title: Urosdeoxycholic acid in primary sclerosing cholangitis: a meta-analysis and systematic review.
abstract: OBJECTIVE
  Primary sclerosing cholangitis (PSC) is a chronic cholestatic liver disease with no proven effective medical therapy. Ursodeoxycholic acid (UDCA) was proposed as a potential treatment for this disorder. However, several randomised controlled trials reported conflicting results regarding the usefulness of UDCA. The aim of this meta-analysis and systematic review is to investigate the efficacy of UDCA in PSC.
  
  
  METHODS
  Literature review was performed to include randomised controlled trials and non-randomised studies comparing UDCA to a placebo in PSC. The included controlled trials were assigned a quality score. Random effects model was used. Outcomes were measured with Weight Mean Difference, Risk Ratio or Risk Difference. Heterogeneity was measured by I(2) measure of inconsistency.
  
  
  RESULTS
  Seven RCTs satisfied the inclusion criteria with a total number of 553 patients. Low dose UDCA was used in 4 studies, high dose UDCA (17-30mg/kg) was used in three studies. UDCA did not decrease the risk of mortality compared to placebo (RR=1.04, 95% CI 0.46-2.35) or the need for liver transplant (RR=1.22, 95% CI 0.7-2.12). UDCA also had no effect on the clinical symptoms. Liver Function Tests (LFTs) were significantly improved in the UDCA treated patients. UDCA did not decrease the incidence of cholangiocarcinoma.
  
  
  CONCLUSIONS
  UDCA had no beneficial effect on the patients' survival, liver histology, prevention of cholangiocarcinoma, or improvement of clinical symptoms. High dose UDCA was associated with increased mortality in one of the large randomised trial included in this analysis.
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Texas Tech University at El Paso, TX, USA. mohamed.othman@ttuhsc.edu
authors.forename: Mohamed O
authors.initials: MO
authors.lastname: Othman
authors.forename: Jeffery
authors.initials: J
authors.lastname: Dunkelberg
authors.forename: Praveen K
authors.initials: PK
authors.lastname: Roy
mesh_terms: D002756:Cholagogues and Choleretics / Q000627:therapeutic use*; D015209:Cholangitis, Sclerosing / Q000188:drug therapy*; D006801:Humans; D016896:Treatment Outcome; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use*
chemical_list: D002756:Cholagogues and Choleretics; D014580:Ursodeoxycholic Acid