Absence of nocturnal acid breakthrough in Helicobacter pylori-positive subjects treated with twice-daily omeprazole.
BACKGROUND
Proton pump inhibitors (PPIs) taken twice daily do not effectively control night-time intragastric pH; nocturnal acid breakthrough (NAB) (arbitrarily defined as intragastric pH < 4 lasting longer than 1 h) occurs in more than 75% of patients. The effectiveness of PPIs depends rather on the Helicobacter pylori status.


OBJECTIVE
To investigate the effectiveness of two regimens of omeprazole in H. pylori-positive subjects as well as the occurrence of NAB.


METHODS
Fifteen otherwise healthy H. pylori-positive subjects participated in this randomized, crossover, double-blind study.


METHODS
Night-time intragastric pH-metry was performed before (baseline) and on day 7 of two treatment courses with omeprazole (1 x 20 mg and 2 x 20 mg). A 14-day (minimum) wash-out period was respected between the two treatment courses.


RESULTS
Group medians (10-90% confidence intervals) for night-time intragastric pH (22:30-06:30 h) were as follows: baseline, 2 (1-6.1); 1 x 20 mg, 5 (3.3-6.9; P < 0.001 versus baseline); instead of, 2 x 20 mg, 6.3 (4.9-7.1; P < 0.001 versus baseline, P = 0.02 versus omeprazole 1 x 20 mg). The percentage of time with intragastric pH < 3 was 65.4% during baseline (P < 0.05 versus both omeprazole regimens), 27% with once-daily omeprazole (P = 0.001 versus omeprazole 2 x 20 mg) and 0% with twice-daily omeprazole. NAB occurred in eight (53.3%) subjects with once-daily omeprazole and in no subject taking twice-daily omeprazole.


CONCLUSIONS
In H. pylori-positive subjects, twice-daily omeprazole is highly effective in controlling nocturnal intragastric acidity. NAB does not occur in those subjects and there is no need to add bedtime H2-receptor antagonists to this regimen.
Martínek
Jan
J
Department of Hepatology and Gastroenterology, IKEM, Prague, Czech Republic. jan.martinek@medicon.cz
Pantoflícková
Drahoslava
D
Hucl
Tomás
T
Benes
Marek
M
Dorta
Gian
G
Lukás
Milan
M
Spicák
Julius
J
D000328:Adult; D001944:Breath Tests; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005744:Gastric Acid / Q000378:metabolism*; D005745:Gastric Acidity Determination; D016481:Helicobacter Infections / Q000150:complications* / Q000175:diagnosis / Q000378:metabolism; D016480:Helicobacter pylori; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D009853:Omeprazole / Q000008:administration & dosage* / Q000627:therapeutic use; D011446:Prospective Studies; D054328:Proton Pump Inhibitors; D018709:Statistics, Nonparametric
D054328:Proton Pump Inhibitors; D009853:Omeprazole