OBJECTIVE: To compare the efficacy of two omeprazole/amoxicillin regimens concerning Helicobacter pylori eradication, ulcer healing, pain relief, and safety in patients with gastric ulcer disease. METHODS: In a prospective, single-blind, single-center study, 70 patients with active, H. pylori-positive (histology and/or culture) gastric ulcers were randomly treated with either omeprazole 20 mg b.i.d. plus amoxicillin 1 g b.i.d. (group I; n = 35) or with omeprazole 40 mg b.i.d. plus amoxicillin 1 g b.i.d. over 2 wk, followed by full dose ranitidine for another 4 wk. Patients were investigated clinically and endoscopically prior to treatment and after 6 wk, including the assessment of H. pylori status by means of urease test, specific culture, and histology. RESULTS: Patients of group I and II had similar demographic and clinical characteristics. Three patients were lost to follow-up. The overall proportion of H. pylori eradication was 88.1% (group I, 91.2%; group II, 84.8%, p = NS). The ulcer healing rate was 79.1% after 6 wk, 92.5% after 10 wk, and 100% after 6 months, without a statistically significant difference between the study groups. Complete pain relief occurred after a median of 2 days (group I) and 1.5 days (group II, p = NS), respectively. Six patients (9.0%) complained of side effects that led to discontinuation of amoxicillin treatment in three patients (4.5%). CONCLUSIONS:Omeprazole plus amoxicillin is a highly effective and well-tolerated therapy regimen to eradicate H. pylori from the gastric mucosa of patients with gastric ulcer disease. In addition, the results clearly suggest that medium- and high-dose omeprazole schedules are equally effective with regard to bacterial eradication, ulcer healing, pain relief, and safety in gastric ulcers. Thus, medium- and not high-dose omeprazole plus amoxicillin should be the treatment regimen of first choice to eradicate H. pylori in gastric ulcer disease.
RCT Entities:
OBJECTIVE: To compare the efficacy of two omeprazole/amoxicillin regimens concerning Helicobacter pylori eradication, ulcer healing, pain relief, and safety in patients with gastric ulcer disease. METHODS: In a prospective, single-blind, single-center study, 70 patients with active, H. pylori-positive (histology and/or culture) gastric ulcers were randomly treated with either omeprazole 20 mg b.i.d. plus amoxicillin 1 g b.i.d. (group I; n = 35) or with omeprazole 40 mg b.i.d. plus amoxicillin 1 g b.i.d. over 2 wk, followed by full dose ranitidine for another 4 wk. Patients were investigated clinically and endoscopically prior to treatment and after 6 wk, including the assessment of H. pylori status by means of urease test, specific culture, and histology. RESULTS:Patients of group I and II had similar demographic and clinical characteristics. Three patients were lost to follow-up. The overall proportion of H. pylori eradication was 88.1% (group I, 91.2%; group II, 84.8%, p = NS). The ulcer healing rate was 79.1% after 6 wk, 92.5% after 10 wk, and 100% after 6 months, without a statistically significant difference between the study groups. Complete pain relief occurred after a median of 2 days (group I) and 1.5 days (group II, p = NS), respectively. Six patients (9.0%) complained of side effects that led to discontinuation of amoxicillin treatment in three patients (4.5%). CONCLUSIONS:Omeprazole plus amoxicillin is a highly effective and well-tolerated therapy regimen to eradicate H. pylori from the gastric mucosa of patients with gastric ulcer disease. In addition, the results clearly suggest that medium- and high-dose omeprazole schedules are equally effective with regard to bacterial eradication, ulcer healing, pain relief, and safety in gastric ulcers. Thus, medium- and not high-dose omeprazole plus amoxicillin should be the treatment regimen of first choice to eradicate H. pylori in gastric ulcer disease.