Does the Addition of Melatonin to Quadruple Therapy Increases the Eradication Rate of Helicobacter pylori? A Double-Blind Randomized Clinical Trial FC12-FC14
Dr. Mohammad Abbasinazari,
Professor, Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Introduction: The failure in eradication of Helicobacter pylori (H.pylori) using standard treatments is a common concern all over the world. Limited data have shown efficacy of melatonin against H.pylori in vitro. We hypothesise that, melatonin as adjuvant to quadruple therapy may improve H.pylori eradication rate.
Aim: To evaluate additive effects of melatonin combined with a quadruple therapy for the eradication of H.pylori.
Materials and Methods: This was a double-blind, placebo-controlled, randomized clinical trial. The trial comprised a 14-days, 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) without melatonin. The data were analysed using the SPSS version 19 and p-values less than 0.05 was considered statistically significant.
Results: 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 was 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 does not have an additive effect on the eradication of H.pylori infection.