Role of levothyroxine suppressive therapy for benign cold nodules of thyroid: A randomized, double-blind, placebo-controlled clinical trial

Bagher Larijani, Mohammad Pajouhi, Mohammad Hasan Bastanhagh, Alireza Sadjadi, Shahriar Aghakhani, Farhad Zare, Nahid Sedighi, Mohammad Reza Eshraghian, Amir Hossein Nadjafi, Mohammad Reza Amini, Hossein Adibi and Seyed Mohammad Akrami

Introduction: There is no consensus on the appropriate management of benign cold nodules of the thyroid gland. This study addresses the problem in an iodine-deficient area, evaluating the efficacy of levothyroxine suppression therapy on a 2-year course. Methods: A total of 58 patients affected with benign cold nodules of the thyroid were enrolled. With a double-blind placebo-controlled design, levothyroxine (1.5–2 μg/kg/day) was delivered to the 31 cases over 2 years. The consequences of this treatment were compared with 27 controls. Nodule size was measured with high-resolution ultrasonography. Results: In the treatment group, the mean volume on baseline was 12.8 ± 11.9 ml and changed to 9.4 ± 9.8, 12.4 ± 16.7 and 10.8 ± 9.7 ml in months 6, 12 and 24, respectively. In the placebo group, these figures were 13.0 ± 10.2, 11.5 ± 8.0, 11.7 ± 13.6 and 11.6 ± 8.5 ml, respectively. No significant difference between the two groups was observed. Conclusion: Thyroid-stimulating hormone suppression with levothyroxine for 2 years was not effective in reducing the size of benign cold nodules of the thyroid gland.