Omeprazole plus clarithromycin and either tinidazole or tetracycline for Helicobacter pylori infection: a randomized prospective study.

Objective: Helicobacter pylori has begun to show resistance to imidazoles and could result in the low efficacy of short-term triple therapy. The aim of this study was to assess whether administration of tetracycline instead of tinidazole in short-term low-dose triple therapy could increase the H. pylori eradication rate.
Methods: In a prospective study, 113 patients with peptic ulcer (n = 36) or non-ulcer dyspepsia (n = 77) were randomized to receive 1-wk treatment, composed of omeprazole 20 mg b.i.d., clarithromycin 250 mg b.i.d., and either tinidazole 500 mg b.i.d. (n = 57) or tetracycline 500 mg b.i.d. (n = 56), upon detection of H. pylori infection at endoscopy.
Results: H. pylori eradication, defined as a negative bacterial finding in a rapid urease test and upon histologic assessment at least 4 wk after cessation of therapy, was achieved in 86% (49 of 57; 95% confidence interval = 76.9-95) of patients in the first group and in 71.4% (40 of 56; 95% confidence interval = 59.6-83.3) in the second group (p = not significant). Side effects occurred in 28% of patients from the tinidazole-based group and in 12.5% from the tetracycline group (p = not significant). Two patients in the tinidazole group discontinued therapy at 5 and 6 days because of side effects.
Conclusions: The administration of tetracycline instead of tinidazole in short-term triple therapy yielded disappointing results in H. pylori eradication.