title: Treatment of functional constipation with the Yun-chang capsule: a double-blind, randomized, placebo-controlled, dose-escalation trial.
abstract: OBJECTIVE
  Functional constipation is a common functional bowel disorder for which there is no reliable medical treatment. This study was designed to determine the therapeutic efficacy and safety of the Yun-chang capsule, a Chinese herbal formula, in the treatment of patients with functional constipation.
  
  
  METHODS
  In our multi-center, prospective, double-blind, randomized, placebo-controlled, dose-escalation trial, patients with functional constipation received 70 mg of Yun-chang capsule plus 35 mg placebo (group A), 105 mg of Yun-chang capsule (group B), or 105 mg placebo (group C), three times daily for 2 weeks. The primary end-points were the changes in main symptom score and cumulative symptom score 2 weeks after the treatment. The secondary end-points were adverse events.
  
  
  RESULTS
  A total of 140 patients were recruited and 132 met the inclusion criteria; 44 patients constituted each of the three treatment groups. Compared with patients in group C, patients in groups A and B had significant improvement in the main symptom score, cumulative symptom score, the change from baseline of the main symptom score, and the change from baseline of the cumulative symptom score at week 1 and week 2. The scores showed slight superiority of group B over group A at week 1 and week 2, although these differences were not statistically significant. There were no differences in adverse events.
  
  
  CONCLUSIONS
  The Yun-chang capsule is efficacious and safe for the treatment of patients with functional constipation. Larger and longer-term trials are required to fully assess the benefits and safety of this treatment for functional constipation.
authors.affiliation: Division of Clinical Pharmacology, West China Hospital, West China School of Medicine, Sichuan University, China.
authors.forename: Guo
authors.initials: G
authors.lastname: Jia
authors.forename: Mao-Bin
authors.initials: MB
authors.lastname: Meng
authors.forename: Zong-Wen
authors.initials: ZW
authors.lastname: Huang
authors.forename: Xia
authors.initials: X
authors.lastname: Qing
authors.forename: Wang
authors.initials: W
authors.lastname: Lei
authors.forename: Xiao-Nan
authors.initials: XN
authors.lastname: Yang
authors.forename: Song-Shan
authors.initials: SS
authors.lastname: Liu
authors.forename: Jun-Cheng
authors.initials: JC
authors.lastname: Diao
authors.forename: Si-Yuan
authors.initials: SY
authors.lastname: Hu
authors.forename: Bing-Hui
authors.initials: BH
authors.lastname: Lin
authors.forename: Rui-Ming
authors.initials: RM
authors.lastname: Zhang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002214:Capsules; D002681:China; D003248:Constipation / Q000188:drug therapy*; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage / Q000627:therapeutic use*; D017410:Practice Guidelines as Topic; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D002214:Capsules; D004365:Drugs, Chinese Herbal; D005765:Gastrointestinal Agents; D010936:Plant Extracts; C551434:yun-chang