Objective: To determine the efficacy of corticosteroids as treatment for acute demyelinative optic neuritis after completion of 1 year of patient follow-up in the Optic Neuritis Treatment Trial.
Design: Randomized placebo controlled multicenter clinical trial.
Setting: Fifteen university or hospital-based centers throughout the United States.
Patients: Four hundred fifty-seven patients with acute demyelinative optic neuritis between 18 and 46 years of age.
Intervention: Either intravenous methylprednisolone sodium succinate (250 mg every 6 hours) for 3 days followed by oral prednisone (1 mg/kg per day) for 11 days, oral prednisone (1 mg/kg per day) for 14 days, or oral placebo for 14 days. The first two regimens were followed by a short taper of corticosteroid therapy.
Main outcome measures: Visual acuity, visual field, contrast sensitivity, and color vision.
Results: Visual acuity at 1 year was 20/40 or better in 95% of the placebo group, 94% of the intravenous group, and 91% of the oral prednisone group. Comparing each corticosteroid group with the placebo group, there were no statistically significant differences in the distributions of any of the four measures of visual function. Patients in the oral prednisone group suffered a higher rate of new attacks of optic neuritis than patients in either of the other two groups.
Conclusions: The visual benefit from treating acute optic neuritis with intravenous followed by oral corticosteroids is short term, limited to an accelerated rate of recovery. The decision whether to prescribe this regimen for optic neuritis, or to prescribe no treatment, must be made for each patient on an individual basis. Oral prednisone alone, in the dose range used in the Optic Neuritis Treatment Trial, should not be prescribed.