Role of Anti-Reflux Mucosal Ablation(ARMA) in a selective subset of refractory Gastroesophageal Reflux Disease(GERD) patients – A Randomized Sham Controlled Trial

Aims Refractory gastroesophageal reflux disease(GERD) remains a clinical challenge, and may requuire endoscopic or surgical intervention. This randomized controlled trial aimed to evaluate the efficacy of anti-reflux mucosal ablation(ARMA) compared to sham in a selective subset of patients with refractory GERD.

Methods This single-center, randomized, two-arm trial included patients between March 2023 to March 2024. Patients with persistent symptoms on optimized PPI therapy having acid exposure time(AET)<6% and>80 reflux episodes were randomized into two groups: ARMA and sham. The primary outcome was to assess improvement of GERD health-related quality of life(GERD-HRQL) and secondary outcomes were AET, DeMeester score, total reflux episodes, heartburn and regurgitation scores. Baseline and 6-month follow-up data were collected. Mixed-effects models were applied to account for the paired structure of the data, with group (ARMA vs. sham) as a fixed effect and participant as a random effect.

Results At baseline, the mean PPI use duration was 3.5(2.7) years and 3.7(1.8) years in ARMA (n=28; 19 male, mean age 41.2(11.2) years) and sham group (n=28; 18 male, mean age 39.9(9.9) years) respectively. Significant improvement was observed in primary outcome for the ARMA group: GERD-HRQL score (Baseline Mean 37.01(9.9), 6-Month Mean 14.93(16) versus sham group baseline Mean 39.11(9.2), 6-Month Mean 36.46(11.8); p<0.001) including heartburn symptom score (p<0.001), and regurgitation symptom score (p<0.001). The ARMA group demonstrated significant reductions from baseline to 6 months in AET (p 0.027), DeMeester score (p 0.028), and total reflux episodes (p 0.001) compared to the sham group. Interaction effects revealed greater improvements over time in the ARMA group compared to sham for AET (p 0.029), total reflux episodes (p 0.001), and non-acid reflux episodes (p 0.009), not for DeMeester score (p>0.05) [1] [2] [3].

Conclusions This trial demonstrates that ARMA provides significant symptom relief and reduction in acid exposure compared to sham in patients within selected subset of refractory GERD. These findings suggest that the ARMA could be an effective treatment option, warranting further investigation and consideration in managing refractory GERD cases.

 

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Conflicts of Interest

Authors do not have any conflict of interest to disclose.

• References

• 1 Gyawali CP, Yadlapati R, Fass R. et al. Updates to the modern diagnosis of GERD: Lyon consensus 2.0. Gut 2024; 73 (02): 361-371 Published 2024 Jan 5
• 2 Inoue H, Tanabe M, de Santiago ER. et al. Anti-reflux mucosal ablation (ARMA) as a new treatment for gastroesophageal reflux refractory to proton pump inhibitors: a pilot study. Endosc Int Open 2020; 8 (02): E133-E138
• 3 Shimamura Y, Inoue H, Tanabe M. et al. Clinical outcomes of anti-reflux mucosal ablation for gastroesophageal reflux disease: An international bi-institutional study. J Gastroenterol Hepatol 2024; 39 (01): 149-156

Publication History

Article published online:
27 March 2025