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

김정은; 최진봉; 김형준; 강경원; 류연; 정희정; 이민희; 신미숙; 김재홍; 최선미

doi:10.14406/acu.2014.002

폐경 후 여성의 전단계 및 1기 고혈압에 대한 침 치료: 다기관 무작위 대조 예비연구
Acupuncture for Prehypertension and Stage 1 Hypertension in Postmenopausal Women: Protocol for a Randomized Controlled Pilot Trial 원문보기

Korean journal of acupuncture, v.31 no.1, 2014년, pp.5 - 13

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)

초록
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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.

Abstract ▼ AI-Helper

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.

주제어

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문제 정의

The purpose of this study is to evaluate the effectiveness of acupuncture for BP control with respect to postmenopausal women diagnosed with prehypertension and stage 1 hypertension. The safety and appropriate treatment number of acupuncture will be evaluated additionally.

제안 방법

During the screening, after each patient rests for at least 5 minutes in a sitting position, the same tester measures BP of both arms using a baumanometer(U.S.A. standard type) and selects an arm that shows higher BP followed by measuring two times more with two minutes interval from the selected arm thereby obtaining a mean value of the three measurements. Both of the BP values measured at two times visits(first and second visits) should meet the selection criteria.
Patients in the treatment groups will receive acupuncture at 8 points(bilateral GB20(Pungji), LI11(Gokji), ST36(Joksamni), and SP6(Sameumgyo)) 2∼3 times per week for either 4 weeks(group A, 10 total sessions) or 8 weeks(group B, 20 total sessions); patients will receive a follow-up evaluation at 12 weeks.
The blood test is conducted for treatment group A and control group C at visit 2 and 16 weeks after random assignment while it is conducted for treatment group B and control group D at visit 2 and 20 weeks after the random assignment. The test items of visit 2 are follicle stimulating hormone(FSH), thyroid stimulating hormone(TSH), free thyroxine(T4), hemoglobin A1c(HbA1c), creatinine, aspartate aminotransferase(AST), alanine aminotransferase(ALT), lipid profile(low density lipoprotein cholesterol, high density lipoprotein cholesterol, total cholesterol, triglyceride), and hs-CRP.
It is expected to provide the overall effectiveness of acupuncture and to explore applicability of acupuncture in real clinical fields. This study searches for the appropriate treatment number of acupuncture additionally by dividing the number of treatment into 10 and 20 and comparing this with control group. The results of this study will help to provide fundamental data and calculate the sample size for future large-scale research.
This study will collect information on each participant’s age, height, weight, BMI, marital status, job, history of smoking and drinking, frequency of exercise, and past health history related to BP.

대상 데이터

The blood test is conducted for treatment group A and control group C at visit 2 and 16 weeks after random assignment while it is conducted for treatment group B and control group D at visit 2 and 20 weeks after the random assignment. The test items of visit 2 are follicle stimulating hormone(FSH), thyroid stimulating hormone(TSH), free thyroxine(T4), hemoglobin A1c(HbA1c), creatinine, aspartate aminotransferase(AST), alanine aminotransferase(ALT), lipid profile(low density lipoprotein cholesterol, high density lipoprotein cholesterol, total cholesterol, triglyceride), and hs-CRP. The follow-up test items are lipid profile and hs-CRP.

데이터처리

The magnitude of change in each variable before and after treatment in each group will be analyzed using a paired t-test or a Wilcoxon signed rank test at a significance level of 5% and a 95% confidence interval. SAS will be used for statistical analysis.

성능/효과

(3) Resting BP measured from the selected arm during screening is in the prehypertension stage(SBP of 120∼139 mmHg or DBP of 80∼89 mmHg) or at stage 1 hypertension(SBP of 140∼159 mmHg or DBP of 90∼99 mmHg).

후속연구

This study searches for the appropriate treatment number of acupuncture additionally by dividing the number of treatment into 10 and 20 and comparing this with control group. The results of this study will help to provide fundamental data and calculate the sample size for future large-scale research.

참고문헌 (32)

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