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Experience of the Optic Neuritis Treatment Trial

Georgia A. Chrousos, MD; Jorge C. Kattah, MD; Roy W. Beck, MD; Patricia A. Cleary, MS; the Optic Neuritis Study Group; Roy Beck, MD; Patricia Cleary, MS; John Keltner, MD; Michael Brodsky, MD; John McCrary III, MD; Barrett Katz, MD; Edward Buckley, MD; John Guy, MD; Georgia Chrousos, MD; James Goodwin, MD; James Corbett, MD; Peter Saviano, MD; Neil Miller, MD; Jonathan Trobe, MD; David Kaufman, DO; Mark Kupers-mith, MD; William Shults, MD; Craig Smith, MD

JAMA. 1993;269(16):2110-2112.

Abstract
Objective.
—To determine the incidence of side effects from short-term glucocorticoid therapy prescribed for treatment of optic neuritis 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.
—A total of 457 patients between the ages of 18 and 46 years with acute demyelinative optic neuritis were studied.

Interventions.
—(1) Intravenous methylprednisolone (250 mg every 6 hours) for 3 days while hospitalized followed by oral prednisone (1 mg/kg per day) for 11 days; (2) oral prednisone (1 mg/kg per day) for 14 days; and (3) oral placebo for 14 days. Each regimen was followed by a short taper.

Results.
—Only two patients experienced major side effects, psychotic depression in one and acute pancreatitis in the other. Both of these patients were from the intravenous methylprednisolone group and both of the side effects resolved without sequelae. Patients in both groups receiving active drugs more often reported sleep disturbances, mood change, stomach upset, and facial flushing and gained more weight during the treatment period than patients in the placebo group (P<.001 for each comparison).

Conclusions.
—Although minor side effects are common, short-term glucocorticoid therapy in young, healthy adults is relatively safe. Because of the infrequency of serious side effects, outpatient administration of high-dose intravenous glucocorticoids may be feasible.

(JAMA. 1993;269:2110-2112)

Author Affiliations
Directors of Central Units: Study Chairman's Office; University of South Florida, Tampa; Data Coordinating Center; George Washington University, Bio-statistics Center, Rockville, Md; Visual Field Reading Center; University of California, Davis. Principal Investigators of Clinical Centers; University of Arkansas, Little Rock; Cullen Eye Institute, Baylor College of Medicine, Houston, Tex; Pacific California Medical Center, Smith Kettlewell Eye Research Institute, San Francisco, Calif; Duke University Medical Center, Durham, NC; University of Florida, Gainesville; Center for Sight, Georgetown University, Washington, DC; University of Illinois, Chicago; Stanley Thompson, MD; University of Iowa, Iowa City; Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pa; Wilmer Eye Institute, Johns Hopkins Hospital, Baltimore, Md; Kellogg Eye Center, University of Michigan, Ann Arbor; Michigan State University, East Lansing; New York (NY) University; Devers Eye Institute, Good Samaritan Hospital, Portland, Ore; University of Washington, Seattle

From the Center for Sight (Dr Chrousos) and the Department of Neurology (Dr Kattah), Georgetown University, Washington, DC; the Department of Ophthalmology, College of Medicine, University of South Florida, Tampa (Dr Beck); and the Biostatistics Center, George Washington University, Rockville, Md (Ms Cleary). A complete list of participants in this research study appears at the end of the article.

Footnotes
Presented in part at the meeting of the Association for Research in Vision and Ophthalmology, Sarasota, Fla, May 5, 1992.

Reprint requests to the Department of Ophthalmology, College of Medicine, University of South Florida, 12901 Bruce B. Downs Blvd, MDC Box 21, Tampa, FL 33612 (Dr Beck).

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