{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T11:27:58Z","timestamp":1792841278594,"version":"4.5.0"},"reference-count":34,"publisher":"Georg Thieme Verlag KG","issue":"05","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Endoscopy"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n                  <jats:p>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) &lt;6%, and &gt;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.<\/jats:p>\n                  <jats:p>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 \u226550% GERD-HRQL score reduction vs. one in the sham group (3.6%; P &lt;0.001). Statistically significant reductions in heartburn, regurgitation, AET, and reflux episodes were seen with ARMA versus sham (P &lt;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\u2019s grading and esophagitis at 6 months; 35.7% of patients were completely off PPIs.<\/jats:p>\n                  <jats:p>ARMA improves symptoms, AET, and reflux episodes in reflux-predominant PPI-refractory GERD.<\/jats:p>","DOI":"10.1055\/a-2740-9297","type":"journal-article","created":{"date-parts":[[2025,11,7]],"date-time":"2025-11-07T00:04:32Z","timestamp":1762473872000},"page":"456-464","source":"Crossref","is-referenced-by-count":8,"title":["Role of antireflux mucosal ablation in \u201creflux-predominant\u201d refractory gastroesophageal reflux disease: a randomized sham-controlled trial"],"prefix":"10.1055","volume":"58","clinical-trial-number":[{"clinical-trial-number":"nct05899491","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Digvijay","family":"Chavan","sequence":"additional","affiliation":[{"name":"Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0945-8563","authenticated-orcid":false,"given":"Krithi Krishna","family":"Koduri","sequence":"additional","affiliation":[{"name":"Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aniruddha Pratap","family":"Singh","sequence":"additional","affiliation":[{"name":"Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajesh Goud","family":"Maragoni","sequence":"additional","affiliation":[{"name":"Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3469-0164","authenticated-orcid":false,"given":"Nitin","family":"Jagtap","sequence":"additional","affiliation":[{"name":"Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rakesh","family":"Kalapala","sequence":"additional","affiliation":[{"name":"Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D. Nageshwar","family":"Reddy","sequence":"additional","affiliation":[{"name":"Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2026,1,9]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"871","DOI":"10.1136\/gutjnl-2012-304269","article-title":"Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review","volume":"63","author":"HB El-Serag","year":"2014","journal-title":"Gut"},{"key":"ref2","doi-asserted-by":"crossref","first-page":"1372","DOI":"10.1080\/07853890.2022.2074535","article-title":"Global, regional and national burden of gastroesophageal reflux disease, 1990\u20132019: update from the GBD 2019 study","volume":"54","author":"D Zhang","year":"2022","journal-title":"Ann Med"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"430","DOI":"10.1136\/gutjnl-2016-313589","article-title":"Global prevalence of, and risk factors for, gastro-oesophageal reflux symptoms: a meta-analysis","volume":"67","author":"LH Eusebi","year":"2018","journal-title":"Gut"},{"key":"ref4","doi-asserted-by":"crossref","first-page":"207","DOI":"10.17235\/reed.2016.4232\/2016","article-title":"Proton-pump inhibitors adverse effects: a review of the evidence and position statement by the Sociedad Espa\u00f1ola de Patolog\u00eda Digestiva","volume":"108","author":"C de la Coba Ortiz","year":"2016","journal-title":"Rev Esp Enferm Dig"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"1250","DOI":"10.1053\/j.gastro.2019.12.014","article-title":"Prevalence of gastroesophageal reflux disease and proton pump inhibitor-refractory symptoms","volume":"158","author":"SD Delshad","year":"2020","journal-title":"Gastroenterology"},{"key":"ref6","doi-asserted-by":"publisher","first-page":"19","DOI":"10.1007\/s10620-020-06141-5","article-title":"Direct comparison of the efficacy and safety of vonoprazan versus proton-pump inhibitors for gastroesophageal reflux disease: a systematic review and meta-analysis","volume":"66","author":"Y Cheng","year":"2021","journal-title":"Dig Dis Sci"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"804","DOI":"10.3748\/wjg.v20.i3.804","article-title":"Systematic