Helicobacter pylori test and treat versus proton pump inhibitor in initial management of dyspepsia in primary care: multicentre randomised controlled trial (MRC-CUBE trial)

Abstract

Objective To determine the cost effectiveness of Helicobacter pylori "test and treat" compared with empirical acid suppression in the initial management of patients with dyspepsia in primary care. Design Randomised controlled trial. Setting 80 general practices in the United Kingdom. Participants 699 patients aged 18-65 who presented to their general practitioner with epigastric pain, heartburn, or both without "alarm symptoms" for malignancy. InterventionH pylori 13C urea breath test plus one week of eradication treatment if positive or proton pump inhibitor alone; subsequent management at general practitioner's discretion. Main outcome measures Cost effectiveness in cost per quality adjusted life year (QALY) (EQ-5D) and effect on dyspeptic symptoms at one year measured with short form Leeds dyspepsia questionnaire. Results 343 patients were randomised to testing for H pylori, and 100 were positive. The successful eradication rate was 78%. 356 patients received proton pump inhibitor for 28 days. At 12 months no significant differences existed between the two groups in QALYs, costs, or dyspeptic symptoms. Minor reductions in costly resource use over the year in the test and treat group "paid back" the initial cost of the intervention. Conclusions Test and treat and acid suppression are equally cost effective in the initial management of dyspepsia. Empirical acid suppression is an appropriate initial strategy. As costs are similar overall, general practitioners should discuss with patients at which point to consider H pylori testing. Trial registration Current Controlled Trials ISRCTN 7644265.

ACG and CAG Clinical Guideline: Management of Dyspepsia

“…Th e impact of reduction of costs and endoscopy was very strong and there was little clinically important heterogeneity among studies. Th e randomized trials that have evaluated H. pylori test and treat all reported H. pylori infection rates that were between 20 and 30% ( refs [38][39][40][41][42][43][44][47][48][49]. A previous guideline ( 12 ) suggested that PPI therapy might be the appropriate fi rst line approach when H. pylori prevalence rates are <15% in the population being tested.…”

Clinical trial: prolonged beneficial effect of Helicobacter pylori eradication on dyspepsia consultations – the Bristol Helicobacter Project

“…We concluded then that the cost-effectiveness of a community H. pylori eradication programme in a population such as ours, with a relatively low prevalence of H. pylori infection, was inferior to that of a targeted H. pylori test and treat strategy focusing on un-investigated dyspeptic patients. There is still debate as to whether a test and treat strategy is more or less appropriate than initial management of dyspeptic patients with acid suppressant medication (in a UK population, the cost-effectiveness is similar), [15][16][17] but the result of such comparisons depends, to a great extent, on the population concerned, in particular the local prevalence of H. pylori infection. In most developed countries, the prevalence of H. pylori infection has been falling in recent years, particularly in younger age groups, with a closely related decrease in the incidence of peptic ulcer disease.…”

Symptoms in patients on long‐term proton pump inhibitors: prevalence and predictors

“…13,20 Studies have shown that testing and treating for H. pylori in uninvestigated dyspepsia (UID) and non-ulcer dyspepsia (NUD) are likely to be beneficial in a significant number of patients. [21][22][23][24] However, these studies have included patients with de novo dyspepsia symptoms without previous use of acid suppression drugs or patients with peptic ulcer disease 25 and the findings may not apply to patients on longterm PPIs without ulcer disease. This study examines the prevalence of dyspepsia symptoms and quality-of-life in patients with longterm use of PPI treatment.…”