Efficacy and safety of polaprezinc in the treatment of gastric ulcer: A multicenter, randomized, double-blind, double-dummy, positive-controlled clinical trial.
Level 2 - randomized trial
Multicenter randomized, double-blind, positive-controlled clinical trial
PubMed 35999163 · doi:10.1016/j.medengphy.2022.103860
What was done
A prospective, multicenter, randomized, double-blind, double-dummy, active-controlled trial across 10 clinical centers enrolled 224 patients with gastric ulcers. Patients were randomized to receive polaprezinc (test group, n = 111) or rebamipide (control group, n = 113) for 8 weeks. The primary endpoint was the effective treatment rate confirmed by gastroscopy after 8 weeks. Secondary endpoints included gastrointestinal symptom improvement rates at 4 and 8 weeks and adverse event occurrences.
What was found
At 8 weeks, gastroscopy-confirmed effective rates were 81.48% for polaprezinc and 74.31% for rebamipide (P = 0.1557). Symptom improvement rates were comparable between the polaprezinc and rebamipide groups at 4 weeks (44.44% vs. 39.45%, P = 0.4559) and 8 weeks (81.48% vs. 77.06%, P = 0.4223). Adverse events and drug reactions were reported as similar between the two groups.
Why it matters
This trial demonstrates that polaprezinc achieves endoscopic healing and symptom resolution rates comparable to rebamipide, supporting its use as an active mucosal protective agent for gastric ulcers.
Limits
The study lacked a placebo arm to account for spontaneous healing, and the abstract does not specify drug dosages, Helicobacter pylori status, non-inferiority margins, or specific rates and types of adverse events.
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