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Acupuncture for patients with mild hypertension: study protocol of an open-label multicenter randomized controlled trial

Juan Li1, Hui Zheng1, Ling Zhao1, Ying Li1, Yan Zhang2, Xiao-rong Chang3, Rui-hui Wang4, Jing Shi5, Jin Cui6, Yin-lan Huang7, Xiang Li1, Jie Chen1, De-hua Li1 and Fan-rong Liang1*

Author Affiliations

1 Chengdu University of Traditional Chinese Medicine Chengdu, Chengdu, Sichuan, PR China

2 First Affiliated Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, PR China

3 Hunan University of Traditional Chinese Medicine, Changsha, Hunan, PR China

4 Shanxi College of Traditional Chinese Medicine, Xi’an, Shanxi, PR China

5 Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, Yunnan, PR China

6 Guiyang College of Traditional Chinese Medicine, Guiyang, Guizhou, PR China

7 Ningxia Medical University, Ningxia, Gansu, PR China

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Trials 2013, 14:380  doi:10.1186/1745-6215-14-380

Published: 11 November 2013

Abstract

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/Design

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.

Discussion

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.

Trial registration

Clinicaltrials.gov Identifier: NCT01701726

Keywords:
Essential hypertension; Acupuncture; Acupoint specificity; Acupoints effect; Randomized controlled trials; Protocol