title: Helicobacter pylori eradication does not exacerbate reflux symptoms in gastroesophageal reflux disease.
abstract: OBJECTIVE
  Observational studies have suggested that Helicobacter pylori may protect against gastrointestinal reflux disease (GERD), but these results could be due to bias or confounding factors. We addressed this in a prospective, double blind, randomized, controlled trial.
  
  
  METHODS
  H. pylori-positive patients with at least a 1-year history of heartburn with a normal endoscopy or grade A esophagitis were recruited. Patients were randomized to 20 mg omeprazole, 250 mg clarithromycin, and 500 mg tinidazole twice a day for 1 week or 20 mg omeprazole twice a day and identical placebos. A second concurrently recruited control group of H. pylori-negative patients were given open label 20 mg omeprazole twice a day for 1 week. All patients received 20 mg omeprazole twice a day for the following 3 weeks and 20 mg omeprazole once daily for a further 4 weeks. Omeprazole was discontinued at 8 weeks and patients were followed up for a further 10 months. A relapse was defined as moderate or severe reflux symptoms. H. pylori eradication was determined by 13C-urea breath test.
  
  
  RESULTS
  The H. pylori-positive cases were randomized to antibiotics (n = 93) or placebo (n = 97). Relapse of GERD occurred in 83% of each of the antibiotic, placebo, and H. pylori-negative groups during the 12-month study period. Life tables revealed no statistical difference between the 2 H. pylori-positive groups (log rank test, P = 0.84) or between the 3 groups (log rank test, P = 0.94) in the time to first relapse. Two patients in each group developed grade B esophagitis at 12 months.
  
  
  CONCLUSIONS
  H. pylori eradication therapy does not seem to influence relapse rates in GERD patients.
authors.affiliation: The General Infirmary at Leeds, West Yorkshire, England. p.moayyedi@bham.ac.uk
authors.forename: P
authors.initials: P
authors.lastname: Moayyedi
authors.forename: C
authors.initials: C
authors.lastname: Bardhan
authors.forename: L
authors.initials: L
authors.lastname: Young
authors.forename: M F
authors.initials: MF
authors.lastname: Dixon
authors.forename: L
authors.initials: L
authors.lastname: Brown
authors.forename: A T
authors.initials: AT
authors.lastname: Axon
mesh_terms: D000328:Adult; D000368:Aged; D017291:Clarithromycin / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D005764:Gastroesophageal Reflux / Q000209:etiology*; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage; D011446:Prospective Studies; D012008:Recurrence; D014011:Tinidazole / Q000008:administration & dosage
chemical_list: D014011:Tinidazole; D017291:Clarithromycin; D009853:Omeprazole