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.