Effect of Metformin or Vitamin E on Ultrasonographic Grade and Biochemical Findings of Children and Adolescents with Nonalcoholic Fatty Liver Disease: A Randomized Clinical Trial

Background: Nonalcoholic fatty liver disease (NAFLD) is the most frequent form of liver disease in children, defined as the infiltration of fat into more than 5% of liver cells with metabolic syndrome consisting of dyslipidemia, insulin resistance, and obesity. Objectives: This study aimed to assay the effect of metformin or vitamin E on ultrasonographic grade and biochemical findings of children and adolescents with NAFLD. Methods: This clinical trial was performed on 150 non-diabetic obese children with NAFLD in the age range of 10 to 14 in Qazvin, Iran, during 2018 - 2019. The participants were randomly assigned to three groups: group 1 was treated with metformin at a dose of 500 mg twice daily for three months; group 2 received vitamin E at a dose of 400 units twice daily; and group 3 received a placebo. In addition, all the three groups were given the same proper diet and advised to increase their physical activity. SPSS software version 23 was used to analyze the data. Results: After the intervention, in groups receiving metformin and vitamin E, the grades of fatty liver decreased significantly (P < 0.05), and the decrease was more significant in the group receiving metformin. Conclusions: Insulin resistance is one of the critical factors in the development of nonalcoholic fatty liver disease. By reducing insulin resistance with drug treatment, desirable results can be achieved.