Polaprezinc Combined with Triple Therapy for Helicobacter Pylori Associated Gastritis: A Prospective, Multicenter, Randomized Clinical Trial

Background: Helicobacter pylori is one of the most prevalent global pathogens and treatment failure is increasing due to rising antibiotic resistance.Polaprezinc is a gastric mucosal protective agent complex of zinc and L-carnosine, shown to improve efficacy when combined with triple therapy in Japan.Aim: To compare the clinical efficacy and safety of the polaprezinc combined to triple therapy versus standard triple therapy in the eradication of H. pylori.Methods: This is a randomized, parallel-group controlled, prospective multicenter study in 11 cities of China.Treatment-naïve patients with H. pylori-associated gastritis were randomly assigned to the following groups: Arm A which consists of triple-therapy (omeprazole 20mg, amoxicillin 1g, and clarithromycin 500mg twice daily) plus polaprezinc 75mg twice daily, Arm B which consists of the same triple-therapy plus polaprezinc 150mg twice daily, or Arm C which is the standard triple-therapy for 14 days.Eradication was considered successful if C 13 or C 14 urea breath test was negative 4 weeks after completion of therapy as the primary outcome.Digestive symptoms improvement 7, 14, 28 days after completion of intervention and rates of adverse effects were the secondary outcomes.Results: 332 enrolled, and 303 patients completed the study, with 106, 96, and 101 patients in Arm A, Arm B, and Arm C. In the intention-to-treat (ITT) analysis, the rate of H. pylori eradication was significantly higher for Arm A (77.0%) and Arm B (75.9%) vs Arm C (58.6%) (p<0.01),whereas there was no difference between Arm A and Arm B (P=0.90) (Table 1, Figure 1).In the per-protocol (PP) analysis, the rate of H. pylori eradication was significantly higher for Arm A (81.1%) and Arm B (83.3%) vs Arm C (61.4%) (P<0.01), while there was no difference between Arm A and Arm B (P=0.62) (Table 1, Figure 1).In all three groups, there were significant symptomatic improvement including abdominal pain, acid reflux, belching, heartburn, bloating, nausea, and vomiting at 7 days, 14 days and 28 days after treatment compared to baseline (P<0.0001).The adverse event rate of Arm B was higher than Arm A (P=0.04) and Arm C (P=0.02), including mild leukopenia, elevated liver enzymes, elevated serum uric acid, and high blood pressure, but there were no serious adverse events.Conclusions: Standard dose polaprezinc combined with standard triple therapy can significantly improve H. pylori eradication rate without an increase in adverse event and is well-tolerated.H. pylori eradication rate in the ITT and PP populations