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Open Access Study protocol

Acupuncture for chronic, stable angina pectoris and an investigation of the characteristics of acupoint specificity: study protocol for a multicenter randomized controlled trial

Dehua Li1, Mingxiao Yang1, Ling Zhao1, Hui Zheng1, Ying Li1, Xiaorong Chang2, Jin Cui3, Ruihui Wang5, Jing Shi4, Junling Lv1, Junyan Leng1, Juan Li1 and Fanrong Liang16*

Author Affiliations

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

2 Hunan University of Traditional Chinese Medicine, Changsha, Hunan, China

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

4 Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, Yunnan, China

5 Shanxi College of Traditional Chinese Medicine, Xi’an, Shanxi, China

6 School of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, No.37, Shi Er Qiao Road, Jinniu District, Chengdu 610075, China

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Trials 2014, 15:50  doi:10.1186/1745-6215-15-50

Published: 5 February 2014

Abstract

Background

Chronic stable angina pectoris (CSAP) is a common cardiovascular condition that endangers a patient’s life quality and longevity. As demonstrated in several clinical trials, acupuncture is attested to be effective for CSAP. Current trials are not adequate enough to provide high-quality evidence for clinical decision making, as a result of inadequate methodology design and small sample size. Notably, stark controversy toward acupoint specificity also exists in the clinical acupuncture trials for CSAP. Therefore, we designed the present study as a randomized controlled trial primarily to investigate the effectiveness of acupuncture in addition to routine care among patients with CSAP. Meanwhile, we examined whether acupoint on the disease-affected meridian (DAM) is superior to either acupoint on the non-affected meridian (NAM) or non-acupoint (NA), to further investigate the meridian-based characteristics of acupoint specificity.

Methods/Design

This study was a multicenter, assessor and statistician blinded, randomized controlled trial in China. In this study, 404 participants in sum will be randomly assigned to four groups through central randomization in a 1:1:1:1 ratio. The whole study period is 20 weeks including a 4-week baseline period, a 4-week treatment period and a 12-week follow-up. Participants in the DAM group receive acupuncture stimulation at acupoints on the disease-affected meridian, and three different control groups will undergo acupuncture stimulation at the NAM, the non-acupoint and no intervention respectively, in addition to basic treatment. Participants in the acupuncture groups will receive 12 sessions of acupuncture treatment over 4 weeks, while the wait-listed (WL) group would receive free acupuncture treatment after the completion of the study. The outcome measures in this trial include the frequency of angina attack during 4 weeks as the primary outcome and eight other secondary outcomes.

Discussion

This trial will provide new and relatively high-quality evidence in acupuncture treatment for CSAP. Moreover, this trial may further validate the meridian-based characteristics of acupoint specificity by comparing the strength of acupoints on the disease-affected meridian versus that of the non-affected meridian, to further inspire optimization of acupuncture therapy for CSAP.

Trial registration

Clinical Trials.gov NCT01686230

Keywords:
Chronic stable angina pectoris; Acupuncture; Acupoint specificity; Randomized controlled trial