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KMID : 1129720140310010005
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Korean Journal of Acupuncture
2014 Volume.31 No. 1 p.5 ~ p.13
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Acupuncture for Prehypertension and Stage 1 Hypertension in Postmenopausal Women: Protocol for a Randomized Controlled Pilot Trial
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김정은:Kim Jung-Eun
최진봉:Choi Jin-Bong/김형준:Kim Hyung-Jun/강경원:Kang Kyung-Won/류연:Liu Yan/정희정:Jung Hee-Jung/이민희:Lee Min-Hee/신미숙:Shin Mi-Suk/김재홍:Kim Jae-Hong/최선미:Choi Sun-Mi
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Abstract
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Objectives : This study aims to evaluate the effectiveness and safety of acupuncture and explore the appropriate number of treatment for postmenopausal women diagnosed with prehypertension and stage 1 hypertension.
Methods : A 4-arm randomized open label pilot trial will be performed at 2 centers. Sixty participants will be divided into 2 treatment groups and 2 control groups. Treatment groups will receive acupuncture at 8 points(bilateral GB20, LI11, ST36, SP6) for 4 weeks(treatment group A, 10 total sessions) or 8 weeks(treatment group B, 20 total sessions), while maintaining usual care. Control groups will not receive acupuncture but will be under usual care for 16 weeks(control group C) or 20 weeks(control group D). Each patient’s living habits will be corrected and drugs that may affect blood pressure(BP) will be prohibited. Treatment group A and control group C will be evaluated at 4, 8, 12, and 16 weeks after randomization, while treatment group B and control group D will be evaluated at 4, 8, 12, 16, and 20 weeks after randomization. The major outcome variable is the magnitude of change in diastolic BP levels at 4 weeks after randomization; auxiliary outcome variables are (1) diastolic BP change at 8, 16, and 20 weeks, (2) systolic BP change, (3) BP control rate, (4) lipid profiles, and (5) high-sensitivity C-reactive protein. Patient safety will be assessed at every visit.
Results and Conclusions : The study findings may help develop evidence for the effectiveness and safety of acupuncture for BP control.
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KEYWORD
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acupuncture, prehypertension, hypertension, randomized controlled trial
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