Control of esophageal and intragastric pH with compounded and manufactured omeprazole in patients with reflux esophagitis: a pilot study.

Background: Proton pump inhibitors (PPI) are the drugs of choice for treatment of gastroesophageal reflux disease (GERD). Omeprazole, the first PPI commercialized, is now available in different formulations.

Objectives: To compare the efficacy of different omeprazole formulations on gastric acid secretion measured by intragastric and esophageal pH monitoring in patients with reflux esophagitis.

Methods: Prospective, open, randomized clinical trial involving H. pylori negative patients with typical symptoms of GERD. Patients were submitted to 24-h intragastric and esophageal pH studies during use of six different formulations of compounded and manufactured omeprazole.

Results: Thirty patients, 19 female, median age 55 years were studied. The intragastric pH was maintained below 4.0 for a median of 36.7% of total time in compounded group and 47.7% in manufactured group (p>0.05). There was also no statistical difference between the median percentage of time of pH below 4.0 in orthostatic and supine position in compounded and manufactured groups (30.1% and 49.6% and 28.8% and 55.2%, respectively). The esophageal pH was maintained below 4.0 for a median of 0.1% of total time in compounded group and 0.4% in manufactured group (p>0.05). In orthostatic position the median percentage of time of esophageal pH below 4.0 was 0.0% in both groups (p>0.05). In supine position, the median percentage of time of esophageal pH below 4.0 was 0.1% and 0.3% in compounded and manufactured groups, respectively (p>0.05).

Conclusion: The omeprazole formulations studied (compounded and manufactured) showed similar control of gastric acid secretion and esophageal acid exposure in patients with reflux esophagitis.