Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 1999 Mar 27;318(7187):833-7.
doi: 10.1136/bmj.318.7187.833.

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

N J Talley  1 , J Janssens, K Lauritsen, I Rácz, E Bolling-Sternevald
Affiliations
Clinical Trial

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

N J Talley et al. BMJ. .

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.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Flow of participants through trial
Figure 2
Figure 2
Proportion of patients with no more than minimal dyspepsia symptoms on basis of diary card data (per protocol analysis)
Figure 3
Figure 3
Mean symptom score and SEM on diary cards at follow up visits
Figure 4
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)
See this image and copyright information in PMC

Comment in

References

    1. Talley NJ, Colin-Jones D, Koch KL, Koch M, Nyrén O, Stanghellini V. Functional dyspepsia. A classification with guidelines for diagnosis and management. Gastroenterol Int. 1991;4:145–160.
    1. Bernersen B, Johnsen R, Bostad L, Straume B, Sommer AI, Burhol PG. Is Helicobacter pylori the cause of dyspepsia? BMJ. 1992;304:1276–1279. - PMC - PubMed
    1. Armstrong D. Helicobacter pylori infection and dyspepsia. Scand J Gastroenterol. 1996;31(suppl 215):38–47. - PubMed
    1. Bytzer P. Diagnosing dyspepsia—any controversies left? Gastroenterology. 1996;110:302–306. - PubMed
    1. Strauss RM, Wang TC, Kelsey PB, Campton CC, Ferraro MT, Perez-Perez G, et al. Association of Helicobacter pylori infection with dyspeptic symptoms in patients undergoing gastroduodenoscopy. Am J Med. 1990;89:464–469. - PubMed

Publication types