RESEARCH - Side effects of glucocorticoid treatment - experience of the optic neuritis treatment trial

December 16, 2005

JAMA

Vol. 269 No. 16

April 28, 1993

Side effects of glucocorticoid treatment. Experience of the Optic Neuritis

Treatment Trial

G. A. Chrousos, J. C. Kattah, R. W. Beck and P. A. Cleary

Center for Sight, town University, Washington, DC.

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.

Not an MD

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Mayo Clinic in Rochester

s Hopkins Medicine

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