No reduction in alanine aminotransferase levels with vitamin E or metformin treatment
WEDNESDAY, April 27 (HealthDay News) -- For pediatric patients with nonalcoholic fatty liver disease (NAFLD), neither treatment with vitamin E nor metformin significantly reduces alanine aminotransferase (ALT) levels compared to placebo, according to a study published in the April 27 issue of the Journal of the American Medical Association.
Joel E. Lavine, M.D., Ph.D., from Columbia University in New York City, and colleagues assessed whether children with NAFLD would benefit from therapeutic intervention with metformin or vitamin E. Participants with NAFLD were randomized to receive a daily dose of 800 IU vitamin E (58 patients), 1,000 mg of metformin (57 patients), or placebo (58 patients) for 96 weeks. The primary study outcome was sustained reduction in ALT defined as 40 U/L or less, or 50 percent or less of the baseline level, measured from 48 to 96 weeks of treatment.
The investigators found that sustained reduction in ALT was similar in the treatment and placebo groups. The mean change from baseline to 96 weeks was −35.2 U/L in the placebo group, −48.3 U/L in the vitamin E group, and −41.7 U/L in the metformin group, which was not significant. The average change in hepatocellular ballooning scores at 96 weeks was significant for vitamin E and metformin, and NAFLD activity scores improved significantly in children treated with vitamin E compared to placebo. In children with non-alcoholic steatohepatitis, 28 percent resolved at 96 weeks with placebo, compared to 58 percent with vitamin E and 41 percent with metformin.
"Neither vitamin E nor metformin was superior to placebo in attaining the primary outcome of sustained reduction in ALT level in patients with pediatric NAFLD," the authors write.
Several of the study authors disclosed financial ties to the pharmaceutical industry.