DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED TRIAL OF SELENIUM IN GRAVES' HYPERTHYROIDISM.
J Clin Endocrinol Metab. 2017 Sep 19;:
Authors: Kahaly GJ, Riedl M, König J, Diana T, Schomburg L
Abstract
Context: Supplemental Selenium (Se) may impact 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 during 24 weeks either sodium selenite 300 µg/day p.o. 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 0.93 (95% CI 0.26-3.25, 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, 0.29-2.66, p=0.81) in the Se and placebo groups, respectively. Serum concentrations of Se and selenoprotein P were unrelated to response and/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, 0.31-2.32, p=0.80). Serum levels of fT3/fT4, TSH-R-Ab, prevalence of moderate-to-severe Graves' orbitopathy, thyroid volume and MMI starting dose were significantly lower in responders versus non-responders. 56 and 63 adverse events occurred in the Se and placebo groups, respectively (p=0.164), while only one drug related side-effect (2.9%) was noted in 35 patients on placebo +MMI.
Conclusions: Supplemental Se did not impact response or recurrence rate in GD.
PMID: 29092078 [PubMed - as supplied by publisher]
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