Metformin in the treatment of non-alcoholic steatohepatitis: a pilot open label trial.
BACKGROUND
Insulin sensitizing agents may be useful in treatment of non-alcoholic fatty liver disease.


OBJECTIVE
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.


CONCLUSIONS
Metformin treatment was associated with only a transient improvement in liver chemistries. A progressive, sustainable reduction in insulin sensitivity was not noted during treatment.
Nair
S
S
Section of Gastroenterology and Hepatology, Ochsner Clinic Foundation, New Orleans, LA 70121, USA. snair@ochsner.org
Diehl
A M
AM
Wiseman
M
M
Farr
G H
GH
Perrillo
R P
RP
D000410:Alanine Transaminase / Q000378:metabolism; D001219:Aspartate Aminotransferases / Q000378:metabolism; D004341:Drug Evaluation; D005260:Female; D006505:Hepatitis / Q000188:drug therapy* / Q000201:enzymology; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007333:Insulin Resistance / Q000502:physiology*; D008297:Male; D008687:Metformin / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D010349:Patient Compliance; D010865:Pilot Projects; D016896:Treatment Outcome
D007004:Hypoglycemic Agents; D008687:Metformin; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase