Double-blind, randomized, placebo-controlled study of oral, high-dose methylprednisolone in attacks of MS

OBJECTIVE: There is only limited evidence from adequately controlled clinical trials to support high‐dose methylprednisolone therapy for attacks of multiple sclerosis (MS) and none supporting oral administration. We assessed the effect of oral high‐dose methylprednisolone therapy in attacks of MS. METHODS: Twenty‐five patients with an attack of MS lasting less than 4 weeks were randomized to placebo treatment. Twenty‐six patients received oral methylprednisolone (500 mg once a day for 5 days with a 10‐day tapering period). The patients received scores on the Scripps Neurological Rating Scale (NRS) and Kurtzke Expanded Disability Status Scale. The symptoms were scored on a visual analog scale (VAS) before treatment and after 1, 3, and 8 weeks of treatment. Primary efficacy measures were NRS and VAS scores in the first 3 weeks and changes in NRS score and answers to an efficacy questionnaire administered after 8 weeks of treatment. RESULTS: Changes in NRS scores among methylprednisolone‐ and placebo‐treated patients differed significantly in the first 3 weeks and after 8 weeks (p = 0.005 and p = 0.0007). VAS scores the first 3 weeks and treatment efficacy after 8 weeks also favored a beneficial effect of methylprednisolone treatment (p = 0.02 and p = 0.05). After 1, 3, and 8 weeks, 4%, 24%, and 32% in the placebo group and 31%, 54%, and 65% in the methylprednisolone group had improved one point on the Expanded Disability Status Scale score (all p < 0.05). No serious adverse events were seen. CONCLUSION: Oral high‐dose methylprednisolone is recommended for managing attacks of MS.