Acupuncture for chronic, stable angina pectoris and an investigation of the characteristics of acupoint specificity: study protocol for a multicenter randomized controlled trialReport as inadecuate




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Trials

, 15:50

First Online: 05 February 2014Received: 08 August 2013Accepted: 24 January 2014DOI: 10.1186-1745-6215-15-50

Cite this article as: Li, D., Yang, M., Zhao, L. et al. Trials 2014 15: 50. doi:10.1186-1745-6215-15-50

Abstract

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

KeywordsChronic stable angina pectoris Acupuncture Acupoint specificity Randomized controlled trial AbbreviationsDAMdisease-affected meridian

AEadverse events

NAMnon-affected meridian

CSAPchronic stable angina pectoris

FASfull analysis set

ITTintention-to-treat population

NAnon-acupoint

PPSper-protocol set

RCTrandomized controlled trial

SAEserious adverse events

SAQSeattle Angina Questionnaire

SASself-rating anxiety scale

SDSself-rating depression scale

SMSshort message service

TCMtraditional Chinese medicine

WLwait-listed.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-50 contains supplementary material, which is available to authorized users.

Dehua Li, Mingxiao Yang contributed equally to this work.

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