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Rebamipide for Managing Dyspeptic Symptoms During Proton-Pump Inhibitor Washout Before Helicobacter pylori Testing: A Randomized, Double-Blind, Placebo-Controlled Trial

Suksai N, Chueansuwan R, Yongsiri S, Witoon R, Juttuporn A

The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology, 2025

65 participants

Abstract

Background/aims: Persistent dyspeptic symptoms are common during the proton pump inhibitor (PPI) washout period before Helicobacter pylori (H. pylori) testing. However, the role of rebamipide in symptom management during this interval remains unclear.

Materials and methods: This double-blind, randomized controlled trial enrolled 65 patients with H. pylori-associated dyspepsia or gastritis, randomized (1:1) to receive rebamipide (100 mg 3 times daily) or placebo for 4 weeks, following a 14-day eradication regimen. The primary outcome was the proportion of responders achieving a ≥25% reduction in pain symptom scores on the Severity of Dyspepsia Assessment scale at week 6. Secondary outcomes included changes in pain symptoms, non-pain symptoms, and dyspepsia-related health scores, as well as eradication rates and safety.

Results: All patients completed the trial. Although the proportion of responders was higher in the rebamipide group (18 patients, 56.3% vs. 13 patients, 39.4%), this difference was not statistically significant (P = .17). Scores for pain, non-pain, and dyspepsia-related health improved similarly in both groups. Eradication rates were comparable (87.5% vs. 90.0%), and no serious adverse events were reported.

Conclusion: The responder rate was higher in the rebamipide group, but the difference did not reach statistical significance. The poten tial benefit of rebamipide as a rescue therapy during the PPI washout period before H. pylori testing warrants further…

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 65 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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