Context. Recent evidence suggests thyroidectomy (Tx) followed by radioiodine remnant ablation to be beneficial to Graves' Ophthalmopathy (GO) patients. Objective. To evaluate the effect of (131)I thyroid ablation following rhTSH stimulation in patients with moderate-to-severe GO. Design, patients and interventions. The study was prospective, randomized, single-blind, and included 40 consecutive patients with moderate-to-severe GO randomized into: 1) Tx-RAI group (20 subjects who underwent total-Tx and (131)I ablation following rhTSH stimulation); 2) Tx group (20 subjects who underwent total-Tx alone). Outcome measures. The overall GO outcome 12 months after thyroidectomy/radioiodine ablation was the main measure. Results. GO evaluation at the end of ivGCs showed eye disease to be improved in 65% of the Tx-RAI group and 60% of the Tx group patients. At 6 and 12 months no further changes in the GO outcome could be observed in the Tx-RAI group. Conversely, five patients from the Tx group, exhibited a deterioration in GO. At 12 months, GO was found to be improved in 70% of the Tx-RAI and 20% of the Tx group patients, the latter being found to be stable (55%) or worse (25%) than at baseline evaluation. At 12 months GO was found to be inactive in a significantly higher percentage of patients in the Tx-RAI than in the Tx group (75% vs 30%, p< 0.01). Conclusions. Postoperative radioiodine ablation proved more effective than thyroidectomy alone in inducing earlier and steadier GO improvement, in patients with moderate-to-severe GO treated with ivGCs over a 24-month follow up period.
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