title: Efficacy of endoluminal gastroplication in Japanese patients with proton pump inhibitor-resistant, non-erosive esophagitis.
abstract: OBJECTIVE
  To evaluate the efficacy, safety, and long-term outcomes of endoluminal gastroplication (ELGP) in patients with proton pump inhibitor (PPI)-resistant, non-erosive reflux disease (NERD).
  
  
  METHODS
  The subjects were NERD patients, diagnosed by upper endoscopy before PPI use, who had symptoms such as heartburn or reflux sensations two or more times a week even after 8 wk of full-dose PPI treatment. Prior to ELGP, while continuing full-dose PPI medication, patients' symptoms and quality of life (QOL) were assessed using the questionnaire for the diagnosis of reflux disease, the frequency scale for symptoms of gastro-esophageal reflux disease (FSSG), gastrointestinal symptoms rating scale, a 36-item short-form. In addition, 24-h esophageal pH monitoring or 24-h intraesophageal pH/impedance (MII-pH) monitoring was performed. The Bard EndoCinch(TM) was used for ELGP, and 2 or 3 plications were made. After ELGP, all acid reducers were temporarily discontinued, and medication was resumed depending on the development and severity of symptoms. Three mo after ELGP, symptoms, QOL, pH or MII-pH monitoring, number of plications, and PPI medication were evaluated. Further, symptoms, number of plications, and PPI medication were evaluated 12 mo after ELGP to investigate long-term effects.
  
  
  RESULTS
  The mean FSSG score decreased significantly from before ELGP to 3 and 12 mo after ELGP (19.1 ± 10.5 to 10.3 ± 7.4 and 9.3 ± 9.9, P < 0.05, respectively). The total number of plications decreased gradually at 3 and 12 mo after ELGP (2.4 ± 0.8 to 1.2 ± 0.8 and 0.8 ± 1.0, P < 0.05, respectively). The FSSG scores in cases with no remaining plications and in cases with one or more remaining plications were 4.4 and 2.7, respectively, after 3 mo, and 2.0 and 2.8, respectively, after 12 mo, showing no correlation to plication loss. On pH monitoring, there was no difference in the percent time pH < 4 from before ELGP to 3 mo after. Impedance monitoring revealed no changes in the number of reflux episodes or the symptom index for reflux events from before ELGP to 3 mo after, but the symptom sensitivity index decreased significantly 3 mo after ELGP (16.1 ± 12.9 to 3.9 ± 8.3, P < 0.01). At 3 mo after ELGP, 6 patients (31.6%) had reduced their PPI medication by 50% or more, and 11 patients (57.9%) were able to discontinue PPI medication altogether. After 12 mo, 3 patients (16.7%) were able to reduce the amount of PPI medication by 50% or more, and 12 patients (66.7%) were able to discontinue PPI medication altogether. A high percentage of cases with remaining plications had discontinued PPIs medication after 3 mo, but there was no difference after 12 mo. No serious complications were observed in this study.
  
  
  CONCLUSIONS
  ELGP was safe, resulted in significant improvement in subjective symptoms, and allowed less medication to be used over the long term in patients with PPI-refractory NERD.
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Aichi Medical University School of Medicine, Aichi 480-1195, Japan. namike@aichi-med-u.ac.jp
authors.forename: Kentaro
authors.initials: K
authors.lastname: Tokudome
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Funaki
authors.forename: Makoto
authors.initials: M
authors.lastname: Sasaki
authors.forename: Shinya
authors.initials: S
authors.lastname: Izawa
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Tamura
authors.forename: Akihito
authors.initials: A
authors.lastname: Iida
authors.forename: Naotaka
authors.initials: N
authors.lastname: Ogasawara
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Konagaya
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Tokura
authors.forename: Kunio
authors.initials: K
authors.lastname: Kasugai
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D016009:Chi-Square Distribution; D004351:Drug Resistance; D017097:Electric Impedance; D050782:Esophageal pH Monitoring; D004941:Esophagitis / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology / Q000601:surgery*; D005260:Female; D018662:Fundoplication / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D054328:Proton Pump Inhibitors
keywords: Endoluminal gastroplication; Esophageal pH; Gastro-esophageal reflux disease; Non-erosive reflux disease; Proton pump inhibitor-resistant