Efficacy of Two-Week Therapy With Bismuth Quadruple Versus Levofloxacin Concomitant for Helicobacter Pylori Infection: A Prospective Single-Center Randomized Controlled Trial
Abstract
Antibiotic-resistance reduces the efficacy of conventional therapy for H.pylori infection worldwide, which necessitates using various protocols according to location. This was an open‑label randomized controlled trial. We used two modified protocols, bismuth quadruple and concomitant levofloxacin. The aim was to compare the eradication rates of previous protocols as empirical first-line treatment to cure H.pylori infection in intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population. We assigned seventy-eight eligible naïve patients, with a 1:1 ratio to receive two-week therapy of (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice daily) (B-group), or (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg, each twice daily) (L-group). We confirmed H.Pylori eradication by stool antigen test at eight weeks. According to IIT, the eradication rates were 76.92%, and 82.05%, for the B-group and L-group respectively. According to PPA, the eradication rates were 78.9%, and 82.1% for the B-group and L-group respectively. P-value was 078. We didn’t report serious adverse effects. The eradication rates in both regimens were fair. Further trials are required to identify the preferred first-line treatment for H.pylori infection in the Syrian population.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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