Inselspital, Bern University Hospital, and Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland (M.D., M.F., S.B., N.R.).
Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland (A.M., I.F.).
Ann Intern Med. 2020 Jun 2;172(11):709-716. doi: 10.7326/M19-3193. Epub 2020 May 5.
L-thyroxine does not improve hypothyroid symptoms among adults with subclinical hypothyroidism (SCH). However, those with greater symptom burden before treatment may still benefit.
To determine whether L-thyroxine improves hypothyroid symptoms and tiredness among older adults with SCH and greater symptom burden.
Secondary analysis of the randomized, placebo-controlled trial TRUST (Thyroid Hormone Replacement for Untreated Older Adults with Subclinical Hypothyroidism Trial). (ClinicalTrials.gov: NCT01660126).
Switzerland, Ireland, the Netherlands, and Scotland.
638 persons aged 65 years or older with persistent SCH (thyroid-stimulating hormone level of 4.60 to 19.9 mIU/L for >3 months and normal free thyroxine level) and complete outcome data.
L-thyroxine or matching placebo with mock dose titration.
1-year change in Hypothyroid Symptoms and Tiredness scores (range, 0 to 100; higher scores indicate more symptoms) on the Thyroid-Related Quality-of-Life Patient-Reported Outcome Questionnaire among participants with high symptom burden (baseline Hypothyroid Symptoms score >30 or Tiredness score >40) versus lower symptom burden.
132 participants had Hypothyroid Symptoms scores greater than 30, and 133 had Tiredness scores greater than 40. Among the group with high symptom burden, the Hypothyroid Symptoms score improved similarly between those receiving L-thyroxine (mean within-group change, -12.3 [95% CI, -16.6 to -8.0]) and those receiving placebo (mean within-group change, -10.4 [CI, -15.3 to -5.4]) at 1 year; the adjusted between-group difference was -2.0 (CI, -5.5 to 1.5; = 0.27). Improvements in Tiredness scores were also similar between those receiving L-thyroxine (mean within-group change, -8.9 [CI, -14.5 to -3.3]) and those receiving placebo (mean within-group change, -10.9 [CI, -16.0 to -5.8]); the adjusted between-group difference was 0.0 (CI, -4.1 to 4.0; = 0.99). There was no evidence that baseline Hypothyroid Symptoms score or Tiredness score modified the effects of L-thyroxine versus placebo ( for interaction = 0.20 and 0.82, respectively).
Post hoc analysis, small sample size, and examination of only patients with 1-year outcome data.
In older adults with SCH and high symptom burden at baseline, L-thyroxine did not improve hypothyroid symptoms or tiredness compared with placebo.
European Union FP7.
左甲状腺素并不能改善亚临床甲状腺功能减退症（SCH）患者的甲状腺功能减退症状。然而，那些治疗前症状负担较重的患者可能仍会受益。
确定左甲状腺素是否能改善 SCH 且症状负担较大的老年患者的甲状腺功能减退症状和疲劳感。
随机、安慰剂对照试验 TRUST（未治疗的老年亚临床甲状腺功能减退症患者甲状腺激素替代治疗试验）的二次分析。（ClinicalTrials.gov：NCT01660126）。
瑞士、爱尔兰、荷兰和苏格兰。
638 名年龄在 65 岁或以上、持续存在 SCH（促甲状腺激素水平为 4.60 至 19.9 mIU/L 持续 3 个月以上且游离甲状腺素水平正常）且具有完整结局数据的患者。
左甲状腺素或匹配的安慰剂与模拟剂量滴定。
在基线甲状腺相关生活质量患者报告结局问卷中，高症状负担组（基线甲状腺功能减退症状评分>30 或疲劳评分>40）与低症状负担组参与者的甲状腺功能减退症状和疲劳评分在 1 年内的变化（范围为 0 至 100；评分越高表示症状越多）。
132 名参与者的甲状腺功能减退症状评分大于 30，133 名参与者的疲劳评分大于 40。在症状负担较高的组中，接受左甲状腺素治疗的患者（组内平均变化，-12.3 [95%CI，-16.6 至-8.0]）与接受安慰剂治疗的患者（组内平均变化，-10.4 [CI，-15.3 至-5.4]）的甲状腺功能减退症状评分在 1 年内相似；调整后的组间差异为-2.0（CI，-5.5 至 1.5； = 0.27）。接受左甲状腺素治疗的患者（组内平均变化，-8.9 [CI，-14.5 至-3.3]）与接受安慰剂治疗的患者（组内平均变化，-10.9 [CI，-16.0 至-5.8]）的疲劳评分也相似；调整后的组间差异为 0.0（CI，-4.1 至 4.0； = 0.99）。没有证据表明基线甲状腺功能减退症状评分或疲劳评分改变了左甲状腺素与安慰剂的疗效（交互检验=0.20 和 0.82）。
事后分析、样本量小、仅检查具有 1 年结局数据的患者。
在基线时症状负担较重的 SCH 老年患者中，与安慰剂相比，左甲状腺素并未改善甲状腺功能减退症状或疲劳感。
欧盟 FP7。
