Evidence map›Paper›PMID 27259970›Full record

Trial reportBMC gastroenterology2016

Rebamipide does not protect against naproxen-induced gastric damage: a randomized double-blind controlled trial.

Thiago Gagliano-Jucá, Ronilson A Moreno, Tiago Zaminelli, Mauro Napolitano, Antônio Frederico N Magalhães, Aloísio Carvalhaes, Miriam S Trevisan, John L Wallace, Gilberto De Nucci

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC gastroenterology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02632812 (Double-blind Trial on the Gastrointestinal Integrity Evaluation After Daily Naproxen 1100 mg + Rebamipide 200mg for 7 Days Versus Naproxen 1100mg + Placebo for 7 Days), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 20% 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.

NCT02632812 phase1completednot on this map

Double-blind Trial on the Gastrointestinal Integrity Evaluation After Daily Naproxen 1100 mg + Rebamipide 200mg for 7 Days Versus Naproxen 1100mg + Placebo for 7 Days

TypeinterventionalSponsorBiolab Sanus FarmaceuticaRan2014 to 2014Enrolled24ConditionsGastrointestinal LesionsArmsRebamipide effervescent granules, Placebo effervescent granules, Naproxen tablet
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Using human iPS cell-derived enterocytes as novel in vitro model for the evaluation of human intestinal mucosal damage.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2018
    Article
  5. Toward More GI-Friendly Anti-Inflammatory Medications.Current treatment options in gastroenterology · 2015
    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

9 authors at 6 institutions in 1 country.

Thiago Gagliano-JucáInstitute of Biophysics Carlos Chagas Filho, Federal University of Rio de Janeiro (UFRJ), 21941-902, Rio de Janeiro, Brazil. thiagogagliano@gmail.com.
Ronilson A MorenoGaleno Research Unit, Campinas, Brazil; Faculty of Medical Sciences, Metropolitan University of Santos, Santos, Brazil.
Tiago ZaminelliDepartment of Pharmacology, Faculty of Medical Sciences, State University of Campinas (UNICAMP), Campinas, Brazil.
Mauro NapolitanoDepartment of Pharmacology, ICB - University of Sao Paulo (USP), 05508-900, Sao Paulo, Brazil.
Antônio Frederico N MagalhãesDepartment of Gastroenterology, Faculty of Medical Sciences, State University of Campinas (UNICAMP), Campinas, Brazil.
Aloísio CarvalhaesBrazilian Society for Digestive Endoscopy (SOBED), Sao Paulo, Brazil.
Miriam S TrevisanDepartment of Gastroenterology, Faculty of Medical Sciences, State University of Campinas (UNICAMP), Campinas, Brazil.
John L WallaceUnicastelo Medical School, University Camilo Castelo Branco (UNICASTELO), Fernandopolis, Brazil.
Gilberto De NucciDepartment of Pharmacology, Faculty of Medical Sciences, State University of Campinas (UNICAMP), Campinas, Brazil.
Universidade Estadual de Campinas (UNICAMP) · BRUniversidade Brasil · BRSociedade Brasileira de Endoscopia Digestiva · BRUniversidade de São Paulo · BRUniversidade Federal do Rio de Janeiro · BRUniversidade Metropolitana de Santos · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRebamipide is a gastroprotective agent with promising results against gastric damage induced by non-steroidal anti-inflammatory drugs. The present study evaluated if rebamipide protects against naproxen-induced gastric damage in healthy volunteers. Changes in gastric PGE2 tissue concentration were also evaluated.

methodsAfter a preliminary endoscopy to rule out previous gastric macroscopic damage, twenty-four healthy volunteers of both sexes were divided into 2 groups. One group received sodium naproxen 550 mg b.i.d. plus placebo for 7 days, while the other group received sodium naproxen 550 mg b.i.d. plus rebamipide 100 mg b.i.d. At the end of treatment, a new endoscopy was performed. Gastric macroscopic damage was evaluated by the Cryer score and by the modified Lanza score. The primary outcome measure of the trial was the macroscopic damage observed in each treatment group at the end of treatment. Biopsies were collected at both endoscopies for PGE2 quantification and histopathological analysis (secondary outcomes). Tissue PGE2 was quantified by ELISA. The randomization sequence was generated using 3 blocks of 8 subjects each. Volunteers and endoscopists were blind to whether they were receiving rebamipide or placebo.

resultsAll recruited volunteers completed the trial. Sodium naproxen induced gastric damage in both groups. At the end of the study, median Cryer score was 4 in both groups (Difference = 0; 95%CI = -1 to 0; p = 0.728). In the placebo group, the mean tissue PGE2 concentration was 1005 ± 129 pg/mL before treatment and 241 ± 41 pg/mL after treatment (p < 0.001). In the rebamipide group, the mean tissue PGE2 concentration was 999 ± 109 pg/mL before treatment, and 168 ± 13 pg/mL after treatment (p < 0.001). There was no difference in mean tissue PGE2 between the two groups (difference = 5; 95%CI from -334.870 to 345.650; p = 0.975). No significant change was observed at the histopathological evaluation, despite the evident macroscopic damage induced by naproxen.

conclusionRebamipide does not protect against naproxen-induced gastric damage in healthy volunteers.

trial registrationClinicalTrials.gov, NCT02632812 . Registered 14 December 2015.

Indexed as

AdolescentAdultAlanineAnti-Inflammatory Agents, Non-SteroidalDinoprostoneDouble-Blind MethodFemaleGastric MucosaGastrointestinal AgentsHumansMaleMiddle AgedNaproxenQuinolonesStomach DiseasesYoung AdultAlanineAnti-Inflammatory Agents, Non-SteroidalDinoprostoneGastrointestinal AgentsNaproxenQuinolonesrebamipideCryer scoreELISAEndoscopyHistopathologyHumanModified Lanza scoreNSAID

Identifiers

PMID27259970
PMCPMC4893238
OpenAlexW2409618648

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.