Eradication of Helicobacter pylori in functional dyspepsia: randomised double blind placebo controlled trial with 12 months' follow up

Objectives To determine whether eradication of Helicobacter pylori relieves the symptoms of functional dyspepsia. Design Multicentre randomised double blind placebo controlled trial. Subjects 278 patients infected with H pylori who had functional dyspepsia. Setting Predominantly secondary care centres in Australia, New Zealand, and Europe. Intervention Patients randomised to receive omeprazole 20 mg twice daily, a moxicillin 1000 mg twice daily, and clarithromycin 500 mg twice daily or pl acebo for 7 days. Patients were followed up for 12 months. Main outcome measures Symptom status (assessed by diary cards) and presence of H pylori (assessed by gastric biopsies and C-13-urea breath testing usi ng urea labelled with carbon-13). Results H pylori was eradicated in 113 patients (85%) in the treatment grou p and 6 patients (4%) in the placebo group. At 12 months follow up there wa s no significant difference between the proportion of patients treated succ essfully by intention to treat in the eradication arm (24%, 95% confidence interval 17% to 32%) and the proportion of patients treated successfully by intention to treat in the placebo group (22%, 15% to 30%). Changes in symp tom scores and quality of life did not significantly differ between the tre atment and placebo groups. When the groups were combined, there was a signi ficant association between treatment success and chronic gastritis score at 12 months; 41/127 (32%) patients with no or mild gastritis were successful ly treated compared with 21/123 (17%) patients with persistent gastritis (P = 0.008). Conclusion No convincing evidence was found that eradication of H pylori re lieves the symptoms of functional dyspepsia 12 months after treatment.