title: Twice-daily standard dose of omeprazole achieves the necessary level of acid inhibition for Helicobacter pylori eradication. A randomized controlled trial using standard and double doses of omeprazole in triple therapy.
abstract: Antibiotic resistances and level of acid inhibition may affect the outcome of eradicating regimens for H. pylori. To evaluate the impact of different degrees of acid inhibition on the efficacy of triple treatment, we treated 323 patients with H. pylori infection with clarithromycin and tinidazole plus omeprazole, either 20 mg bid or 40 mg bid. Gastric biopsies and antimicrobial susceptibility testing were performed. Eradication was evaluated by means of breath test. Eradication rates were (intention to treat and per protocol) 83.3 and 84.3% in patients receiving 40 mg omeprazole and 81.9 and 84.1% in those receiving 80 mg omeprazole. Culture was successful in 218 patients (68.7%). Resistance to clarithromycin and metronidazole were found in 13.7 and 20.6%, respectively. Eighteen further patients (8.2%) presented double resistance. Resistance was comparable across the two groups. In resistant patients the eradication rate was significantly lower (66.6% [95% CI, 56-76%], vs 86% [95% CI, 78-91%]; P = 0.001). Antibiotic resistance (OR, 2.73; 95% CI, 1.4-5.3) and smoking (OR, 2.68; 95% CI, 1.4-5.2) were independent predictors of eradication failure. Omeprazole, 20 mg bid, achieves the optimal acid inhibition in H. pylori eradication. Increasing antisecretory activity does not significantly enhance cure rates.
authors.affiliation: Department of Gastroenterology, Cardarelli Hospital, Napoli, Italy. gimanes@tin.it
authors.forename: G
authors.initials: G
authors.lastname: Manes
authors.forename: O
authors.initials: O
authors.lastname: Pieramico
authors.forename: F
authors.initials: F
authors.lastname: Perri
authors.forename: D
authors.initials: D
authors.lastname: Vaira
authors.forename: N
authors.initials: N
authors.lastname: Giardullo
authors.forename: M
authors.initials: M
authors.lastname: Romano
authors.forename: G
authors.initials: G
authors.lastname: Nardone
authors.forename: A
authors.initials: A
authors.lastname: Balzano
mesh_terms: D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005744:Gastric Acid / Q000378:metabolism; D005773:Gastroscopy / Q000379:methods; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects* / Q000302:isolation & purification; D006801:Humans; D007558:Italy; D016015:Logistic Models; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage*; D011336:Probability; D011446:Prospective Studies; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D013276:Stomach Ulcer / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology*; D016896:Treatment Outcome
chemical_list: D009853:Omeprazole