A Cochrane review [Abstract] 1 included 5 studies with a total of 215 patients with multiple sclerosis (MS). The relapse of MS had begun less than 4 weeks before. The proportion of patients with Expanded Disability Status Scale (EDSS) improvement at 4 weeks was measured in 3 trials, while 2 trials examined magnetic resonance imaging (MRI) outcomes. Methylprednisolone dose was 500 mg for 3 days in one trial and 1000 mg for 5 days in another trial for both oral and intravenous (i.v.) regimens. The third trial used either oral 3-week regimen with halving doses every week, beginning from 48 mg and ending up with 12 mg daily, or 1000 mg i.v. for 3 days. In the fourth trial there was a single dose of either 1250 mg oral or 1000 mg i.v. cortisone. The fifth trial used 1000 mg i.v. vs. 1250 mg of oral methylprednisolone for 3 days. At week 4 there was no significant difference between oral and i.v. steroid treatment in relapse recovery (MD -0.22, 95% CI -0.71 to 0.26) or proportion of patients with gadolinium enhancing lesions (OR 1.13, 95% CI 0.43 to 2.99). Regarding adverse events, there was a trend towards more cases of impaired sense of taste and mood disturbance with oral steroid treatment, otherwise the treatments were equally safe.
Comment: The quality of evidence is downgraded by study quality (wide time interval from relapse to the treatment), inconsistency (heterogeneity in treatments and outcomes) and imprecise results (few patients with wide confidence intervals).
A total of 199 patients with MS were recruited into the multicentre, double-blind, randomised, controlled trial 2. They had reported a relapse within the previous 15 days and received either oral or i.v. methylprednisolone 1000 mg, once a day for 3 days. The primary endpoint was the proportion of patients who had improved by day 28 (decrease of at least one point in most affected score in EDSS), A total of 66 (81%) of 82 patients in the oral group and 72 (80%) of 90 patients in the i.v. group achieved the primary endpoint (absolute treatment difference 0·5%, 90% CI -9.5 to 10.4). Rates of adverse events were similar, but insomnia was more frequently reported in the oral group (77 [77%]) than in the i.v. group (63 [64%]).
Clinical comment: This publication provides robust evidence for the non-inferiority of oral vs. i.v. methylprednisolone and serves as an upgrading evidence for this evidence summary.
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