Clinical question: Is there any difference between oral and intravenous methylprednisolone for multiple sclerosis relapses?
Background: When relapses of multiple sclerosis occur, studies have shown that intravenous steroids are the treatment of choice. Prior Cochrane meta-analyses have not found any significant difference between intravenous and oral treatments; however, the studies all have had limitations. This study was designed to provide a statistically significant answer.
Study design: Randomized, double-blinded, noninferiority trial.
Setting: Thirteen multiple sclerosis centers in France.
Synopsis: Patients were selected if they had had a relapse within the previous 15 days; the mean time was seven days. One hundred patients were in the oral steroid group, and 99 were in the intravenous steroid group. Each group received 1 g of methylprednisolone daily for three days. In addition, each group received saline infusions or placebo capsules to keep the study blind.
After 28 days, 81% of the oral group and 80% of the intravenous group had improvements of their symptoms. Side effects from the medications were similar as well.
The study was limited by the fixed dosing (1 g daily) that was not bioequivalent. Also, MRIs, although not always used in relapses, could have added more objective information, as everyone was followed clinically using the Kurtzke Functional System Scale.
Bottom line: Consider using oral instead of IV steroids in patients with relapsing multiple sclerosis.
Citation: Le Page E, Veillard D, Laplaud DA, et al. Oral versus intravenous high-dose methylprednisolone for treatment of relapses in patients with multiple sclerosis (COPOUSEP): a randomised, controlled, double-blind, non-inferiority trial. Lancet. 2015;386(9997):974-981.