review: laparoscopic fundoplication for gastroesophageal reflux disease in partial responders to proton pump inhibitors","volume":"20","author":"L Lundell","year":"2014","journal-title":"World J Gastroenterol"},{"key":"ref8","doi-asserted-by":"crossref","first-page":"6601","DOI":"10.3748\/wjg.v27.i39.6601","article-title":"Endoscopic anti-reflux therapy for gastroesophageal reflux disease","volume":"27","author":"E Rodr\u00edguez de Santiago","year":"2021","journal-title":"World J Gastroenterol"},{"key":"ref9","doi-asserted-by":"publisher","first-page":"E239","DOI":"10.1055\/a-1322-2209","article-title":"Long-term outcomes of transoral incisionless fundoplication for gastro-esophageal reflux disease: systematic-review and meta-analysis","volume":"9","author":"S Testoni","year":"2021","journal-title":"Endosc Int Open"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"818","DOI":"10.1007\/s00464-009-0671-4","article-title":"A prospective randomized trial of sham, single-dose Stretta, and double-dose Stretta for the treatment of gastroesophageal reflux disease","volume":"24","author":"AMA Aziz","year":"2010","journal-title":"Surg Endosc"},{"key":"ref11","doi-asserted-by":"crossref","first-page":"686","DOI":"10.1136\/gutjnl-2020-321811","article-title":"Endoscopic full-thickness plication for the treatment of PPI-dependent GERD: results from a randomised, sham controlled trial","volume":"71","author":"R Kalapala","year":"2022","journal-title":"Gut"},{"key":"ref12","doi-asserted-by":"crossref","first-page":"1566","DOI":"10.1007\/s11605-022-05396-9","article-title":"Objective outcomes of an extended anti-reflux mucosectomy in the treatment of PPI-dependent gastroesophageal reflux disease (with video)","volume":"26","author":"J He","year":"2022","journal-title":"J Gastrointest Surg"},{"key":"ref13","first-page":"346","article-title":"Anti-reflux mucosectomy for gastroesophageal reflux disease in the absence of hiatus hernia: a pilot study","volume":"27","author":"H Inoue","year":"2014","journal-title":"Ann Gastroenterol"},{"key":"ref14","doi-asserted-by":"crossref","first-page":"1190","DOI":"10.1016\/j.gie.2020.04.046","article-title":"Clinical feasibility of a new antireflux ablation therapy on gastroesophageal reflux disease (with video)","volume":"92","author":"OV Hern\u00e1ndez Mondrag\u00f3n","year":"2020","journal-title":"Gastrointest Endosc"},{"key":"ref15","doi-asserted-by":"publisher","first-page":"149","DOI":"10.1111\/jgh.16370","article-title":"Clinical outcomes of anti-reflux mucosal ablation for gastroesophageal reflux disease: An international bi-institutional study","volume":"39","author":"Y Shimamura","year":"2024","journal-title":"J Gastroenterol Hepatol"},{"key":"ref16","doi-asserted-by":"crossref","first-page":"347","DOI":"10.1111\/den.13727","article-title":"Endoscopic treatment of proton pump inhibitor-refractory gastroesophageal reflux disease with anti-reflux mucosectomy: Experience of 109 cases","volume":"33","author":"K Sumi","year":"2021","journal-title":"Dig Endosc"},{"key":"ref17","doi-asserted-by":"publisher","first-page":"E133","DOI":"10.1055\/a-1031-9436","article-title":"Anti-reflux mucosal ablation (ARMA) as a new treatment for gastroesophageal reflux refractory to proton pump inhibitors: a pilot study","volume":"8","author":"H Inoue","year":"2020","journal-title":"Endosc Int Open"},{"key":"ref18","doi-asserted-by":"crossref","first-page":"E1740","DOI":"10.1055\/a-1552-3239","article-title":"Antireflux mucosectomy (ARMS) and antireflux mucosal ablation (ARMA) for gastroesophageal reflux disease: a systematic review and meta-analysis","volume":"9","author":"E Rodr\u00edguez de Santiago","year":"2021","journal-title":"Endosc Int Open"},{"key":"ref19","doi-asserted-by":"publisher","first-page":"687","DOI":"10.1111\/den.14169","article-title":"Endoscopic management of gastroesophageal reflux disease: Panacea for proton pump inhibitors dependent\/refractory patients","volume":"34","author":"R Kalapala","year":"2022","journal-title":"Dig Endosc"},{"key":"ref20","doi-asserted-by":"publisher","first-page":"690","DOI":"10.1111\/den.14711","article-title":"Pilot study on anti-reflux mucoplasty: Advancing endoscopic anti-reflux therapy for gastroesophageal reflux disease","volume":"36","author":"H Inoue","year":"2024","journal-title":"Dig Endosc"},{"key":"ref21","doi-asserted-by":"publisher","first-page":"361","DOI":"10.1136\/gutjnl-2023-330616","article-title":"Updates