Use acupuncture to treat functional constipation: study protocol for a randomized controlled trial

Trials

Zhi-shun Liu¹  Bing Zhu³  Bao-hui Jia¹  Yu-ying Cai¹  Xiang-hong Jing³  Min Chen⁴  Hua-bing Zheng⁴  Feng Zhong²  Si-yuan Zhou²  Fang Zeng²  Hui Zheng²  Ying Li² 

[1] Guang’anMen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China;Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China;Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, 100700, China;First Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China

关键词: Study protocol;    Functional constipation;    Acupuncture;   

Others  :  1095482
DOI  :  10.1186/1745-6215-13-104

 received in 2011-11-01, accepted in 2012-07-03,  发布年份 2012

【 摘 要 】

Background

Whether acupuncture is effective for patients with functional constipation is still unclear. Therefore, we report the protocol of a randomized controlled trial of using acupuncture to treat functional constipation.

Design

A randomized, controlled, four-arm design, large-scale trial is currently undergoing in China. Seven hundred participants are randomly assigned to three acupuncture treatment groups and Mosapride Citrate control group in a 1:1:1:1 ratio. Participants in acupuncture groups receive 16 sessions of acupuncture treatment, and are followed up for a period of 9 weeks after randomization. The acupuncture groups are: (1) Back-Shu and Front-Mu acupoints of Large Intestine meridians (Shu-Mu points group); (2) He-Sea and Lower He-Sea acupoints of Large Intestine meridians (He points group); (3) Combining used Back-Shu, Front-Mu, He-Sea, and Lower He-Sea acupoints of Large Intestine meridians (Shu-Mu-He points group). The control group is Mosapride Citrate group. The primary outcome is frequency of defecation per week at the fourth week after randomization. The secondary outcomes include Bristol stool scale, the extent of difficulty during defecating, MOS 36-item Short Form health survey (SF-36), Self-Rating Anxiety Scale (SAS), and Self-rating Depression Scale (SDS). The first two of second outcomes are measured 1 week before randomization and 2, 4, and 8 weeks after randomization. Other second outcomes are measured 1 week before randomization and 2 and 4 weeks after randomization, but SF-36 is measured at randomization and 4 weeks after randomization.

Discussion

The result of this trial (which will be available in 2012) will confirm whether acupuncture is effective to treat functional constipation and whether traditional acupuncture theories play an important role in it.

Trials registration

Clinical Trials.gov NCT01411501

【 授权许可】

   
2012 Li et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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