Acupuncture for patients with functional dyspepsia: study protocol of a randomised controlled trial
- Hui Zheng1,
- Jing Xu1,
- Juan Li1,
- Xiang Li1,
- Ling Zhao1,
- Xiaorong Chang2,
- Mi Liu2,
- Biao Gong3,
- Xuezhi Li3,
- Fanrong Liang1
- 1The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China
- 2Department of Acupuncture & Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan, China
- 3Traditional Chinese Medicine, Chongqing Medical University, Chongqing, Chongqing, China
- Correspondence to Professor Fanrong Liang;
- Received 13 June 2013
- Revised 20 June 2013
- Accepted 21 June 2013
- Published 30 July 2013
Introduction Whether acupuncture is efficacious for patients with functional dyspepsia is still controversial. So we designed a randomised controlled trial to settle the problem.
Methods and analysis We designed a multicentre, two-arm, sham-controlled clinical trial. 200 participants with functional dyspepsia will be randomly assigned to the true acupuncture (TA) group and sham acupuncture (SA) group in a 1:1 ratio. Participants in the TA group will receive acupuncture at points selected according to syndrome differentiation. Participants in the sham acupuncture group will receive penetrations at sham points. Participants in both groups will receive 20 sessions of electroacupuncture in 4 weeks, five times continuously with a 2 day rest in a week. The primary outcome is the proportion of patients reporting the absence of dyspeptic symptoms at 16 weeks after inclusion. The secondary outcome includes a Short-Form Leeds Dyspepsia Questionnaire, the Chinese version of the 36-Item Short Form Survey, the Chinese version of the Nepean dyspepsia index, etc.
Ethics and dissemination The study protocol has been approved by the institutional review boards and ethics committees of the first affiliated hospital of Chengdu University of TCM, the first affiliated hospital of Hunan University of TCM and Chongqing Medical University, respectively (from April to August 2012). The results of this trial will be disseminated in a peer-reviewed journal and presented at international congresses.
Trials registration ClinicalTrials.gov NCT01671670.
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