title: Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial.
abstract: BACKGROUND
  Functional constipation is a common clinical complaint. Although the effectiveness of Ma Zi Ren Wan for alleviating functional constipation symptoms has been proven in a previous randomized placebo-controlled study, further evidence is needed to make clinical recommendations about Chinese herbal medicine. In particular, a comparison with conventional western medicine for functional constipation patients is needed.
  
  
  METHODS
  This is a prospective, double-blinded, double dummy, randomized, controlled trial. After a 2-week run-in period, eligible patients (Rome III) with excessive traditional Chinese medicine syndrome will randomly be assigned to the Chinese medicine arm (Ma Zi Ren Wan and western medicine placebo), western medicine arm (senna and Chinese medicine placebo) or placebo arm (Chinese medicine placebo and western medicine placebo). Patients will undergo an 8-week treatment and an 8-week follow-up. The primary outcome is the responder rate for complete spontaneous bowel movement (CSBM) during treatment. Patients with a mean increase of CSBM ≧1/week in comparison with their baselines are defined as responders. The secondary outcomes include responder rate during follow-up, changes of colonic transit as measured with radio-opaque markers, individual and global symptom assessments, and reported adverse effects.
  
  
  CONCLUSIONS
  This study is the first study to compare a Chinese Herbal Medicine (Ma Zi Ren Wan) with a laxative that is commonly used in the clinical practice of western medicine, and with a placebo. This study will complete the investigation of Ma Zi Ren Wan for functional constipation, and should, therefore, suggest recommendations for clinical practice. Furthermore, the process of first conducting a systematic review, then implementing a dose determination study followed by a placebo-control trial, and finally, comparing traditional Chinese medicine with an active conventional medicine in a controlled trial can be a reference to other researches on Chinese medicine interventions in the future.
  
  
  BACKGROUND
  NCT01695850.
authors.forename: Linda L D
authors.initials: LL
authors.lastname: Zhong
authors.forename: Chung Wah
authors.initials: CW
authors.lastname: Cheng
authors.forename: Yawen
authors.initials: Y
authors.lastname: Chan
authors.forename: King Hong
authors.initials: KH
authors.lastname: Chan
authors.forename: Ting Wa
authors.initials: TW
authors.lastname: Lam
authors.forename: Xiao Rui
authors.initials: XR
authors.lastname: Chen
authors.forename: Chi Tak
authors.initials: CT
authors.lastname: Wong
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University, 1/F, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Hong Kong, SAR, China. justinwu@cuhk.edu.hk.
authors.forename: Justin C Y
authors.initials: JC
authors.lastname: Wu
authors.forename: Zhao Xiang
authors.initials: ZX
authors.lastname: Bian
mesh_terms: D002985:Clinical Protocols; D003248:Constipation / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D003672:Defecation / Q000187:drug effects*; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005769:Gastrointestinal Motility / Q000187:drug effects; D006723:Hong Kong; D006801:Humans; D054368:Laxatives / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D020127:Recovery of Function; D012107:Research Design; D012676:Senna Extract / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal; D054368:Laxatives; C000591093:ma zi ren wan; D012676:Senna Extract