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Open Access Study protocol

Effect of electroacupuncture versus prucalopride for severe chronic constipation: protocol of a multi-centre, non-inferiority, randomised controlled trial

Baoyan Liu1, Yang Wang1, Jiani Wu1, Qian Mo1, Weiming Wang1, Liyun He2, Shiyan Yan2 and Zhishun Liu1*

Author Affiliations

1 Guang’anmen Hospital, China Academy of Chinese Medical Sciences, No.5 Beixiange Street Xicheng District 100053 Beijing, China

2 China Academy of Chinese Medical Sciences, Beijing 100053, China

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BMC Complementary and Alternative Medicine 2014, 14:260  doi:10.1186/1472-6882-14-260

Published: 23 July 2014

Abstract

Background

Acupuncture is safe and may be effective for severe chronic constipation. The World Gastroenterology Organisation recommends prucalopride for patients for whom previous laxative use failed to provide satisfactory relief.

Methods/design

In this prospective, multi-centre, randomised controlled trial, five hundred sixty patients with severe chronic constipation (two or less spontaneous complete bowel movements per week) from 14 centres will be randomised to receive either electroacupuncture or prucalopride. Participants in the electroacupuncture group will receive electroacupuncture for eight weeks, while participants in the control group will take prucalopride (2 mg once daily) for 32 weeks. The primary outcome measure is the proportion of patients having ≥3 spontaneous, complete bowel movements per week, averaged over week three to eight. The secondary outcome measures include eight items, including the proportion of patients having ≥3 spontaneous, complete bowel movements per week averaged over week 9–32, the proportion of patients with one or more increases in spontaneous, complete bowel movements per week from baseline, mean Bristol Stool Scale, etc. Statistical analysis will include the CMH test, nonparametric tests and t tests.

Discussion

We aimed to compare the effect of electroacupuncture versus prucalopride for severe chronic constipation. The limitation of this study is that participants and acupuncturists will not be blinded.

Trial registration

ClinicalTrials.gov Identifier: NCT 02047045.

Keywords:
Acupuncture; Prucalopride; Severe chronic constipation