to the modern diagnosis of GERD: Lyon consensus 2.0","volume":"73","author":"CP Gyawali","year":"2024","journal-title":"Gut"},{"key":"ref22","doi-asserted-by":"publisher","first-page":"35","DOI":"10.1155\/2011\/626752","article-title":"What is nonacid reflux disease?","volume":"25","author":"MA Storr","year":"2011","journal-title":"Can J Gastroenterol"},{"key":"ref23","doi-asserted-by":"crossref","first-page":"929","DOI":"10.1007\/s10620-020-06400-5","article-title":"Non-acid reflux: what to do when you don\u2019t feel the burn","volume":"66","author":"A Horton","year":"2021","journal-title":"Dig Dis Sci"},{"key":"ref24","doi-asserted-by":"publisher","first-page":"994","DOI":"10.1007\/s10620-020-06348-6","article-title":"Provider variability in the management patterns of increased nonacid reflux","volume":"66","author":"CA Reddy","year":"2021","journal-title":"Dig Dis Sci"},{"key":"ref25","doi-asserted-by":"publisher","first-page":"252","DOI":"10.1007\/s11894-008-0052-5","article-title":"Refractory GERD: what is it?","volume":"10","author":"R Fass","year":"2008","journal-title":"Curr Gastroenterol Rep"},{"key":"ref26","doi-asserted-by":"publisher","first-page":"15","DOI":"10.1016\/j.mcna.2018.08.002","article-title":"Proton pump inhibitor\u2013refractory gastroesophageal reflux disease","volume":"103","author":"R Yadlapati","year":"2019","journal-title":"Med Clin N Am"},{"key":"ref27","doi-asserted-by":"publisher","first-page":"17","DOI":"10.5056\/jnm23145","article-title":"Refractory gastroesophageal reflux disease: diagnosis and management","volume":"30","author":"TA Davis","year":"2024","journal-title":"J Neurogastroenterol Motil"},{"key":"ref28","doi-asserted-by":"publisher","first-page":"1340","DOI":"10.1136\/gutjnl-2011-301897","article-title":"Diagnosis and management of patients with reflux symptoms refractory to proton pump inhibitors","volume":"61","author":"D Sifrim","year":"2012","journal-title":"Gut"},{"key":"ref29","doi-asserted-by":"publisher","first-page":"1023","DOI":"10.1002\/bjs.6684","article-title":"Oesophageal acid hypersensitivity is not a contraindication to Nissen fundoplication","volume":"96","author":"JA Broeders","year":"2009","journal-title":"Br J Surg"},{"key":"ref30","doi-asserted-by":"publisher","first-page":"1382","DOI":"10.1111\/nmo.12838","article-title":"Prevalence, characteristics, and treatment outcomes of reflux hypersensitivity detected on pH-impedance monitoring","volume":"28","author":"A Patel","year":"2016","journal-title":"Neurogastroenterol Motil"},{"key":"ref31","doi-asserted-by":"publisher","first-page":"446","DOI":"10.1016\/j.gie.2009.10.027","article-title":"A lexicon for endoscopic adverse events: report of an ASGE workshop","volume":"71","author":"PB Cotton","year":"2010","journal-title":"Gastrointest Endosc"},{"key":"ref32","doi-asserted-by":"publisher","first-page":"1419","DOI":"10.1038\/ajg.2011.146","article-title":"Response of regurgitation to proton pump inhibitor therapy in clinical trials of gastroesophageal reflux disease","volume":"106","author":"PJ Kahrilas","year":"2011","journal-title":"Am J Gastroenterol"},{"key":"ref33","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2024-081123","article-title":"CONSORT 2025 statement: updated guideline for reporting randomised trials","volume":"389","author":"S Hopewell","year":"2025","journal-title":"BMJ"},{"key":"ref34","doi-asserted-by":"publisher","first-page":"288","DOI":"10.1067\/mge.2003.361","article-title":"Circumferential EMR of carcinoma arising in Barrett\u2019s esophagus: case report","volume":"58","author":"H Satodate","year":"2003","journal-title":"Gastrointest Endosc"}],"container-title":["Endoscopy"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1055\/a-2740-9297.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,22]],"date-time":"2026-04-22T22:52:15Z","timestamp":1776898335000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.thieme-connect.de\/DOI\/DOI?10.1055\/a-2740-9297"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,6]]},"references-count":34,"journal-issue":{"issue":"05","published-online":{"date-parts":[[2026,4,22]]},"published-print":{"date-parts":[[2026,5]]}},"URL":"https:\/\/doi.org\/10.1055\/a-2740-9297","archive":["Portico","CLOCKSS"],"relation":{},"ISSN":["0013-726X","1438-8812"],"issn-type":[{"value":"0013-726X","type":"print"},{"value":"1438-8812","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2025,11,6]]},"published":{"date-parts":[[2025,11,6]]}}}