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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 …