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


Journal

Annals of internal medicine
ISSN: 1539-3704
Titre abrégé: Ann Intern Med
Pays: United States
ID NLM: 0372351

Informations de publication

Date de publication:
02 06 2020
Historique:
pubmed: 5 5 2020
medline: 18 11 2020
entrez: 5 5 2020
Statut: ppublish

Résumé

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; 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.

Sections du résumé

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;
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.

Identifiants

pubmed: 32365355
pii: 2765669
doi: 10.7326/M19-3193
doi:

Substances chimiques

Thyrotropin 9002-71-5
Thyroxine Q51BO43MG4

Banques de données

ClinicalTrials.gov
['NCT01660126']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

709-716

Auteurs

Maria de Montmollin (M)

Inselspital, Bern University Hospital, and Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland (M.D., M.F., S.B., N.R.).

Martin Feller (M)

Inselspital, Bern University Hospital, and Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland (M.D., M.F., S.B., N.R.).

Shanthi Beglinger (S)

Inselspital, Bern University Hospital, and Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland (M.D., M.F., S.B., N.R.).

Alex McConnachie (A)

Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland (A.M., I.F.).

Drahomir Aujesky (D)

Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.A.).

Tinh-Hai Collet (TH)

Service of Endocrinology, Diabetes and Metabolism, Lausanne University Hospital, and University of Lausanne, Lausanne, Switzerland (T.C.).

Ian Ford (I)

Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland (A.M., I.F.).

Jacobijn Gussekloo (J)

Leiden University Medical Center, Leiden, the Netherlands (J.G., R.K.P.).

Patricia M Kearney (PM)

School of Public Health, University College Cork, Cork, Ireland (P.M.K.).

Vera J C McCarthy (VJC)

School of Nursing and Midwifery, University College Cork, Cork, Ireland (V.J.M.).

Simon Mooijaart (S)

Institute for Evidence-based Medicine in Old Age, Leiden University Medical Center, Leiden, the Netherlands (S.M.).

Rosalinde K E Poortvliet (RKE)

Leiden University Medical Center, Leiden, the Netherlands (J.G., R.K.P.).

Terence Quinn (T)

Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland (T.Q., D.J.S.).

David J Stott (DJ)

Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland (T.Q., D.J.S.).

Torquil Watt (T)

Copenhagen University Hospital Herlev, Herlev, Denmark, and University of Copenhagen, Copenhagen, Denmark (T.W., R.W.).

Rudi Westendorp (R)

Copenhagen University Hospital Herlev, Herlev, Denmark, and University of Copenhagen, Copenhagen, Denmark (T.W., R.W.).

Nicolas Rodondi (N)

Inselspital, Bern University Hospital, and Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland (M.D., M.F., S.B., N.R.).

Douglas C Bauer (DC)

University of Copenhagen, Copenhagen, Denmark; and University of California, San Francisco, San Francisco, California (D.C.B.).

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