Randomized controlled comparison of nitroimidazoles for the eradication ofHelicobacter pylori and relief of ulcer-associated and non-ulcer dyspepsia.

Background: A combination of omeprazole, clarithromycin and either metronid azole or tinidazole is commonly used for Helicobacter pylori eradication, M etronidazole is considerably cheaper than tinidazole but the two have not p reviously been compared in a randomized trial. Methods: One hundred and twenty dyspeptic H. pylori-positive patients with endoscopically defined peptic ulcer [DU (n = 65), GU (n = 12)] or non-ulcer dyspepsia (NUD, n = 43) were randomized to receive a 1-week course of twic e daily omeprazole 20 mg, clarithromycin 250 mg and either metronidazole 40 0 mg (OCM) or tinidazole 500 mg (OCT) in a double-blind fashion, Eradicatio n of H. pylori, safety and side-effects of treatment, dyspeptic symptom sco re and consumption of antisecretory drugs were assessed at 6 weeks and 1 ye ar after treatment. Results: H, pylori eradication was successfully achieved in 57/60 (95%, ITT analysis) of patients receiving OCT and 58/60 (97%, ITT analysis) receivin g OCM. Both regimens had similar side-effect profiles, which accounted for only one patient withdrawal. All patients remained uninfected (as assessed by C-14-urea breath test) at 1-year follow-up, but major symptom improvemen ts and decreased antisecretory drug use were only seen in patients with DU (P < 0.0001). Conclusions: Treatment with OCM is as effective as the more expensive OCT a t eradicating H, pylori. H. pylori eradication results in long-term relief of dyspeptic symptoms and reduced antisecretory consumption only in patient s with DU, and not in those with NUD.