Study the Effect of Melatonin on Fatigue in Patients with Multiple Sclerosis

Background and Aim: Multiple Sclerosis is (MS) is a common demyelinating disease of CNS that inflammation and stress oxidative processes have an important role in clinical courses and progression of it. The aim of the present study was to determine the anti-inflammatory effects of Melatonin on fatigue in MS. Materials and Methods: In a double-blind clinical trials study, 62 patients with relapsing remitting MS were randomized to oral Melatonin 3 mg or placebo daily for 8 weeks. Scale of Fatigue in MS was studied by assessing FSS (Fatigue Severity Scale) on weeks 1 and 8. Findings: 47 patients in intervention group and 15 patients in placebo group completed the study. In intervention group, treatment with Melatonin produced a significant decrease in FSS vs placebo group (before intervention: the average of FSS in patient group was 32.04±13.97 and in control group was 35.86±15.44; after intervention: the average of FSS in patient group was 30.42±12.40 and in control group was 41±12.66). Although in control group, the average of FSS was 35.866 and it was 41 after intervention. Because the score of placebo patient is near or upper than 36, this study suggested that Melatonin has a significant effect on improving and decreasing fatigue in MS. Conclusion: The use of melatonin alongside of First-line drugs such as mitoxantrone, IFN – B or glatimer acetate can improve fatigue and disability in patient with MS.