title: Effect of therapeutic doses of acetaminophen (up to 4 g/day) on serum alanine aminotransferase levels in subjects consuming ethanol: systematic review and meta-analysis of randomized controlled trials.
abstract: OBJECTIVE
  To quantify the effect of therapeutic doses of acetaminophen on serum alanine aminotransferase (ALT) levels in subjects who consumed ethanol.
  
  
  METHODS
  Systematic review of six randomized placebo-controlled trials, of which five were included in a meta-analysis.
  
  
  METHODS
  Subjects included in the meta-analysis were those who consumed ethanol and received acetaminophen in doses up to 4 g/day (551 subjects) or placebo (350 subjects).
  
  
  RESULTS
  A comprehensive literature search of the MEDLINE, EMBASE, and International Pharmaceutical Abstracts databases and the Cochrane Central Register of Controlled Trials was performed to identify randomized, placebo-controlled trials that enrolled subjects who consumed ethanol, received acetaminophen in therapeutic doses up to 4 g/day, and had serum ALT level measurements. A total of 184 articles were identified; six articles met all criteria. Five of the six articles reported ALT levels on study day 4 for both groups of subjects who received acetaminophen or placebo. Thus, for the meta-analysis, we used the primary outcome of mean change in serum ALT level from baseline to day 4 in the acetaminophen groups compared with the placebo groups. We found that the difference in mean change from baseline ALT levels between the acetaminophen and placebo groups on day 4 was 0.0 U/L (95% confidence interval -0.2-0.1 U/L). There were no reports of liver dysfunction, liver failure, or death in any of the trials.
  
  
  CONCLUSIONS
  In randomized, placebo-controlled trials of subjects who consumed ethanol, no elevation of ALT level on study day 4 was noted when subjects ingested up to 4 g/day of acetaminophen.
authors.affiliation: Denver Health and Hospital Authority Rocky Mountain Poison and Drug Center, Denver, Colorado 80204, USA.
authors.forename: Barry
authors.initials: B
authors.lastname: Rumack
authors.forename: Kennon
authors.initials: K
authors.lastname: Heard
authors.forename: Jody
authors.initials: J
authors.lastname: Green
authors.forename: Donald
authors.initials: D
authors.lastname: Albert
authors.forename: Becki
authors.initials: B
authors.lastname: Bucher-Bartelson
authors.forename: Michael
authors.initials: M
authors.lastname: Bodmer
authors.forename: Marco L A
authors.initials: ML
authors.lastname: Sivilotti
authors.forename: Richard C
authors.initials: RC
authors.lastname: Dart
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage / Q000009:adverse effects*; D000410:Alanine Transaminase / Q000097:blood*; D000428:Alcohol Drinking / Q000009:adverse effects*; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000009:adverse effects; D000431:Ethanol / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008111:Liver Function Tests; D016032:Randomized Controlled Trials as Topic
chemical_list: D018712:Analgesics, Non-Narcotic; D000082:Acetaminophen; D000431:Ethanol; D000410:Alanine Transaminase