title: Propylthiouracil for alcoholic liver disease.
abstract: BACKGROUND
  Randomised clinical trials have addressed the question whether propylthiouracil has any beneficial effects in patients with alcoholic liver disease.
  
  
  OBJECTIVE
  To assess the beneficial and harmful of propylthiouracil for patients with alcoholic liver disease.
  
  
  METHODS
  The Cochrane Hepato-Biliary Group Controlled Trials Register (May 2005), The Cochrane Central Register of Controlled Trials in The Cochrane Library (Issue 2, 2005), MEDLINE (1950 to May 2005), EMBASE (1980 to May 2005), and The Web of Science (May 2005) were searched. These electronic searches were combined with full text searches. Manufacturers and researchers in the field were also contacted.
  
  
  METHODS
  Randomised clinical trials studying patients with alcoholic steatosis, alcoholic fibrosis, alcoholic hepatitis, and/or alcoholic cirrhosis were included irrespective of blinding, publication status, or language. Interventions encompassed propylthiouracil at any dose versus placebo or no intervention.
  
  
  METHODS
  All analyses were performed according to the intention-to-treat method in RevMan Analyses. The methodological quality of the randomised clinical trials was evaluated by components (generation of the allocation sequence; allocation concealment; double blinding; follow-up).
  
  
  RESULTS
  Combining the results of six randomised clinical trials including 710 patients demonstrated no significant effects of propylthiouracil versus placebo on all-cause mortality (relative risks (RR) 0.93, 95% confidence interval (CI) 0.66 to 1.30), liver-related mortality (RR 0.80, 95% CI 0.50 to 1.29), complications of the liver disease, or liver histology. Propylthiouracil was associated with a non-significant increased risk of non-serious adverse events and with the seldom occurrence of serious adverse events (leukopenia).
  
  
  CONCLUSIONS
  We could not demonstrate any significant beneficial effect of propylthiouracil on all-cause mortality, liver-related mortality, liver complications, and liver histology of patients with alcoholic liver disease. Propylthiouracil was associated with adverse events. Confidence intervals were wide. Accordingly, there is no evidence for using propylthiouracil for alcoholic liver disease outside randomised clinical trials.
authors.affiliation: Ospedale San Paolo, Divisione di Medicina Generale, Via Terracina, Napoli, Campania, Italy 80100. arambaldi@hotmail.com
authors.forename: A
authors.initials: A
authors.lastname: Rambaldi
authors.forename: C
authors.initials: C
authors.lastname: Gluud
mesh_terms: D000963:Antimetabolites / Q000627:therapeutic use*; D006801:Humans; D008108:Liver Diseases, Alcoholic / Q000188:drug therapy*; D011441:Propylthiouracil / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D000963:Antimetabolites; D011441:Propylthiouracil