Evidence map›Paper›PMID 35325295›Full record

SynthesisJournal of gastroenterology2022

Systematic review and meta-analysis: analysis of variables influencing the interpretation of clinical trial results in NAFLD.

Javier Ampuero, Rocío Gallego-Durán, Douglas Maya-Miles, Rocío Montero, Sheila Gato, Ángela Rojas, Antonio Gil, Rocío Muñoz, Manuel Romero-Gómez

Open access · hybridAbstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Journal of gastroenterology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 15% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Review
  10. Review
  11. Emerging pharmacological treatment options for MAFLD.Therapeutic advances in endocrinology and metabolism · 2022
    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

9 authors at 2 institutions in 2 countries.

Javier Ampuero *Digestive Disease Department, Virgen del Rocio University Hospital, Avenida Manuel Siurot s/n, 41013, Sevilla, Spain. jampuero-ibis@us.es.ORCID 0000-0002-8332-2122
Rocío Gallego-Durán *SeLiver Group, Instituto de Biomedicina de Sevilla/CSIC, Universidad de Sevilla, Sevilla, Spain.
Douglas Maya-MilesSeLiver Group, Instituto de Biomedicina de Sevilla/CSIC, Universidad de Sevilla, Sevilla, Spain.
Rocío MonteroSeLiver Group, Instituto de Biomedicina de Sevilla/CSIC, Universidad de Sevilla, Sevilla, Spain.
Sheila GatoSeLiver Group, Instituto de Biomedicina de Sevilla/CSIC, Universidad de Sevilla, Sevilla, Spain.
Ángela RojasSeLiver Group, Instituto de Biomedicina de Sevilla/CSIC, Universidad de Sevilla, Sevilla, Spain.
Antonio GilSeLiver Group, Instituto de Biomedicina de Sevilla/CSIC, Universidad de Sevilla, Sevilla, Spain.
Rocío MuñozSeLiver Group, Instituto de Biomedicina de Sevilla/CSIC, Universidad de Sevilla, Sevilla, Spain.
Manuel Romero-GómezDigestive Disease Department, Virgen del Rocio University Hospital, Avenida Manuel Siurot s/n, 41013, Sevilla, Spain.
Centre for Biomedical Network Research on Rare Diseases · ESInstituto de Biomedicina de Sevilla · ES

Funding

Consejería de Salud, Junta de Andalucía PI-0075-2014Instituto de Salud Carlos III GLD19/00100Instituto de Salud Carlos III IFI18/00041Instituto de Salud Carlos III PI16/01842Instituto de Salud Carlos III PI17/00535Instituto de Salud Carlos III PI19/00589Instituto de Salud Carlos III PI19/01404
6 · The paper itself

Abstract

backgroundNAFLD clinical trials have shown suboptimal results, particularly for liver fibrosis, despite the robust preclinical drug development. We aimed to assess the histological response after the experimental treatment versus placebo by carrying out a meta-analysis of NAFLD clinical trials.

methodsAfter a systematic review of NAFLD clinical trials to May 2021, applying strict selection criteria, the following primary outcomes were observed: (a) NASH resolution, with no worsening of fibrosis when available; (b) fibrosis improvement  ≥ 1 stage, with no worsening of NAS when available; (c) worsening of NAS; (d) worsening of liver fibrosis  ≥ 1 stage, including the progression to cirrhosis on histopathology. Other histological, clinical, and biochemical outcomes were considered secondary endpoints. Heterogeneity was explored by subgroup and sensitivity analyses, and univariable meta-regression.

resultsTwenty-seven randomized clinical trials were included. The pooled efficacy for NASH resolution receiving experimental therapy was 19% (95%CI 15-23; I

conclusionThis meta-analysis provides information about the efficacy of the therapy versus placebo by comparing different and combined trial outcomes such as NASH resolution, fibrosis improvement, and NAS and fibrosis worsening. Changes in the experimental design and selection criteria of the clinical trials might be suitable to increase the efficacy.

Indexed as

Non-alcoholic Fatty Liver DiseaseBiopsyHumansHypoglycemic AgentsLiver CirrhosisHypoglycemic AgentsDrugFibrosisNAFLDNASHPlacebo

Identifiers

PMID35325295
PMCPMC9016009
OpenAlexW4220965790

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.