Journal Article

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

Lv, Nong-Hua, Shi, Rui-Hua, Xu, Hong, Zou, Yi-You, Qian, Jia-Ming, Luo, He-Sheng, Ren, Jian-Lin, Fang, Jing-Yuan, Li, Jian-Sheng, Ji, Feng, Luo, Han-Qing, Li, Yan-Qing, Tan, Bei

2017

Overview

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.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Adenocarcinoma / Adult / Amoxicillin / Amoxicillin - administration & dosage / Amoxicillin - pharmacology / Antibiotic resistance / Antibiotics / Antiinfectives and antibacterials / Antimicrobial activity / Aspirin / Attenuation / Biochemistry / Biology and Life Sciences / Bismuth / Bismuth compounds / Bismuth subsalicylate / Cancer / Care and treatment / Carnosine / Carnosine - administration & dosage / Carnosine - analogs & derivatives / Carnosine - pharmacology / Causes of / Chlorides / Clarithromycin / Clarithromycin - administration & dosage / Clarithromycin - pharmacology / Clinical isolates / Clinical trials / Comparative analysis / Complications / Diagnosis / Digestive tract / Dosage and administration / Drug dosages / Drug resistance / Drug Therapy, Combination - methods / Effectiveness / Endoscopy / Eradication / Female / Gastritis / Gastritis - drug therapy / Gastritis - microbiology / Gastroenterology / Gastrointestinal tract / Head / Healing / Health aspects / Health care / Helicobacter Infections - drug therapy / Helicobacter pylori / Helicobacter pylori - drug effects / Hospitals / Humans / Hypersensitivity / Incidence / Infections / Intention to Treat Analysis / Intervention / Intestine / Liver / Lymphoma / Male / Medical science / Medicine / Medicine and Health Sciences / Middle Aged / Mucosa / Nausea / Omeprazole - administration & dosage / Omeprazole - pharmacology / Organometallic Compounds - administration & dosage / Organometallic Compounds - pharmacology / Pathogens / People and Places / Pharmacology / Physical Sciences / Pressure / Prospective Studies / Protocol (computers) / Reagents / Research and Analysis Methods / Science / Sodium / Therapy / Treatment Outcome / Ulcers / Urea / Vomiting / Zinc / Zinc compounds / Zinc Compounds - administration & dosage / Zinc Compounds - pharmacology