CONTROL OF ESOPHAGEAL AND INTRAGASTRIC P H WITH COMPOUNDED AND MANUFACTURED OMEPRAZOLE IN PATIENTS WITH REFLUX ESOPHAGITIS: A PILOT STUDY

Main Article Content

Luciana D Moretzsohn
Emanuella B Carvalho
Junia D Franco
Marcela P Soares
Eliza M Brito
K Belarmino
Luiz G Coelho

Keywords

Omeprazole/therapeutic use, gastroesophageal reflux/drug therapy, esophageal pH monitoring, gastric acidity determination

Abstract

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.

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