title: Acupoint application in patients with chronic stable angina pectoris: study protocol of a randomized, double-blind, controlled trial.
abstract: 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.
authors.affiliation: The Department of Acupuncture & Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan 610075, China.
authors.forename: Yulan
authors.initials: Y
authors.lastname: Ren
authors.affiliation: The Department of Acupuncture, Teaching Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan 610072, China.
authors.forename: Dehua
authors.initials: D
authors.lastname: Li
authors.affiliation: The Department of Acupuncture & Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan 610075, China.
authors.forename: Hui
authors.identifier: 0000-0002-1975-3307
authors.initials: H
authors.lastname: Zheng
authors.affiliation: The Department of Acupuncture & Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan 610075, China.
authors.forename: Junling
authors.initials: J
authors.lastname: Lv
authors.affiliation: The Department of Acupuncture & Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan 610075, China.
authors.forename: Junyan
authors.initials: J
authors.lastname: Leng
authors.affiliation: The Department of Acupuncture & Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan 610075, China.
authors.forename: Linglin
authors.initials: L
authors.lastname: Zhang
authors.affiliation: The Department of Acupuncture & Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan 610075, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Zhang
authors.affiliation: The Department of Acupuncture & Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan 610075, China.
authors.forename: Hailong
authors.initials: H
authors.lastname: Fan
authors.affiliation: The Department of Acupuncture & Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan 610075, China.
authors.forename: Fanrong
authors.initials: F
authors.lastname: Liang