Evaluating the effect of adding Fish oil to Fingolimod on TNF-α, IL1β, IL6, and IFN-γ in patients with relapsing-remitting multiple sclerosis: A double-blind randomized placebo-controlled trial.

OBJECTIVES: Fish oil is claimed to improve outcome in multiple sclerosis (MS) through anti-inflammatory and antioxidant effects by reducing cytokines including TNF-α, IFN-γ, IL6, and IL-1β. We aimed to evaluate the efficacy of adding fish oil to Fingolimod on these serum cytokines.

PATIENTS AND METHODS: This double-blind randomized trial was conducted during April 2015 to September 2016 in Isfahan, Iran. Patients with diagnosis of relapsing remitting MS, aged 18-45years old and expanded disability status scale (EDSS) ≤5 were enrolled in the study. The experimental group received 1g/day of fish oil. Serum levels of TNF-α, IFN-γ, IL6, and IL-1β were measured before intervention, 6 months, and 12 months after intervention as the primary outcome. Also, EDSS was evaluated before and at the end of study.

RESULTS: 50 patients were recruited initially and nine of them left the study. We found no difference between serum levels of TNF-α, IFN-γ, IL6, and IL-1β at three time-points between two groups (P-value >0.05). Also, there was no statistically significant difference in the mean EDSS between the experimental group and the control group after 12 months of intervention (P-value=0.08).

CONCLUSIONS: Administration of fish oil did not lower the serum levels of TNF-α, IL1β, IL6, and IFN-γ compared to placebo. Similarly, it did not improve the disability in patients.