A Randomized, Controlled Study Evaluating the Effects of Silymarin Addition to Deferasirox on the Liver Function of Children with Transfusion-Dependent Thalassemia

Aziz  Eghbali; Roghayeh  Rahimi Afzal; Mojtaba  Hashemi; Aygin  Eghbali; Bahar  Taherkhanchi; Bahador  Bagheri

doi:10.18502/ijpho.v11i4.7169

Aziz Eghbali Department of Pediatrics, Aliasghar Clinical Research Development Center, Iran University of Medical Sciences, Tehran, Iran
Roghayeh Rahimi Afzal Department of Pediatrics, Arak University of Medical Scinces, Arak, Iran
Mojtaba Hashemi Department of Pediatrics, Arak University of Medical Scinces, Arak, Iran
Aygin Eghbali School of Medicine, Iran University of Medical Sciences, Tehran, Iran
Bahar Taherkhanchi Department of Pediatrics, Erfan Niyayesh Hospital, Tehran, Iran
Bahador Bagheri Cancer Research Center, Semnan University of Medical Sciences, Semnan, Iran

DOI: https://doi.org/10.18502/ijpho.v11i4.7169

Keywords: Deferasirox, Liver Function, Silymarin, Thalassemia

Abstract

Background: Frequent blood transfusion can lead to iron overload which is potentially dangerous for the heart and liver. Silymarin has well-documented protective effects on hepatocytes. The purpose of this study was to evaluate the hepatoprotective effects of silymarin addition to iron chelators in children with thalassemia.

Materials and Methods: This randomized, double-blinded, and placebo-controlled trial was performed on 40 subjects with thalassemia major and intermedia in Amir Kabir Hospital, Arak, Iran. Subjects were randomized 1:1 oral to 30 mg/kg deferasirox plus placebo, or deferasirox plus oral 70-140 mg silymarin (twice daily) for 6 months. Cardiac and hepatic iron levels and levels of Gamma-glutamyltransferase (GGT), Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP), total bilirubin, albumin, total protein, and total cholesterol were measured at baseline and after 6 months of treatment.

Results: The mean age of patients was 16 years and 60% of patients were female. After 6 months, there were significant increases in the levels of ALT, AST, GGT, and TG in the placebo group as compared to the silymarin group (P < 0.05). In contrast, ALT, AST, and GGT had significant reductions compared to the silymarin group (P =0.05). Patients in the placebo group had a rise in total bilirubin (P = 0.07), but total protein and albumin did not have significant changes in the silymarin group (P > 0.05). Finally, a significant improvement was noted in cardiac iron values in patients using silymarin; 22.2 ± 6.6 ms at baseline vs 26.9 ± 7.1 ms at 6 months (P < 0.05).

Conclusion: This study suggests that twice-daily addition of silymarin to deferasirox could improve liver function in children with thalassemia major and intermedia. Silymarin seems safe in pediatrics.