A randomized controlled trial of acupuncture to treat functional constipation: design and protocol

BMC Complementary and Alternative Medicine

Study Protocol

MingMin Zhang¹  Wei Wang²  XiaoHu Xu³  GuangYing Huang³  CuiHong Zheng³ 

[1] Department of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, 430030, Wuhan, Hubei, People's Republic of China;Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, 430030, Wuhan, Hubei, People's Republic of China;Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, 430030, Wuhan, Hubei, People's Republic of China;

关键词: Irritable Bowel Syndrome;    Acupuncture Treatment;    Functional Constipation;    Sham Acupuncture;    Mosapride;   

DOI  :  10.1186/1472-6882-14-423

 received in 2014-05-22, accepted in 2014-09-30,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundFunctional constipation (FC) is a common functional gastrointestinal disorders (FGIDs) which has a major impact on the quality of life. Acupuncture is widely used as an alternative and complementary medicine (CAM) for FC, but the available evidence of its effectiveness is scarce. Therefore, we will perform a randomized controlled trial to determine whether acupuncture improves symptom and quality of life in FC patients more effectively than sham acupuncture or gastrointestinal prokinetic agent. This article will report the protocol of the trial.MethodsThe current trial is a multicenter, randomized, three-arm controlled study undergoing in China. About 243 people who aged from 18 to 65 years with FC will be recruited in this study. These participants will be randomly allocated into three treatment groups, including electro-acupuncture (EA), Mosapride (M) and Mosapride & Sham Electro-acupuncture (MS) groups in a 1:1:1 ratio. Both the EA and sham EA receives 16 sessions of needling at Quchi (LI11) and Shangjuxu (ST37) during 4 weeks of treatment, and a follow-up period of 4 weeks. These groups will be compared on the primary outcomes of the number of times of defecation at baseline and 2, 4, 8 weeks after randomization. The secondary outcome measures include: stool consistency, intensity of defecating difficulty, MOS item Short Form health survey (SF-36), Self-Rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), and the validated Patient Assessment of Constipation Quality of Life (PAC-QOL). These outcomes are measured at baseline and 2, 4 weeks after randomization, but SF-36 is measured at baseline and 4 weeks after randomization.DiscussionThis study will supply significant evidence for using acupuncture to treat FC, and will help us to observe whether it is a therapeutic effect rather than a placebo effect.

【 授权许可】

Unknown   
© Xu et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.