Iron‐chelating effect of silymarin in patients with β‐thalassemia major: A crossover randomised control trial

This study aimed to determine the potential iron‐chelating effects of silymarin in patients with β‐thalassemia major receiving standard iron‐chelation therapy. We evaluated whether addition of silymarin to standard iron‐chelation therapy could improve iron burden markers and liver and cardiac function in these patients, via a placebo‐controlled, crossover clinical study. Silymarin (140 mg) or placebo were administered thrice daily to all patients (n = 82) for 12 weeks, and after a 2‐week washout period, patients were crossed over to the other groups. Silymarin efficacy was assessed by measuring serum iron level, ferritin level, total iron‐binding capacity and liver and cardiac function on magnetic resonance imaging. Silymarin treatment resulted in a negative change in the serum iron and ferritin levels and a positive change in the total iron‐binding capacity levels (treatment effect, p < .001, p = .06, and p = .05, respectively). Silymarin treatment led to positive changes in cardiac and liver function in both treatment sequences of study; however, this was not statistically significant. There was a negative change in liver iron concentration in both treatment sequences (treatment effect, p = .02). In conclusion, combined iron‐chelation and silymarin therapy was effective for improving the iron‐burden status in patients with β‐thalassemia major.