One-week triple therapy with omeprazole plus azithromycin and secnidazole is ineffective in eradicating "helicobacter pylori"

ABSTRACT

Background: There is not yet consensus on the most effective treatment for the helicobacter pylori infection, particularly in most developing countries. Azithromycin is a new macrolide and relatively novel agent for H. pylori eradication with an in vitro MIC90 lower than 1 mg/ml.Secnidazole, a nitromidazole that causes fewer side effects than metronidazole, was recenty reported to be used, for the firt time, in the treatment of H. pylori infection. Aim: To evaluate, in a prospective, randomized, single-center study, the association of twodifferent doses of omeprazole, azithromycin and secnidazole in H. pylori eradication. Patients and methods: After informed consent, 55 patients (36m,19F) with duodenal ulcer associated with H. pylori infection were randomized to receive omeprazole 20mg uid (Group A) or 20mg bid (Group B) for sevem days plus azithromycin 500mg uid for six days and secnidazole 2,000mg uid in the first, fourth and seventh day. The H. pylori status was assessed before and 60-90 days posttreatment using urease test, histology and 13C-urea breath test. Statistical analysis was performed by X² test. Results: The two groups had similar demographic characteristics. Fifty-five patients (36M, 19F) were enrolled. Six patients did not show-up for the second visit posttreatment. So, of the 49 evaluable patients, 25por cento (6/24) in Group A and 44por cento(11/25) in Group B wereeradicated, in a per protocol (PP) analysis. Intetion-to-treat (ITT) eradication rates were 21,4por cento (6/28) in Group A and 40.7por cento (11/27) im Group B. The differences betweem ITT and PP analysis from the two groups were not statistically significant. Conclusions: This study shows a very low eradication rate with the two regimens comprising of omeprazole, azithromycin and secnidazole and therefore, should not be recommended for thetreatment of H. pylori infection