Trial reportGut and liver2014
Preventive efficacy and safety of rebamipide in nonsteroidal anti-inflammatory drug-induced mucosal toxicity.
Trial report in Gut and liver, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.
- Efficacy of Rebamipide in Organic and Functional Dyspepsia: A Systematic Review and Meta-Analysis.Digestive diseases and sciences · 2018Pooled it
- Rebamipide does not protect against naproxen-induced gastric damage: a randomized double-blind controlled trial.BMC gastroenterology · 2016Trial
- Targeting the NLRP3-NEK7 axis with rebamipide: Drug repurposing in Parkinson's disease.Neural regeneration research · 2026Article
- Rebamipide Induces Hair Regeneration Through EP4-Driven Lipid Metabolism Remodeling.International journal of molecular sciences · 2025Article
- Rebamipide Attenuates Lupus Nephritis by Enhancing Antioxidative Defense in Podocytes: Evidence from a Lupus-Prone Mouse Model.International journal of molecular sciences · 2025Article
- Rebamipide in gastric mucosal protection and healing: An Asian perspective.World journal of gastrointestinal pharmacology and therapeutics · 2025Review
- Rebamipide Prevents the Hemoglobin Drop Related to Mucosal-Damaging Agents at a Level Comparable to Proton Pump Inhibitors.Gut and liver · 2024Article
- Article
- Recovery from indomethacin-induced gastrointestinal bleeding by treatment with teprenone.Journal of pharmaceutical health care and sciences · 2023Article
- Proton pump inhibitors and gastroprotection in patients treated with antithrombotic drugs: A cardiologic point of view.World journal of cardiology · 2023Review
- Evaluation of Safety, Tolerability and Pharmacokinetic Characteristics of SA001 and Its Active Metabolite Rebamipide after Single and Multiple Oral Administration.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Rebamipide as a Potential Alternative Gastroprotective Agent to Proton Pump Inhibitor in Elderly Chronic Nonsteroidal Anti-Inflammatory Drug Users without Risk Factors.International journal of general medicine · 2022Article
- Underutilization of gastrointestinal prophylaxis in high-risk chronic nonsteroidal anti-inflammatory drug users in Korea.International journal of clinical pharmacy · 2021Article
- Toward More GI-Friendly Anti-Inflammatory Medications.Current treatment options in gastroenterology · 2015Article
- Initial Steps to Prevent Nonsteroidal Anti-Inflammatory Drug- or Aspirin-Induced Enteropathy: Long-Term Outcome Data.Gut and liver · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
aimsThe use of proton pump inhibitors or misoprostol is known to prevent the gastrointestinal complications of nonsteroidal anti-inflammatory drugs (NSAIDs). Rebamipide is known to increase the mucosal generation of prostaglandins and to eliminate free oxygen radicals, thus enhancing the protective function of the gastric mucosa. However, it is unknown whether rebamipide plays a role in preventing NSAID-induced gastropathy. The aim of this study was to determine the effectiveness of rebamipide compared to misoprostol in preventing NSAID-induced gastrointestinal complications in patients requiring continuous NSAID treatment.
methodsWe studied 479 patients who required continuous NSAID treatment. The patients were randomly assigned to groups that received 100 mg of rebamipide three times per day or 200 μg of misoprostol three times per day for 12 weeks. The primary endpoint of the analysis was the occurrence rate of gastric ulcers, as determined by endoscopy after 12 weeks of therapy.
resultsOf the 479 patients in the study, 242 received rebamipide, and 237 received misoprostol. Ultimately, 44 patients (18.6%) withdrew from the misoprostol group and 25 patients (10.3%) withdrew from the rebamipide group. There was a significant difference in withdrawal rate between the two groups (p=0.0103). The per protocol analysis set was not valid because of the dropout rate of the misoprostol group; thus, the intention to treat (ITT) analysis set is the main set for the efficacy analysis in this study. After 12 weeks, the occurrence rate of gastric ulcers was similar in the rebamipide and misoprostol groups (20.3% vs 21.9%, p=0.6497) according to ITT analysis. In addition, the therapeutic failure rate was similar in the rebamipide and misoprostol groups (13.6% vs 13.1%, p=0.8580). The total severity score of the gastrointestinal symptoms was significantly lower in the rebamipide group than in the misoprostol group (p=0.0002). The amount of antacid used was significantly lower in the rebamipide group than in the misoprostol group (p=0.0258).
conclusionsRebamipide can prevent gastric ulcers when used with NSAIDs and can decrease the gastrointestinal symptoms associated with NSAID administration. When the possibility of poor compliance and the potential adverse effects of misoprostol are considered, rebamipide appears to be a clinically effective and safe alternative.
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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.