The effectiveness of omeprazole, clarithromycin and tinidazole in eradicating Helicobacter pylori in a community screen and treat programme

Abstract

Introduction: Helicobacter pylori screening and treatment has been proposed as a cost‐effective method of preventing gastric cancer. Aim: 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. Methods: 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. Results: 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. Conclusions: 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.

A Community‐Based Study of Helicobacter pylori Therapy Using the Strategy of Test, Treat, Retest, and Re‐treat Initial Treatment Failures

“…Table 3 lists the regimens used in major therapeutic trials of population‐based H. pylori eradication [5,19–21]. With an initial regimen of PPI‐based triple therapy, the eradication rates have ranged from 73% to 89% in evaluable subjects [5,20,21]. The efficacy was similar to that in hospital‐based studies (eradication rates, 75–90%) [22], and obviously better than the dual regimen (63.9%) used in the Gail et al.…”

Long‐Term Follow‐up after Eradication of Helicobacter pylori with Omeprazole, Clarithromycin, and Tinidazole (OCT Regimen) in a Japanese Population

“…The incidence of adverse events with the OCT regimen is reported to be high, with bitter taste and diarrhea being the most common [17]. In the present study, however, side effects were rare, with no patients reporting bitter taste and only relatively few complaining of diarrhea, which was nevertheless mild enough not to interfere with daily activities.…”

“…OCT showed a rate of cure of 98% in H. pylori ‐positive patients. In previous studies conducted overseas, however, eradication rates for the OCT regimen varied between 60% and 85%[15–17]. Nearly all patients in the present study were middle‐aged men who had excellent compliance with medication, suggesting that the background of patients may affect the efficacy of therapy.…”

Helicobacter pylori: a clinical update

“…The ef®cacy of PAC and PCN are similar and therefore the treatment of choice will depend on the tolerability and cost of the two regimens. Mild adverse events are common with these therapies but severe side-effects are rare (Moayyedi et al 2000c), with both regimens being equally well tolerated. PAC is more expensive than PCN because twice the dose of clarithromycin and PPI is used.…”