First-Line Eradication of Helicobacter pylori with High-Dose Dual Therapy Versus Quadruple Therapy with Bismuth for 14 Days: A Multicenter, Prospective and Randomized Study
DOI:
https://doi.org/10.52787/agl.v52i2.179Keywords:
Helicobacter pylori, bismuth quadruple therapy, high dose dual therapy, adverse effectsAbstract
Introduction. Given the high prevalence of Helicobacter pylori infection worldwide and the high antibiotic resistance for the pathogen, the use of aggressive treatments to eradicate the infection has become necessary. For this reason, the use of extended dual therapy is proposed as first line versus conventional quadruple therapy used to treat this pathology.
Objectives. To evaluate and compare the efficacy and safety of quadruple bismuth therapy (BQT) versus high dose dual therapy (HDT) of esomeprazole and amoxicillin as first-line empirical therapy to eradicate Helicobacter pylori infection.
Patients and Methods. Prospective trial that included 266 H. pylori-naive infected patients, randomized to receive either BQT (esomeprazole 40 mg bid, bismuth subsalicylate 262 mg bid, amoxicillin 1 g bid and levofloxacin 500 mg bid) for 14 days or an HDT (esomeprazole 40 mg tid, amoxicillin 1 g tid) for 14 days. Eradication of infectione was assessed through a breath test six to eight weeks after completion of therapy. Adverse events and compliance were assessed with questionnaires carried out by telephone or personal contact.
Results. Demographic, clinical and endoscopic characteristics were similar between groups. The intention-to-treat (ITT) eradication rates (133 patients in each group) were 84.9% in the BQT group and 88.7% in the HDT group (p = 0.36). Per protocol eradication rates were 90.3% in BQT and 96.6% in HDT (p = 0.04). The prevalence of side effects after BQT was 36.8%, significantly higher than that of the HDT group (16.5%) (p < 0.001); with a tendency to lower compliance of patients with BQT (p = 0.06).
Conclusions. Extended dual therapy induced a significantly higher eradication rate of Helicobacter pylori infection than bismuth-containing quadruple therapy. In addition, it showed a higher compliance rate. On the other hand, quadruple bismuth therapy presented more adverse effects. The importance of this study is the demonstration that dual therapy can be used as first-line eradication therapy for Helicobacter pylori in Colombia.
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