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Treating Helicobacter pylori infection in primary care patients with uninvestigated dyspepsia: the Canadian adult dyspepsia empiric treatment—Helicobacter pylori positive (CADET-Hp) randomised controlled trial

BMJ 2002; 324 doi: https://doi.org/10.1136/bmj.324.7344.1012 (Published 27 April 2002) Cite this as: BMJ 2002;324:1012
  1. Naoki Chiba, associate clinical professor of medicine (chiban{at}on.aibn.com)a,
  2. Sander J O Veldhuyzen van Zanten, professor of medicineb,
  3. Paul Sinclair, research scientistc,
  4. Ralph A Ferguson, research scientistc,
  5. Sergio Escobedo, statisticianc,
  6. Eileen Grace, health economistc
  1. a Division of Gastroenterology, McMaster University, Hamilton, ON, Canada L8N 3Z5
  2. b Division of Gastroenterology, Dalhousie University, Halifax, NS, Canada B3H 2Y9
  3. c AstraZeneca Canada Inc, 1004 Middlegate Road, Mississauga, ON, Canada L4Y 1M4
  1. Correspondence to: N Chiba, Surrey GI Clinic/Research, 105-21 Surrey Street West, Guelph, ON, Canada N1H 3R3
  • Accepted 25 January 2002

Abstract

Objective: To determine whether a “test for Helicobacter pylori and treat” strategy improves symptoms in patients with uninvestigated dyspepsia in primary care.

Design: Randomised placebo controlled trial.

Setting: 36 family practices in Canada.

Participants: 294 patients positive for H pylori (13C- urea breath test) with symptoms of dyspepsia of at least moderate severity in the preceding month.

Intervention: Participants were randomised to twice daily treatment for 7 days with omeprazole 20 mg, metronidazole 500 mg, and clarithromycin 250 mg or omeprazole 20 mg, placebo metronidazole, and placebo clarithromycin. Patients were then managed by their family physicians according to their usual care.

Main outcome measures: Treatment success defined as no symptoms or minimal symptoms of dyspepsia at the end of one year. Societal healthcare costs collected prospectively for a secondary evaluation of actual mean costs.

Results: In the intention to treat population (n=294), eradication treatment was significantly more effective than placebo in achieving treatment success (50% v 36%; P=0.02; absolute risk reduction=14%; number needed to treat=7, 95% confidence interval 4 to 63). Eradication treatment cured H pylori infection in 80% of evaluable patients. Treatment success at one year was greater in patients negative for H pylori than in those positive for H pylori (54% v 39%; P=0.02). Eradication treatment reduced mean annual cost by $C53 (Embedded Image86 to 180) per patient.

Conclusions: A “test for H pylori with 13C-urea breath test and eradicate” strategy shows significant symptomatic benefit at 12 months in the management of primary care patients with uninvestigated dyspepsia.

What is already known on this topic

What is already known on this topic Dyspepsia is a common problem in primary health care, although controversy exists about its definition

Studies of H pylori eradication in patients with uninvestigated dyspepsia have shown reduced need for endoscopy and thus significant cost savings compared with a strategy of prompt endoscopy

The “test for H pylori and treat” strategy has been recommended for uninvestigated dyspepsia, but there have been no randomised controlled trials showing improvement in symptoms

What this study adds

What this study adds When given eradication treatment in primary care, H pylori positive patients with uninvestigated dyspepsia show improvement in overall dyspepsia symptoms at 12 months

This supports the “test for H pylori and treat” strategy

Footnotes

  • Funding The study was financially supported by AstraZeneca Canada Inc.

  • Competing interests NC and SJOVvanZ have acted as consultants and have received research support and honorariums for giving talks on this subject by the sponsor, AstraZeneca Canada, who manufacture omeprazole. PS and RAF are former employees of AstraZeneca Canada, and SE and EG are current employees of AstraZeneca Canada (sponsors of the study).

  • Accepted 25 January 2002
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