestions for developing future clinical trials are discussed. Results: Shortcomings of our multicenter study include lack of allocation concealment and assessor blinding, subjective outcome measurement, short-term follow-up, and fixed acupuncture regimen despite pragmatic purpose of this study. Improving trial design, using objective or validated outcomes, assessing long-term effects of acupuncture, and individualizing acupuncture regimen are needed in future clinical trials. Conclusion: We expect these practical discussions to enable researchers to plan and develop future well-designed clinical trials for evaluating the effects of acupuncture on hot flashes or other women's health issues.

Abstract

Purpose: This report aims to administer methodologic issues around recently- conducted multicenter study for evaluating the effects of acupuncture on menopausal hot flashes and discuss practical issues for further implementation of acupuncture clinical trial for hot flashes. Methods: Study process were mentioned, and issues related to avoiding risk of bias, designing appropriate control group, optimal outcome measurement, potential different effects of menopausal status on study outcomes, and suggestions for developing future clinical trials are discussed. Results: Shortcomings of our multicenter study include lack of allocation concealment and assessor blinding, subjective outcome measurement, short-term follow-up, and fixed acupuncture regimen despite pragmatic purpose of this study. Improving trial design, using objective or validated outcomes, assessing long-term effects of acupuncture, and individualizing acupuncture regimen are needed in future clinical trials. Conclusion: We expect these practical discussions to enable researchers to plan and develop future well-designed clinical trials for evaluating the effects of acupuncture on hot flashes or other women's health issues.

참고문헌 (38)

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