George J Kahaly1, Michaela Riedl1, Jochem König2, Tanja Diana1, Lutz Schomburg3. 1. Department of Medicine I, Johannes Gutenberg University Medical Center, 55101 Mainz, Germany. 2. Institute of Medical Biostatistics, Epidemiology and Informatics, Johannes Gutenberg University Medical Center, 55101 Mainz, Germany. 3. Institute for Experimental Endocrinology, Charité-Universitätsmedizin Berlin, 13353 Berlin, Germany.
Abstract
Context: Supplemental selenium (Se) may affect the clinical course of Graves disease (GD). Objective: Evaluate efficacy of add-on Se on medical treatment in GD. Design: Double-blind, placebo-controlled, randomized supplementation trial. Setting: Academic endocrine outpatient clinic. Patients: Seventy untreated hyperthyroid patients with GD. Intervention: Additionally to methimazole (MMI), patients received for 24 weeks either sodium selenite 300 µg/d po or placebo. MMI was discontinued at 24 weeks in euthyroid patients. Main Outcome Measures: Response rate (week 24), recurrence rate (week 36), and safety. Results: A response was registered in 25 of 31 patients (80%) and in 27 of 33 (82%) at week 24 [odds ratio (OR) 0.93; 95% confidence interval (CI), 0.26 to 3.25; P = 0.904] in the Se (+MMI) and placebo (+MMI) groups, respectively. During a 12-week follow-up, 11 of 23 (48%) and 12 of 27 (44%) relapsed (OR 1.13; 95% CI, 0.29 to 2.66; P = 0.81) in the Se and placebo groups, respectively. Serum concentrations of Se and selenoprotein P were unrelated to response or recurrence rates. At week 36, 12 of 29 (41%) and 15 of 33 (45%) were responders and still in remission in the Se and placebo groups, respectively (OR 0.85; 95% CI, 0.31 to 2.32; P = 0.80). Serum levels of free triiodothyronine/free tetraiodothyronine, thyroid-stimulating hormone receptor antibody, prevalence of moderate to severe Graves orbitopathy, thyroid volume, and MMI starting dose were significantly lower in responders than in nonresponders. A total of 56 and 63 adverse events occurred in the Se and placebo groups, respectively (P = 0.164), whereas only one drug-related side effect (2.9%) was noted in 35 patients on placebo + MMI. Conclusions: Supplemental Se did not affect response or recurrence rates in GD.
RCT Entities:
Context: Supplemental selenium (Se) may affect the clinical course of Graves disease (GD). Objective: Evaluate efficacy of add-on Se on medical treatment in GD. Design: Double-blind, placebo-controlled, randomized supplementation trial. Setting: Academic endocrine outpatient clinic. Patients: Seventy untreated hyperthyroidpatients with GD. Intervention: Additionally to methimazole (MMI), patients received for 24 weeks either sodium selenite 300 µg/d po or placebo. MMI was discontinued at 24 weeks in euthyroid patients. Main Outcome Measures: Response rate (week 24), recurrence rate (week 36), and safety. Results: A response was registered in 25 of 31 patients (80%) and in 27 of 33 (82%) at week 24 [odds ratio (OR) 0.93; 95% confidence interval (CI), 0.26 to 3.25; P = 0.904] in the Se (+MMI) and placebo (+MMI) groups, respectively. During a 12-week follow-up, 11 of 23 (48%) and 12 of 27 (44%) relapsed (OR 1.13; 95% CI, 0.29 to 2.66; P = 0.81) in the Se and placebo groups, respectively. Serum concentrations of Se and selenoprotein P were unrelated to response or recurrence rates. At week 36, 12 of 29 (41%) and 15 of 33 (45%) were responders and still in remission in the Se and placebo groups, respectively (OR 0.85; 95% CI, 0.31 to 2.32; P = 0.80). Serum levels of free triiodothyronine/free tetraiodothyronine, thyroid-stimulating hormone receptor antibody, prevalence of moderate to severe Graves orbitopathy, thyroid volume, and MMI starting dose were significantly lower in responders than in nonresponders. A total of 56 and 63 adverse events occurred in the Se and placebo groups, respectively (P = 0.164), whereas only one drug-related side effect (2.9%) was noted in 35 patients on placebo + MMI. Conclusions: Supplemental Se did not affect response or recurrence rates in GD.
Authors: Gustavo R G Andrade; Bartira Gorgulho; Paulo A Lotufo; Isabela M Bensenor; Dirce M Marchioni Journal: Nutrients Date: 2018-05-30 Impact factor: 5.717