title: Use acupuncture to treat functional constipation: study protocol for a randomized controlled trial.
abstract: 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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinical Trials.gov NCT01411501.
authors: Chengdu University of Traditional Chinese Medicine, and First Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
authors: Ying
authors: Y
authors: Li
authors: Hui
authors: H
authors: Zheng
authors: Fang
authors: F
authors: Zeng
authors: Si-yuan
authors: SY
authors: Zhou
authors: Feng
authors: F
authors: Zhong
authors: Hua-bing
authors: HB
authors: Zheng
authors: Min
authors: M
authors: Chen
authors: Xiang-hong
authors: XH
authors: Jing
authors: Yu-ying
authors: YY
authors: Cai
authors: Bao-hui
authors: BH
authors: Jia
authors: Bing
authors: B
authors: Zhu
authors: Zhi-shun
authors: ZS
authors: Liu
mesh_terms: D015669:Acupuncture Points; D015670:Acupuncture Therapy; D000293:Adolescent; D000328:Adult; D000368:Aged; D001549:Benzamides / Q000627:therapeutic use; D002681:China; D003248:Constipation / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D003672:Defecation; D005765:Gastrointestinal Agents / Q000627:therapeutic use; D006801:Humans; D008875:Middle Aged; D009025:Morpholines / Q000627:therapeutic use; D018579:Patient Selection; D020127:Recovery of Function; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001549:Benzamides; D005765:Gastrointestinal Agents; D009025:Morpholines; C062720:mosapride