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


CONCLUSIONS
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.
Sellebjerg
F
F
Department of Neurology, Glostrup Hospital, University of Copenhagen, Denmark. sellebjerg@dadlnet.dk
Nielsen
H S
HS
Frederiksen
J L
JL
Olesen
J
J
D000208:Acute Disease; D000284:Administration, Oral; D000328:Adult; D000704:Analysis of Variance; D005260:Female; D006801:Humans; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage* / Q000627:therapeutic use*; D009902:Optic Neuritis / Q000188:drug therapy*; D014792:Visual Acuity / Q000187:drug effects
D008775:Methylprednisolone