A Rambaldi1, G Iaquinto, C Gluud. 1. Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, H:S Rigshopitalet, Blegdamsvej 9, Department 7201, Copenhagen, Denmark, DK-2100. arambaldi@hotmail.com
Abstract
BACKGROUND: Alcohol is one of the most common causes of liver disease in the Western World today. Randomised clinical trials have examined the effects of anabolic-androgenic steroids for alcoholic liver disease. OBJECTIVES: The objectives were to assess the beneficial and harmful effects of anabolic-androgenic steroids for patients with alcoholic liver disease based on the results of randomised clinical trials. SEARCH STRATEGY: The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Controlled Trials Register on The Cochrane Library, MEDLINE, EMBASE, and full text searches were combined (all searched December 2001). Manufacturers and researchers in the field were also contacted. SELECTION CRITERIA: Only randomised clinical trials studying patients with alcoholic steatosis, alcoholic fibrosis, alcoholic hepatitis, and/or alcoholic cirrhosis were included. Interventions encompassed anabolic-androgenic steroids at any dose or duration versus placebo or no intervention. The trials could be double blind, single blind, or unblinded. The trials could be unpublished or published and no language limitations were applied. DATA COLLECTION AND ANALYSIS: All analyses were performed according to the intention-to-treat method. The statistical package (RevMan and MetaView) provided by the Cochrane Collaboration was used. The methodological quality of the randomised clinical trials was evaluated by components of methodological quality. MAIN RESULTS: Combining the results of five randomised clinical trials randomising 499 patients with alcoholic hepatitis and/or cirrhosis demonstrated no significant effects of anabolic-androgenic steroids on mortality (relative risk (RR) 0.96, 95% confidence interval (CI) 0.72 to 1.28), liver related mortality (RR 0.83, 95% CI 0.60 to 1.15), complications of liver disease (RR 1.25, 95% CI 0.74 to 2.10), and liver histology. Further, anabolic-androgenic steroids did not significantly affect a number of other outcome measures. Anabolic-androgenic steroids were not associated with a significantly increased risk of non-serious adverse events but with the seldom occurrence of serious adverse events (RR 4.54, 95% CI 0.57 to 36.30). REVIEWER'S CONCLUSIONS: This systematic review could not demonstrate any significant beneficial effects of anabolic-androgenic steroids on any clinically important outcomes (mortality, liver related mortality, liver complications, and histology) of patients with alcoholic liver disease.
BACKGROUND:Alcohol is one of the most common causes of liver disease in the Western World today. Randomised clinical trials have examined the effects of anabolic-androgenic steroids for alcoholic liver disease. OBJECTIVES: The objectives were to assess the beneficial and harmful effects of anabolic-androgenic steroids for patients with alcoholic liver disease based on the results of randomised clinical trials. SEARCH STRATEGY: The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Controlled Trials Register on The Cochrane Library, MEDLINE, EMBASE, and full text searches were combined (all searched December 2001). Manufacturers and researchers in the field were also contacted. SELECTION CRITERIA: Only randomised clinical trials studying patients with alcoholic steatosis, alcoholic fibrosis, alcoholic hepatitis, and/or alcoholic cirrhosis were included. Interventions encompassed anabolic-androgenic steroids at any dose or duration versus placebo or no intervention. The trials could be double blind, single blind, or unblinded. The trials could be unpublished or published and no language limitations were applied. DATA COLLECTION AND ANALYSIS: All analyses were performed according to the intention-to-treat method. The statistical package (RevMan and MetaView) provided by the Cochrane Collaboration was used. The methodological quality of the randomised clinical trials was evaluated by components of methodological quality. MAIN RESULTS: Combining the results of five randomised clinical trials randomising 499 patients with alcoholic hepatitis and/or cirrhosis demonstrated no significant effects of anabolic-androgenic steroids on mortality (relative risk (RR) 0.96, 95% confidence interval (CI) 0.72 to 1.28), liver related mortality (RR 0.83, 95% CI 0.60 to 1.15), complications of liver disease (RR 1.25, 95% CI 0.74 to 2.10), and liver histology. Further, anabolic-androgenic steroids did not significantly affect a number of other outcome measures. Anabolic-androgenic steroids were not associated with a significantly increased risk of non-serious adverse events but with the seldom occurrence of serious adverse events (RR 4.54, 95% CI 0.57 to 36.30). REVIEWER'S CONCLUSIONS: This systematic review could not demonstrate any significant beneficial effects of anabolic-androgenic steroids on any clinically important outcomes (mortality, liver related mortality, liver complications, and histology) of patients with alcoholic liver disease.
Authors: Kaushik Agarwal; Nickolas Kontorinis; Nickolas Kontorinis; Douglas T Dieterich; Douglas T Dieterich Journal: Curr Treat Options Gastroenterol Date: 2004-12