Acupuncture for chronic stable angina pectoris based on the theory of Meridian-Viscera Association: study protocol for a multicenter randomized controlled trial

BACKGROUND: Acupuncture has long been used to treat chronic stable angina pectoris (CSAP), but the acupuncture prescription for CSAP varies. This trial will compare the therapeutic effects between the acupoints on the Heart Meridian and the acupoints on the Lung Meridian for treating CSAP, so as to provide a better prescription for acupuncture treatment of CSAP. METHODS: This is a multicenter randomized controlled trial. A total of 148 CSAP patients will be randomly allocated into two groups through central randomization in a 1:1 ratio. This trial will include a 2-week screening period, a 4-week treatment period, and a 4-week follow-up period. The primary outcome is the frequency of angina attacks from baseline to 4 weeks after inclusion. Secondary outcomes include the frequency of angina attacks from baseline to 4 weeks after acupuncture treatment, the pain intensity of angina, total ischemia burden, heart rate variability, QT dispersion, the score of Seattle Angina Questionnaire, and the score of Short-Form of McGill Pain Questionnaire. These outcome measures will be evaluated at baseline, at the end of acupuncture treatment, and at the end of follow-up. DISCUSSION: We hypothesize that the effectiveness of puncturing at acupoints on the Heart Meridian will not be the same as those on the Lung Meridian. The results will provide further evidence of Meridian-Viscera Association theory and references for acupoints selection in the clinical practice. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900025804. Registered on September 9, 2019