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

Abstract

IntroductionWhether acupuncture is efficacious for patients with functional dyspepsia is still controversial. So we designed a randomised controlled trial to settle the problem.Methods and analysisWe 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 disseminationThe 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 registrationClinicalTrials.gov NCT01671670.

Electroacupuncture for patients with refractory functional dyspepsia: A randomized controlled trial

“…The trial design conformed to the Declaration of Helsinki; ethical approval of the trial was granted in each study center (The Regional Institutional Review Board of Sichuan Province, The Ethics Committee of The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, and The Ethics Committee of Teaching Hospital of Chongqing Medical University). 1 …”

“…In the sham acupuncture group, four sham points were needled in each patient. The sham points were selected through a systematic review of published acupuncture trials, expert consensus, and the result of our previous study …”

“…At visit 1, the patients started acupuncture treatment after they finished baseline evaluation Traditional Chinese Medicine, and The Ethics Committee of Teaching Hospital of Chongqing Medical University). 15 The participants were informed that they would receive one of the two acupuncture treatments; one followed the style of traditional Chinese medicine, and the other one did not, but it was also effective according to previous studies. The method for informing patients was used in previously reported acupuncture trials, 16,17 and it was advantageous in maintaining blinding.…”

The efficacy of oral Zhizhu Kuanzhong, a traditional Chinese medicine, in patients with postprandial distress syndrome

“…14 A randomized controlled study found that acupuncture is superior to sham acupuncture in FD symptom improvement with a long-lasting effect. 15 Pooled data showed significant efficacy of Si-Ni-San (TCM formula) for upper GI disorders (odds ratio = 3.9, 95% confidence interval = 3.09-4.92) and FD (n = 2989; odds ratio = 3.94, 95% confidence interval = 3.17-4.90). 16 Zhizhu Kuanzhong has been proved to be effective in improving the reflux symptoms in gastroesophageal reflux disease patients.…”

“…Xiaoyao pill is efficacious for patients with premenopausal FD . A randomized controlled study found that acupuncture is superior to sham acupuncture in FD symptom improvement with a long‐lasting effect . Pooled data showed significant efficacy of Si‐Ni‐San (TCM formula) for upper GI disorders (odds ratio = 3.9, 95% confidence interval = 3.09–4.92) and FD ( n = 2989; odds ratio = 3.94, 95% confidence interval = 3.17–4.90) …”