Efficacy of omeprazole plus two antimicrobials for the eradication of Helicobacter pylori in a Turkish population

• Published in: Clinical therapeutics 1999-09, Vol.21 (9), p.1539-1548
• Main Authors: Uygun, Ahmet, Ates, Yüksel, Erdil, Ahmet, Kadayifci, Abdurrahman, Cetin, Celalettin, Gulsen, Mustafa, Karaeren, Necmettin, Dagalp, Kemal
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Anti-Bacterial Agents - adverse effects; Anti-Bacterial Agents - therapeutic use; Anti-Ulcer Agents - adverse effects; Anti-Ulcer Agents - therapeutic use; Antibacterial agents; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antitrichomonal Agents - adverse effects; Antitrichomonal Agents - therapeutic use; Biological and medical sciences; Clarithromycin - adverse effects; Clarithromycin - therapeutic use; Drug Interactions; Drug Therapy, Combination; duodenal ulcer; dyspepsia; eradication; Female; Helicobacter Infections - drug therapy; Helicobacter pylori; Helicobacter pylori - physiology; Humans; Male; Medical sciences; Metronidazole - adverse effects; Metronidazole - therapeutic use; Middle Aged; omeprazole; Omeprazole - administration & dosage; Omeprazole - adverse effects; Omeprazole - therapeutic use; Ornidazole - adverse effects; Ornidazole - therapeutic use; Patient Dropouts; Pharmacology. Drug treatments; Random Allocation; Roxithromycin - adverse effects; Roxithromycin - therapeutic use; Tinidazole - adverse effects; Tinidazole - therapeutic use; triple therapy; Turkey
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/S0149-2918(00)80009-0

Omeprazole combined with 2 antimicrobials has been suggested as a first-line option for Helicobacter pylori eradication in recent years. However, controversy exists regarding the efficacy of this protocol. This open-label, prospective clinical study investigated the efficacy of omeprazolebased triple therapy for H pylori eradication in 518 patients with H pylori-positive functional dyspepsia with or without duodenal ulcer. Amoxicillin, macrolides (clarithromycin or roxithromycin), and nitroimidazoles (metronidazole, ornidazole, or tintdazole) were the antibiotics used in the study. Nonulcer patients were randomly assigned to 1 of 8 different treatment protocols anu duodenal ulcer patients were randomly assigned to 1 of 4 different treatment protocols consisting of omeprazole (20 mg once daily for nonulcer patients, 20 mg twice daily for ulcer patients for 14 days) with a combination of 2 of the above antimicrobials (for 10 days). H pylori infection was assessed by histologic findings and a rapid urease test before therapy and 4 weeks after therapy ended. Four hundred fifty-nine patients completed their regimens; 327 had functional dyspepsia (180 men, 147 women; median age, 39 years; range, 18 to 70 years) and 132 had ulcers (81 men, 51 women; median age, 40 years; range, 18 to 70 years). Eradication of H pylori was achieved in 58.8% (270 of 459) of all patients, 58.1% (190 of 327) of nonulcer dyspeptic patients, and 60.6% (80 of 132) of duodenal ulcer patients. The eradication rate varied from 47.2% to 69.4% in different treatment protocols. There were no statistically significant differences in eradication rates in any treatment group. All drugs were generally well tolerated in all groups, and no patient discontinued treatment because of side effects. Therapy witn omeprazole and 2 antimicrobials for H pylori had limited efficacy in a Turkish population. The reason for these results, which conflict with those of other studies, is not clear. Further investigations of regimens for the eradication of H pylori in our population are necessary.