Therapeutic Effects of Silymarin in Patients With B-thalassemia Major

Isfahan University of Medical Sciences140 enrolled

Overview

Silymarin, a flavonolignan complex isolated from Silybum marianum, has a strong antioxidant, hepatoprotective and iron chelating activities. The present study has been designed to investigate the therapeutic activity of orally administered silymarin in patients with thalassemia major under conventional iron chelation therapy. A 6-month randomized, double-blind, clinical trial was conducted in 140 beta-thalassemia major patients in two well-matched groups. Patients are randomized to receive a silymarin tablet (140 mg) three times a day plus conventional desferrioxamine therapy or the same therapy but a placebo tablet instead of silymarin. Clinical laboratory tests of iron status and liver function are assessed at the beginning and the end of the trial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

140

Conditions

Beta-thalassemia Major Iron Overload

Interventions

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Presence of major Beta-thalassemia * Age 12 years or older * Iron overload condition (serum ferritin levels between 1000-5000 ng/mL) Regular desferrioxamine administration (50 mg/kg) * Continuous blood transfusions * Negative CRP test Exclusion criteria: * Hepatitis B or C infection * Positive HIV test * Chronic renal or heart failure * Iron chelating therapy with other iron chelators

Outcomes

Primary Outcomes

Serum ferritin level

Time frame: after 3 months and 6 months from beginning of the trial

Secondary Outcomes

Liver enzymes (SGOT, SGPT, Alkaline Phosphatase), serum Hepcidin, and soluble transferrin receptor levels

Time frame: At the beginning and the end of the trial