Levofloxacin-based concomitant versus sequential therapy for Helicobacter pylori eradication in treatment-naïve Syrian patients: a randomized trial showing no superiority of sequential therapy
Abstract
Background: Helicobacter pylori (H. pylori) infection remains highly prevalent worldwide, including the Eastern Mediterranean region. In Syria, standard triple therapy effectiveness has declined due to increasing antibiotic resistance, misuse, and healthcare limitations. As susceptibility-guided therapy and recommended regimens may be unavailable, empirical levofloxacin-based therapies remain used. This randomized trial compared two levofloxacin-based regimens under local conditions, as sequential therapy has not been evaluated previously in Syrian patients.
Methods: This single-center, prospective, open-label, randomized superiority trial included 150 treatment-naïve adults with histologically confirmed H. pylori infection. Participants were assigned equally to receive either a 14-day levofloxacin-based concomitant regimen or a 14-day levofloxacin-based sequential regimen. The primary outcome was eradication success, confirmed by negative stool antigen testing 6 weeks after therapy and analyzed using intention-to-treat analysis. Treatment-related adverse events were recorded.
Results: Intention-to-treat eradication rates were 84%(63/75) with concomitant therapy and 81.3%(61/75) with sequential therapy. The risk difference was 2.7% points (95%CI:-9.4 to 14.8), with no significant difference between groups (p = 0.83;OR = 1.20(95% CI:0.516-2.81). Baseline characteristics were comparable. Both regimens were generally well tolerated. Nausea was the most frequent adverse event,…
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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