BACKGROUND: Controversy surrounds the optimal composition, dosage, and duration of therapies for eradication of Helicobacter pylori. We prospectively compared omeprazole-based dual and triple therapies in the eradication of H. pylori in a randomized manner. METHODS:Between June 1995 and March 1997, 1000 consecutive patients with acid-peptic disease associated with H. pylori infection (duodenal ulcer, 388 patients, gastric ulcer, 179 patients; duodenitis, 173 patients; gastritis, 260 patients) were prospectively recruited. They were randomized to either a 2-wk (OA) course of omeprazole 20 mg and amoxicillin 1 g, both given twice daily, or treatment for 1 wk (OCM) with omeprazole 20 mg once daily, clarithromycin 500 mg twice daily, and metronidazole 400 mg twice daily. RESULTS:The age of these 1000 patients ranged from 16 to 90 yr, with a mean of 54.9 yr. Side effects occurred in 29.6% (95% confidence interval [CI] 25.6-33.8%) and 10.6% (95% CI 8.0-13.6%) of patients taking OCM and OA, respectively (p < 0.0001). Apart from taste disturbance, however, there were no significant differences in the incidences of side effects between the two groups. One patient in the OA group and four patients of the OCM group could not tolerate the medications, and therefore did not complete treatment (p = 0.37). Seven and 13 patients in the OA and OCM groups, respectively, refused a second endoscopy (p = 0.25). The remaining 975 patients underwent a second endoscopy. Positive endoscopic findings were significantly more common in the OA group (51/492; 10.4%; 95% CI 7.8-13.4%) than in the OCM group (25/483; 5.2%; 95% CI 3.4-7.5%) in the per-protocol (PP) analysis (p = 0.004). On intent-to-treat (ITT) analysis, the overall eradication rates in the OA and OCM groups were 73.6% (95% CI 69.5-77.4%) and 92% (95% CI 89.3-94.2%), respectively (p < 0.0001). On PP analysis, the corresponding rates were 74.8% (95% CI 70.7-78.6%) and 95.2% (95% CI 92.9-97.0%), respectively (p < 0.0001). CONCLUSIONS: A course of omeprazole, clarithromycin, and metronidazole for 1 wk is a safe, well-tolerated, efficacious, and cost-effective treatment for H. pylori infection.
RCT Entities:
BACKGROUND: Controversy surrounds the optimal composition, dosage, and duration of therapies for eradication of Helicobacter pylori. We prospectively compared omeprazole-based dual and triple therapies in the eradication of H. pylori in a randomized manner. METHODS: Between June 1995 and March 1997, 1000 consecutive patients with acid-peptic disease associated with H. pylori infection (duodenal ulcer, 388 patients, gastric ulcer, 179 patients; duodenitis, 173 patients; gastritis, 260 patients) were prospectively recruited. They were randomized to either a 2-wk (OA) course of omeprazole 20 mg and amoxicillin 1 g, both given twice daily, or treatment for 1 wk (OCM) with omeprazole 20 mg once daily, clarithromycin 500 mg twice daily, and metronidazole 400 mg twice daily. RESULTS: The age of these 1000 patients ranged from 16 to 90 yr, with a mean of 54.9 yr. Side effects occurred in 29.6% (95% confidence interval [CI] 25.6-33.8%) and 10.6% (95% CI 8.0-13.6%) of patients taking OCM and OA, respectively (p < 0.0001). Apart from taste disturbance, however, there were no significant differences in the incidences of side effects between the two groups. One patient in the OA group and four patients of the OCM group could not tolerate the medications, and therefore did not complete treatment (p = 0.37). Seven and 13 patients in the OA and OCM groups, respectively, refused a second endoscopy (p = 0.25). The remaining 975 patients underwent a second endoscopy. Positive endoscopic findings were significantly more common in the OA group (51/492; 10.4%; 95% CI 7.8-13.4%) than in the OCM group (25/483; 5.2%; 95% CI 3.4-7.5%) in the per-protocol (PP) analysis (p = 0.004). On intent-to-treat (ITT) analysis, the overall eradication rates in the OA and OCM groups were 73.6% (95% CI 69.5-77.4%) and 92% (95% CI 89.3-94.2%), respectively (p < 0.0001). On PP analysis, the corresponding rates were 74.8% (95% CI 70.7-78.6%) and 95.2% (95% CI 92.9-97.0%), respectively (p < 0.0001). CONCLUSIONS: A course of omeprazole, clarithromycin, and metronidazole for 1 wk is a safe, well-tolerated, efficacious, and cost-effective treatment for H. pylori infection.