Evidence map›Paper›PMID 26537478›Full record

Trial reportEndocrine2016

Timing of breakfast does not influence therapeutic efficacy of liquid levothyroxine formulation.

Silvia Morelli, Gianpaolo Reboldi, Sonia Moretti, Elisa Menicali, Nicola Avenia, Efisio Puxeddu

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Endocrine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

22 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. An Overview on Different L-Thyroxine (l-TFrontiers in endocrinology · 2022
    Review
  12. Review
  13. L-T4 Therapy in Enteric Malabsorptive Disorders.Frontiers in endocrinology · 2021
    Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Article
  19. Article
  20. Review
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

6 authors.

Silvia MorelliDepartment of Medicine, University of Perugia, Perugia, Italy.
Gianpaolo ReboldiDepartment of Medicine, University of Perugia, Perugia, Italy.
Sonia MorettiDepartment of Medicine, University of Perugia, Perugia, Italy.
Elisa MenicaliDepartment of Medicine, University of Perugia, Perugia, Italy.
Nicola AveniaResearch Centre of Thyroid Proteomics and Genomics (CRiProGeT), University of Perugia, Terni, Italy.
Efisio PuxedduDepartment of Medicine, University of Perugia, Perugia, Italy. efisio.puxeddu@unipg.it.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Oral levothyroxine (L-T4) is the mainstay of hypothyroidism treatment. Many factors may influence its absorption, including the timing of administration. Objective of the study is to demonstrate the therapeutic equivalence of administering liquid L-T4 with breakfast or 10 min before breakfast. This was a pilot study conducted with a crossover design AB/BA where A stays for L-T4 with breakfast and B for L-T4 10 min before breakfast. A post hoc analysis was conducted to compare L-T4 administered at breakfast or 10 min before breakfast with L-T4 administered 30 min before breakfast. Sixty-one hypothyroid patients were enrolled and assigned to one of the two treatment sequences. All patients were evaluated for TSH levels at the end of each period. Fifty-nine patients completed the study. The mean thyrotropin concentration was 1.52 ± 0.73 µU/ml when L-T4 was administered with breakfast and 1.46 ± 0.81 µU/ml when it was taken 10 min before breakfast, without clinically and statistically significant differences (P = 0.59), regardless of treatment sequence and period. The mean thyrotropin concentration was 1.54 ± 0.9 µU/ml when L-T4 was administered at 0-10 min intervals before breakfast and 1.25 ± 0.7 µU/ml when it was taken 30 min before breakfast (ratio = 1.23, within our definition of equivalence set at 0.8-1.25). There is therapeutic equivalence between liquid L-T4 administration at breakfast or 10 min before breakfast. We can also hypothesize that there are no clinically relevant differences between liquid L-T4 administration 30 min before breakfast or at shorter intervals.

Indexed as

BreakfastAdultAgedCross-Over StudiesDrug CompoundingEatingFemaleHormone Replacement TherapyHumansHypothyroidismMaleMiddle AgedPilot ProjectsSolutionsThyrotropinThyroxineSolutionsThyrotropinThyroxineTriiodothyronineHypothyroidismLevothyroxineOral solutionReplacement therapyTherapeutic equivalenceTSH

Identifiers

PMID26537478

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.