Intravenous methylprednisolone sped the recovery of vision but only marginally improved long-term vision in optic neuritis
ACP J Club. 1992 July-Aug;117:9. doi:10.7326/ACPJC-1992-117-1-009
Beck RW, Cleary PA, Anderson MM, et al. A randomized, controlled trial of corticosteroids in the treatment of acute optic neuritis. N Engl J Med. 1992 Feb 27;326:581-8.
To compare the effects on vision of treatment of optic neuritis with intravenous methylprednisolone followed by oral prednisone or with oral prednisone alone.
Randomized, placebo-controlled trial with 6 to 24 months of follow-up.
15 tertiary care medical centers.
457 patients (77%, women; 85%, white; mean age, 32 y) were enrolled. Patients had a history of acute unilateral optic neuritis with visual symptoms ≤ 8 days, evidence of a relative afferent pupillary defect, and a visual-field defect in the affected eye. Patients were excluded if they had previous optic neuritis in the same eye or a systemic disease other than multiple sclerosis that could cause optic neuritis. Follow-up at 6 months was 98%, and compliance was satisfactory in ≥ 90% of patients in all study arms as measured by pill count.
151 patients received intravenous methylprednisolone (250 mg every 6 h for 3 d) followed by oral prednisone (1 mg/kg body weight per d) for 11 days (methylprednisolone group). 156 received the above dose of oral prednisone for 14 days (oral prednisone group), and 150 received oral placebo on the same schedule (placebo group).
Main outcome measures
Visual fields and contrast sensitivity measured at 6 months. The study had a 90% power to detect a 30% reduction in abnormal contrast sensitivity at 6 months (expected placebo prevalence, 75%, α = 0.02).
At 6 months, the methylprednisolone group had better contrast sensitivity (P = 0.026) and visual fields (P = 0.054) than the placebo group. The oral prednisone group and the placebo group had similar vision. The rate of return to normal vision, using analysis of life-table curves, was higher for contrast sensitivity (P = 0.02) and visual fields (P < 0.001) in the methylprednisolone group compared with the placebo group. The oral prednisone group had a higher rate of new or recurrent optic neuritis compared with placebo after 24 months (relative risk 1.79, 95% CI 1.08 to 2.95, P < 0.02).
Intravenous methylprednisolone followed by oral prednisone sped the recovery of optic neuritis compared with placebo, but patients had only slightly better vision at 6 months. Oral prednisone was no better than placebo for treatment and could have increased the risk for optic neuritis recurrence in either eye.
Sources of funding: National Eye Institute and Upjohn Company.
Address for article reprint: Dr. R.W. Beck, Department of Ophthalmology, University of South Florida College of Medicine, 12901 North Bruce B. Downs Boulevard, Tampa, FL 33612, USA.
Optic neuritis causes sudden, often severe loss of vision in 1 or both eyes. Although no solid evidence exists to support the use of steroid treatment in this disease, many clinicians have prescribed oral prednisone for the treatment of acute optic neuritis.
The randomized controlled trial of corticosteroids in the treatment of acute optic neuritis by Beck and colleagues gives us convincing evidence that oral prednisone treatment actually does more harm than good. It is clear from this scientifically sound study that not only does oral prednisone treatment have no advantages over placebo, it is also associated with more frequent subsequent attacks of optic neuritis. The use of oral prednisone alone, therefore, is not indicated in the treatment of acute optic neuritis.
A major objective of the study by Beck and colleagues was to determine whether oral prednisone after intravenous methylprednisolone had any effect on visual outcome in acute optic neuritis. In this group the patients recovered visual function faster than in the placebo group, but their visual outcome at the end of the 6-month, follow-up period was only slightly better than that measured in the placebo group. Although there was a statistically significant difference in favor of the methylprednisolone group in terms of visual fields, contrast sensitivity, and color vision, the clinical effect was small.
Because the clinical benefit is small and a small but definite risk for side effects exists, oral prednisone after intravenous methylprednisolone should probably not be used for mild-to-moderate cases of acute optic neuritis. If a patient, however, has severe unilateral visual loss or if the loss is bilateral, this treatment should be considered. In this situation a shortening of the recovery time and mild, long-term benefit in some visual parameters could be important to the patient.
Barbara Scherokman, MD
Uniformed Services University of the Health SciencesBethesda, Maryland, USA