Efficacy of 1 week omeprazole or lansoprazole-amoxycillin-clarithromycin therapy for Helicobacter pylori infection in the Japanese population

Background: The effectiveness of curative therapy for Helicobacter pylori m ay vary according to the geographic region and patient population, thus the efficacy of each treatment regimen should be determined according to the s pecific patient population. However, there is no literature available conce rning the efficacy of 1 week omeprazole-amoxycillin-clarithromycin (OAC) re gimens for the cure of H. pylori infection in Japan. Methods: Helicobacter pylori-positive patients (224) with peptic ulcer dise ase or non-ulcer dyspepsia were randomized to receive one of three differen t omeprazole or lansoprazole-amoxycillin-clarithromycin (PPI/AC) regimens f or 7 days: (1) OAC 20 regimen (n=76), omeprazole (OPZ) 20 mg daily, amoxyci llin (AMOX) 500 mg t.d.s. and clarithromycin (CAM) 200 mg b.d.; (2) LAC 30 regimen (n=73), Lansoprazole (LPZ) 30 mg daily, AMOX 500 mg t.d.s. and CAM 200 mg b.d.; and (3) OPZ 40 regimen (n = 75), OPZ 20 b.d., AMOX 500 mg t.d. s. and CAM 200 mg b.d. Cure of the infection was determined by the [C-13]-u rea breath test, 1 month after completion of the treatment. Results: Intention-to-treat based cure rates for OAC 20, LAC 30 and OAC 40 regimens were 75.0% (95% CI, 64-84%), 82.2% (95%, CI 72-90), and 80.0% (95% CI, 69-88), respectively and perprotocol based cure rates of these regimen s were 79.2% (95% CI, 68-88%), 83.3% (95%, CI 73-91), and 83.1% (95% CI, 72 -91%), respectively. Adverse effects, which included diarrhoea, glossitis o r skin rash, were reported by 26.1% of the patients. However, these were mi ld and did not affect compliance. Conclusion: One week PPI/AC regimens for H. pylori infection with smaller p roton pump inhibitors and antimicrobial dosages compared to regimens used i n Western countries were revealed to provide sufficient cure rate (more tha n 80% by ITT analysis) with mild adverse effects in the Japanese population .