Acupuncture for patients with mild hypertension: study protocol of an open-label multicenter randomized controlled trial.
BACKGROUND
Several studies using acupuncture to treat essential hypertension have been carried out. However, whether acupuncture is efficacious for hypertension is still controversial. Therefore, this trial aims to evaluate the efficacy and safety of acupuncture for patients with mild hypertension.


METHODS
This is a large scale, open-label, multicenter, randomized controlled clinical trial with four parallel arms. We will recruit 428 hypertensive patients with systolic blood pressure (SBP) between 140 and 159 mmHg, diastolic blood pressure (DBP) between 90 and 99 mmHg. The participants will be randomly assigned to four different groups (three acupuncture groups and one waiting list group) (1).The affected meridian acupuncture group (n = 107) is treated with acupoints on the affected meridians (2).The non-affected meridian acupuncture group (n = 107) is treated with acupoints on the non-affected meridians (3).The invasive sham acupuncture group (n = 107) is provided with sham acupoints treatment (4).The waiting-list group (n = 107) is not offered any intervention until they complete the trial. Each patient allocated to acupuncture groups will receive 18 sessions of acupuncture treatment over 6 weeks. This trial will be conducted in 11 hospitals in China. The primary endpoint is the change in average 24-hSBP before and 6 weeks after randomization. The secondary endpoints are average SBP and average DBP during the daytime and night-time, and 36-Item Short Form Survey (SF-36), and so on.


CONCLUSIONS
This is the first large scale, multicenter, randomized, sham controlled trial of acupuncture for essential hypertension in China. It may clarify the efficacy of acupuncture as a treatment for mild hypertension.


BACKGROUND
Clinicaltrials.gov Identifier: NCT01701726.
Juan
J
Li
Hui
H
Zheng
Ling
L
Zhao
Ying
Y
Li
Yan
Y
Zhang
Xiao-rong
XR
Chang
Rui-hui
RH
Wang
Jing
J
Shi
Jin
J
Cui
Yin-lan
YL
Huang
Xiang
X
Li
Jie
J
Chen
De-hua
DH
Li
Chengdu University of Traditional Chinese Medicine Chengdu, Chengdu, Sichuan, PR China. acuresearch@126.com.
Fan-rong
FR
Liang
D015669:Acupuncture Points; D015670:Acupuncture Therapy / Q000009:adverse effects / Q000379:methods*; D000328:Adult; D000368:Aged; D001794:Blood Pressure; D002681:China; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D012107:Research Design; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome