Eradication of Helicobacter pylori in functional dyspepsia: randomised double blind placebo controlled trial with 12 months' follow up. The Optimal Regimen Cures Helicobacter Induced Dyspepsia (ORCHID) Study Group

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.

Figure 1

Flow of participants through trial

Figure 2

Proportion of patients with no more than minimal dyspepsia symptoms on basis of diary card data (per protocol analysis)

Figure 3

Mean symptom score and SEM on diary cards at follow up visits

Figure 4

Intention to treat analysis showing mean (SEM) scores for quality of life and severity of symptoms in patients with functional dyspepsia. Possible psychological well being index scores (top) ranged from 132 (best) to 22 (worst); possible gastrointestinal symptom rating scale (bottom) mean scores ranged from 1 (no symptoms) to 7 (worst symptoms)