Systematic review and economic evaluation of Helicobacter pylori eradication treatment for non-ulcer dyspepsia

British Medical Journal,  Sept 16, 2000  by Paul Moayyedi,  Shelly Soo,  Jonathan Deeks,  David Forman,  James Mason,  Michael Innes,  Brendan Delaney

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Abstract

Objectives To evaluate efficacy and cost effectiveness of Helicobacter pylori eradication treatment in patients with non-ulcer dyspepsia infected with H pylori.

Design Systematic review of randomised controlled trials comparing H pylori eradication with placebo or another drug treatment. Results were incorporated into a Markov model comparing health service costs and benefits of H pylori eradication with antacid treatment over one year.

Data sources Six electronic databases were searched for randomised controlled trials from January 1966 to May 2000. Experts in the field, pharmaceutical companies, and journals were contacted for information on any unpublished trials. Trial reports were reviewed according to predefined eligibility and quality criteria.

Main outcome measures Relative risk reduction for remaining dyspeptic symptoms (the same or worse) at 3-12 months. Cost per dyspepsia-free month estimated from Markov model based on estimated relative risk reduction.

Results Twelve trials were included in the systematic review, nine of which evaluated dyspepsia at 3-12 months in 2541 patients. H pylori eradication treatment was significantly superior to placebo in treating non-ulcer dyspepsia (relative risk reduction 9% (95% confidence interval 4% to 14%)), one case of dyspepsia being cured for every 15 people treated. H pylori eradication cost 56 [pounds sterling] per dyspepsia-free month during first year after treatment.

Conclusion H pylori eradication may be cost effective treatment for non-ulcer dyspepsia in infected patients but further evidence is needed on decision makers' willingness to pay for relief of dyspepsia.

Introduction

There is unequivocal evidence that infection with Helicobacter pylori is the principal cause of peptic ulcer disease. The organism is present in 85-95% of patients with peptic ulcer disease, and treating the infection is effective in healing these ulcers.[1] Treatment to eradicate H pylori results in permanent cure of peptic ulcer disease, whereas 60-80% of such patients relapse within a year if treated with antisecretory drugs alone.

The evidence for an association between H pylori and non-ulcer dyspepsia is more uncertain. Many trials evaluating the efficacy of H pylori eradication treatment for non-ulcer dyspepsia have been poorly designed and have given conflicting results.[2] A recent review of the literature indicated that H pylori eradication treatment is effective in non-ulcer dyspepsia,[3] but the results of other reviews that include more recent trials have been less clear.[4 5]

Several well designed trials have been published in the past two years. These have also given conflicting results, suggesting that any effect of H pylori eradication treatment on non-ulcer dyspepsia is at best small and may not be an efficient use of resources. We have conducted a rigorous systematic review of available randomised trials and performed an economic analysis of the results to establish whether H pylori eradication is a cost effective treatment for non-ulcer dyspepsia.

Methods

Systematic review

Search strategy

Randomised controlled trials fulfilling the eligibility criteria listed in the box were suitable for inclusion in the review, regardless of language and publication status. We identified studies by searching six electronic databases using both subject terms and text words; by reviewing bibliographies of retrieved trials; by contacting experts in 15 countries and pharmaceutical companies; and by requesting information of articles in peer review or in press from editors of general medical and gastroenterology journals (full details of the searches are given on the BMJ's website). Electronic searches were initially undertaken in March 1999, and updated in May 2000. In addition, we routinely scanned general medical and major gastroenterology journals over the previous year to ensure inclusion of the most recent studies.

Assessment of eligibility and trial quality

Dyspepsia was defined according to published definitions.[6 7] Two investigators independently reviewed all identified papers according to the eligibility and quality criteria. Abstracts were not included unless further details were available from the authors. Where disagreements occurred a third reviewer was involved and the majority view taken. The quality of trials was evaluated according to predefined criteria (see box). The quality assessment focused on whether the methods used for randomisation, concealment of allocation, and blinding of participants and investigators were stated. Use of intention to treat analyses and completeness of follow up were also recorded, and the use of validated dyspepsia and quality of life measures was noted. Trials described as randomised but which did not state a method of randomisation were included.

Data extraction

A single investigator extracted data from eligible trials on a standardised form, which was checked by a second investigator. Data from intention to treat analyses were used whenever they were provided, and outcomes were recorded for the final assessment. Where dyspepsia outcomes were recorded in categories they were regrouped into an a priori dichotomy of those with improved (mild symptoms) or resolved dyspepsia (no symptoms) versus those with the same or worse dyspepsia (moderate or severe symptoms). Dichotomies and scale measures of dyspepsia were recorded as reported, as were assessments of quality of life.