L-Thyroxine Therapy for Older Adults With Subclinical Hypothyroidism and Hypothyroid Symptoms: Secondary Analysis of a Randomized Trial
Research output: Contribution to journal › Journal article › Research › peer-review
Standard
L-Thyroxine Therapy for Older Adults With Subclinical Hypothyroidism and Hypothyroid Symptoms : Secondary Analysis of a Randomized Trial. / de Montmollin, Maria; 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.
In: Annals of Internal Medicine, Vol. 172, No. 11, 02.06.2020, p. 709-716.Research output: Contribution to journal › Journal article › Research › peer-review
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
TY - JOUR
T1 - L-Thyroxine Therapy for Older Adults With Subclinical Hypothyroidism and Hypothyroid Symptoms
T2 - Secondary Analysis of a Randomized Trial
AU - de Montmollin, Maria
AU - Feller, Martin
AU - Beglinger, Shanthi
AU - McConnachie, Alex
AU - Aujesky, Drahomir
AU - Collet, Tinh-Hai
AU - Ford, Ian
AU - Gussekloo, Jacobijn
AU - Kearney, Patricia M
AU - McCarthy, Vera J C
AU - Mooijaart, Simon
AU - Poortvliet, Rosalinde K E
AU - Quinn, Terence
AU - Stott, David J
AU - Watt, Torquil
AU - Westendorp, Rudi
AU - Rodondi, Nicolas
AU - Bauer, Douglas C.
PY - 2020/6/2
Y1 - 2020/6/2
N2 - 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.
AB - 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.
KW - Aged
KW - Aged, 80 and over
KW - Double-Blind Method
KW - Female
KW - Humans
KW - Hypothyroidism/drug therapy
KW - Male
KW - Thyrotropin/blood
KW - Thyroxine/therapeutic use
KW - Treatment Outcome
U2 - 10.7326/M19-3193
DO - 10.7326/M19-3193
M3 - Journal article
C2 - 32365355
VL - 172
SP - 709
EP - 716
JO - Annals of Internal Medicine
JF - Annals of Internal Medicine
SN - 0003-4819
IS - 11
ER -
ID: 258780863