Evidence map›Paper›PMID 32335854›Full record

Trial reportDrugs in R&D2020

Frequency and Types of Pathological Upper Gastrointestinal Endoscopy Findings in Clinically Healthy Individuals.

Elisabeth Scheidl, Claus Benz, Peter Loeff, Volker Groneck, Andreas König, Alban Schulte-Fischedick, Hendrik Lück, Uwe Fuhr

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in Drugs in R&D, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 48% 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

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. 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

8 authors at 1 institution in 1 country.

Elisabeth ScheidlClinical Pharmacology Unit, Department I of Pharmacology, Center for Pharmacology, University Hospital Cologne (AöR), Gleueler Straße 24, 50931, Köln, Germany.
Claus BenzDepartment of Gastroenterology, Ev. Krankenhaus Köln-Weyertal, Köln, Germany.
Peter LoeffDepartment of Gastroenterology, Ev. Krankenhaus Köln-Weyertal, Köln, Germany.
Volker GroneckDepartment of Gastroenterology, Ev. Krankenhaus Köln-Weyertal, Köln, Germany.
Andreas KönigDepartment of Gastroenterology, Ev. Krankenhaus Köln-Weyertal, Köln, Germany.
Alban Schulte-FischedickDepartment of Gastroenterology, Ev. Krankenhaus Köln-Weyertal, Köln, Germany.
Hendrik LückITECRA GmbH & Co. KG, Köln, Germany.
Uwe FuhrClinical Pharmacology Unit, Department I of Pharmacology, Center for Pharmacology, University Hospital Cologne (AöR), Gleueler Straße 24, 50931, Köln, Germany. uwe.fuhr@uk-koeln.de.
University Hospital Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveBeyond its application for diagnostics in patients, esophagogastroduodenoscopy (EGD) is used to assess gastrointestinal drug effects in clinical trials, where the interpretation of any pathological findings depends on the respective background variability. The objective of this analysis was to characterize the occurrence of pathological findings in the upper gastrointestinal tract in symptom-free healthy individuals.

methodsA baseline EGD was performed in clinically healthy individuals in three clinical trials aimed to assess gastrointestinal tolerability of drugs. Pathological findings were described by type (redness, erosion, ulcer or other), number, size and location, and by clinical relevance as assessed by the endoscopist. Characteristics of volunteers were tested as potential covariates.

resultsA total of 294 EGDs were assessed. Characteristics of individuals were as follows: 257 (87.4%) males, age (mean ± SD) 32.0 ± 8.1 years, body weight 76.0 ± 10.6 kg, body mass index (BMI) 24.0 ± 2.5 kg/m

conclusionUpper gastrointestinal tract mucosal lesions, including those assessed as clinically relevant, are frequent in clinically healthy individuals, impeding the assessment of causality for both disease and drug effects on gastrointestinal health.

Indexed as

Endoscopy, Digestive SystemAdultFemaleHealthy VolunteersHumansMaleUpper Gastrointestinal Tract

Identifiers

PMID32335854
PMCPMC7221033
OpenAlexW3018661976

What OpenQuestion holds

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Registered trials

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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.