According to a report published in Clinical Case Reports, the flavonolignan silymarin, which is isolated from milk thistle (Silybum marianum), appears to be safe and efficacious in decreasing serum ferritin levels in patients with beta-thalassemia intermedia (beta-TI).
“Flavonoids are phenolic substances that are widely found in plant raw materials. They are known as potent antioxidants and metal-chelators, suggesting that they could be effective therapeutic agents in pathological conditions caused by oxidative stress and iron overload,” the researchers wrote in their report.
To determine whether silymarin might be an effective iron-chelating agent for the treatment of iron-overload disorders, the researchers conducted a cross-sectional, 6-month study of silymarin monotherapy in a group of patients with beta-TI who refused conventional iron-chelating treatments.
Patients diagnosed with non-transfusion-dependent beta-TI at the thalassemia ward of Seyed-al-Shohada Hospital of the Isfahan University of Medical Sciences in Isfahan, Iran, were eligible for the study. They were required to be ≥5 years of age, have never or only sporadically received blood transfusions, have ferritin levels ≥500 ng/mL, and have never received iron chelation therapy.
All patients were treated with a standardized commercial preparation of milk thistle (80% silymarin; Legalon® capsules, Madaus Pharma) at a daily dose of 420 mg (140 mg, 3 times per day), for 6 months. Over the course of the study, they were visited monthly for safety and adherence evaluations. The primary objective was to assess the efficacy of the silymarin monotherapy regimen for the reduction of serum ferritin levels, measured at the start of the study and every 3 months.
A total of 10 patients were included in the study. Of those, 4 were excluded due to poor adherence or initiation of conventional iron-chelating therapy. Overall, 6 patients (3 males and 3 females) completed the 6-month trial. Patients had an average age of 26.7 years (range, 10-47).
The researchers demonstrated that silymarin monotherapy significantly reduced patients’ mean serum ferritin level after 3 and 6 months relative to baseline (P <.05 and P <.01, respectively).
According to self-reported data used in the study, patients did not experience any adverse events but reported that their skin became lighter and their appetites increased after initiating silymarin therapy.
“This finding suggests silymarin as a safe and effective natural iron-chelating agent for the treatment of iron-overloaded conditions,” wrote Reisi and colleagues, “[and] warrants further investigation in more patients with longer follow-up.”
The primary limitations of the study included the small sample size and relatively short follow-up duration.
Reisi N, Esmaeil N, Gharagozloo M, Moayedi B. Therapeutic potential of silymarin as a natural iron-chelating agent in β-thalassemia intermedia. Clin Case Rep. Published online January 24, 2022. doi:10.1002/ccr3.5293