Role of antireflux mucosal ablation in “reflux-predominant” refractory gastroesophageal reflux disease: a randomized sham-controlled trial

Abstract

Background

Refractory gastroesophageal reflux disease (GERD) often requires endoscopic or surgical intervention. We evaluated the efficacy of antireflux mucosal ablation (ARMA) versus sham treatment in patients with reflux-predominant refractory GERD.

Methods

This single-center, randomized sham-controlled trial enrolled patients with persistent GERD symptoms on optimized proton pump inhibitor (PPI) therapy, with acid exposure time (AET) <6%, and >80 reflux episodes on 24-hour pH-impedance monitoring. Patients were randomized to the ARMA or sham groups. The primary outcome was the proportion of patients achieving 50% improvement in GERD health-related quality-of-life (GERD-HRQL) score from baseline to 6 months. Secondary outcomes included heartburn and regurgitation symptom scores, AET, DeMeester score, reflux episodes, endoscopy findings, and PPI consumption. Mixed-effects models were applied, with group (ARMA vs. sham) as fixed effect and participant as random effect.

Results

58 patients (ARMA, n = 28; median age 41; 32% women vs. sham, n = 30; median age 40; 36% women) were included. Baseline mean (SD) duration of PPI use was similar: ARMA, 3.5 (2.7) years; sham, 3.7 (1.8) years. At 6 months, 20 of the ARMA group (71.4%) achieved ≥50% GERD-HRQL score reduction vs. one in the sham group (3.6%; P <0.001). Statistically significant reductions in heartburn, regurgitation, AET, and reflux episodes were seen with ARMA versus sham (P <0.05). Interaction effects revealed greater improvements over time with ARMA versus sham for AET (P = 0.03), total reflux episodes (P = 0.001), and nonacid reflux episodes (P = 0.009), but not for DeMeester score. The ARMA group improved in endoscopic Hill’s grading and esophagitis at 6 months; 35.7% of patients were completely off PPIs.

Conclusion

ARMA improves symptoms, AET, and reflux episodes in reflux-predominant PPI-refractory GERD.

Publication History

Received: 07 April 2025

Accepted after revision: 06 November 2025

Accepted Manuscript online:
06 November 2025

Article published online:
09 January 2026

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