الفهرس 
Title : The potential hepatoprotective effect of metformin in patients with beta thalassemia major
ContantsOnly 14 pages are availabe for public view
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Abstract
Background: Iron overload-induced oxidative stress and transfusion-acquired hepatitis C virus (HCV) infection are the main reasons of liver damage in beta thalassemia major (Ý-TM) patients. Aim: Based on metformin{u2019}s hepatic benefits in non-diabetic populations, the aim of the present study was to investigate the safety and potential hepatoprotective effect of metformin in HCV-infected Ý-TM adolescent patients focusing on its effects on liver biochemical profile, oxidative stress status and fibrosis severity. Patients and Methods: This was a prospective, randomized, parallel, controlled, open label study in which 60 out of 225 screened Ý-TM adolescent patients, infected with HCV, aged 11 to 18 years and receiving no antiviral therapy; were selected and randomly assigned to treatment group or control group in 1:1 allocation. Both groups were receiving regular packed red blood cells transfusions, iron chelation therapy and other supportive medications; metformin (500 mg, twice daily) was added to the regimen of the treatment group only. Patients were followed-up for six months with assessment of liver biochemical profile (liver enzymes, total and direct bilirubin, albumin and international normalized ratio (INR)), oxidative stress markers (total antioxidant capacity (TAC) and malondialdehyde (MDA)), liver fibrosis, clinical symptoms improvement and metformin{u2019}s adverse effects. The study was registered in ClinicalTrials.gov (NCT02984475). Chi-square and Fisher{u2019}s Exact tests were used to test non-numerical variables; student{u2019}s t-test was applied to test numerical parametric variables. One-way repeated measures analysis of variance (RM-ANOVA) and mixed RM-ANOVA were used to test the within group time effect and time{u00D7}group interaction effect respectively. All tests were two-tailed and at level of significance of P {u02C2} 0.05. Results: HCV antibodies were positive in 40.44% of the screened patients. Baseline demographics and laboratory parameters of the two groups were comparable (P > 0.05). There was a significant decrease over time in aspartate aminotransferase (AST) serum level in the treatment group only (P= 0.013). However, improvement was not clinically significant and did not attain normalityHCV antiviral treatment