Triple therapy with omeprazole, amoxicillin and clarithromycin is effective against Helicobacter pylori infection in gastric ulcer patients as well as in duodenal ulcer patients. Results of a randomized controlled trial in Japan.

BACKGROUND/AIMS: There have been few reliable published studies permitting assessment of therapeutic regimens for Helicobacter pylori infection in gastric ulcer (GU) patients. The aim of the present study was to evaluate the efficacy of omeprazole-based dual and triple therapy regimens, both including clarithromycin, for the cure of H. pylori infection in active GU and duodenal ulcer (DU) patients. The study was conducted in Japan, a country in which GU is more prevalent than DU.

METHODS

Two hundred and thirty-four consecutive peptic ulcer patients (GU: n = 124; DU: n = 103; GDU: n = 7) suffering from H. pylori infection were randomly treated with either omeprazole 20 mg b.i.d. + amoxicillin 500 mg q.i.d. + clarithromycin 400 mg b.i.d. (OAC) or with omeprazole 20 mg b.i.d. + clarithromycin 400 mg b.i.d. (OC) for 14 days. H. pylori infection was evaluated by histology and culture from antral and corpus biopsies 6 weeks after completing antimicrobial therapy.

RESULTS

Follow-up data were available in 202 patients. The cure rates of H. pylori infection in GU patients were 83.9% (47/56) with OAC and 59. 2% (29/49) with OC. Corresponding rates in DU patients were 91.5% (43/47) and 70.5% (31/44), respectively. The cure rates with OAC were significantly higher than those with OC (p < 0.001, chi2 test). The cure rates in GU patients were lower than those in DU patients for both regimens, but these differences were not statistically significant. Side effects were generally mild and did not interfere with compliance. One patient in the OAC group and 2 patients in the OC group complained of severe side effects that led to therapy discontinuation.

CONCLUSIONS

Triple therapy with omeprazole, amoxicillin and clarithromycin is a safe and effective regimen for the cure of H. pylori infection in GU patients as well as in DU patients. We recommend this triple regimen as a first-line treatment in all patients with peptic ulcers associated with H. pylori infection in Japan.