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.


OBJECTIVE
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).


CONCLUSIONS
The omeprazole formulations studied (compounded and manufactured) showed similar control of gastric acid secretion and esophageal acid exposure in patients with reflux esophagitis.
Moretzsohn
Luciana D
LD
Instituto Alfa de Gastroenterologia, Hospital das Clínicas, Medical School of Federal University of Minas Gerais, Brazil.
Carvalho
Emanuella B
EB
Franco
Junia D
JD
Soares
Marcela P
MP
Brito
Eliza M
EM
Belarmino
K
K
Coelho
Luiz G
LG
D000328:Adult; D000368:Aged; D001938:Brazil; D002626:Chemistry, Pharmaceutical; D004339:Drug Compounding; D050782:Esophageal pH Monitoring; D004942:Esophagitis, Peptic / Q000188:drug therapy* / Q000378:metabolism; D005260:Female; D005744:Gastric Acid / Q000378:metabolism*; D005745:Gastric Acidity Determination; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000378:metabolism; D005765:Gastrointestinal Agents / Q000737:chemistry / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000737:chemistry / Q000627:therapeutic use*; D010865:Pilot Projects; D011187:Posture; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000737:chemistry / Q000627:therapeutic use*; D016896:Treatment Outcome
D005765:Gastrointestinal Agents; D054328:Proton Pump Inhibitors; D009853:Omeprazole