Methods: Individual patient RCT, managed using the MidReC-en e-Trials portal. Patients aged 18 and over with epigastric pain or heartburn were randomised to either receive a C13 Urea breath test for H.pylori, followed by eradication therapy if positive or no testing. All patients received omeprazole 20mg od for 4 weeks. Dyspepsia symptoms (Short Form Leeds Dyspepsia Questionnaire), Quality of Life (EQ-5D) and health resource utilisation (costs were measured at baseline, 12 weeks and 52 weeks. Stochastic economic analysis using incremental net benefit.
Results: 699 subjects were recruited from 80 practices across England. 342 were male and the ages ranged from 18 to 65 with mean 41. Data were returned for 556 (80%), 558 (81%) and 666 (95%) for SF LDQ, EQ-5D and resource utilisation respectively at 12 months. 331 subjects had predominant epigastric pain and 277 heartburn. The mean SF-LDQ scores changed from 15.5 and 17.0 to 6.8 and 8.6 (p<0.003) for test and treat and acid suppression respectively at 12 months. In terms of cost-effectiveness, test and treat generated an additional 0.04 QALYs at an additional cost of $7 ($237 v. £230). A plot of Incremental Net Monetary Benefit v the ceiling ratio shows that the two strategies were equivalent in cost-effectiveness, but with a wide uncertainty as the ceiling ratio increases.
Conclusions: H.pylori test and treat is similarly cost-effective to PPI in the initial management of dyspepsia, having equal QALYs and costs, but results in a small, but significant improvement in dyspepsia symptoms at one year.