Acupuncture on disease-affected meridians will be evaluated for its efficacy in reducing angina attack frequency compared to non-affected meridians, non-acupoints, and wait-list controls in 404 patients with chronic stable angina pectoris.
RCT (n=404)
Assessor and statistician blinded
Stratified block dynamic randomization with permuted block
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Does acupuncture on the disease-affected meridian reduce the frequency of angina attacks in patients with chronic stable angina pectoris compared to non-affected meridian, non-acupoint, or wait-list controls?
This study protocol outlines a multicenter randomized controlled trial to evaluate the efficacy and meridian-based acupoint specificity of acupuncture as an adjunct to routine care for chronic stable angina pectoris.
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.
Li et al. (Wed,) conducted a rct in Chronic stable angina pectoris (n=404). Acupuncture on disease-affected meridian (DAM) vs. Acupuncture on non-affected meridian (NAM), non-acupoint (NA), or waiting list (WL) was evaluated on Change from baseline in frequency of angina attack at 4 months. Acupuncture on disease-affected meridians will be evaluated for its efficacy in reducing angina attack frequency compared to non-affected meridians, non-acupoints, and wait-list controls in 404 patients with chronic stable angina pectoris.