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

Abstract
Summary: 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.