SIDE-EFFECTS OF GLUCOCORTICOID TREATMENT - EXPERIENCE OF THE OPTIC NEURITIS TREATMENT TRIAL

Objective.-To determine the incidence of side effects from short-term glucocorticoid therapy prescribed for treatment of optic neuritis in t he Optic Neuritis Treatment Trial. Design.-Randomized, placebo-control led, multicenter clinical trial. Setting.-Fifteen university- or hospi tal-based centers throughout the United States. Patients.-A total of 4 57 patients between the ages of 18 and 46 years with acute demyelinati ve optic neuritis were studied. Interventions.-(1) Intravenous methylp rednisolone (250 mg every 6 hours) for 3 days while hospitalized follo wed by oral prednisone (1 mg/kg per day) for 11 days; (2) oral prednis one (1 mg/kg per day) for 14 days; and (3) oral placebo for 14 days. E ach 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 intrav enous methylprednisolone group and both of the side effects resolved w ithout sequelae. Patients in both groups receiving active drugs more o ften reported sleep disturbances, mood change, stomach upset, and faci al flushing and gained more weight during the treatment period than pa tients in the placebo group (P<.001 for each comparison). Conclusions. -Although minor side effects are common, short-term glucocorticoid the rapy in young, healthy adults is relatively safe. Because of the infre quency of serious side effects, outpatient administration of high-dose intravenous glucocorticoids may be feasible.