A Study on the Methodology of Acupuncture Clinical Trial on the Postmenopausal and Perimenopausal Hot Flashes

갱년기 안면홍조에 대한 침 임상시험 방법론 연구

Purpose: In spite of many arguments on the result of WHI (Women's Health Initiative) study, no one can deny the necessity for researches on the alternative treatment to HRT (hormone replacement therapy). In this study, the author wanted to investigate the method of precedent acupuncture RCTs (randomized controlled trials) to make out the appropriate acupuncture study design on postmenopausal and perimenopausal hot flashes in Korea. Methods: Precedent studies were investigated using Pubmed search and key-words "acupuncture and hot flash", "acupuncture and menopause", "acupuncture and vasomotor", limited to RCT, from 2000 to 2008 April. Results: As a result. 10 studies were searched. In the hereafter studies, multi-center clinical trials which consist of population group of postmenopausal and perimenopausal women that would be pre-stratified and more than 50 patients per treatment arm seem adequate. Sham control study can make out the proper consequence because many people are get used to acupuncture in Korea. Flexible choice of acupoints addressed an individual's symptoms using standardized algorithm is recommended. Treatment consist of 4 weeks' observation, 11 acupuncture sessions during 7 weeks, follow-up of 3 months or more after treatment and hot flash score as a primary outcome measure seem appropriate. After all, higher level of description according to global standard must be obtained in the study report and publishing. Conclusion: The researchers should develope the methodology of acupuncture clinical trial on the postmenopausal and perimenopausal hot flashes.