Immunomodulatory Effects of Silymarin in Patients With Beta-Thalassemia Major
Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
Participant gender:
Summary
A wide spectrum of immune abnormalities has been described by numerous studies involving
β-thalassemic patients with multiple transfusions. The abnormalities observed are both
quantitative and functional, and concern several components of the immune response.
Flavonoids are phenolic compounds widely distributed in plants, which were reported to exert
multiple biological effects, including antioxidant and free radical scavenging abilities.
Silymarin, a flavonolignan complex isolated from milk thistle (Silybum marianum L. Gaertn),
have been classified as cytoprotective, antioxidant, anti-inflammatory, and especially as
hepatoprotective agents. Silymarin is already being used clinically for treatment of liver
diseases.It is considered safe and well-tolerated, with reported adverse events similar to
placebo. Several studies have also reported immunomodulatory actions of silymarin. It
increases lymphocyte proliferation, interferon gamma, interleukin (IL)-4 and IL-10 secretions
by stimulated lymphocytes in a dose-dependent manner. It has been shown that in vitro
treatment of peripheral blood mononuclear cells with silymarin causes restoration of the
thiol status and increases in T cell proliferation and activation. Because reactive oxygen
species and iron overload play important roles in the pathophysiology of thalassemia,
silymarin may be an effective therapy due to its antioxidant, immunomodulatory,
cytoprotective and iron chelating activities. The present study designed to investigate the
therapeutic activity of orally administered silymarin for treatment of β-thalassemia major, a
well-known and prevalent disease in Iran, which is associated with oxidative stress, iron
overload and immune abnormalities.