Polaprezinc combined with clarithromycin-based triple therapy for Helicobacter pylori-associated gastritis: A prospective, multicenter, randomized clinical trial.
Level 2 - randomized trial
Individual multicenter randomized controlled trial
PubMed 28407007 · doi:10.1371/journal.pone.0175625
What was done
A prospective, multicenter, open-label randomized controlled trial was conducted in 11 cities in China comparing 14 days of clarithromycin-based triple therapy with or without polaprezinc in treatment-naive patients with Helicobacter pylori-associated gastritis. Participants were randomized to Arm A (triple therapy: omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg 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 primary endpoint was H. pylori eradication rate; secondary endpoints were symptom improvement and adverse events.
What was found
A total of 303 patients completed the study (106 in Arm A, 96 in Arm B, 101 in Arm C). By intention-to-treat analysis, H. pylori eradication was 77.0% in Arm A and 75.9% in Arm B versus 58.6% in Arm C (P < 0.01 for both vs C; P = 0.90 for Arm A vs B). Per-protocol eradication rates were 81.1% in Arm A and 83.3% in Arm B versus 61.4% in Arm C (P < 0.01 vs C; P = 0.62 for Arm A vs B). All groups showed significant symptom improvement at days 7, 14, and 28 versus baseline (P < 0.0001). Adverse event incidence was higher in Arm B (5.1%) than in Arm A (2.8%, P = 0.04) and Arm C (1.9%, P = 0.02), with no serious adverse events reported.
Why it matters
Adding standard-dose polaprezinc (75 mg twice daily) to standard triple therapy significantly improves H. pylori eradication rates without increasing adverse effects.
Limits
The study was open-label, increasing risk of reporting bias for symptoms and adverse effects. The abstract reports the number of completed patients (303) rather than the initial randomized total. Eradication rates remained below the optimal 90% threshold across all arms, and baseline clarithromycin resistance patterns were not reported.
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