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

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.

• Authors: F Sellebjerg, H S Nielsen, J L Frederiksen, J Olesen
• Journal: Neurology (Neurology) Vol. 52 Issue 7 Pg. 1479-84 (Apr 22 1999) ISSN: 0028-3878 [Print] United States
• PMID: 10227638 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Methylprednisolone

Topics

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