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Improvement of Goiter Volume Reduction after 0.3 mg Recombinant Human Thyrotropin-Stimulated Radioiodine Therapy in Patients with a Very Large Goiter: A Double-Blinded, Randomized Trial

Departments of Endocrinology and Metabolism (S.J.B., V.E.N., L.H.), Radiology (P.B.A.), Oncology (L.B.), and Nuclear Medicine (H.B.-J., P.G.), Odense University Hospital, DK-5000 Odense, Denmark

Address all correspondence and requests for reprints to: Steen J. Bonnema, M.D., Ph.D., Department of Endocrinology and Metabolism, Odense University Hospital, DK-5000 Odense C, Denmark. E-mail: steen.bonnema{at}dadlnet.dk.

Introduction: The effect of ¹³¹I therapy amplification by recombinant human (rh) TSH prestimulation in very large goiters has not been evaluated in a double-blinded, placebo-controlled study.

Methods: Twenty-nine patients (22 females; age range 37–87 yr) with a large multinodular goiter (median 160 ml, range 99–440 ml) were randomized to receive placebo (n = 15) or 0.3 mg rhTSH (n = 14) 24 h before ¹³¹I administration. Goiter volume was monitored by magnetic resonance imaging.

Results: On average, the goiter volume was unchanged 1 wk after therapy in both groups, but the largest deviations from baseline were observed in the rhTSH group. After 12 months the median goiter volume was reduced from 170 to 121 ml in the placebo group and from 151 to 72 ml in the rhTSH group, respectively (within group: P = 0.001; between group: P = 0.019). This corresponds to reductions of 34.1 ± 3.2 and 53.3 ± 3.3%, respectively (between group: P < 0.001). In the placebo group, the goiter reduction correlated positively with the retained thyroid ¹³¹I dose, whereas such a relationship was absent in the rhTSH group. Adverse effects, mainly related to thyroid pain and cervical compression, were more frequent in the rhTSH group. At 12 months, goiter-related complaints were significantly reduced in both groups without any between-group difference. One and three patients in the placebo and the rhTSH group, respectively, developed hypothyroidism.

Conclusion: rhTSH-stimulated ¹³¹I therapy improves the reduction of very large goiters by more than 50%, compared with ¹³¹I therapy alone, but at the expense of more adverse effects after therapy. Our data suggest that rhTSH stimulation may work through mechanisms that go beyond the increase in thyroid ¹³¹I uptake.