Azithromycin effect on helicobacter pylori eradication: double blind randomized clinical trial

Abstract

Background/aims: To evaluate the efficacy of one- and two-week regimen of quadruple therapy containing azithromycin for Helicobacter pylori infection eradication.

Methodology: A total of 84 H. pylori-infected patients, were randomized into three groups: First group (n=31): 6 g AzOAB: Azithramycin 500 mg twice daily for 6 days and Omeprazole 20 mg, Amoxicillin 1 g, Bismuth 240 mg all twice daily for 2 weeks. Second group (n=28): 3 g AzOAB: Azithramycin 500 mg twice daily for 3 days and Omeprazole 20 mg, Amoxicillin 1 g, Bismuth 240 mg all twice daily for 1 week. Third group (n=25): 1.5 g AzOAB: Azithromycin 250 mg twice daily for 3 days and Omeprazole 20 mg, Amoxicillin 1 g, Bismuth 240 mg all twice daily for 1 week. Eradication was defined as a negative urea breath test, four weeks after the end of treatment.

Results: The eradication rate in the first, second and third group was 92% (95% CI: 84-99.8%), 88.46% (95% CI: 84.47-84.74%), 80% (95% CI: 79.88-80.11%) respectively, based on per-protocol analysis. There was no significant difference between eradication rates (P=0.44). The frequency of drug side effects in the study groups was respectively 19.23%, 7.6% and 0%. There was no statistically significant difference between the three regimens (P=0.06). However, frequency of drug side effects between 6 g AzOAB and 1.5 g AzOAB was statistically significant (P=0.02).

Conclusions: According to the results of these 3 regimens, it seems that one week quadruple regimens of 3 g Azithromycin may be more favorable for H. pylori eradication.