Effect of Levothyroxine Therapy on the Development of Depressive Symptoms in Older Adults With Subclinical Hypothyroidism: An Ancillary Study of a Randomized Clinical Trial.

摘要: Importance Previous trials on the effect of levothyroxine depressive symptom scores in patients with subclinical hypothyroidism were limited by small sample sizes (N = 57 to 94) and potential biases. Objective To assess development symptoms older adults largest trial this subject update a previous meta-analysis including results from study. Design, Setting, Participants This predefined ancillary study analyzed data participants Thyroid Hormone Replacement for Untreated Older Adults Subclinical Hypothyroidism (TRUST) trial, double-blind, randomized, placebo-controlled, parallel-group clinical conducted April 2013 October 31, 2016. The TRUST included aged 65 years or diagnosed hypothyroidism, defined as presence persistently elevated thyroid-stimulating hormone (TSH) levels (4.6-19.9 mIU/L) free thyroxine (T4) within reference range. Participants identified general practitioner laboratory databases recruited community Switzerland, Netherlands, Ireland, UK. This subgroup 472 Netherlands Switzerland; after exclusions, total 427 (211 randomized 216 placebo) analyzed. analysis was December 1, 2019, September 2020. Interventions Randomization either placebo. Main Outcomes Measures Depressive 12 months measured Geriatric Depression Scale (GDS-15), higher indicating more (minimal clinically important difference = 2). Results A (mean [SD] age, 74.52 [6.29] years; 239 women [56%]) analysis. mean (SD) TSH level 6.57 (2.22) mIU/L at baseline decreased 3.83 (2.29) group; placebo group, it 6.55 (2.04) 5.91 (2.66) mIU/L. At baseline, GDS-15 score 1.26 (1.85) group 0.96 (1.58) group. 1.39 (2.13) 1.07 (1.67) an adjusted between-group difference 0.15 vs (95% CI, -0.15 0.46; P = .33). In least 2, 0.61 -0.32 1.53; P = .20). Results did not differ according sex, levels. A (N = 278) association updated include these findings, resulting overall standardized 0.09 -0.05 0.22). Conclusions Relevance This found that therapy compared months; thus, do provide evidence favor persons reduce risk developing symptoms. Trial Registration ClinicalTrials.gov Identifier: NCT01853579.