[24-hour gastric pH profile with 2 x 20 mg and 2 x 40 mg omeprazole in patients with Helicobacter pylori-associated gastroduodenal ulcer disease].

Fifty patients suffering from Helicobacter pylori associated duodenal (n = 25) or gastric ulcer disease (n = 25) were randomly treated with either omeprazole 20 mg b.i.d. (n = 25) or 40 mg b.i.d. (n = 25). From day 8 to 9, a 24-hour gastric pH measurement was performed in all patients. Patients with duodenal ulcer disease treated with 40 mg or 80 mg omeprazole demonstrated similar gastric pH patterns without statistically significant differences with regard to the mean (5.10 versus 5.17, p = 0.6439) and median pH (5.35 versus 5.30, p = 0.8277) as well as to the percent of time spent below distinctive pH thresholds. Patients suffering from gastric ulcer disease respond somewhat better to the higher omeprazole dose as compared to the 40 mg omeprazole regimen reaching statistical significance (mean pH: 5.04 versus 5.74, p = 0.0124; median pH: 5.30 versus 5.95, p = 0.0114; %-time spent below pH 2, 3, 4, and 5, respectively). In conclusion, there was virtually no (duodenal ulcer) or only a slight (gastric ulcer), probably clinically irrelevant, benefit to doubling the omeprazole dose (20 mg b.i.d. vs. 40 mg b.i.d.) with regard to the 24-hour gastric pH patterns.

RCT Entities:   Population Interventions Outcomes