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

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Abstract
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, amoxicillin 1000 mg twice daily, and clarithromycin 500 mg twice daily or placebo 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 13C-urea breath testing using urea labelled with carbon-13). Results: H pylori was eradicated in 113 patients (85%) in the treatment group and 6 patients (4%) in the placebo group. At 12 months follow up there was no significant difference between the proportion of patients treated successfully 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 symptom scores and quality of life did not significantly differ between the treatment and placebo groups. When the groups were combined, there was a significant association between treatment success and chronic gastritis score at 12 months; 41/127 (32%) patients with no or mild gastritis were successfully treated compared with 21/123 (17%) patients with persistent gastritis (P=0.008). Conclusion: No convincing evidence was found that eradication of H pylori relieves the symptoms of functional dyspepsia 12 months after treatment. Dyspepsia (pain or discomfort centred in the upper abdomen) is frequently unexplained; such patients are classed as having functional (or non-ulcer) dyspepsia H pylori gastritis is common in patients with functional dyspepsia but the benefits of treatment are controversial No significant benefit in relief of symptoms was found between patients successfully treated for H pylori infection and those with persistent infection Eradication of H pylori does not relieve the symptoms of functional dyspepsia