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Specific therapy for nonalcoholic steatohepatitis (NASH) is lacking. Numerous trials have evaluated candidate treatments, but most of these studies were nonrandomized and were of short duration with unclear efficacy endpoints.
Now, pursuing earlier findings that thiazolidinediones and antioxidants can lead to improvements in NASH, investigators have conducted a phase III, multicenter, double-blind trial involving 247 nondiabetic NASH patients who were randomized to receive pioglitazone (30 mg daily), vitamin E (800 IU daily), or placebo for 96 weeks. All patients underwent baseline liver biopsies, and 90% underwent end-of-treatment biopsies. The primary outcome was improvement in histological features of NASH, assessed according to standardi…