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

Background. Chronic stable angina pectoris (CSAP) is a major syndrome of ischemic heart disease (IHD). CSAP manifests as chest pain or discomfort and affects patients' quality of life. Acupoint application (AP) has been reported to be effective for managing the symptoms of CSAP, but the evidence is not convincing. Therefore, we designed a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of AP in the treatment of CSAP. Methods and Analysis. Two hundred participants with CSAP will be randomly assigned in a 1 : 1 : 1 : 1 ratio into 4 groups. All participants will receive 12 sessions of treatment in 4 weeks and the same basic treatment procedure. The participants will be visited and assessed for 12 weeks, including a 4-week screening, a 4-week treatment phase, and a 4-week follow-up phase. The primary outcome is the change in the total frequency of self-reported angina attack at 4th week compared with the baseline. The secondary outcomes include the intensity of angina pain, consumption of nitroglycerin or Suxiao Jiuxin pills, CCS angina classification, SAQ, SAS and SDS score. Ethics. The study protocol has been reviewed and approved by the Sichuan Regional Ethics Review Committee on TCM (number 2013kl-001). This trial is registered with clinicaltrials.gov NCT02029118.

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