Background Non‐alcoholic fatty liver disease (NAFLD) is characterized by fat accumulation
in the liver, which may progress to non‐alcoholic steatohepatitis (NASH) and cirrhosis. It is
suspected in persons with elevated aminotransferase levels and features of insulin
resistance (or metabolic) syndrome. The pathogenesis of NAFLD is not clear and there is no
universal treatment. Objectives To assess beneficial and harmful effects of drugs improving
insulin resistance for NAFLD and/or NASH.

The authors rewrote the background section of the protocol prepared earlier by Angelico
2006, expanded types of studies, and expanded and changed the inclusion criteria. The
review will also include patients with diabetes. Text on concomitant interventions and
combination therapy was also added. The types of outcomes were modified in accordance
with updated guidelines in the Handbook, ie, modified primary outcomes (added adverse
events, quality-of-life measures, added details to hepatic-related morbidity) and secondary …