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PLoS One. 2017 Apr 13;12(4):e0175625. doi: 10.1371/journal.pone.0175625. eCollection 2017.

Polaprezinc combined with clarithromycin-based triple therapy for Helicobacter pylori-associated gastritis: A prospective, multicenter, randomized clinical trial.

Author information

1
Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing, China.
2
Department of Gastroenterology, the First Bethune Hospital of Jilin University, Jilin, China.
3
Department of Gastroenterology, the First Affiliated Hospital of Nanchang University, Nanchang, China.
4
Department of Gastroenterology, Jiangsu Province Hospital and First Affiliated Hospital with Nanjing Medical University, Nanjing, China.
5
Department of Gastroenterology, Renmin Hospital of Wuhan University and Hubei General Hospital, Wuhan, China.
6
Department of Gastroenterology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
7
Department of Gastroenterology, Zhongshan Hospital of Xiamen University, Xiamen, China.
8
Department of Gastroenterology, Xiangya Hospital of Central South University, Changsha, China.
9
Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, China.
10
Department of Gastroenterology, First Affiliated Hospital of Zhejiang University, Hanzhou, China.
11
Department of Gastroenterology, Renji Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China.

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.

PMID:
28407007
PMCID:
PMC5391070
DOI:
10.1371/journal.pone.0175625
[Indexed for MEDLINE]
Free PMC Article

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