Abstract:Aims/Background: The aim of this review was to determine the benefits and adverse effects of propylthiouracil for patients with alcoholic liver disease. Methods: Systematic Cochrane Review of randomised clinical trials. The Cochrane Hepato-Biliary Controlled Clinical Trials Register, The Cochrane Library, MEDLINE, and full text searches were combined. All analyses were performed according to the intention-to-treat method. Only randomised clinical trials studying patients with alcoholic steatosis, alcoholic fibrosis, alcoholic hepatitis and/or alcoholic cirrhosis were included. Interventions encompassed propylthiouracil at any dose versus placebo or no intervention. The trials could be double-blind, single-blind or unblinded. Results: Six randomised clinical trials randomising 710 patients demonstrated no significant effects of propylthiouracil versus placebo on mortality (Peto odds ratio (OR) 0.91, 95% confidence interval (CI) 0.59 to 1.40), liver-related mortality (OR 0.78, CI 0.45 to 1.33), complications to the liver disease (OR 1.14, CI 0.58 to 2.24), and liver histology. Propylthiouracil was associated with a nonsignificant trend toward an increased risk of nonserious adverse events (OR 1.49, CI 0.74 to 2.99) and with the rare occurrence of serious adverse events (leukopenia). Conclusions: This systematic review could not demonstrate any significant effect of propylthiouracil on any clinically important outcomes (mortality, liver-related mortality, liver complications and liver histology) of patients with alcoholic liver disease.