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. 2024 Jan 1;13(1):e230175.
doi: 10.1530/ETJ-23-0175. Online ahead of print.

Selenium supplementation and placebo are equally effective in improving quality of life in patients with hypothyroidism

Camilla Larsen  1 , Kristian Hillert Winther  2 , Per Karkov Cramon  3 , Åse Krogh Rasmussen  4 , Ulla Feldt-Rasmusssen  5 , Nils Jakob Knudsen  6 , Jakob Bue Bjorner  7 , Lutz Schomburg  8 , Kamil Demircan  9 , Thilo Samson Chillon  10 , Jeppe Gram  11 , Stinus Gadegaard Hansen  12 , Frans Brandt  13 , Birte Nygaard  14 , Torquil Watt  15 , Laszlo Hegedus  16 , Steen Joop Bonnema  17
Affiliations

Selenium supplementation and placebo are equally effective in improving quality of life in patients with hypothyroidism

Camilla Larsen et al. Eur Thyroid J. .

Abstract

Purpose: We investigated whether selenium supplementation improves quality-of-life (QoL) in patients with autoimmune thyroiditis (ID:NCT02013479).

Methods: We included 412 patients ≥18 years with serum thyroid peroxidase antibody (TPOAb) level ≥100 IU/mL in a multicentre double-blinded randomised clinical trial. The patients were allocated 1:1 to daily supplementation with either 200 μg selenium as selenium-enriched yeast or matching placebo tablets for 12 months, as add-on to levothyroxine (LT4) treatment. QoL, assessed by the Thyroid-related Patient-Reported-Outcome questionnaire (ThyPRO-39), was measured at baseline, after six weeks, three, six, 12, and 18 months.

Results: In total, 332 patients (81%) completed the intervention period, of whom 82% were women. Although QoL improved during the trial, no difference in any of the ThyPRO-39 scales was found between the selenium group and the placebo group after 12 months of intervention. In addition, employing linear mixed model regression no difference between the two groups was observed in the ThyPRO-39 composite score (28.8 [95%CI:24.5-33.6] and 28.0 [24.5-33.1], respectively; P=0.602). Stratifying the patients according to duration of the disease at inclusion, ThyPRO-39 composite score, TPOAb level, or selenium status at baseline did not significantly change the results. TPOAb levels after 12 months of intervention were lower in the selenium group than in the placebo group (1995 [95%CI:1512-2512] vs. 2344 kIU/L [1862-2951]; P=0.016) but did not influence LT4 dosage or free triiodothyronine/free thyroxin ratio.

Conclusion: In hypothyroid patients on LT4 therapy due to autoimmune thyroiditis, daily supplementation with 200 μg selenium or placebo for 12 months improved QoL to the same extent.

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Conflict of interest statement

LS holds shares of selenOmed GmbH, a company involved in selenium status assessment. No competing financial interests exist. The other authors declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the study reported. Steen Bonnema is on the editorial board of European Thyroid Journal. Steen was not involved in the review or editorial process for this paper, on which he is listed as an author.

Figures

Figure 1
Figure 1
Flow diagram.
Figure 2
Figure 2
Linear mixed model regressions showing changes in (A) serum selenium, (B) serum TPOAb, (C) serum FT3I/FT4 ratio, and (D) LT4 dose in patients randomised to daily supplementation with either 200 μg selenium or placebo. The intervention ended after 12 months, and the patients were followed for further 6 months. Data presented as predicted mean and 95% CI.
Figure 3
Figure 3
Radar plot showing mean ThyPRO-39 scale scores at baseline and after 12 months of intervention with either selenium supplementation or placebo. Scores in the general population are shown for comparison (from ref. 5). Each scale ranges 0–100, with higher scores indicating poorer quality of life.
Figure 4
Figure 4
Linear mixed model regressions showing the difference in (A) composite score, (B) goitre symptoms score, and (C) hypothyroid symptoms score in patients randomised to daily supplementation with either 200 μg selenium or placebo. The intervention ended after 12 months, and the patients were followed for further 6 months.
Figure 5
Figure 5
Radar plots showing mean ThyPRO-39 scale scores at baseline and after 12 months of intervention with either selenium supplementation or placebo. Scores in the general population are shown for comparison (from ref. 5). (A) Patients who started treatment with levothyroxine less than 3 months prior to inclusion. (B) Patients who started treatment with levothyroxine more than 3 months prior to inclusion. Each scale ranges 0–100, with higher scores indicating poorer quality of life.
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