Randomised Clinical Trial Comparing the Efficacy of A Gluten-Free Diet Versus A Regular Diet in A Series of Relapsing-Remitting Multiple Sclerosis Patients

Objectives: To analyse the clinical efficacy of a Gluten-Free Diet (GFD) compared with a Regular Diet (RD) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients. Methods: Seventy-two RRMS patients were included into a prospective study. Annual relapse rate (ARR), Expanded Disability Status Scale (EDSS) and lesional activity were compared. Patients were randomly separated according to diet: (GFD, n=36) and (RD, n=36). Follow-up study period was 5.3 ± 1.6 years (median 4.5 years). Results: At the end of the study period, a clear improvement in the EDSS was observed in GFD (1.5 ± 1.4) compared with RD (2.1 ± 1.5) (p=0.001), and lesional activity (MRI) was found in 10 (28%) in GFD, compared to 24 (67%) in RD (p=0.001) [OR: 5.200; (CI95%: 1.901- 14.220)]. Average ARR was lower in GFD (0.4 ± 0.6) compared to RD (0.6 ± 0.6) (NS).