Comparison of Different Doses of 131I in Severe Graves' Hyperthyroidism

Comparison of Different Doses of 131I in Severe Graves' Hyperthyroidism: A Clinical Trial With Historical Control

The purpose of this study is to determine whether higher doses of radioiodine increase treatment efficacy in severe Graves' disease.

Graves' disease (GD) is the most frequent cause of hyperthyroidism, affecting mainly women aged 40-60 years. Radioiodine (¹³¹I), introduced in 1941, has become a cornerstone in the treatment of GD hyperthyroidism. Because of its safety, low costs and rapid effect, it is considered a first line therapy in the United States. However, treatment failure occurs in about 15-25% of patients treated with radioiodine. Patients not cured with the first dose of radioiodine usually present severe hyperthyroidism, characterized by large goiter, high 24-hour radioiodine uptake (24h-RAIU) and very high levels of thyroid hormones. We have previously shown that large goiter (≥48ml) is an independent predictor of treatment failure. In these patients, the therapeutic failure was 40.0% while in patients with smaller goiter was only 6.5% (P=0.005; unpublished). It is generally accepted that higher doses of radioiodine improves cure rates. Indeed, a recent meta-analysis found a correlation between radioiodine dose and therapeutic success in GD patients. To our knowledge, there are no published studies evaluating cure rates with different radioiodine doses in severe GD.

A subgroup of patients with Graves' Disease and goiter ≥48ml treated with 200µCi of ¹³¹I/ml thyroid tissue, corrected by 24h-RAIU, from a randomized controlled trial run at our institution between February 1997 and March 2000, serves as a historical control.

Patients with Graves' Disease and goiter ≥48ml, prospectively assigned to receive 250 µCi of ¹³¹I/ml thyroid tissue, corrected by 24h-RAIU.

Inclusion Criteria: Consecutive patients with a recent diagnosis of Graves' disease and goiter ≥ 48 ml, attending the Endocrine Division at Hospital de Clinicas de Porto Alegre are eligible. Exclusion Criteria: Patients with previous treatment with radioiodine or thyroidectomy, Signs of moderate or severe ophthalmopathy (proptosis > 22 mm, ophthalmoplegia, chemosis, or lagophthalmos), Severe heart disease (symptomatic coronary heart disease, class III heart failure, New York Heart Association criteria), Debilitating conditions, and Large and compressive goiters (> 150 g).

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Dora JM, Escouto Machado W, Andrade VA, Scheffel RS, Maia AL. Increasing the radioiodine dose does not improve cure rates in severe graves' hyperthyroidism: a clinical trial with historical control. J Thyroid Res. 2013;2013:958276. doi: 10.1155/2013/958276. Epub 2013 Jul 31.