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Propylthiouracil before ¹³¹I Therapy of Hyperthyroid Diseases: Effect on Cure Rate Evaluated by a Randomized Clinical Trial

Departments of Endocrinology and Metabolism (S.J.B., F.N.B., L.H.) and Nuclear Medicine (A.V., J.M.), Odense University Hospital, DK-5000 Odense, Denmark

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

A randomized clinical trial was performed to clarify whether pretreatment with propylthiouracil (PTU) before radioiodine (¹³¹I) therapy influences the final outcome of this therapy, as has been indicated by retrospective studies. Untreated consecutive hyperthyroid patients with Graves’ disease (n = 23) or a toxic nodular goiter (n = 57) were randomized to either PTU (+PTU; n = 39) or no pretreatment (–PTU; n = 41) before compensated ¹³¹I therapy. The median PTU dose was 100 mg, which was discontinued 4 d before treatment. The median ¹³¹I activity was 302 MBq (range, 87–600 MBq). After ¹³¹I therapy, the serum free T₄ index increased in the +PTU group from 97.7 ± 47.5(±SD) nmol/liter at the time of therapy to 152.3 ± 77.6 nmol/liter at 3 wk (P < 0.001) and 140.4 ± 75.9 nmol/liter at 6 wk (P < 0.001). In the –PTU group, the serum free T₄ index, which was initially 254.3 ± 145.7 nmol/liter, decreased significantly to 212.0 ± 113.0 nmol/liter at 3 wk (P < 0.05) and 165.8 ± 110.0 nmol/liter at 6 wk (P < 0.005). After 1 yr of follow-up, the treatment failure rate in patients with a toxic nodular goiter was four times higher in the +PTU group than in the –PTU group (nine of 20 vs. three of 25 patients; P = 0.06), whereas the difference among patients with Graves’ disease was less obvious (four of six vs. four of nine; P = 0.81). Patients in the +PTU group who were cured had higher serum TSH (s-TSH) levels at the time of ¹³¹I therapy than those who were not cured. By adjusting for a possible interfactorial relationship through a regression analysis, including the s-TSH level and type of disease, only PTU pretreatment had a significant adverse effect on the cure rate (P = 0.03). In conclusion, this randomized trial demonstrates that PTU pretreatment reduces the cure rate of ¹³¹I therapy in hyperthyroid diseases, although this adverse effect seems to be attenuated by the concomitant rise in s-TSH.

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