Melatonin as adjuvant theraphy for improving helicobacter pylori eradication rate

Mahdieh Kamarei,1,* Mohammad abbasinazari,2 Saeed abdi,3

1. Student, Departmen of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Science, Tehran, Iran
2. Professor, Departmen of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University, Tehran, Iran
3. Assistant Professor, Gastroenterology and Liver Diseases Research Center , Shahid Beheshti University, Tehran, Iran.

Abstract


Introduction

Eradication of h. pylori can lead to reduction in the recurrence of peptic ulcer diseases and prevention of gastric cancer. the failure in eradication of helicobacter pylori (h. pylori) using standard treatments is a common concern all over the world. we evalu¬ated additive effects of melatonin combined with a quadruple therapy for the eradication of h. pylori

Methods

This is a double-blind, placebo-controlled, randomized clinical trial. the trial comprises a 14-day, quadruple eradication regimen (omeprazole 20 mg twice daily; bismuth subsalicylate 525 mg four times daily; amoxicillin 1000 mg twice daily; and metronidazole 500 mg twice daily) supplemented with melatonin 3 mg/d (mel group) or a comparable placebo (placebo group).

Results

A total number of 118 patients underwent the process of randomization. eradication rates of intention-to-treat analysis (itt; n = 118) were 73% in the mel group and 65% in the placebo group. eradication rates of per protocol analysis (pp; n = 98) were 80% and 79% in the mel and placebo groups, respectively. there is no significant difference between the two groups either by itt or pp analysis (p = 0.74 and p = 0.91, respectively).

Conclusion

According to the result of the trial, mel 3 mg/d for 14 days does not have an additive effect on the eradication of h. pylori infection.

Keywords

Helicobacter pylori, melatonin, quadruple therapy, eradication