Can rebamipide and proton pump inhibitor combination therapy promote the healing of endoscopic submucosal dissection-induced ulcers? A randomized, prospective, multicenter study.

BACKGROUND: There has been no consensus regarding the optimal treatment durations and drug regimens in patients with endoscopic submucosal dissection (ESD)-induced ulcers.
OBJECTIVE: To assess the efficacy of proton pump inhibitor (PPI) and rebamipide combination therapy compared with PPI monotherapy for ESD-induced ulcer healing.
DESIGN: Randomized, prospective, controlled study; clinical trial.
SETTING: Five hospitals in a University Medical Center group in Korea. PATIENTS: This study involved 290 adults (309 lesions) who underwent ESD for gastric adenoma or early gastric cancer. INTERVENTION: PPI and rebamipide combination therapy. MAIN OUTCOME MEASUREMENTS: The ulcer healing rate at 4 weeks after ESD.
RESULTS: The ulcer healing rates at 4 weeks after ESD in the PPI and rebamipide combination therapy group were significantly higher than those in the PPI alone group, both in the full analysis (94.9% vs 89.9%; P < .0001) and in the per-protocol analysis (94.5% vs 91.2%; P = .020). This combination therapy was an independent predictive factor for a high ulcer healing rate (adjusted odds ratio [OR] 5.572; 95% confidence interval [CI], 2.615-11.876; P = .014). Additionally, the combination therapy group exhibited a higher quality of ulcer healing than the PPI monotherapy group (reviewer 1: P = .027; OR 1.949; 95% CI, 1.077-3.527; reviewer 2: P = .027; OR 1.933; 95% CI, 1.074-3.481). LIMITATIONS: Open-label study.
CONCLUSION: PPI and rebamipide combination therapy had a superior 4-week ESD-induced ulcer healing rate and quality of ulcer healing compared with PPI monotherapy. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01167101.). Copyright Â

RCT Entities:   Population Interventions Outcomes