Azithromycin based triple therapy versus standard clarithromycin based triple therapy in eradication of Helicobacter pylori infection in Iran: a randomized controlled clinical trial

Abstract

In regarding to azithromycin's high tissue concentration, long biologic half life, low cost, and excellent anti bacterial profile for Helicobacter pylori in Iran, we sought to compare an azithromycin-based regimen with an already established clarithromycinbased regimen in regards to the eradication of Helicobacter pylori infection. A prospective, open label, randomized controlled trial was conducted on 165 patients who presented to gastrointestinal clinics of QOM Medical University Clinics, with complaint of dyspepsia. All patients received upper gastrointestinal endoscopy, and underwent rapid urease test to confirm Helicobacter pylori infection. Patients were randomized to a treatment arm, which consisted of, clarithromycin, amoxicillin, and omeprazole, or another treatment arm consisting of azithromycin, amoxicillin, and omeprazole. Informed consent was obtained from all patients participating in the trial. Urease breath test was performed in patients 6 weeks after end of treatment to assess eradication. All side effects were recorded. Comparison between the two groups was made using a chi-square test. Seventy six and 89 patients received regimen clarithromycin, amoxicillin, and omeprazole and azithromycin, amoxicillin, and omeprazole, respectively, and completed the study course. Per protocol, eradication rate was 83% with clarithromycin, amoxicillin, and omeprazole and 75% with azithromycin, amoxicillin, and omeprazole (p =0.158). Eradication rate for a subgroup of patients with peptic ulcer disease in two groups were 83% and 74%, respectively (p=0.134). Only one patient in each group was compelled to stop the treatment due to a severe skin hypersensitivity reaction. Other lesser side effects were comparable within the two groups. The results of this study suggest that azithromycin, amoxicillin, and omeprazole at best is as effective as clarithromycin, amoxicillin, and omeprazole; and this new therapy could be considered as an alternative choice for Helicobacter pylori eradication, especially in geographic areas with lower economic status.