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Neurology 1999;52:1479
© 1999 American Academy of Neurology


Articles

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

F. Sellebjerg, MD, PhD, H. Schaldemose Nielsen, MD, J. L. Frederiksen, MD and J. Olesen, MD, PhD

From the MS Clinic, Department of Neurology, Glostrup Hospital, University of Copenhagen, Denmark.

Address correspondence and reprint requests to Dr. Finn Sellebjerg, Department of Neurology, Glostrup Hospital, University of Copenhagen, 57 Nordre Ringvej, DK-2600 Glostrup Copenhagen, Denmark; e-mail: sellebjerg{at}dadlnet.dk

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.




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