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

Abstract

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.

PPAR-alpha/gamma agonists, glucagon-like peptide-1 receptor agonists and metformin for non-alcoholic fatty liver disease: A network meta-analysis

“…Of these, 22 studies were selected for this meta-analysis ( Figure 1 ). 18 – 39 The characteristics of the included studies are summarized in Table 1 . 18 – 39 A total of 1698 patients with NAFLD were included in the 22 studies, with a mean age of 44.3 years and a median follow-up time of 12–96 weeks.…”

“… 18 – 39 The characteristics of the included studies are summarized in Table 1 . 18 – 39 A total of 1698 patients with NAFLD were included in the 22 studies, with a mean age of 44.3 years and a median follow-up time of 12–96 weeks. Among the included studies, one study explored the efficacy of the dual PPARα and PPARγ agonist saroglitazar, 20 while seven studies assessed the effects of GLP-1RAs.…”

“… 18 , 19 , 21 – 23 , 38 , 39 The remaining 14 studies evaluated the efficacy of metformin. 24 – 37 Twenty studies used placebo as the control; 18 – 37 and two studies compared the effect between liraglutide and metformin. 38 , 39 According to the Cochrane Collaboration’s tool for assessing risk of bias, all of these studies were at a low-to-moderate risk of bias (see supplementary materials, Supplementary Figure 1).…”

“…With regard to the primary outcome of lowering circulating ALT levels, the direct meta-analysis included 21 RCTs. 18 – 36 , 38 , 39 Compared with placebo, saroglitazar was associated with an improvement in ALT levels in patients with NAFLD (95% CI: −1.66, −0.74) ( Figure 2a ). GLP-1RAs such as semaglutide, liraglutide and dulaglutide or metformin did not significantly improve ALT levels in NAFLD patients ( Figure 2a ).…”