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Randomized, Single Blind Trial of Intravenous versus Oral Steroid Monotherapy in Graves’ Orbitopathy

Departments of Medicine I (G.J.K., M.D.), Biology (M.D.), Ophthalmology (S.P.), and Medical Statistics (G.H.), Gutenberg University, Mainz 55101, Germany

Address all correspondence and requests for reprints to: Dr. George J. Kahaly, University Hospital, Mainz 55101, Germany, E-mail: gkahaly{at}mail.uni-mainz.de.

Context: Glucocorticoids are effective for severe Graves’ orbitopathy (GO), which causes substantial morbidity. The question at issue is how best to use them.

Objective: The objective of this study was to optimize glucocorticoid application in GO.

Design: The study design was a randomized trial over 12 wk with 6-month follow-up.

Setting: The study was performed at university joint thyroid and ophthalmic clinics.

Patients: Seventy euthyroid out-patients with untreated, active, and severe GO were studied.

Intervention: Patients received either once weekly iv methylprednisolone (0.5 g, then 0.25 g, 6 wk each) or oral prednisolone starting with 0.1 g/d, then tapering the dose by 0.01 g/wk.

Main Outcome Measures: At 3 months, the primary end point was a composite of improvements in proptosis, lid fissure width, and rate of diplopia in primary gaze, visual acuity, eye muscle thickness, and patient’s quality of life.

Results: Intravenous glucocorticoid therapy resulted in rapid, significant, and sustained improvement. At 3 months, 27 of 35 patients (77%) in the iv group had a treatment response compared with 18 of 35 (51%) in the oral group (P < 0.01). Improvements over baseline values for disease severity (e.g. visual acuity; P = 0.01) and activity (e.g. chemosis; P < 0.01) and for quality of life (P < 0.001) were greater in the iv group. TSH receptor antibody titers decreased during iv steroid administration (P < 0.001), and smoking had a strong impact on the therapy response (P < 0.001). Additional treatment was required less frequently in the iv group. Intravenous steroids were safe, with different rates of adverse events between the two groups (P < 0.001).

Conclusions: In patients with active and severe GO, iv glucocorticoids were more effective and better tolerated than oral steroids.

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