title: The effect of Helicobacter pylori infection and eradication in patients with gastro-oesophageal reflux disease: A parallel-group, double-blind, placebo-controlled multicentre study.
abstract: OBJECTIVE
  This study aimed to resolve controversy regarding the effects of Helicobacter pylori eradication therapy and H. pylori infection in gastro-oesophageal reflux disease.
  
  
  METHODS
  A randomized, double-blind, multicentre trial was performed in patients presenting with reflux symptoms. H. pylori-positive patients were randomized to receive either antibiotics or placebo for 7 days. H. pylori-negative patient controls received placebo. All received esomeprazole 20 mg b.d. for 7 days, followed by 40 mg o.d. to complete an 8-week course, and were followed up for 32 weeks by telephone.
  
  
  RESULTS
  In this study, 198/589 (34%) patients were H. pylori-positive and 113 H. pylori-negative patients served as controls. Baseline endoscopy revealed 63% Los Angeles grade 0A and 37% Los Angeles grade BCD oesophagitis with no difference between patient groups. Symptom improvement on esomeprazole was seen in 89%. H. pylori eradication was successful in 82%. H. pylori eradication had no effect on symptomatic relapse (hazard ratio 1.15, 95% CI 0.74-1.8; p = 0.5). Overall, H. pylori-positive patients had a lower probability of relapse compared to H. pylori-negative controls (hazard ratio 0.6, 95% CI 0.43-0.85; p = 0.004). Relapse hazard was modulated also by oesophagitis grade (BCD vs. 0A, hazard ratio 2.1, 95% CI 1.5-3.0).
  
  
  CONCLUSIONS
  Relapse of gastro-oesophageal reflux disease symptoms after a course of high dose acid suppression took longer for H. pylori-positive patients than H. pylori-negative controls; however eradication therapy had no effect on the risk of relapse; ClincialTrials.gov number, NCT00574925.
authors.affiliation: University Hospital Zürich, Zürich, Switzerland ; Zurich Center for Integrative Human Physiology (ZIHP), Zurich, Switzerland.
authors.forename: Werner
authors.initials: W
authors.lastname: Schwizer
authors.affiliation: Menne Biomed, Tübingen, Germany.
authors.forename: Dieter
authors.initials: D
authors.lastname: Menne
authors.affiliation: Hanusch-Hospital, Vienna, Austria.
authors.forename: Kurt
authors.initials: K
authors.lastname: Schütze
authors.affiliation: Institute for Pathology, Klinikum Bayreuth, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Vieth
authors.affiliation: Institute for Pathology, Klinikum Bayreuth, Germany.
authors.forename: Reiner
authors.initials: R
authors.lastname: Goergens
authors.affiliation: Otto-von-Guericke-University, Magdeburg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Malfertheiner
authors.affiliation: Klinikum der Philipps-Universität, Marburg, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Leodolter
authors.affiliation: University Hospital Zürich, Zürich, Switzerland ; Zurich Center for Integrative Human Physiology (ZIHP), Zurich, Switzerland.
authors.forename: Michael
authors.initials: M
authors.lastname: Fried
authors.affiliation: University Hospital Zürich, Zürich, Switzerland ; Zurich Center for Integrative Human Physiology (ZIHP), Zurich, Switzerland ; NIHR Nottingham Digestive Diseases Biomedical Research Unit, Nottingham University Hospitals, Nottingham, UK.
authors.forename: Mark R
authors.initials: MR
authors.lastname: Fox
keywords: H. pylori eradication therapy; Helicobacter pylori; esomeprazole; gastritis; gastro-oesophageal reflux disease; oesophagitis; symptomatic relapse