BACKGROUND:Omeprazole or lansoprazole, amoxicillin, clarithromycin (PPI/AC) therapy has been reported to provide a high cure rate of H. pylori infection with few adverse effects. Effectiveness of H. pylori therapy may vary among different geographic regions and patient populations. However, there are few reports in Japan as to its effectiveness. We have, therefore, studied the effectiveness of H. pylori therapy in a large group of Japanese patients. METHODS: For this study, 366 H. pylori-positive patients with peptic ulcer disease or non-ulcer dyspepsia (263 men and 103 women, mean age 48.5 years) were assigned to 6 groups, each receiving a different PPI/AC regimen. Group 1 received omeprazole (OPZ) 20 mg, amoxicillin (AMOX) 1500 mg, and clarithromycin (CAM) 400 mg; Group 2 OPZ 40 mg, AMOX 1500 mg, and CAM 400; and Group 3 OPZ 20 mg, AMOX 2000 mg, and CAM 600 mg daily for 14 days. The group treated with lansoprazole (LPZ) 30 mg, AMOX 1500 mg and CAM 400 mg was used for 14 days in Group 1L. OPZ 20 mg, AMOX 750 mg, and CAM 200 mg were given to Group 4 for 28 days and OPZ 20 mg, AMOX 1500 mg, CAM 400 mg was administered to Group 5 for 7 days. Cure of infection was assessed by 13C urea breath test one month after completion of therapy. RESULTS:Cure rates calculated by excluding the patients who showed borderline value of 13C urea breath test (delta 13C value between 5 and 10% in Groups 1, 1L, 2, 3, 4, and 5 were 82.7% (95% CI; 74-90), 88.9% (76-96), 84.9% (72-93), 81.3% (67-91), 84.6% (72-93), and 85.1% (72-94) on an intention-to-treat basis, and 88% (80-94), 95.2% (84-99), 95.6% (85-99), 90.7% (78-97), 95.7% (85-99) and 88.9% (76-96) on a per-protocol basis, respectively. Adverse effects that affected compliance were observed in 10 of 237 patients on 14-day regiments, one of 47 on a 28-day regimen and one of 46 on a 7-day regimen. CONCLUSION: Two weeks PPI/AC therapy is highly effective for cure of H. pylori infection in the Japanese population. The low dose one month regimen and the one week OAC regimen were also effective in our patient population.
RCT Entities:
BACKGROUND:Omeprazole or lansoprazole, amoxicillin, clarithromycin (PPI/AC) therapy has been reported to provide a high cure rate of H. pyloriinfection with few adverse effects. Effectiveness of H. pylori therapy may vary among different geographic regions and patient populations. However, there are few reports in Japan as to its effectiveness. We have, therefore, studied the effectiveness of H. pylori therapy in a large group of Japanese patients. METHODS: For this study, 366 H. pylori-positive patients with peptic ulcer disease or non-ulcer dyspepsia (263 men and 103 women, mean age 48.5 years) were assigned to 6 groups, each receiving a different PPI/AC regimen. Group 1 received omeprazole (OPZ) 20 mg, amoxicillin (AMOX) 1500 mg, and clarithromycin (CAM) 400 mg; Group 2 OPZ 40 mg, AMOX 1500 mg, and CAM 400; and Group 3 OPZ 20 mg, AMOX 2000 mg, and CAM 600 mg daily for 14 days. The group treated with lansoprazole (LPZ) 30 mg, AMOX 1500 mg and CAM 400 mg was used for 14 days in Group 1L. OPZ 20 mg, AMOX 750 mg, and CAM 200 mg were given to Group 4 for 28 days and OPZ 20 mg, AMOX 1500 mg, CAM 400 mg was administered to Group 5 for 7 days. Cure of infection was assessed by 13C urea breath test one month after completion of therapy. RESULTS: Cure rates calculated by excluding the patients who showed borderline value of 13C urea breath test (delta 13C value between 5 and 10% in Groups 1, 1L, 2, 3, 4, and 5 were 82.7% (95% CI; 74-90), 88.9% (76-96), 84.9% (72-93), 81.3% (67-91), 84.6% (72-93), and 85.1% (72-94) on an intention-to-treat basis, and 88% (80-94), 95.2% (84-99), 95.6% (85-99), 90.7% (78-97), 95.7% (85-99) and 88.9% (76-96) on a per-protocol basis, respectively. Adverse effects that affected compliance were observed in 10 of 237 patients on 14-day regiments, one of 47 on a 28-day regimen and one of 46 on a 7-day regimen. CONCLUSION: Two weeks PPI/AC therapy is highly effective for cure of H. pyloriinfection in the Japanese population. The low dose one month regimen and the one week OAC regimen were also effective in our patient population.