Helicobacter pylori test and treat versus proton pump inhibitor in initial management of dyspepsia in primary care: multicentre randomised controlled trial (MRC-CUBE trial).

Abstract

OBJECTIVE:

To determine the cost effectiveness of Helicobacter pylori "test and treat" compared with empirical acid suppression in the initial management of patients with dyspepsia in primary care.

DESIGN:

Randomised controlled trial.

SETTING:

80 general practices in the United Kingdom.

PARTICIPANTS:

699 patients aged 18-65 who presented to their general practitioner with epigastric pain, heartburn, or both without "alarm symptoms" for malignancy.

INTERVENTION:

H pylori 13C urea breath test plus one week of eradication treatment if positive or proton pump inhibitor alone; subsequent management at general practitioner's discretion.

MAIN OUTCOME MEASURES:

Cost effectiveness in cost per quality adjusted life year (QALY) (EQ-5D) and effect on dyspeptic symptoms at one year measured with short form Leeds dyspepsia questionnaire.

RESULTS:

343 patients were randomised to testing for H pylori, and 100 were positive. The successful eradication rate was 78%. 356 patients received proton pump inhibitor for 28 days. At 12 months no significant differences existed between the two groups in QALYs, costs, or dyspeptic symptoms. Minor reductions in costly resource use over the year in the test and treat group "paid back" the initial cost of the intervention.

CONCLUSIONS:

Test and treat and acid suppression are equally cost effective in the initial management of dyspepsia. Empirical acid suppression is an appropriate initial strategy. As costs are similar overall, general practitioners should discuss with patients at which point to consider H pylori testing.

TRIAL REGISTRATION:

Current Controlled Trials ISRCTN87644265.

• Authors: Brendan C Delaney, Michelle Qume, Paul Moayyedi, Richard F A Logan, Alexander C Ford, Cathy Elliott, Cliodna McNulty, Sue Wilson, F D Richard Hobbs
• Journal: BMJ (Clinical research ed.) (BMJ) Vol. 336 Issue 7645 Pg. 651-4 (Mar 22 2008) ISSN: 1756-1833 [Electronic] England
• PMID: 18310262 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Proton Pump Inhibitors

Topics

• Adolescent
• Adult
• Aged
• Cost-Benefit Analysis
• Dyspepsia (drug therapy, economics)
• Family Practice (economics)
• Female
• Helicobacter Infections (diagnosis, drug therapy, economics)
• Helicobacter pylori (isolation & purification)
• Humans
• Male
• Middle Aged
• Proton Pump Inhibitors (economics, therapeutic use)
• Quality of Life
• Quality-Adjusted Life Years
• Surveys and Questionnaires
• Treatment Outcome