Background: Endoscopic anti-reflux interventions (EARIs) have been emerging methods for patients with gastroesophageal reflux disease (GERD) who remain symptomatic despite treatment with optimal acid suppressor agents. Anti-reflux mucosal ablation (ARMA) is an EARI in which the lower esophageal sphincter is reinforced by the ablation of gastroesophageal mucosa on the cardia side. Aim: To evaluate the efficacy and safety of ARMA in comparison to proton pump inhibitors (PPIs) in patients with persistent GERD symptoms.
Method: In this non-randomized controlled interventional trial, between October 2023 to February 2024, patients with persistent GERD symptoms were allocated to either ARMA or PPI. GERD-Health Related Quality of Life (GERD-HRQL) Questionnaire, Frequency Scale for the Symptoms of GERD (FSSG), upper endoscopy, PPI use and adverse events were evaluated at baseline and three months post-ARMA.
Results: A total of 48 patients (31 females [64.6%]; mean age 39.47±14.88) completed our study of 24 patients underwent ARMA (17 females [70.8%]; mean age 41.35±14.43) and 24 were taking esomeprazole 20 mg twice daily. After three months, ARMA significantly alleviated both mean GERD-HRQL (29.08±7.95 versus 7.42±3.85, P<0.001) and FSSG (24.71±5.17 versus 7.46±3.63, p<0.001). Furthermore, three-month GERD-HRQL and FSSG were significantly lower in the ARMA group in comparison to the PPI group. (7.42±3.85 versus 23.83±7.29, p<0.001 and 7.46±3.63 versus 20.75±5.33, p<0.001, respectively. Notably, 79.2% of patients in the ARMA were able to discontinue PPIs in comparison to 8.3% of patients in the control group (p<0.001). Multivariate analysis revealed that undergoing ARMA was the only predictor of GERD-HRQL and FSSG scores. Only one patient experienced heartburn after ARMA but no major adverse complications were observed.
Conclusion: Our study demonstrated that ARMA was feasible, tolerable and safe. Also, in short-term, it can alleviate the symptoms of GERD in patients with persistent symptoms more efficiently in comparison to esomeprazole. However, longer follow-ups and randomized studies are required to determine the exact efficacy of ARMA.