Zhaoxuan He,#1,2 Yi Yang,#2,3 Qiao Wen,#1,2 Tao Yin,1,2 Zhengjie Li,1,2 Peihong Ma,1,2 Hui Zheng,1Yunhong Yang,1,2 Yongliang Jiang,4 Jianqiao Fang,4 Lei Lan,1,2 and Fang Zeng1,2,5

1Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075 Sichuan China

2Acupuncture-Brain Research Center, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan China

3School of Administration, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan China

4Department of Neurobiology and Acupuncture Research/The Third Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang China

5Key Laboratory of Sichuan Province for Acupuncture & Chronobiology, Chengdu, Sichuan China

Zhaoxuan He, Email: nc.ude.mctudc@nauxoahzeh.

Abstract

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

Keywords: Chronic stable angina pectoris, Acupoint, Randomized controlled trial, Intradermal needle, Meridian-Viscera Association