Korean Journal of Acupuncture

Society for Meridian and Acupoint (경락경혈학회)
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Acupuncture for Prehypertension and Stage 1 Hypertension in Postmenopausal Women: Protocol for a Randomized Controlled Pilot Trial

폐경 후 여성의 전단계 및 1기 고혈압에 대한 침 치료: 다기관 무작위 대조 예비연구

  • Kim, Jung-Eun (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine) ;
  • Choi, Jin-Bong (College of Korean Medicine, Dongshin University) ;
  • Kim, Hyeong-Jun (College of Korean Medicine, Semyung University) ;
  • Kang, Kyung-Won (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine) ;
  • Liu, Yan (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine) ;
  • Jung, Hee-Jung (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine) ;
  • Lee, Min-Hee (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine) ;
  • Shin, Mi-Suk (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine) ;
  • Kim, Jae-Hong (College of Korean Medicine, Dongshin University) ;
  • Choi, Sun-Mi (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine)
  • 김정은 (한국한의학연구원 침구경락연구그룹) ;
  • 최진봉 (동신대학교 한의과대학) ;
  • 김형준 (세명대학교 한의과대학) ;
  • 강경원 (한국한의학연구원 침구경락연구그룹) ;
  • 류연 (한국한의학연구원 침구경락연구그룹) ;
  • 정희정 (한국한의학연구원 침구경락연구그룹) ;
  • 이민희 (한국한의학연구원 침구경락연구그룹) ;
  • 신미숙 (한국한의학연구원 침구경락연구그룹) ;
  • 김재홍 (동신대학교 한의과대학) ;
  • 최선미 (한국한의학연구원 침구경락연구그룹)
  • Received : 2014.01.22
  • Accepted : 2014.03.10
  • Published : 2014.03.27
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Abstract

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.

목적 : 본 연구는 전단계 및 1기 고혈압에 해당하는 폐경 후 여성을 대상으로 침 치료의 유효성과 안전성을 평가하고 적정 치료 횟수를 탐색할 목적으로 실시하는 연구이다. 방법 : 네 군, 무작위 배정, 공개 예비연구가 두 임상연구센터에서 진행될 것이다. 총 60명의 대상자가 두 치료군과 두 대조군에 배정되게 된다. 치료군의 대상자는 통상적 관리와 함께 8개 혈위(양측 풍지, 곡지, 족삼리, 삼음교)에 치료군 A는 4주간 10회, 치료군 B는 8주간 20회 침 치료를 받을 것이다. 대조군의 대상자는 침 치료를 받지 않고 대조군 C는 16주간, 대조군 D는 20주간 통상적 관리를 하게 된다. 각 대상자의 생활습관은 교정될 것이며 혈압에 영향을 줄 수 있는 약물은 금지될 것이다. 치료군 A와 대조군 C는 무작위 배정 4, 8, 12, 16주 후에, 치료군 B와 대조군 D는 무작위 배정 4, 8, 12, 16, 20주 후에 평가를 받을 것이다. 주요결과변수는 무작위 배정 4주 후 이완기 혈압 변화량이다. 보조결과변수는 (1) 무작위 배정 8, 16, 20주 후 이완기 혈압 변화량, (2) 수축기 혈압 변화량, (3) 혈압 조절률, (4) 지질대사지표, (5) 고감도 C-반응단백이다. 결론 : 본 연구의 결과는 혈압 조절에 대한 침의 유효성 및 안전성에 관한 근거 구축에 도움이 될 것이다.

Keywords

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