RANDOMIZED TRIAL OF ORAL AND INTRAVENOUS METHYLPREDNISOLONE IN ACUTE RELAPSES OF MULTIPLE-SCLEROSIS

Background An intravenous rather than oral course of methylprednisolon e is often prescribed for treating acute relapses in multiple sclerosi s (MS) despite the lack of evidence to support this route of administr ation. Our double-blind placebo-controlled randomised trial was design ed to compare the efficacy of commonly used intravenous and oral stero id regimens in promoting recovery from acute relapses in MS. Methods 4 2 patients with clinically definite relapse in MS received oral, and 3 8 intravenous, methylprednisolone, Clinical measurements at entry and at 1 week, 4 weeks, 12 weeks, and 24 weeks included Kurtzke's expanded disability status scale (EDSS), Hauser's Ambulatory Index, and an arm -function index. The primary outcome criterion was a difference betwee n the two treatment groups of one or more EDSS grades at 4 weeks. Find ings There were no significant differences between the two groups at a ny stage of the study in any measurement taken: the mean difference in EDSS at 4 weeks (adjusted for baseline level) was 0.07 grades more in those taking oral steroids (95% CI -0.46 to 0.60). The most optimisti c outcome for intravenous therapy is an average benefit of less than h alf a grade improvement on EDSS over oral treatment. Interpretation Si nce our study did not show any clear advantage of the intravenous regi me we conclude that it is preferable to prescribe oral rather than int ravenous steroids for acute relapses in MS for reasons of patient conv enience, safety, and cost.