Sequential therapy versus quadruple therapy for Helicobacter pylori eradication: A prospective double-blinded randomized controlled trial.

ABSTRACT

Backgrounds and Aims: This controlled randomized clinical trial was designed to compare effectiveness, side effects, and severity of symptoms before and after therapy between quadruple (QT) and sequential regimens (SQ) for Helicobacter Pylori (H. pylori). Methods: Patients were randomly allocated into two groups. Group A received a 14-day QT including pantoprazole 40 mg q12 h, bismuth subcitrate 240 mg q12 h, clarithromycin 500 mg q12 h, and amoxicillin 1000 mg q12 h and group B received ST including pantoprazole 40 mg q12 h and amoxicillin 1000 mg q12 h for the initial 5 days followed by pantoprazole 40 mg q12 h, clarithromycin 500 mg q12 h and tinidazole 500 mg q12 h for the next 5 days. Adverse drug reactions and patients' compliance were assessed after finishing the treatment course and also 4 weeks after. All patients were naive, therefore ST and QT were first-line therapies. To evaluate severity of symptoms we used Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) before taking the first dose of regimens, at the end of therapy, and also 4 weeks after (follow-up). Results: The mean age in Group A (n = 83) was 48.55 ± 12.56 and 47.24 ± 12.78 in Group B (n = 79). No statistically significant differences were observed between the two groups regarding age, gender, endoscopic findings, and also eradication rate. The analysis demonstrated a significant decrease in SF-LDQ score between baseline and after therapy and baseline and follow-up in both regimen groups. Both regimens were well tolerated by the majority of patients, and there were no significant differences between the two groups in terms of adverse drug reactions. Conclusion: This study showed that ST can be used as an alternative first-line therapy to QT in patients with H. pylori infection.