Metformin in the treatment of non-alcoholic steatohepatitis: a pilot open label trial

Aliment Pharmacol Ther. 2004 Jul 1;20(1):23-8. doi: 10.1111/j.1365-2036.2004.02025.x.


Background: Insulin sensitizing agents may be useful in treatment of non-alcoholic fatty liver disease.

Aim: A pilot study to evaluate the efficacy and safety of metformin in non-alcoholic fatty liver disease.

Methods: In an open labelled study, patients with histologically confirmed non-alcoholic fatty liver disease were given metformin (20 mg/kg) for 1 year. Insulin resistance (by log homeostasis assessment model analysis for insulin resistance and Quantitative Insulin Sensitivity Check Index) and post-treatment hepatic histology were compared with pre-treatment histology.

Results: Fifteen patients completed 1 year of treatment. During the initial 3 months, there was improvement in alanine aminotransferase and aspartate aminotransferase (P-value 0.01 and 0.02, respectively) along with improvement in insulin sensitivity. However, after 3 months, there was no further improvement in insulin sensitivity and there was gradual rise in aspartate aminotransferase and alanine aminotransferase back to pre-treatment levels. Among the 10 patients with post-treatment biopsy, three (33%), showed improvement in steatosis, two (20%) showed improvement in inflammation score and one (10%) showed improvement in fibrosis.

Conclusion: Metformin treatment was associated with only a transient improvement in liver chemistries. A progressive, sustainable reduction in insulin sensitivity was not noted during treatment.

Publication types

  • Clinical Trial

MeSH terms

  • Alanine Transaminase / metabolism
  • Aspartate Aminotransferases / metabolism
  • Drug Evaluation
  • Female
  • Hepatitis / drug therapy*
  • Hepatitis / enzymology
  • Humans
  • Hypoglycemic Agents / administration & dosage*
  • Hypoglycemic Agents / adverse effects
  • Insulin Resistance / physiology*
  • Male
  • Metformin / administration & dosage*
  • Metformin / adverse effects
  • Middle Aged
  • Patient Compliance
  • Pilot Projects
  • Treatment Outcome


  • Hypoglycemic Agents
  • Metformin
  • Aspartate Aminotransferases
  • Alanine Transaminase