PepZinGI® improves standard therapy to eradicate Helicobacter pylori, study shows
- Multicenter, randomized, open-label, controlled study
- 303 patients with H. pylori-associated gastritis on standard drug therapy
- Addition of PepZinGI® significantly improves H. pylori eradication
- Effective dosage is as low as 75 mg, twice daily, for 14 days
This multicenter, randomized, open-label, controlled study investigated the efficacy and safety of polaprezinc (PepZinGI® zinc-carnosine) as an adjunct to standard triple therapy compared to triple therapy alone for the eradication of Helicobacter pylori. The study was conducted in 11 cities in China.
Patients with H. pylori-associated gastritis without previous treatment were randomly assigned to one of three treatment arms for a 14-day treatment:
- Arm A: Triple Therapy* + polaprezinc (75 mg, twice daily)
- Arm B: Triple Therapy* + polaprezinc (150 mg, twice daily)
- Arm C: Triple Therapy* alone
*Triple therapy indicates treatment with omeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg, each twice daily.
The primary study endpoint was the rate of H. pylori eradication. Secondary endpoints included symptom improvement and lower incidence of adverse events.
A total of 91% (303/332) of the enrolled patients completed the study with similar numbers in each groups (e.g., about 100 patients).
Based on intention-to-treat (ITT) analysis, the rate of H. pylori eradication was significantly higher for Arms A (77%) and B (76%) compared to Arm C (59%) (P<.01), with no significant between-group difference between Arms A and B reported (P=.90).
Based on per-protocol (PP) analysis, the rate of H. pylori eradication was significantly higher for Arms A (81%) and B (83%) compared to Arm C (61%) (P<.01), with no significant between-group difference between Arms A and B reported (P=.62).
Compared to baseline, all three groups reported significant symptom improvement at 7, 14, and 28 days after treatment (P<.0001). No serious adverse events were reported in any group. The adverse event rate for Arm B (5%) was higher than for Arms A (3%) (P=.04) and C (2%) (P=.02).
These preliminary findings suggest that adding PepZinGI® zinc-carnosine (as little as 75 mg, twice daily, for 14 days) to standard drug therapy can significantly improve the rate of H. pylori eradication and is well tolerated in patients with H. pylori-associated gastritis.