title: Reduced medication dependency and improved symptoms and quality of life 12 months after enteryx implantation for gastroesophageal reflux.
abstract: BACKGROUND
  The need is well recognized for additional data on endoluminal therapies for gastroesophageal reflux disease (GERD). This prospective multicenter clinical trial was designed to assess safety and effectiveness of Enteryx, a nonresorbable copolymer implanted into the lower esophagus, in reducing usage of proton pump inhibitors (PPIs) and improving reflux symptoms and quality of life.
  
  
  METHODS
  Enteryx implantation was performed under fluoroscopic visualization without general anesthesia in 93 patients with symptomatic GERD responsive to and relapsing upon cessation of PPI therapy. Subjective and objective data were collected up to 12 months postprocedure. The criterion for treatment success was reduction in PPI dosage of > or =50%.
  
  
  RESULTS
  At 12 months, treatment success was attained in 86% (confidence interval, 77%-93%) of 74 evaluable patients and elimination of PPI therapy in 65% (confidence interval, 53%-76%). The treatment success rate by intent-to-treat analysis was 69% (confidence interval, 58%-78%). Reflux-related heartburn (P < 0.0001), regurgitation symptoms (P = 0.0005), and physical (P < 0.0001) and mental quality of life (P = 0.0012) scores improved. The most frequent complications were chest pain (77%), dysphagia/odynophagia (27%), and sensation of fever (26%).
  
  
  CONCLUSIONS
  Enteryx implantation provides an effective and safe alternative for management of gastroesophageal reflux, reducing medication dependency and symptoms and enhancing quality of life.
authors.affiliation: Medizinische Klinik, Evangelisches Krankenhaus Düsseldorf, Kirchfeldstrasse 40, 40217 Düsseldorf, Germany. BrgSchumacher@aol.com
authors.forename: Brigitte
authors.initials: B
authors.lastname: Schumacher
authors.forename: Horst
authors.initials: H
authors.lastname: Neuhaus
authors.forename: Marianne
authors.initials: M
authors.lastname: Ortner
authors.forename: René
authors.initials: R
authors.lastname: Laugier
authors.forename: Martin
authors.initials: M
authors.lastname: Benson
authors.forename: Jean
authors.initials: J
authors.lastname: Boyer
authors.forename: Thierry
authors.initials: T
authors.lastname: Ponchon
authors.forename: Friedrich
authors.initials: F
authors.lastname: Hagenmüller
authors.forename: Jean-Charles
authors.initials: JC
authors.lastname: Grimaud
authors.forename: Patrick
authors.initials: P
authors.lastname: Rampal
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Rey
authors.forename: Karl-Hermann
authors.initials: KH
authors.lastname: Fuchs
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Allgaier
authors.forename: Jürgen
authors.initials: J
authors.lastname: Hochberger
authors.forename: Hubert J
authors.initials: HJ
authors.lastname: Stein
authors.forename: Juan Andrés Ramírez
authors.initials: JA
authors.lastname: Armengol
authors.forename: Peter D
authors.initials: PD
authors.lastname: Siersema
authors.forename: Jacques
authors.initials: J
authors.lastname: Devière
mesh_terms: D005260:Female; D005764:Gastroesophageal Reflux / Q000175:diagnosis / Q000188:drug therapy / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011145:Polyvinyls; D011446:Prospective Studies; D054328:Proton Pump Inhibitors; D011788:Quality of Life; D013997:Time Factors
chemical_list: D011145:Polyvinyls; D054328:Proton Pump Inhibitors; C020320:ethylene-vinyl alcohol copolymer