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Open Access Study protocol

The efficacy and safety study of electro-acupuncture for severe chronic functional constipation: study protocol for a multicenter, randomized, controlled trial

Zhishun Liu1, Jia Liu2, Ye Zhao2, Yuying Cai1, Liyun He2, Huanfang Xu1, Xiaohua Zhou3, Shiyan Yan2, Lixing Lao4 and Baoyan Liu1*

Author Affiliations

1 GuangAn Men Hospital, China Academy of Chinese Medical Sciences, No. 5, Beixiange street, Xicheng District Beijing 100053, China

2 China Academy of Chinese Medical Sciences, No. 16, Dongzhimen Nei Nanxiaojie, Dongcheng District, Beijing 100700, China

3 Department of Biostatistics, University of Washington, Office H655E, HSB Box #357232, Seattle, WA 98198, USA

4 Center for Integrative Medicine, University of Maryland School of Medicine, East Hall, 520 W. Lombard Street, Baltimore, MD 21201, USA

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Trials 2013, 14:176  doi:10.1186/1745-6215-14-176

Published: 15 June 2013

Abstract

Background

Previous research has shown that electro-acupuncture (EA) may be effective for functional constipation. We report a protocol for a randomized controlled trial using EA to confirm the efficacy and safety for severe chronic functional constipation.

Methods/design

This is a randomized, controlled trial. A total of 1,034 patients will be randomly allocated into the EA group (n=517) and the sham EA group (n=517). The EA group receives needling at ST25, SP14 and ST37 and the sham EA group receives needling at sham ST25, SP14 and ST37. The primary outcome measure is the changed number of weekly average complete spontaneous bowel movements(CSBMs) during 8 weeks of treatment, compared with baseline. The secondary outcome measures are: 1) the proportion of participants having three or more CSBMs on average per week; 2) the changed number of weekly average CSBMs during weeks 9 to 20; 3) the changed number of weekly average spontaneous bowel movements during 8 weeks of treatment; 4) stool consistency; 5) degree of difficulty in defecation; 6) patient assessment of constipation quality of life questionnaire (PAC-QOL); 7) incidence of adverse events; and 8) usage of medicine for constipation.

Discussion

This trial will evaluate the efficacy and safety of EA for severe chronic functional constipation.

Trial registration

Protocol Registration System of ClinicalTrial.gov, NCT01726504

Keywords:
Chronic functional constipation; Electro-acupuncture; Multicenter RCT; Efficacy; Safety