title: A randomized double-blind, placebo-controlled study of therapeutic effects of silymarin in β-thalassemia major patients receiving desferrioxamine.
abstract: OBJECTIVE
  Thalassemia is one of the most common genetic disorders worldwide. Chronic blood transfusions treat the underlying anemia but may lead to iron toxicity. Effective iron chelation remains one of the main targets of clinical management of thalassemia major. In this study, iron-chelating activity of silymarin, a flavonolignan isolated from silybum marianum, was examined in β-thalassemia major.
  
  
  METHODS
  Patients were treated with the combination of desferrioxamine and silymarin (Legalon(®) ; n = 49) or desferrioxamine plus placebo (n = 48) for 9 months. The serum levels of ferritin, iron, total iron-binding capacity (TIBC), soluble transferrin receptor, and hepcidin were determined at the baseline and after 9-month therapy. Liver function test was performed before and after treatment in both groups.
  
  
  RESULTS
  Serum ferritin levels decreased significantly from the beginning to the end of silymarin treatment (3028.8 ± 2002.6 vs. 1972.2 ± 1250.6 ng/mL); however, no significant change in serum ferritin was observed in the patients receiving placebo (2249.0 ± 1304.2 vs. 2015.6 ± 1146.8). Moreover, serum iron and TIBC levels were significantly reduced in silymarin group compared with placebo. Patients on silymarin therapy also exhibited a significant decrease in serum levels of hepcidin and soluble transferrin receptor after 9-month treatment period. A significant improvement in liver function test was observed in silymarin group in comparison with placebo.
  
  
  CONCLUSIONS
  This study shows that silymarin is effective at reducing iron overload in patients when used in conjunction with desferrioxamine. Therapeutic effects of silymarin on a background of desferrioxamine suggest the potential effectiveness of silymarin alone in reducing body iron burden.
authors.affiliation: Department of Immunology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
authors.forename: Behjat
authors.initials: B
authors.lastname: Moayedi
authors.forename: Marjan
authors.initials: M
authors.lastname: Gharagozloo
authors.forename: Nafiseh
authors.initials: N
authors.lastname: Esmaeil
authors.forename: Mohammad R
authors.initials: MR
authors.lastname: Maracy
authors.forename: Hamid
authors.initials: H
authors.lastname: Hoorfar
authors.forename: Mohsen
authors.initials: M
authors.lastname: Jalaeikar
mesh_terms: D000293:Adolescent; D000328:Adult; D023181:Antimicrobial Cationic Peptides / Q000097:blood; D003676:Deferoxamine / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D004357:Drug Synergism; D005260:Female; D005293:Ferritins / Q000097:blood; D064451:Hepcidins; D006801:Humans; D007501:Iron / Q000097:blood; D007502:Iron Chelating Agents / Q000494:pharmacology / Q000627:therapeutic use*; D019190:Iron Overload / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D008099:Liver / Q000187:drug effects / Q000201:enzymology; D008297:Male; D020944:Silybum marianum / Q000737:chemistry; D010919:Placebos; D011990:Receptors, Transferrin / Q000097:blood; D012838:Silymarin / Q000494:pharmacology / Q000627:therapeutic use*; D065227:Transfusion Reaction; D017086:beta-Thalassemia / Q000628:therapy
chemical_list: D023181:Antimicrobial Cationic Peptides; D004338:Drug Combinations; C578702:HAMP protein, human; D064451:Hepcidins; D007502:Iron Chelating Agents; D010919:Placebos; D011990:Receptors, Transferrin; D012838:Silymarin; D005293:Ferritins; D007501:Iron; D003676:Deferoxamine