Helicobacter pylori eradication does not exacerbate reflux symptoms in gastroesophageal reflux disease

Background & Aims: Observational studies have suggested that Helicobacter p ylori 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. pylo ri-positive patients with at least a 1-year history of heartburn with a. no rmal endoscopy or grade A esophagitis were recruited. Patients were randomi zed to 20 mg omeprazole, 250 mg clarithromycin, and 500 mg tinidazole twice a day for I 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 patient s 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 a t 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 wa s determined by (13)G-urea breath test. Results. The H. pylori-positive cas es 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-nega tive groups during the 12-month study period. Life tables revealed no stati stical 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 f irst relapse. Two patients in each group developed grade B esophagitis at 1 2 months. Conclusions: H. pylori eradication therapy does not seem to influ ence relapse rates in GERD patients.