title: 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.
abstract: BACKGROUND
  The effect of (131)I 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 (131)I 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 (131)I 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.
  
  
  CONCLUSIONS
  rhTSH-stimulated (131)I therapy improves the reduction of very large goiters by more than 50%, compared with (131)I 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 (131)I uptake.
authors.affiliation: Department of Endocrinology and Metabolism, Odense University Hospital, DK-5000 Odense C, Denmark. steen.bonnema@dadlnet.dk
authors.forename: Steen J
authors.initials: SJ
authors.lastname: Bonnema
authors.forename: Viveque E
authors.initials: VE
authors.lastname: Nielsen
authors.forename: Henrik
authors.initials: H
authors.lastname: Boel-Jørgensen
authors.forename: Peter
authors.initials: P
authors.lastname: Grupe
authors.forename: Peter B
authors.initials: PB
authors.lastname: Andersen
authors.forename: Lars
authors.initials: L
authors.lastname: Bastholt
authors.forename: Laszlo
authors.initials: L
authors.lastname: Hegedüs
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017024:Chemotherapy, Adjuvant; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006042:Goiter / Q000188:drug therapy* / Q000473:pathology* / Q000532:radiotherapy*; D006801:Humans; D007457:Iodine Radioisotopes / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009929:Organ Size / Q000187:drug effects; D017060:Patient Satisfaction; D010919:Placebos; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D013960:Thyroid Function Tests; D013972:Thyrotropin / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D007457:Iodine Radioisotopes; D010919:Placebos; D011994:Recombinant Proteins; D013972:Thyrotropin