Background and aim: The purpose of this study was to compare the efficacy of tinidazole- versus clarithromycin-based triple regimens for eradication of Helicobacter pylori in North Indian patients of peptic ulcer disease, and to correlate the outcome with in vitro antibiotic susceptibility.
Methods: One hundred and forty-six H. pylori-infected patients with active ulcer were included in the prospective, randomized study. A total of 70 patients received lansoprazole 30 mg b.d., amoxycillin 1000 mg b.d. and tinidazole 500 mg b.d. (LAT), and 76 patients received lansoprazole 30 mg b.d., amoxycillin 1000 mg b.d. and clarithromycin 500 mg b.d. (LAC) for 14 days. The H. pylori status was assessed by urea breath test, rapid urease test, and histology and antibiotic sensitivity pattern by Epsilometer test.
Results: In per-protocol analysis of 112 patients the H. pylori eradication rate was 42.3% (95% confidence interval (CI): 0.29-0.56) in LAT, and 64.8% (95%CI: 0.52-0.78) in LAC (95%CI of difference of proportions: 0.13-0.33, P = 0.01). Ulcer healed in 69.2% in the LAT group (95%CI: 0.57-0.82) and 81.7% in the LAC group (95%CI: 0.72-0.92; P = 0.02). Antibiotic susceptibility testing was done in 31 patients. Metronidazole resistance was present in 41.9% isolates but was unrelated to the outcome of the LAT regimen.
Conclusion: Imidazole-based eradication regimens should be abandoned in North India regardless of in vitro susceptibility results.