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

doi:10.1136/bmj.39479.640486.AE

BMJ, doi: 10.1136/bmj.39479.640486.AE, (Published 29 February 2008)

Research

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, professor of primary care¹, Michelle Qume, research fellow¹, Paul Moayyedi, professor of gastroenterology², Richard F A Logan, professor of epidemiology³, Alexander C Ford, lecturer⁴, Cathy Elliott, research associate³, Cliodna McNulty, consultant microbiologist⁵, Sue Wilson, professor of epidemiology¹, F D Richard Hobbs, professor of primary care and general practice¹

¹ Primary Care Clinical Sciences, University of Birmingham, Birmingham B15 2TT, ² McMaster University, Hamilton, ON, Canada, ³ Division of Epidemiology and Public Health, University of Nottingham, Nottingham, ⁴ Centre for Gastrointestinal Disease, Leeds General Infirmary, Leeds, ⁵ Health Protection Agency Primary Care Unit, Gloucester

Correspondence to: B Delaney b.c.delaney{at}bham.ac.uk

Objective To determine the cost effectiveness of Helicobacterpylori "test and treat" compared with empirical acid suppressionin the initial management of patients with dyspepsia in primarycare.

Design Randomised controlled trial.

Setting 80 general practices in the United Kingdom.

Participants 699 patients aged 18-65 who presented to theirgeneral practitioner with epigastric pain, heartburn, or bothwithout "alarm symptoms" for malignancy.

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

Main outcome measures Cost effectiveness in cost per qualityadjusted life year (QALY) (EQ-5D) and effect on dyspeptic symptomsat 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. At12 months no significant differences existed between the twogroups in QALYs, costs, or dyspeptic symptoms. Minor reductionsin 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 equallycost effective in the initial management of dyspepsia. Empiricalacid suppression is an appropriate initial strategy. As costsare similar overall, general practitioners should discuss withpatients at which point to consider H pylori testing.

Trial registration Current Controlled Trials ISRCTN 7644265.

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