A randomized, controlled trial of oral high-dose methylprednisolone in acute optic neuritis

Objective: To assess the efficacy of oral high-dose methylprednisolone in a cute optic neuritis (ON). Background: It has been determined that oral high -dose methylprednisolone is efficacious in attacks of MS. Methods: A total of 60 patients with symptoms and signs of ON with a duration of less than 4 weeks and a visual acuity of 0.7 or less were randomized to treatment with placebo (n = 30) or oral methylprednisolone (n = 30; 500 mg daily for 5 da ys, with a 10-day tapering period). Visual function was measured and sympto ms were scored on a visual analog scale (VAS) before treatment and after 1, 3, and 8 weeks. Primary efficacy measures were spatial vision and VAS scor es the first 3 weeks (analysis of variance with baseline values as the cova riate), and changes-in spatial vision and VAS scores after 8 weeks. A signi ficance level of p < 0.0125 was employed. Results: The VAS score (p = 0.008 ) but not the spatial visual function (p = 0.03) differed in methylpredniso lone- and placebo-treated patients during the first 3 weeks. After 8 weeks the improvement in VAS scores (p = 0.8) and spatial visual function (p = 0. 5) was comparable with methylprednisolone- and placebo-treated patients. A post hoc subgroup analysis suggested that patients with more severe baselin e visual deficit and patients treated early after onset of symptoms had a m ore pronounced response to treatment. The risk of a new demyelinating attac k within 1 year was unaffected by treatment. No serious adverse events were seen. Conclusion: Oral high-dose methylprednisolone treatment improves rec overy from ON at 1 and 3 weeks, but no effect could be demonstrated at 8 we eks or on subsequent attack frequency.