We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
2017 - In older adults with subclinical hypothyroidism, levothyroxine did not improve symptoms or tiredness.
- Authors
Shah, Reema
- Abstract
Question In older adults with subclinical hypothyroidism (SCH), what is the effectiveness of levothyroxine compared with placebo? Methods Design Randomized placebo-controlled trial (RCT) (Thyroid Hormone Replacement for Untreated Older Adults with Subclinical Hypothyroidism Trial [TRUST]). ClinicalTrials.gov NCT01660126. Allocation Concealed.* Blinding Blinded* (patients, clinicians, study personnel, investigators, outcome assessors, and statisticians). Follow-up period Median 17 to 18 months. Setting UK, The Netherlands, and Switzerland. Patients 737 adults ≥ 65 years of age (mean age 74 y, 54% women) who had persistent SCH (thyrotropin level 4.60 to 19.99 mIU/L) measured ≥ 2 times within 3 to 36 months and whose free thyroxine level was within the reference range. Exclusion criteria included current use of levothyroxine, antithyroid drugs, amiodarone, or lithium; thyroid surgery or radioactive iodine in the past 12 months; dementia; hospital admission for major illness or elective surgery in the past 4 weeks; an acute coronary syndrome in the past 4 weeks; or terminal illness. Intervention Dose-adjusted levothyroxine, starting dose 50 μg/d (25 μg/g for patients with body weight < 50 kg or coronary heart disease), adjusted to achieve a thyrotropin level within the reference range (0.40 to 4.59 mIU/L) (n = 368), or matching dose-adjusted placebo (n = 369). Outcomes Thyroid-Related Quality-of-Life Patient-Reported Outcome measure (ThyPRO) Hypothyroid Symptoms score (4 items, score range 0 to 100, higher score = more symptoms) and Tiredness score (7 items, score range 0 to 100, higher score = more tiredness) at 12 months. 750 patients were required to detect a 3.0-point change in the Hypothyroid Symptom score and a 4.1-point change in the Tiredness score with 80% power (α = 0.025 for each of the 2 primary outcomes) and assumed standard deviations of 13.3 and 18.3 points, respectively. Secondary outcomes included serious adverse events, atrial fibrillation, and withdrawal of study drug. Patient follow-up 87% (modified intention-to-treat analysis including patients with data at 12 mo). Main results At 12 months, thyrotropin levels were 3.63 and 5.48 mIU/L in the levothyroxine and placebo groups, respectively (between-group difference -1.92 mIU/L, 95% CI -2.24 to -1.59). The main results are in the Table. Conclusion In older adults with subclinical hypothyroidism, levothyroxine did not improve symptoms or tiredness compared with placebo.
- Subjects
UNITED Kingdom; NETHERLANDS; SWITZERLAND; FATIGUE (Physiology); HYPOTHYROIDISM; THYROXINE; TREATMENT effectiveness; SYMPTOMS
- Publication
ACP Journal Club, 2017, Vol 167, Issue 4, p1
- ISSN
1056-8751
- Publication type
Article
- DOI
10.7326/ACPJC-2017-167-4-014