Comparing the efficacy of two-week therapy with bismuth quadruple versus levofloxacin concomitant regimen for Helicobacter Pylori infection in Syrian patients. A randomized controlled trial
Abstract
Background: Antibiotic-resistant reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, lead to varying treatment protocols according to locations. The primary outcome of this research is to estimate the eradication rates of modified bismuth quadruple versus modified levofloxacin concomitant as empirical first-line treatment by intention to treat analysis (ITT) and per-protocol analysis (PPA) in a referral hospital in Syria.Settings and Design: an open‑label parallel blind randomized controlled trial.Methods: We randomly assigned seventy-eight naïve who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (B-group) which receive (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for two weeks), or (L-group) which receive (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test at eight weeks. Results: Thirty-nine patients were allocated in each group. In the B- group, thirty-eight patients completed the follow-up, thirty patients were cured. While in the L-group, thirty-nine completed the follow-up, thirty-two patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the B-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371…
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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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