RANDOMIZED DOUBLE-BLIND TRIAL OF PREDNISONE VERSUS RADIOTHERAPY IN GRAVES OPHTHALMOPATHY

Corticosteroids are usually given for management of Graves' ophthalmop athy, but they have many and serious side-effects. By comparison, retr obulbar irradiation is well tolerated, although its efficacy has been evaluated only in uncontrolled studies. Therefore, we did a double-bli nd randomised trial, in which 28 patients with moderately severe Grave s' ophthalmopathy were treated with a 3-month course of oral prednison e and sham irradiation, and 28 received retrobulbar irradiation (20 Gy ) and placebo capsules. Therapeutic outcome, assessed twenty-four week s after the start of treatment, was determined by the change in the hi ghest NOSPECS class. A successful outcome was observed in 14 prednison e-treated and in 13 irradiated patients. Responders to treatment (but not nonresponders) in both groups showed improvements in total and sub jective eye score and a decrease in eye-muscle volume. Response to eit her treatment was due largely to changes in soft-tissue involvement an d eye-muscle motility. Mean elevation in responders to radiotherapy in creased from 18.5-degrees (95% CI 14.8-22.2) at baseline to 21.8-degre es (18.6-25.0) at week twenty-four (p=0.003), but did not change in pr ednisone responders. Side-effects were more frequent and severe during prednisone than during radiotherapy. Radiotherapy and oral prednisone appear to be equally effective as initial treatment in patients with moderately severe Graves' ophthalmopathy. In view of its better tolera bility, radiotherapy should be considered the treatment of first choic e.