Efficacy and safety of nitazoxanide based quadruple regimen as first line therapy for treating Helicobacter pylori infected naïve patients

Résumé

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.

Citer ce document

Accès au document

Texte intégral en lecture en ligne, réservé aux abonnés SPHAERO et aux membres de l'institution. Se connecter

Auteur(s)

Statistiques

Consultations : 1

Téléchargements : 0