Radioiodine ablation of postsurgical thyroid remnants after treatment with recombinant human TSH (rhTSH) in patients with moderate-to-severe graves' orbitopathy (GO): a prospective, randomized, single-blind clinical trial.

CONTEXT

Recent evidence suggests thyroidectomy (Tx) followed by radioiodine remnant ablation to be beneficial to Graves' orbitopathy (GO) patients.

OBJECTIVE

The aim of the study was to evaluate the effect of (131)I thyroid ablation after recombinant human TSH stimulation in patients with moderate-to-severe GO.

DESIGN, PATIENTS, AND INTERVENTIONS: The study was prospective, randomized, and single-blind, and it included 40 consecutive patients with moderate-to-severe GO randomized into: 1) a Tx-radioactive iodine (RAI) group (20 subjects who underwent total-Tx and (131)I ablation after recombinant human TSH stimulation); and 2) a Tx group (20 subjects who underwent total-Tx alone).

OUTCOME MEASURES

The overall GO outcome 12 months after Tx/radioiodine ablation was the main measure.

RESULTS

GO evaluation at the end of iv glucocorticoids 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 < .01).

CONCLUSIONS

Postoperative radioiodine ablation proved more effective than Tx alone in inducing earlier and steadier GO improvement in patients with moderate-to-severe GO treated with iv glucocorticoids over a 24-month follow-up period.