Evidence map›Paper›PMID 29509918›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2018

Effects of Altering Levothyroxine (L-T4) Doses on Quality of Life, Mood, and Cognition in L-T4 Treated Subjects.

Mary H Samuels, Irina Kolobova, Meike Niederhausen, Jeri S Janowsky, Kathryn G Schuff

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 3 pooled it
6.2field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 3 syntheses or guidelines pooled it, 81 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Cognitive functioning in thyroid cancer survivors: a systematic review and meta-analysis.Journal of cancer survivorship : research and practice · 2019
    Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Critical Approach to Hypothyroid Patients With Persistent Symptoms.The Journal of clinical endocrinology and metabolism · 2023
    Article
  12. Symptoms in Patients Being Treated for Hypothyroidism: New Data in a Continuing Controversy.Thyroid : official journal of the American Thyroid Association · 2023
    Article
  13. Serum Thyrotropin and Triiodothyronine Levels in Levothyroxine-treated Patients.The Journal of clinical endocrinology and metabolism · 2023
    Observational
  14. Brain Fog in Hypothyroidism: What Is It, How Is It Measured, and What Can Be Done About It.Thyroid : official journal of the American Thyroid Association · 2022
    Review
  15. Article
  16. Hypothyroidism.Nature reviews. Disease primers · 2022
    Review
  17. Article
  18. Primary hypothyroidism and quality of life.Nature reviews. Endocrinology · 2022
    Review
  19. Enhanced Well-Being Associated with Thyrotoxicosis: A Neglected Effect of Thyroid Hormones?International journal of endocrinology and metabolism · 2022
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Mary H SamuelsDivision of Endocrinology, Diabetes and Clinical Nutrition, Oregon Health & Science University, Portland, Oregon.
Irina KolobovaPenn State Health St. Joseph, Family and Community Medicine Residency Program, Reading, Pennsylvania.
Meike NiederhausenBiostatistics & Design Program, OHSU-PSU School of Public Health, Oregon Health & Science University, Portland, Oregon.
Jeri S JanowskySaturday Academy, Portland, Oregon.
Kathryn G SchuffDivision of Endocrinology, Diabetes and Clinical Nutrition, Oregon Health & Science University, Portland, Oregon.
Oregon Health & Science University · USPennsylvania State University · USSaturday Academy · US

Funding

Oregon Clinical and Translational Research Institute - The National COVID Cohort Collaborative (N3C)UL1TR002369 · NCATS · OREGON HEALTH & SCIENCE UNIVERSITY · PI Cynthia D Morris, Christopher G. Slatore · 2017 to 2026
$78.4M
Neurocognitive and Metabolic Effects of Mild HypothyroidismR01DK075496 · NIDDK · OREGON HEALTH & SCIENCE UNIVERSITY · PI SAMUELS, MARY H · 2008 to 2012
$2.1M
Inflammatory cytokine-mediated induction of HIV cardiomyopathyK01RR024120 · NCRR · HARVARD MEDICAL SCHOOL · PI YEARLEY, JENNIFER · 2007 to 2008
$246k
NCATS NIH HHS UL1 TR002369NCRR NIH HHS K01 RR024120NIDDK NIH HHS R01 DK075496
6 · The paper itself

Abstract

Background: The brain is a critical target organ for thyroid hormone, but it is unclear whether variations in thyroid function within and near the reference range affect quality of life, mood, or cognition. Methods: A total of 138 subjects with levothyroxine (L-T4)-treated hypothyroidism and normal thyrotropin (TSH) levels underwent measures of quality of life (36-Item Short Form Health Survey, Underactive Thyroid-Dependent Quality of Life Questionnaire), mood (Profile of Mood States, Affective Lability Scale), and cognition (executive function, memory). They were then randomly assigned to receive an unchanged, higher, or lower L-T4 dose in double-blind fashion, targeting one of three TSH ranges (0.34 to 2.50, 2.51 to 5.60, or 5.61 to 12.0 mU/L). Doses were adjusted every 6 weeks based on TSH levels. Baseline measures were reassessed at 6 months. Results: At the end of the study, by intention to treat, mean L-T4 doses were 1.50 ± 0.07, 1.32 ± 0.07, and 0.78 ± 0.08 μg/kg (P < 0.001), and mean TSH levels were 1.85 ± 0.25, 3.93 ± 0.38, and 9.49 ± 0.80 mU/L (P < 0.001), respectively, in the three arms. There were minor differences in a few outcomes between the three arms, which were no longer significant after correction for multiple comparisons. Subjects could not ascertain how their L-T4 doses had been adjusted (P = 0.55) but preferred L-T4 doses they perceived to be higher (P < 0.001). Conclusions: Altering L-T4 doses in hypothyroid subjects to vary TSH levels in and near the reference range does not affect quality of life, mood, or cognition. L-T4-treated subjects prefer perceived higher L-T4 doses despite a lack of objective benefit. Adjusting L-T4 doses in hypothyroid patients based on symptoms in these areas may not result in significant clinical improvement.

Indexed as

Hormone Replacement TherapyQuality of LifeAdultAffectAgedCognitionDose-Response Relationship, DrugFemaleHumansHypothyroidismMaleMiddle AgedThyrotropinThyroxineTreatment OutcomeThyrotropinThyroxine

Identifiers

PMID29509918
PMCPMC6457033
OpenAlexW2793046691

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.