Abstract
The efficacy and safety of polaprezinc combined with triple therapy was compared with triple therapy alone in the eradication of Helicobacter pylori. A randomized, parallel-group, open-label, controlled, prospective multicenter study was conducted in 11 cities in China. Treatment-naive patients with H. pylori–associated gastritis were randomly assigned to one of three arms for a 14-day treatment: Arm A triple therapy (omeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg, each twice daily) plus polaprezinc 75 mg twice daily; Arm B triple therapy plus polaprezinc 150 mg twice daily, or Arm C triple therapy alone. The rate of H. pylori eradication was the primary endpoint. Secondary endpoints were symptom improvement and lower incidence of adverse events. 303 patients completed the study– 106, 96, and 101 patients in Arms A, B, and C, respectively. Intention-to-treat (ITT) analysis showed that the rate of H. pylori eradication was significantly higher for Arms A (77.0%) and B (75.9%) compared to Arm C (58.6%) (P < 0.01), whereas there was no difference between Arms A and B (P = 0.90). Per-protocol (PP) analysis showed that the rate of H. pylori eradication was significantly higher for Arms A (81.1%) and B (83.3%) compared to Arm C (61.4%) (P < 0.01), whereas there was no significant difference between Arms A and B (P = 0.62). All three groups reported significant symptom improvement at 7, 14, and 28 days after treatment, compared to baseline (P < 0.0001). The adverse event rate for Arm B (5.1%) was higher than for Arms A (2.8%) (P = 0.04) and C (1.9%) (P = 0.02). There were no serious adverse events in any group. It appears that standard dose polaprezinc combined with triple therapy can significantly improve the H. pylori eradication rate, without an increase in toxicity.
Highlights
Helicobacter pylori (H. pylori), one of the most globally prevalent pathogens, colonizes about 50% of the world’s population [1]
124 were excluded: 86 did not meet inclusion criteria, 26 declined to participate, and 12 were excluded for other reasons. 332 patients were enrolled and randomized into three groups for ITT analysis: 113 in Arm A, 108 in Arm B and 111 in Arm C. 316 patients accepted the intervention and first-time safety assessment for the safety analysis set. 303 patients completed the study for PP analysis: 106 in Arm A, 96 in Arm B, and 101 in Arm C
Arm A, polaprezinc 150 mg/d combined with omeprazole, amoxicillin, clarithromycin for 14 days
Summary
Helicobacter pylori (H. pylori), one of the most globally prevalent pathogens, colonizes about 50% of the world’s population [1]. In China, the rate of H. pylori infection remains elevated at 40%–60%, in part due to increasing rates of antibiotic resistance and decreasing rates of efficacy with proton pump inhibitor (PPI)– based triple therapy regimens [4]. As rates of antibiotic resistance have increased, the rates of H. pylori eradication using standard triple therapy (PPI, clarithromycin, and amoxicillin) have declined well below 80%. Extending therapy from 7 to 10 days increases the eradication rate by only about 5% Common therapies, such as sequential therapy, concomitant therapy, and levofloxacin-based triple therapy have demonstrated no advantage for native Chinese patients [4]. The Fourth Chinese National Consensus Report on the management of H. pylori infection suggested that combining a mucosal protective agent with triple therapy may have the same efficacy as bismuth-containing quadruple therapy [6]. Few clinical studies in China have evaluated the efficacy of adding a mucosal protective agent to enhance eradication of H. pylori
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