Author(s): Talley NJ, Janssens J, Lauritsen K, Rcz I, BollingSternevald E
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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.
This article was published in BMJ
and referenced in General Medicine: Open Access