Acupuncture for patients with functional dyspepsia: study protocol of a randomised controlled trial.

Abstract:

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.

journal_name

BMJ Open

journal_title

BMJ open

authors

Zheng H,Xu J,Li J,Li X,Zhao L,Chang X,Liu M,Gong B,Li X,Liang F

doi

10.1136/bmjopen-2013-003377

subject

Has Abstract

pub_date

2013-07-30 00:00:00

issue

7

issn

2044-6055

pii

bmjopen-2013-003377

journal_volume

3

pub_type

杂志文章

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