, Volume 2, Issue 2, pp 196-201
Date: 28 Feb 2008

A randomized controlled pilot study of Pentoxifylline in patients with non-alcoholic steatohepatitis (NASH)

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Abstract

Purpose

Tumor necrosis factor-α (TNF-α) is implicated in non-alcoholic steatohepatitis (NASH). Pentoxifylline inhibits TNF-α. We wanted to evaluate the efficacy of Pentoxifylline on NASH patients.

Methods

Patients with biopsy proven NASH and persistently elevated alanine aminotransferase (ALT) greater than 1.5 times the upper limit of normal were randomized to 3 months of treatment with a step 1 American Heart Association diet and daily exercise with Pentoxifylline or placebo. Liver function tests, serum lipids and TNF-α, Interleukin 6 (IL-6), and plasma hyaluronic acid were measured at baseline, at weeks 6 and 12. Categorical data were analyzed by Fisher’s exact test while independent sample t-test and Mann–Whitney test were used for continuous data.

Results

Eleven patients were randomized into the Pentoxifylline and nine to the placebo group. After 3 months of treatment body mass index (BMI), ALT and aspartate aminotransferase (AST) decreased significantly in both groups. There was no difference between the two groups in reduction of BMI (P = 0.897). There was significantly greater reduction in AST in the Pentoxifylline group (P = 0.038). There was a trend toward lower ALT level (P = 0.065) in the Pentoxifylline group. TNF-α and IL-6 decreased significantly in both groups after treatment, but there was no significant difference between the two groups.

Conclusion

Three months of Pentoxifylline treatment in combination with diet and exercise results in significantly greater reduction in AST levels in patients with NASH as compared with controls.

This study was funded by the National Healthcare Group Small Innovative Grant NHG-grant number. RPR/04029. It received ethics approval by the National Healthcare Group Domain Specific Research Board D-registration number DSRB-D/04/083.