HIGHLY EFFECTIVE TWICE-DAILY TRIPLE THERAPIES FOR HELICOBACTER-PYLORIINFECTION AND PEPTIC-ULCER DISEASE - DOES IN-VITRO METRONIDAZOLE RESISTANCE HAVE ANY CLINICAL RELEVANCE

Objectives: To compare cure rates of Helicobacter pylori (H. pylori) i nfection, ulcer healing, and side effects of three simplified regimens of triple therapy in patients with peptic ulcer disease. Methods: Two hundred thirty-one patients were prospectively randomized to receive either regimen OAM (omeprazole 20 mg b.i.d., amoxicillin 750 mg b.i.d. , and metronidazole 400 g b.i.d.), OCM (omeprazole 20 mg b.i.d., clari thromycin 250 mg b.i.d., and metronidazole 400 mg b.i.d.), or BCM (bis muth subcitrate 240 mg b.i.d., clarithromycin 250 mg b.i.d., and metro nidazole 400 mg b.i.d.), all for 10 days. Side effects were reported i mmediately afterward in a self-administered questionnaire. Upper endos copy was carried out before treatment and 2 months after treatment. Th ree antral and three corpus biopsy specimens were analyzed microbiolog ically and with rapid urease test to determine the presence of H. pylo ri. Altogether 143 patients (62%) had an active ulcer at start of trea tment. Metronidazole resistant (M-R) H. pylori strains were found in 3 0% of patients, while none had clarithromycin resistant (C-R) strains. Results: According to intention-to-treat analysis, H. pylori cure rat es were 91, 95, and 95% with OAM, OCM, and BCM, respectively (p = 0.63 ). In patients with metronidazole-sensitive (M-S) strains versus M-R s trains, the cure rates were 96 versus 77% with OAM (p = 0.025), 94 ver sus 94% with OCM, and 94 versus 96% with BCM. Ulcer healing rates were 95, 94, and 92%, respectively (p = 0.91). There were no significant d ifferences in side effects between the regimens, and only five patient s (2%) had to stop the treatment prematurely. Conclusions: All treatme nt regimens were highly effective for cure of H. pylori infection and for ulcer healing. Metronidazole resistance reduced the efficacy of OA M, but was of no importance for the efficacy of OCM or BCM. Side effec ts were of minor importance.