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Randomised controlled trial of Helicobacter pylori testing and endoscopy for dyspepsia in primary care
B C Delaney1, S Wilson, A Roalfe
1Department of Primary Care and General Practice, Division of Primary Care, Public and Occupational Health, University of Birmingham Medical School, Birmingham B15 2TT, UK. b.c.delaney@bham.ac.uk
Insights
Near patient testing for Helicobacter pylori (H pylori) and endoscopy increased procedure rates but not symptom relief or quality of life. This strategy proved more costly than standard care for dyspepsia management.
Area of Science:
- Gastroenterology
- Health Economics
- Primary Care Medicine
Background:
- Dyspepsia is a common condition managed in primary care.
- Helicobacter pylori (H pylori) infection is a potential cause of dyspepsia.
- Current management strategies vary, impacting resource utilization and patient outcomes.
Purpose of the Study:
- To evaluate the cost-effectiveness of a near-patient H pylori testing strategy followed by endoscopy for dyspepsia management.
- To compare this strategy against usual primary care practices.
Main Methods:
- A randomized controlled trial involving 478 patients under 50 years old with dyspepsia was conducted across 31 UK primary care centers.
- The intervention group received near-patient H pylori testing with open-access endoscopy for positive results.
- The control group received standard care, including acid-suppressing drugs or specialist referral at the general practitioner's discretion.
Main Results:
- The intervention group showed higher rates of H pylori testing (40%) and endoscopy (45% vs. 25% in controls).
- Peptic ulcer diagnoses were more frequent in the intervention group (7.4% vs. 2.1%).
- No significant differences were observed in symptom improvement, quality of life, prescribing, consultation, or referral rates between groups. The intervention group incurred higher costs (£367.85 vs. £253.16 per patient).
Conclusions:
- The near-patient H pylori testing and endoscopy strategy effectively increases endoscopy utilization in primary care.
- However, this strategy does not provide additional benefits in symptom relief or quality of life compared to usual care.
- The increased costs associated with the intervention strategy are not offset by demonstrable clinical or quality-of-life improvements.
Objective:
To determine the cost effectiveness of a strategy of near patient Helicobacter pylori testing and endoscopy for managing dyspepsia.
Design:
Randomised controlled trial.
Setting:
31 UK primary care centres.
Participants:
478 patients under 50 years old presenting with dyspepsia of longer than four weeks duration.
Interventions:
Near patient testing for H pylori and open access endoscopy for patients with positive results. Control patients received acid suppressing drugs or specialist referral at general practitioner's discretion.
Main Outcome Measures:
Cost effectiveness based on improvement in symptoms and use of resources at 12 months; quality of life.
Results:
40% of the study group tested positive for H pylori. 45% of study patients had endoscopy compared with 25% of controls. More peptic ulcers were diagnosed in the study group (7.4% v 2.1%, P=0.011). Paired comparison of symptom scores and quality of life showed that all patients improved over time with no difference between study and control groups. No significant differences were observed in rates of prescribing, consultation, or referral. Costs were higher in the study group ( 367.85 pound sterling v 253.16 pound sterling per patient).
Conclusions:
The test and endoscopy strategy increases endoscopy rates over usual practice in primary care. The additional cost is not offset by benefits in symptom relief or quality of life.
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