Significant immunomodulatory and hepatoprotective impacts of Silymarin in MS patients: A double-blind placebo-controlled clinicaltrial

Abstract

Interferon beta (IFN-β) has successfully been experimented with to treat multiple sclerosis (MS). However, patients sometimes do not respond effectively to treatment, and ‌adverse effects, including liver toxicity, accompany this therapy. ‌Accordingly, we decided to treat MS patients simultaneously with Silymarin (SM) as an immunomodulatory and hepatoprotective agent and IFN-β in a clinical trial study. Complete blood count (CBC), liver enzyme levels, and the serum concentration of inflammatory and anti-inflammatory cytokines were measured. Also, the frequency of immune cells was determined by flow cytometry. Liver enzyme levels were significantly lower in the intervention group (p < 0.05). The percentage of Th17 cells in the intervention group was significantly reduced compared to the placebo group (P < 0.001). Also, the frequency of Treg cells after treatment with SM plus IFN-β was significantly increased compared to the placebo group (p < 0.05). Furthermore, the IL-17 and IFN(γ) cytokine levels were significantly reduced in the intervention group (p < 0.05). Moreover, the levels of anti-inflammatory cytokines IL-10 and TGF(β) were significantly increased in the intervention group (P < 0.05).Overall, the results provide novel and supplementary information on SM's notable immunoregulatory effects on inflammatory response and liver function in MS patients. Clinical Trial Identifier Number: IRCTID: IRCT20171220037977N1.