Effect of the mucolytic erdosteine on the success rate of PPI-based first-line triple therapy for Helicobacter pylori eradication: a prospective, double-blind, randomized, placebo-controlled study

Abstract

Objective. Because Helicobacter pylori creates a well-sheltered microenvironment within the gastric mucus layer, it has been speculated that the disruption of this space by a mucolytic agent may enhance the eradication rate. The aim of the present study was to investigate the effect of erdosteine, a strong mucolytic agent, on the effectiveness of PPI-based, first-line triple therapy in the eradication of H. pylori. Material and methods. Initially, 196 patients were enrolled to the study. Of these, 79 H. pylori-positive patients were randomized to the erdosteine group (triple therapy consisting of pantoprazole, amoxicillin and clarithromycin plus erdosteine; n = 40) or the placebo group (triple therapy plus placebo; n = 39) for 14 days. Endoscopic biopsies and ¹³C-urea breath tests were performed at entry and at 4–6 weeks after the completion of the treatment. Additionally, rapid urease tests were performed at entry. Results. The eradication of H. pylori was achieved in 30 (75%) of the 40 patients in the erdosteine group and in 20 (51.3%) of the 39 patients in the placebo group, according to the ITT analysis (p = 0.028). When the PP analysis was performed as well, H. pylori eradication was achieved in 30 (78.9%) of the 38 patients in the erdosteine group and in 20 (52.6%) of the 38 patients in the placebo group (p = 0.016). Conclusions. Erdosteine is an efficient adjuvant therapy that could be used in conjunction with first-line triple therapy in the treatment of H. pylori.

Key Words::

• Eradication therapy
• erdosteine
• Helicobacter pylori
• mucolytic agents

Acknowledgements

This manuscript was presented as a poster presentation at the “18th World Congress of the International Association of Surgeons, Gastroenterologist and Oncologists, İstanbul, Turkey, 8–11 October, 2008.”

Declaration of interest: We report that we have no commercial associations (e.g. equity ownership or interest, consultancy, patent and licensing agreement, or institutional and corporate associations) that might be a conflict of interest in relation to the submitted manuscript.