Clinical

Vitamin E improves liver histology in pediatric NAFLD

Last Updated: 2010-11-02 17:40:24 -0400 (Reuters Health)

By Anne Harding

NEW YORK (Reuters Health) - Children with nonalcoholic fatty liver disease (NAFLD) who took vitamin E had significant improvements in their liver histology, researchers said this week at the annual meeting of the American Association for the Study of Liver Diseases in Boston.

The children were enrolled in a 96-week randomized trial comparing the effects of vitamin E, metformin, and placebo on a variety of endpoints. Neither intervention achieved the primary goal - a reduction in serum alanine aminotransferase (ALT) levels throughout weeks 48 to 96 to below 40 IU/L or <50% of baseline

However, kids in the vitamin E arm had greater improvements in hepatocellular ballooning than those on placebo (mean score change of -0.5 vs. 0.1, P=0.006) and mean NAFLD activity score (-1.8 vs. -0.7, P=0.02).

Among the children who had nonalcoholic steatohepatitis (NASH) at the study's outset, 25 of 43 (58%) in the vitamin E group had resolution by week 96, compared to 11 of 39 (28%) in the placebo group (P=0.006).

Metformin had no effect on any of those features - and neither vitamin E nor metformin was better than placebo for improving fibrosis, lobular inflammation, or portal inflammation scores.

Right now, treatment for NAFLD and NASH in children consists of "lifestyle advice about diet and exercise," said Dr. Joel E. Lavine of Columbia University in New York City, the study's first author. Based on the new findings, he told Reuters Health, pediatric NALFD patients who have biopsies showing ballooning and ALT levels above 60 IU/L could benefit from adding vitamin E to standard-of-care lifestyle advice.

At the outset, Dr. Lavine and colleagues from 10 centers randomly assigned 173 children ages 8 to 17 years, all with ALT above 60 U/L and biopsy-confirmed NAFLD, to take either 400 IU of vitamin E twice a day (58 patients), 500 mg of metformin twice daily (57 patients), or placebo (58 patients) for 96 weeks.

"This is the first pediatric trial for any liver disease, ever, that used histology as a predesignated endpoint," Dr. Lavine noted. "It also showed the feasibility of being able to do it effectively. Eighty-five percent of the children that were randomized completed the course of treatment and underwent a research liver biopsy."