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

Abstract

BackgroundChronic 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/DesignThis 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.DiscussionThis 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 registrationClinical Trials.gov NCT01686230

Effect of Electroacupuncture at Different Acupoints on the Expression of NMDA Receptors in ACC and Colon in IBS Rats

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Does acupuncture reduce the risk of acute myocardial infarction?

“…PC5-PC6 and ST36-ST37 are considered important acupoints in CVD 14 . An interesting acupuncture clinical trial protocol about point specificity in patients with stable angina pectoris was registered by Li et al 17 . Patient age is also an important factor.…”

A protocol of histone modification-based mechanistic study of acupuncture in patients with stable angina pectoris

“…Allocation to the treatment groups uses a stratified block dynamic randomization method with a permuted block, which is a computer-based system [26]. Separate randomization files will be created for each of the two recruiting sites.…”

“…To address these problems and to hopefully provide a more conclusive answer to these questions, a team within our research group has designed a protocol to start a multicenter RCT [26]. In order to study the underling molecular mechanisms, we will first confirm the efficacy of electro-acupuncture as a treatment method for stable angina pectoris using a relatively small patient population.…”

“…A few published randomized controlled trials (RCTs) concerning acupuncture treatment for stable angina pectoris claim that convincing evidence for the effectiveness of acupuncture in treating stable angina pectoris patients is still inadequate, due to the poor quality of existing studies. To address these problems and to hopefully provide a more conclusive answer to these questions, a team within our research group has designed a protocol to start a multicenter RCT [ 26 ]. In order to study the underling molecular mechanisms, we will first confirm the efficacy of electro-acupuncture as a treatment method for stable angina pectoris using a relatively small patient population.…”