L-Thyroxine Therapy for Older Adults With Subclinical Hypothyroidism and Hypothyroid Symptoms: Secondary Analysis of a Randomized Trial.

de Montmollin, Maria Karolina; Feller, Martin; Beglinger, Shanthi; McConnachie, Alex; Aujesky, Drahomir; Collet, Tinh-Hai; Ford, Ian; Gussekloo, Jacobijn; Kearney, Patricia M; McCarthy, Vera J C; Mooijaart, Simon; Poortvliet, Rosalinde K E; Quinn, Terence; Stott, David J; Watt, Torquil; Westendorp, Rudi; Rodondi, Nicolas; Bauer, Douglas C (2020). L-Thyroxine Therapy for Older Adults With Subclinical Hypothyroidism and Hypothyroid Symptoms: Secondary Analysis of a Randomized Trial. Annals of internal medicine, 172(11), pp. 709-716. American College of Physicians 10.7326/M19-3193

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Background L-thyroxine does not improve hypothyroid symptoms among adults with subclinical hypothyroidism (SCH). However, those with greater symptom burden before treatment may still benefit. Objective To determine whether L-thyroxine improves hypothyroid symptoms and tiredness among older adults with SCH and greater symptom burden. Design Secondary analysis of the randomized, placebo-controlled trial TRUST (Thyroid Hormone Replacement for Untreated Older Adults with Subclinical Hypothyroidism Trial). (ClinicalTrials.gov: NCT01660126). Setting Switzerland, Ireland, the Netherlands, and Scotland. Participants 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. Intervention L-thyroxine or matching placebo with mock dose titration. Measurements 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. Results 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; P = 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; P = 0.99). There was no evidence that baseline Hypothyroid Symptoms score or Tiredness score modified the effects of L-thyroxine versus placebo (P for interaction = 0.20 and 0.82, respectively). Limitation Post hoc analysis, small sample size, and examination of only patients with 1-year outcome data. Conclusion In older adults with SCH and high symptom burden at baseline, L-thyroxine did not improve hypothyroid symptoms or tiredness compared with placebo. Primary Funding Source European Union FP7.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine
04 Faculty of Medicine > Medical Education > Institute of General Practice and Primary Care (BIHAM)
04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine > Centre of Competence for General Internal Medicine

UniBE Contributor:

de Montmollin, Maria Karolina; Feller, Martin; Beglinger, Shanthi; Aujesky, Drahomir and Rodondi, Nicolas

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

0003-4819

Publisher:

American College of Physicians

Funders:

[4] Swiss National Science Foundation
[116] Schweizerische Herzstiftung

Language:

English

Submitter:

Andrea Flükiger-Flückiger

Date Deposited:

12 May 2020 14:34

Last Modified:

10 Jun 2020 18:49

Publisher DOI:

10.7326/M19-3193

PubMed ID:

32365355

BORIS DOI:

10.7892/boris.143971

URI:

https://boris.unibe.ch/id/eprint/143971

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