Background and Aim: Sitafloxacin-based therapy is a potent candidate for third-line Helicobacter pylori eradication treatment. In this systematic review, we summarise current reports with sitafloxacin-based therapy as a third-line treatment. Methods: Clinical studies were systematically searched using PubMed, Cochrane library, Web of Science, and the Igaku-Chuo-Zasshi database. We combined data from clinical studies using a random-effects model and calculated pooled event rates, 95% confidence intervals (CIs), and the pooled odds ratio (OR). Results: We included twelve clinical studies in the present systematic review. The mean eradication rate for 7-day regimens of either PPI (proton pump inhibitor) or vonoprazan–sitafloxacin–amoxicillin was 80.6% (95% CI, 75.2–85.0). The vonoprazan–sitafloxacin–amoxicillin regimen was significantly superior to the PPI–sitafloxacin–amoxicillin regimen (pooled OR of successful eradication: 6.00; 95% CI: 2.25–15.98, p < 0.001). The PPI–sitafloxacin–amoxicillin regimen was comparable with PPI–sitafloxacin–metronidazole regimens (pooled OR: 1.06; 95% CI: 0.55–2.07, p = 0.86). Conclusions: Although the 7-day regimen composed of vonoprazan, sitafloxacin, and amoxicillin is a good option as the third-line Helicobacter pylori eradication treatment in Japan, the extension of treatment duration should be considered to further improve the eradication rate. Considering the safety concern of fluoroquinolones, sitafloxcin should be used after confirming drug susceptibility.
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