Multicenter, double-blind, sham endoscopy-controlled, randomized trial evaluating the efficacy of antireflux mucosal ablation for the treatment of gastroesophageal reflux disease
Abstract
Abstract Background Antireflux mucosal ablation (ARMA) is a novel endoscopic technique for gastroesophageal reflux disease (GERD) but has only been assessed in noncontrolled studies. The objective of this randomized controlled study was to evaluate its efficacy in patients with proton pump inhibitor (PPI)-responsive GERD. Methods We conducted a double-blind, sham endoscopy-controlled, randomized trial across 12 Spanish hospitals. Adults with PPI-responsive GERD and abnormal esophageal acid exposure time (AET > 6 %) were randomly assigned (1:1) to receive ARMA or sham endoscopy. The primary outcome was clinical success at 12 months, defined as a ≥ 50 % reduction in the GERD-Health-Related Quality of Life score. Inability to discontinue PPIs to allow symptom assessment was considered treatment failure. Secondary outcomes included PPI discontinuation, AET, manometric parameters, mucosal healing, and adverse events. Results Of 186 patients screened, 60 were included (ARMA 31; sham 29). At 12 months, clinical success was achieved in 16 patients (51.6 %) in the ARMA group and in 11 (37.9 %) in the sham group ( P = 0.29; risk ratio 1.36, 95 %CI 0.76 to 2.42). No significant differences were observed in PPI discontinuation, AET, manometric findings, or mucosal healing. Postprocedural pain (27.3 % vs. 3.3 %) and dysphagia (45.5 % vs. 10.0 %) occurred more frequently in the ARMA group. No severe adverse events were recorded. Conclusions ARMA was not superior to sham endoscopy in…
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: 186 participants or records.
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