Evidence map›Paper›PMID 29847892›Full record

Trial reportThe Korean journal of internal medicine2019

The efficacy and safety of irsogladine maleate in nonsteroidal anti-inflammatory drug or aspirin-induced peptic ulcer and gastritis.

Ki-Nam Shim, Jin Il Kim, Nayoung Kim, Sang Gyun Kim, Yun Ju Jo, Su Jin Hong, Jeong Eun Shin, Gwang Ha Kim, Kyung Sik Park, Suck Chei Choi and 4 more

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

Trial report in The Korean journal of internal medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04885751 (Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy in Patients With NSAIDs and Low Dose Steroid), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.9field-weighted citation impact, top 24% 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.

NCT04885751 phase4unknown statusnot on this mapstarted 2021, after this paper: background citation

Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy in Patients With NSAIDs and Low Dose Steroid: A Single-center, Randomized, Open Labeled, Pilot Study

TypeinterventionalSponsorSeoul National University Boramae HospitalRan2021 to 2022Enrolled50ConditionsRheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis, Other Musculoskeletal DisorderArmsEupatilin, Rebamipide
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 11 citations in OpenAlex.

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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

14 authors at 13 institutions in 1 country.

Ki-Nam ShimDepartment of Internal Medicine, College of Medicine, Ewha Womans University, Ewha Medical Research Institute, Seoul, Korea.
Jin Il KimDepartment of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Nayoung KimDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Sang Gyun KimDepartment of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Yun Ju JoDepartment of Internal Medicine, Eulji University School of Medicine, Seoul, Korea.
Su Jin HongDigestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Korea.
Jeong Eun ShinDepartment of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea.
Gwang Ha KimDepartment of Internal Medicine, Pusan National University School of Medicine, and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea.
Kyung Sik ParkDepartment of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
Suck Chei ChoiDepartment of Internal Medicine, Wonkwang University College of Medicine and Digestive Disease Research Institute, Iksan, Korea.
Joong Goo KwonDepartment of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, Korea.
Jie-Hyun KimDepartment of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Hyun Jin KimDepartment of Internal Medicine, Gyeongsang National University School of Medicine, Jinju, Korea.
Ji Won KimDepartment of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul, Korea.
Yonsei University · KRCatholic University of Korea · KRDaegu Catholic University · KRDankook University · KREulji University · KREwha Womans University Medical Center · KRGyeongsang National University · KRKeimyung University · KRPusan National University Hospital · KRSeoul National University · KRSeoul National University Bundang Hospital · KRSoonchunhyang University · KRWonkwang University · KR

Funding

Taejoon Pharm Co. Ltd
6 · The paper itself

Abstract

BACKGROUND/

aimsIrsogladine maleate, an enhancer of gastric mucosal protective factors, has demonstrated its efficacy for various gastric mucosal injuries. The aim of this study was to evaluate the efficacy and safety of irsogladine for prevention of nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin-induced peptic ulcer and gastritis.

methodsIn this multicenter, randomized, double-blind, exploratory clinical trial, 100 patients over 50 years of age who needed continuous NSAIDs or aspirin for more than 8 weeks were randomly assigned to either test group (irsogladine maleate 2 mg, twice daily, 39 patients for full analysis) or placebo group (37 patients for full analysis). Primary outcomes were incidence of peptic ulcer and ratio of modified Lanza score (MLS) 2 to 4. Secondary outcome was the number of acute erosions confirmed by endoscopy at 8 weeks. Adverse effects were also compared.

resultsThere were no significant differences in gastric protective effects between test and placebo groups. However, two cases of peptic ulcer in the placebo group but none in the test group were observed. These two cases of peptic ulcer were Helicobacter pylori-negative. In addition, H. pylori-negative group showed significant changes in MLS score (p = 0.0247) and edema score (p = 0.0154) after the treatment compared to those before treatment in the test group. There was no significant difference in adverse events between the two groups.

conclusionThe efficacy of irsogladine maleate was found in H. pylori-negative group, suggesting its potential as a protective agent against NSAIDs or aspirin-induced peptic ulcer and gastritis.

Indexed as

AgedAged, 80 and overAnti-Inflammatory Agents, Non-SteroidalAnti-Ulcer AgentsDouble-Blind MethodFemaleGastric MucosaGastritisHumansMaleMiddle AgedRepublic of KoreaRisk FactorsStomach UlcerTime FactorsTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalAnti-Ulcer AgentsirsogladineTriazinesAnti-inflammatory agents, non-steroidalAspirinGastritisIrsogladine maleatePeptic ulcer

Identifiers

PMID29847892
PMCPMC6718769
OpenAlexW2806838516

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.