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Design
Cost-effectiveness analysis from a health service perspective of a randomised (allocation concealed*), unblinded,* controlled trial with 18 months of follow up.
Setting
31 primary care centres in the UK.
Patients
478 patients (mean age 37 y, 57% men) who had had dyspepsia (epigastric pain or heartburn with or without nausea and bloating) for > 4 weeks. Exclusion criteria included patients who had had endoscopy or a positive result on barium meal examination in the previous 3 years or were unable to give informed consent. 99% of patients completed the trial.
Intervention
Patients were allocated to testing (Helisal test), and endoscopy (n=285) or usual management (n=193). Endoscopies on patients with positive results on the Helisal test were done according to usual practice at open access services at 6 local hospitals. Patients with negative results received empirical acid-suppressing drugs. Patients in the control group received the usual management strategy used by their general practitioner.
Main cost and outcome measures
Change in symptoms (Birmingham dyspepsia symptom score) and quality of life (measured as regards to pain, emotion, and social function by questionnaire) at 18 months were the main outcome measures. Costs associated with managing dyspepsia included attendance at accident and emergency departments, barium meal examination, testing for campylobacter-like organisms, endoscopy, and H pylori testing. Costs were estimated in British pounds.
Main results
In both trial groups, a reduction in symptoms and an increase in quality of life were seen. The groups did not differ in the magnitude of improvement (table
). Mean total costs per patient were £368 for testing and endoscopy, and £253 for usual management.
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Footnotes
Sources of funding: National Health Services; The Astra Foundation supplied the Helisal tests.
For correspondence: Dr B C Delaney, University of Birmingham Medical School, Department of General Practice, Vincent Drive, Edgbaston, Birmingham, BI5 2TT, UK. Fax +44 (0) 121 414 6571.
University of Sydney Penrith, Australia
Management of dyspepsia in primary care remains controversial. Prompt upper endoscopy remains the "gold standard", but it is costly and has limited availability. Some guidelines (eg, the British Society of Gastroenterology) have recommended non-invasive testing for H pylori followed by endoscopy in those with infection to identify peptic ulcer disease and appropriately target treatment. The trial by Delaney et al indicates, contrary to expectation, that this approach is not as cost-effective as usual management.
Increased costs in the testing and endoscopy group were driven primarily by endoscopy; the rate of endoscopy in the usual treatment group was about half that in the study group, with similar outcomes. The efficacy of testing and endoscopy may have been diluted by contamination with patients who had gastroesophageal reflux disease and with the use of an office whole-blood serological H pylori test, which is less accurate. Indeed, although more ulcers were detected in the testing and endoscopy group (7% v 2%), the rate was lower than expected (20% to 60%).
Lassen et al1 reported that non-invasive H pylori testing followed by eradication treatment had an outcome similar to prompt endoscopy, although endoscopy had a slight advantage with respect to satisfaction. Other data suggest that "test and treat" has the advantage of cost savings compared with endoscopy and is well accepted.2 Hence, test and treat is currently widely recommended. However, in younger populations in whom the background prevalence of H pylori and peptic ulcer is relatively low, a short empirical trial of acid-suppression treatment (eg, using a proton pump inhibitor) may be the most cost-effective management approach because serious disease will rarely be masked. Head to head management trials are currently in progress to test this hypothesis.
References
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