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Randomized Controlled Trial
. 2008 Mar 22;336(7645):651-4.
doi: 10.1136/bmj.39479.640486.AE. Epub 2008 Feb 29.

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

Brendan C Delaney  1 , Michelle Qume, Paul Moayyedi, Richard F A Logan, Alexander C Ford, Cathy Elliott, Cliodna McNulty, Sue Wilson, F D Richard Hobbs
Affiliations
Randomized Controlled Trial

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

Brendan C Delaney et al. BMJ. .

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.

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Conflict of interest statement

Competing interests: BCD, RFAL and PM have received speakers’ fees from companies that market proton pump inhibitors.

Figures

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Fig 1 Flow of participants through study
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Fig 2 Incremental net benefit for test and treat versus proton pump inhibitor (PPI) (95% confidence interval) against maximum willingness to pay
See this image and copyright information in PMC

Comment in

References

    1. McCormick A, Fleming D, Charlton J. Morbidity statistics from general practice: fourth national morbidity study 1991-1992 London: Office of Population Censuses and Surveys, 1995
    1. Jones RH, Lydeard SE, Hobbs FD, Kenkre JE, Williams EI, Jones SJ, et al. Dyspepsia in England and Scotland. Gut 1990;31:401-5. - PMC - PubMed
    1. Delaney BC, Moayyedi P. Dyspepsia. In: Stevens A, Raftery J, Mant J, eds. Health care needs assessment 3rd series Oxford: Routledge, 2006
    1. Delaney BC, Ford AC, Forman D, Moayyedi P, Qume M. Initial management strategies for dyspepsia. Cochrane Database Syst Rev 2005;(4):CD001961. - PubMed
    1. Mason JM, Delaney BC, Moayyedi P, Thomas M, Walt R, North of England Dyspepsia Guideline Development Group. Managing dyspepsia without alarm signs in primary care: new national guidance for England and Wales. Aliment Pharmacol Ther 2005;21:1135-43. - PubMed

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