BMJ 1999;318:833-837 ( 27 March )

Papers

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

Nicholas J Talley, professor, a Jef Janssens, professor, b Karsten Lauritsen, specialist, c István Rácz, specialist, d Elisabeth Bolling-Sternevald, scientist, e on behalf of the Optimal Regimen Cures Helicobacter Induced Dyspepsia (ORCHID) Study Group.

a Department of Medicine, University of Sydney, Nepean Hospital, Penrith, New South Wales 2751, Australia, b KUL Gasthuisberg, Dienst Maag-en Darmziekten, Leuven, Belgium 3000, c Department of Medical Gastroenterology, Odense University, Denmark 5000, d Petz Aladar Teaching and County Hospital, Eyôr, Hungary 9002, e Department of Biomedicine and Surgery, University of Linköping, Molndal, Sweden 581 85

Correspondence to: Professor Talley talley{at}pnc.com.au

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.


Key messages

  • 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




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