TRIPLE THERAPY WITH OMEPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN IS EFFECTIVE AGAINST HELICOBACTER-PYLORI INFECTION IN GASTRIC-ULCER PATIENTSAS WELL AS IN DUODENAL-ULCER PATIENTS - RESULTS OF A RANDOMIZED CONTROLLED TRIAL IN JAPAN

Background/Aims: There have been few reliable published studies permit -efficacy of omeprazole-based dual and triple therapy regimens, both i ncluding 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 hundre d 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 da ta were available in 202 patients. The cure rates of H. pylori infecti on in GU patients were 83.9% (47/56) with OAC and 59.2% (29/49) with O C, 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, chi(2) test). The cure rates in GU pati ents were lower than those in DU patients for both regimens, but these differences were not statistically significant. Side effects were gen erally mild and did not interfere with compliance. One patient in the OAC group and 2 patients in the OC group complained of severe side eff ects that led to therapy discontinuation. Conclusions: Triple therapy with omeprazole, amoxicillin and clarithromycin is a safe and effectiv e regimen for the cure of H. pylori infection in GU patients as well a s in DU patients. We recommend this triple regimen as a first-line tre atment in all patients with peptic ulcers associated with H. pylori in fection in Japan.