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

Neurology. 1999 Apr 22;52(7):1479-84. doi: 10.1212/wnl.52.7.1479.

Abstract

Objective: To assess the efficacy of oral high-dose methylprednisolone in acute 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 days, with a 10-day tapering period). Visual function was measured and symptoms 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 scores the first 3 weeks (analysis of variance with baseline values as the covariate), and changes in spatial vision and VAS scores after 8 weeks. A significance 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 methylprednisolone- 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 baseline visual deficit and patients treated early after onset of symptoms had a more pronounced response to treatment. The risk of a new demyelinating attack within 1 year was unaffected by treatment. No serious adverse events were seen.

Conclusion: Oral high-dose methylprednisolone treatment improves recovery from ON at 1 and 3 weeks, but no effect could be demonstrated at 8 weeks or on subsequent attack frequency.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Administration, Oral
  • Adult
  • Analysis of Variance
  • Female
  • Humans
  • Male
  • Methylprednisolone / administration & dosage*
  • Methylprednisolone / therapeutic use*
  • Optic Neuritis / drug therapy*
  • Visual Acuity / drug effects

Substances

  • Methylprednisolone