Background/objective: Metronidazole resistance is a major problem in many developing countries. Our main objective was to study the outcome of a non-metronidazole and omeprazole-based antibiotic regimen in eradicating Helicobacter pylori in patients with duodenal ulcer.
Design: A prospective study of 50 consecutive patients with proven peptic ulcer (mean age 36.6 +/- 10.5 years, range 17-60, male:female = 2), referred from the primary health centres.
Main outcome measure: The primary outcome of the study was H. pylori eradication, at least 4 weeks after stopping antibiotic treatment.
Methods: Patients were considered eligible for the study if they had endoscopic evidence or a past medical history of peptic ulcer and had not received any antibiotics for at least 4 weeks prior to admission into the study. H. pylori infection was confirmed by serology, histology, a rapid urease test (RUT) and culture. After an initial oesophago-gastroduodenoscopy (OGD), each patient received a 2-week course of omeprazole (20 mg twice daily), and each of amoxycillin capsules (500 mg) and clarithromycin tablets (250 mg) thrice daily after food. The follow-up OGDs were performed after a mean period of 10.04 weeks (range 4-48) and at 10.4 +/- 2.5 months (range 6-14 months) after stopping treatment.
Results: All 50 patients completed the study. The sensitivity values for serology, RUT and histopathology were 98, 96 and 100%, respectively. H. pylori culture was positive in only 15 of 50 patients (30% sensitivity). H. pylori was eradicated in 47 (94%) patients. There was no evidence of H. pylori infection in the 27 of 35 (77%) patients, who returned for a third OGD. At the time of the second OGD, there was a significant reduction of pain-days (from 5.47 to 1.16), and antral (from 1.95 to 0.78) and corpus (from 1.8 to 0.6) mucosal cellular infiltrate scores, when compared with the first OGD (P < 0.001 in each case).
Conclusion: Exclusion of metronidazole from the treatment regimen of patients with H. pylori-positive duodenal ulcer in a region with metronidazole resistance yielded an excellent H. pylori eradication rate of 94%, when omeprazole, amoxicillin and clarithromycin were used.