{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,2]],"date-time":"2026-01-02T07:35:15Z","timestamp":1767339315483,"version":"3.46.0"},"reference-count":26,"publisher":"BMJ","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Gut"],"published-print":{"date-parts":[[2007,1]]},"abstract":"<jats:p>\n                    <jats:bold>Background:<\/jats:bold>\n                    Endoscopic treatment for gastro-oesophageal reflux disease (GORD) is rapidly emerging, but there is a great need for randomised controlled trials to evaluate the efficacy.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Design and setting:<\/jats:bold>\n                    A single-centre, double-blind, randomised, sham-controlled trial of endoscopic gastroplication by the Endocinch suturing system.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Patients and interventions:<\/jats:bold>\n                    60 patients with GORD were randomly assigned to three endoscopic gastroplications (n\u200a=\u200a20), a sham procedure (n\u200a=\u200a20) or observation (n\u200a=\u200a20). The research nurse and patients in the active and sham groups were blinded to the procedure assignment. After 3 months, open-label active treatment was offered to all patients.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Outcome measures:<\/jats:bold>\n                    The primary outcome measures were proton pump inhibitor (PPI) use and GORD symptoms, and secondary measures were quality of life, 24-h oesophageal acid exposure, oesophageal manometry and adverse events. Follow-up assessments were performed at 3, 6 and 12 months.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Results:<\/jats:bold>\n                    At 3 months, the percentage of patients who had reduced drug use by \u2a7e50% was greater in the active treatment group (65%) than in the sham (25%) or observation groups (0%) (p&lt;0.02). Symptoms (heartburn and to a lesser extent regurgitation) improved more in the active group than in the sham group. Three Short Form-20 quality of life subscales (role function, general health and bodily pain perception) improved in the active group versus sham. Oesophageal acid exposure was modestly decreased after active treatment (p&lt;0.02), but not significantly greater than after the sham procedure (p\u200a=\u200a0.61). The active treatment effects on PPI use, symptoms and quality of life persisted after 6 and 12 months of open-label follow-up (n\u200a=\u200a41), but 29% of patients were retreated in this period. No serious adverse events occurred.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Conclusions:<\/jats:bold>\n                    Endoscopic gastroplication, using the Endocinch device, reduced acid-inhibitory drug use, improved GORD symptoms and improved the quality of life at 3 months compared with a sham procedure. The effects persisted up to 12 months. However, the reduction in oesophageal acid exposure was not greater after endoscopic treatment than after a sham procedure.\n                  <\/jats:p>","DOI":"10.1136\/gut.2006.096842","type":"journal-article","created":{"date-parts":[[2006,6,8]],"date-time":"2006-06-08T20:49:09Z","timestamp":1149799749000},"page":"20-28","source":"Crossref","is-referenced-by-count":99,"title":["Endoscopic gastroplication for the treatment of gastro-oesophageal reflux disease: a randomised, sham-controlled trial"],"prefix":"10.1136","volume":"56","author":[{"given":"M P","family":"Schwartz","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"H","family":"Wellink","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"H G","family":"Gooszen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J 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