Efficacy and safety of nitazoxanide based quadruple regimen as first line therapy for treating Helicobacter pylori infected naïve patients
2025
Amro M Hassan | Muhammad Abdel-Gawad | Maie M Mahmoud | Emad Abdelrazzak | Safwat S Sawy | Mohamed A Sayed | Rasha Maree O Ali | Waleed S EL-Nasser | Mohamed Ahmad Younes Hussein | Mohamed Ramadan Izzaldin | Mohammed F Mohammed
Background: Eradication of H. pylori is a challenging issue in many parts of the world including Egypt. Aim: To evaluate the safety and efficacy of adding nitazoxanide as an adjuvant drug to the standard clarithromycin-based regimen, a single-center phase 4 prospective superiority parallel open-label randomized controlled trial was conducted. Methodology: Two hundred naïve H. pylori-positive patients were randomly distributed into 4 groups in ratio 1:1:1:1; Group 1: 50 patients were treated by clarithromycin 500mg bid, amoxicillin1gm bid, omeprazole 20 mg, Group 2: 50 patients were treated by clarithromycin 500mg bid, metronidazole 500mg bid, omeprazole 20 mg bid, group 3: 50 patients were treated by clarithromycin 500mg bid, nitazoxanide 500mg bid, omeprazole 20 mg bid, and group 4: 50 patients were treated by clarithromycin 500mg bid, amoxicillin1gm bid, nitazoxanide 500mg bid, omeprazole 20 mg bid. All patients were treated for 14 days and assessed 4 weeks after treatment. Results: Adding nitazoxanide to standard clarithromycin based triple therapy achieved a high eradication rate of 84% in intention to treat analysis (ITT), and 89.36% in per protocol (PP) analysis with high significant p (0.01). Conclusions: adding nitazoxanide as an adjuvant drug to the standard clarithromycin-based regimen is effective and could be used as a first line regimen in the eradication of H. pylori.
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