Helicobacter pylori screening and treatment has been proposed as a cost-effective method of preventing gastric cancer.
To assess, in a randomized controlled trial, the efficacy of therapy in eradicating H. pylori as part of a screening programme, and to report the adverse events associated with this strategy.
Subjects between the ages of 40–49 years were randomly selected from the lists of 36 primary care centres. Participants attended their local practice and H. pylori status was determined by 13C-urea breath test. Infected subjects were randomized to receive omeprazole 20 mg b.d., clarithromycin 250 mg b.d. and tinidazole 500 mg b.d. for 7 days (OCT) or identical placebos. Eradication was determined by a 13C-urea breath test 6 months and 2 years after the first visit. Successful eradication was defined as two negative 13C-urea breath tests or one negative and one missing test. Adverse events and compliance were assessed at the 6-month visit.
A total of 32 929 subjects were invited to attend, 8407 were evaluable, and 2329 (28%) of these were H. pylori-positive. A total of 1161 subjects were randomized to OCT and 1163 to placebo; over 80% returned for a repeat 13C-urea breath test on at least one occasion. The eradication rates in those allocated to OCT were as follows: intention-to-treat, 710 out of 1161 (61%; 95% confidence interval: 58–64%); evaluable 710 out of 967 (73%; 95% CI: 71–76%); took all medication 645 out of 769 (84%; 95% CI: 81–87%). Adverse events occurred in 45% of the treatment group and in 18% of the placebo group (relative risk 2.5; 95% CI: 2.1–2.9). Compliance, male gender, no antibiotic prescription in the subsequent 2 years and experiencing a bitter taste with the medication were independently associated with treatment success.
The OCT regimen has an eradication rate of 61% in intention-to-treat analysis and is therefore less successful in treating H. pylori as part of a screening programme compared with hospital studies in dyspeptic patients.