OBJECTIVES:Triple therapy and amoxycillin plus omeprazole are the two most widely recommended regimens for the eradication of Helicobacter pylori. However, no controlled studies with a large number of cases are available for the reliable comparison of these two regimens. The aim of this controlled, randomized, prospective study was to compare the effect of these two regimens and a further regimen for metronidazole-resistant patients on duodenal ulcer healing, H. pylori eradication, and prevention of ulcer relapse. METHODS:Patients (n = 144) with proven duodenal ulcer (DU) were randomized to one of the three following regimens: group A, omeprazole (2 x 40 mg) plus amoxycillin (4 x 500 mg) for 2 wk; group B, triple therapy: bismuth nitrate (4 x 375 mg) plus metronidazole (4 x 250 mg) and tetracycline (4 x 500 mg) daily for 2 wk and ranitidine (150 mg) for the first week and bismuth nitrate (4 x 375 mg) alone for a further 2 wk; group C, omeprazole (20 mg) plus amoxycillin (4 x 500 mg) and tinidazole (2 x 500 mg) for 2 wk. RESULTS: A total of 46 patients in group A, 39 in group B, and 43 in group C completed the study. One patient in group A and three in group B did not tolerate the regimens and dropped out of the study. Control endoscopy was performed 8 wk after the start of treatment and when symptoms appeared (up to 1 yr after the start of treatment). In subjects who completed the study, both the healing rate of DU in group B (97% compared with 74 and 73% in A and C, respectively, p < 0.02) and the H. pylori eradication rate in group B (85 compared with 35%, p < 0.0001 in A and 58%, p < 0.02, in C) were significantly higher than in groups A and C. The symptomatic ulcer relapse during the 1-yr follow-up in patients with initially healed ulcers was similar in all groups (18, 16, and 19% in A, B, and C, respectively). The predictor of healing using logistic regression analysis was night pain (p < 0.05). The predictor of H. pylori eradication was sex (p < 0.05). CONCLUSION: The 2-wk triple therapy plus an additional 2-wk treatment with the bismuth derivative (without a prolonged administration of acid suppressing drugs) seems to be an effective and economic treatment not only for the eradication of H. pylori but also for the healing of acute DU. The higher incidence of side effects found after triple therapy compared with the other two regimens was tolerated by the patients.
RCT Entities:
OBJECTIVES: Triple therapy and amoxycillin plus omeprazole are the two most widely recommended regimens for the eradication of Helicobacter pylori. However, no controlled studies with a large number of cases are available for the reliable comparison of these two regimens. The aim of this controlled, randomized, prospective study was to compare the effect of these two regimens and a further regimen for metronidazole-resistant patients on duodenal ulcer healing, H. pylori eradication, and prevention of ulcer relapse. METHODS:Patients (n = 144) with proven duodenal ulcer (DU) were randomized to one of the three following regimens: group A, omeprazole (2 x 40 mg) plus amoxycillin (4 x 500 mg) for 2 wk; group B, triple therapy: bismuth nitrate (4 x 375 mg) plus metronidazole (4 x 250 mg) and tetracycline (4 x 500 mg) daily for 2 wk and ranitidine (150 mg) for the first week and bismuth nitrate (4 x 375 mg) alone for a further 2 wk; group C, omeprazole (20 mg) plus amoxycillin (4 x 500 mg) and tinidazole (2 x 500 mg) for 2 wk. RESULTS: A total of 46 patients in group A, 39 in group B, and 43 in group C completed the study. One patient in group A and three in group B did not tolerate the regimens and dropped out of the study. Control endoscopy was performed 8 wk after the start of treatment and when symptoms appeared (up to 1 yr after the start of treatment). In subjects who completed the study, both the healing rate of DU in group B (97% compared with 74 and 73% in A and C, respectively, p < 0.02) and the H. pylori eradication rate in group B (85 compared with 35%, p < 0.0001 in A and 58%, p < 0.02, in C) were significantly higher than in groups A and C. The symptomatic ulcer relapse during the 1-yr follow-up in patients with initially healed ulcers was similar in all groups (18, 16, and 19% in A, B, and C, respectively). The predictor of healing using logistic regression analysis was night pain (p < 0.05). The predictor of H. pylori eradication was sex (p < 0.05). CONCLUSION: The 2-wk triple therapy plus an additional 2-wk treatment with the bismuth derivative (without a prolonged administration of acid suppressing drugs) seems to be an effective and economic treatment not only for the eradication of H. pylori but also for the healing of acute DU. The higher incidence of side effects found after triple therapy compared with the other two regimens was tolerated by the patients.