Randomised controlled trial of effects of Helicobacter pylori infection and its eradication on heartburn and gastro-oesophageal reflux: Bristol helicobacter projectBMJ 2004; 328 doi: https://doi.org/10.1136/bmj.328.7453.1417 (Published 10 June 2004) Cite this as: BMJ 2004;328:1417
- Richard F Harvey, consultant gastroenterologist ()1,
- J Athene Lane, research fellow2,
- Liam J Murray, senior lecturer3,
- Ian M Harvey, professor of epidemiology and public health4,
- Jenny L Donovan, professor2,
- Prakash Nair, consultant gastroenterologist5
- 1 Frenchay Hospital, North Bristol NHS Trust, Bristol BS16 1LE
- 2 Department of Social Medicine, University of Bristol, Bristol BS8 2PR
- 3 Department of Epidemiology and Public Health, The Queen's University of Belfast, Belfast BT9 5EE
- 4 School of Medicine, Health Policy and Practice, University of East Anglia, Norwich NR4 7TJ
- 5 Peterborough General Hospital, Peterborough
- Correspondence to: R F Harvey
- Accepted 12 March 2004
Objectives To investigate the effects of Helicobacter pylori infection and its eradication on heartburn and gastro-oesophageal reflux.
Design Cross sectional study, followed by a randomised placebo controlled trial.
Setting Seven general practices in Bristol, England.
Participants 10 537 people, aged 20-59 years, with and without H pylori infection (determined by the 13C-urea breath test).
Main outcome measures Prevalence of heartburn and gastro-oesophageal acid reflux at baseline and two years after treatment to eradicate H pylori infection.
Results At baseline, H pylori infection was associated with increased prevalence of heartburn (odds ratio 1.14, 95% confidence interval 1.05 to 1.23) but not reflux (1.05, 0.97 to 1.14). In participants with H pylori infection, active treatment had no effect on the overall prevalence of heartburn (0.99, 0.88 to 1.12) or reflux (1.04, 0.91 to 1.19) and did not improve pre-existing symptoms of heartburn or reflux.
Conclusions H pylori infection is associated with a slightly increased prevalence of heartburn but not reflux. Treatment to eradicate H pylori has no net benefit in patients with heartburn or gastro-oesophageal reflux.
Contributors RFH initiated the study, helped to plan the project, analysed the results, wrote the initial draft of the paper, and is the guarantor. JAL ran the Bristol helicobacter project from day to day and helped with analysis of the data and the final version of the paper. PN helped to set up the project. LJM, IMH, and JLD helped to plan the project, analyse the results, and produce the final version of the paper.
Funding This study was funded jointly by the NHS South and West Regional Research and Development Directorate and GlaxoSmithKline UK. The Department of Social Medicine is the lead centre for the MRC Health Services Research Collaboration.
Competing interests RFH and JAL were reimbursed by GlaxoSmithKline for attending the AGA symposium in 2000
Ethical approval The local research ethics committee approved the study
- Accepted 12 March 2004