Helicobacter pylori eradication does not cause reflux oesophagitis in functional dyspeptic patients:: a randomized, investigator-blinded, placebo-controlled trial

Background: The protective role of Helicobacter pylori in gastro-oesophageal reflux disease has been widely discussed. Aim: To assess the risk of reflux oesophagitis in patients with functional dyspepsia after treatment for H. pylori infection. Methods: A randomized, placebo-controlled, investigator-blinded trial was carried out on 157 functional dyspeptic patients. Patients were randomized to receive lansoprazole, amoxicillin and clarithromycin (antibiotic group) or lansoprazole and identical antibiotic placebos (control group). Upper gastrointestinal endoscopy was performed at baseline, 3 and 12 months after randomization. The primary aim was to detect the presence of reflux oesophagitis. Analyses were performed on an intention-to-treat basis. Results: A total of 147 patients (94%) and 133 (85%) completed 3 months and 12 months follow-up, respectively. The eradication rate of H. pylori was 90% in the antibiotic group (74 of 82) and 1% (one of 75) in the control group. At 3 months, reflux oesophagitis was diagnosed in 3.7% (three of 82) in the antibiotic group and 4% (three of 75) in the control group (P > 0.2). At 12 months, diagnosis was established in five new cases within the first group and in four within the second (P > 0.2). No difference was found in heartburn symptoms. Conclusions: H. pylori eradication does not cause reflux oesophagitis in this western population of functional dyspeptic patients.