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A Prospective Randomized Double-blind Trial

Viveque Egsgaard Nielsen, MD; Steen Joop Bonnema, MD, PhD; Henrik Boel-Jørgensen, MD; Peter Grupe, MD; Laszlo Hegedüs, MD, DSc

Arch Intern Med. 2006;166:1476-1482.

Background  Use of recombinant human thyrotropin increases the thyroid radioiodine (iodine 131 [¹³¹I]) uptake and may have a role in the context of ¹³¹I therapy of benign goiter.

Methods  In a double-blind, placebo-controlled trial, 57 patients with nodular nontoxic goiter (51 women and 6 men) were randomized to receive either 0.3 mg of recombinant human thyrotropin (n = 28) or placebo (n = 29) 24 hours before ¹³¹I therapy. The ¹³¹I dose was calculated based on thyroid size (measured by ultrasound), thyroid ¹³¹I uptake, and ¹³¹I half-life. The follow-up period was 1 year and included measurements of thyroid size and function and patient satisfaction.

Results  Baseline median goiter volume was 51 mL (range, 20-99 mL) in the placebo group and 59 mL (range, 25-92 mL) in the thyrotropin group (P = .75). At 12 months, the mean ± SEM relative goiter reduction was 46.1% ± 4.0% in the placebo group and 62.1% ± 3.0% in the thyrotropin group (P = .002 between groups). The difference was most pronounced among patients with large goiters. Within each group, there was no significant correlation between retained thyroid ¹³¹I dose and goiter reduction. Adverse effects were significantly more frequent in the thyrotropin group (34 vs 12 events; P<.001). Permanent hypothyroidism developed in 3 patients (11%) in the placebo group compared with 16 patients (62%) in the thyrotropin group (P<.001). Patient satisfaction was high and uninfluenced by the use of recombinant human thyrotropin.

Conclusions  Stimulation with recombinant human thyrotropin prior to ¹³¹I therapy improves thyroid size reduction by 35%, with a 5-fold higher rate of hypothyroidism. These effects are, at least partially, mediated through mechanisms other than an increase in retained ¹³¹I thyroid dose. Further recombinant human thyrotropin dose-finding studies are warranted before routine use.

Trial Registration  clinicaltrials.gov Identifier: NCT00145366

Author Affiliations: Departments of Endocrinology and Metabolism (Drs Nielsen, Bonnema, and Hegedüs) and Nuclear Medicine (Drs Boel-Jørgensen and Grupe), Odense University Hospital, Odense, Denmark.

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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
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J. Clin. Endocrinol. Metab. 2007;92:3424-3428.
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