Proton pump inhibitor or testing for Helicobacter pylori as the first step for patients presenting with dyspepsia? A cluster-randomized trial.
OBJECTIVE
The optimal approach for management of patients with dyspepsia has not been determined. The aim of this study was to compare the efficacy of three strategies for management of dyspepsia: empirical antisecretory therapy, testing for Helicobacter pylori (H. pylori), or a combination of the two.


METHODS
Cluster-randomized trial in general practices. Initial treatment with proton pump inhibitor (PPI) was performed in 222 patients, H. pylori test-and-eradicate in 250 patients, and PPI followed by H. pylori-testing if symptoms improved in 250 patients. Symptoms, quality of life, patient satisfaction, and use of resources were recorded during a 1-yr follow-up.


RESULTS
The prevalence of H. pylori infection was 24%. We found no difference among the three strategies (p=0.16) in terms of the proportion of days without dyspeptic symptoms. After 1 yr gastrointestinal symptom scores and quality-of-life scores had improved significantly and equally in the three groups (p<0.001), but no statistically significant differences were found among the groups. The mean use of endoscopies per patient after 1 yr was higher in the PPI group (0.36 [95% CI 0.30-0.43]) than in the test-and-eradicate group (0.28 [95% CI 0.23-0.34]) and the combination group (0.22 [95% CI 0.17-0.27]), p=0.02. H. pylori-positive patients given eradication therapy had more days without dyspeptic symptoms (p<0.001), used less antisecretory therapy (p<0.01), and were more satisfied (p<0.001) than H. pylori-negative patients.


CONCLUSIONS
The strategies based on H. pylori test enjoyed similar symptom resolution, but reduced endoscopic workload and lower 1-yr total costs compared with empirical antisecretory therapy.
Jarbol
Dorte Ejg
DE
Department of Medical Gastroenterology, Odense University Hospital, Odense Denmark.
Kragstrup
Jakob
J
Stovring
Henrik
H
Havelund
Troels
T
Schaffalitzky de Muckadell
Ove B
OB
D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001944:Breath Tests; D017291:Clarithromycin / Q000627:therapeutic use; D003718:Denmark / Q000453:epidemiology; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000175:diagnosis* / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000188:drug therapy* / Q000453:epidemiology; D016480:Helicobacter pylori; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D015995:Prevalence; D011446:Prospective Studies; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole