Vitamin E or metformin does not result in sustained reduction of alanine aminotransferase (ALT) levels in children and adolescents with nonalcoholic fatty liver disease (NAFLD), according to a study in the Journal of the American Medical Association.
Vitamin E or metformin does not result in sustained reduction of alanine aminotransferase (ALT) levels in children and adolescents with nonalcoholic fatty liver disease (NAFLD), according to a study in the Journal of the American Medical Association.
However, vitamin E appears to resolve nonalcoholic steatohepatitis (NASH), a severe form of fatty liver disease.
Investigators conducted a randomized, double-blind, placebo-controlled clinical trial at 10 research centers involving 173 children aged 8 to 17 years with NAFLD confirmed by liver biopsy. None of the children had diabetes or cirrhosis.
The primary outcome was sustained reduction in ALT levels. Secondary outcomes included improvements of histologic features of NAFLD and resolution of NASH. The children received vitamin E (400 IU twice daily), metformin (500 mg twice daily), or placebo for 96 weeks.
Vitamin E or metformin was comparable to placebo at attaining sustained reduction of ALT levels (26%, 16%, and 17%, respectively).
When studying the 121 children with NASH or borderline NASH, 58% had resolution of NASH with vitamin E versus 41% with metformin and 28% with placebo after 96 weeks of treatment. “This was mainly attributable to significant improvement in hepatocellular ballooning by vitamin E treatment,” say the investigators. Vitamin E also had a positive effect on NALFD activity score, but its effects were insignificant on steatosis, inflammation, and fibrosis.
“The data suggest that children treated with vitamin E who had biopsy-proven NASH or borderline NASH had significant improvement in secondary histologic outcomes with vitamin E,” the researchers conclude. “However, risk of biopsy might outweigh the benefits of therapy, so development of noninvasive markers for identification and monitoring of those who may benefit is desirable.” They advocate lifestyle modification for all children with NAFLD.
Lavine JE, Schwimmer JB, Van Natta ML, et al. Effect of vitamin E or metformin for treatment of nonalcoholic fatty liver disease in children and adolescents. The TONIC randomized controlled trial. JAMA. 2011;305(16):1659-1668.
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