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KMID : 0644120100230010042
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Journal of Oriental Gynecology
2010 Volume.23 No. 1 p.42 ~ p.52
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Methodologic Lessons Learned from Multicenter, Randomized, Controlled Clinical Trial of Acupuncture for Hot Flashes in Peri- and Postmenopausal Women
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Kim Kun-Hyung
Yoon Hyun-Min
Hwang Deok-Sang
Lee Jin-Moo
Kim Dong-Il
Jung Hee-Jung
Kang Kyung-Won
Lee Myeong-Soo
Choi Sun-Mi
Kim Hyung-Jun
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Abstract
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Purpose: This report aims to administer methodologic issues around recently conducted multicenter study for evaluating the effects of acupuncture on menopusal 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.
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KEYWORD
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Acupuncture, Hot flashes, Multicenter clinical trial, Menopausal symptom, Vasomotor symptom, Pragmatic trial
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