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

IF 3.5 2区 医学 Q2 ENDOCRINOLOGY & METABOLISM European Thyroid Journal Pub Date : 2024-01-01 DOI:10.1530/ETJ-23-0175
Camilla Larsen, Kristian Hillert Winther, Per Karkov Cramon, Åse Krogh Rasmussen, Ulla Feldt-Rasmusssen, Nils Jakob Knudsen, Jakob Bue Bjorner, Lutz Schomburg, Kamil Demircan, Thilo Samson Chillon, Jeppe Gram, Stinus Gadegaard Hansen, Frans Brandt, Birte Nygaard, Torquil Watt, Laszlo Hegedus, Steen Joop Bonnema
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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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在改善甲状腺功能减退症患者的生活质量方面,硒补充剂和安慰剂同样有效。
目的:我们研究了补硒是否能改善自身免疫性甲状腺炎患者的生活质量(QoL)(ID:NCT02013479):我们在一项多中心双盲随机临床试验中纳入了412名血清甲状腺过氧化物酶抗体(TPOAb)水平≥100 IU/mL、年龄≥18岁的患者。这些患者按 1:1 的比例被分配到每天补充 200 μg 硒(富硒酵母)或相应的安慰剂片剂,为期 12 个月,作为左甲状腺素(LT4)治疗的补充剂。在基线期、6周后、3个月、6个月、12个月和18个月后,通过甲状腺相关患者报告收入问卷(ThyPRO-39)对QoL进行评估:共有 332 名患者(81%)完成了干预期,其中 82% 为女性。虽然在试验期间患者的 QoL 有所改善,但在干预 12 个月后,硒组与安慰剂组在 ThyPRO-39 量表中均未发现差异。此外,通过线性混合模型回归,也未发现两组患者的 ThyPRO-39 综合评分存在差异(分别为 28.8 [95%CI:24.5-33.6] 和 28.0 [24.5-33.1];P=0.602)。根据纳入时的病程、ThyPRO-39 综合评分、TPOAb 水平或基线时的硒状况对患者进行分层并不会显著改变结果。干预12个月后,硒组的TPOAb水平低于安慰剂组(1995 [95%CI:1512-2512] vs. 2344 kIU/L [1862-2951];P=0.016),但不影响LT4剂量或游离三碘甲状腺原氨酸/游离甲状腺素比率:结论:对于因自身免疫性甲状腺炎而接受LT4治疗的甲减患者,每天补充200微克硒或安慰剂12个月,对其生活质量的改善程度相同。
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来源期刊
European Thyroid Journal
European Thyroid Journal Medicine-Endocrinology, Diabetes and Metabolism
CiteScore
6.70
自引率
2.10%
发文量
156
期刊介绍: The ''European Thyroid Journal'' publishes papers reporting original research in basic, translational and clinical thyroidology. Original contributions cover all aspects of the field, from molecular and cellular biology to immunology and biochemistry, from physiology to pathology, and from pediatric to adult thyroid diseases with a special focus on thyroid cancer. Readers also benefit from reviews by noted experts, which highlight especially active areas of current research. The journal will further publish formal guidelines in the field, produced and endorsed by the European Thyroid Association.
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