Can Use of Silymarin Improve Inflammatory Status in Patients with β-Thalassemia Major? A Crossover, Randomized Controlled Trial

Abstract

Background: In β-thalassemia major (β-TM) patients, iron overload is one of the main causes of inflammation. This study investigated whether use of silymarin could improve inflammatory status in patients with β-TM and iron overload, through a placebo-controlled, crossover study. Methods: Silymarin (140 mg, 3 times a day) or placebo were prescribed to all patients (n = 82) for 12 weeks, and after a 2-week washout period, patients were crossed over to the other group. The efficacy of silymarin was assessed by measuring serum C-reactive protein (CRP) (mg/dL), interleukin (IL)-6 (pg/mL), and IL-10 (pg/mL). Results: Sixty-nine patients completed the study. Data analysis showed that compared to the placebo, silymarin could decrease CRP, IL-6, and raise IL-10 significantly (the p values for all variables were <0.001). Cohen’s d for CRP adjusted according to the baseline CRP value was –1.72, the 95% confidence interval (CI) –2.12 to –1.33. The adjusted Cohen’s d equal to –1.12, 95% CI –1.48 to –0.76, and 0.78, 95% CI 0.43–1.12, were also estimated for IL-6 and IL-10, respectively. Conclusion: The results of the current study demonstrate that the combination of iron chelation therapy with silymarin can improve inflammatory status in patients with β-TM in the clinical setting.