Postgraduate Department, Xi'an Medical University, Xi'an, Shaanxi 710021, China.
State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Medical University, Xi'an, Shaanxi 710032, China.
Chin Med J (Engl). 2023 Jul 20;136(14):1690-1698. doi: 10.1097/CM9.0000000000002696. Epub 2023 May 22.
With the development of traditional Chinese medicine research, berberine has shown good efficacy and safety in the eradication of Helicobacter pylori (H. pylori). The present study aimed to evaluate the efficacy and safety of triple therapy containing berberine, amoxicillin, and vonoprazan for the initial treatment of H. pylori.
This study was a single-center, open-label, parallel, randomized controlled clinical trial. Patients with H. pylori infection were randomly (1:1:1) assigned to receive berberine triple therapy (berberine 500 mg, amoxicillin 1000 mg, vonoprazan 20 mg, A group), vonoprazan quadruple therapy (vonoprazan 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, colloidal bismuth tartrate 220 mg, B group), or rabeprazole quadruple therapy (rabeprazole 10 mg, amoxicillin 1000 mg, clarithromycin 500 mg, colloidal bismuth tartrate 220 mg, C group). The drugs were taken twice daily for 14 days. The main outcome was the H. pylori eradication rate. The secondary outcomes were symptom improvement rate, patient compliance, and incidence of adverse events. Furthermore, factors affecting the eradication rate of H. pylori were further analyzed.
A total of 300 H. pylori-infected patients were included in this study, and 263 patients completed the study. An intention-to-treat (ITT) analysis showed that the eradication rates of H. pylori in berberine triple therapy, vonoprazan quadruple therapy, and rabeprazole quadruple therapy were 70.0% (70/100), 77.0% (77/100), and 69.0% (69/100), respectively. The per-protocol (PP) analysis showed that the eradication rates of H. pylori in these three groups were 81.4% (70/86), 86.5% (77/89), and 78.4% (69/88), respectively. Both ITT analysis and PP analysis showed that the H. pylori eradication rate did not significantly differ among the three groups (P >0.05). In addition, the symptom improvement rate, overall adverse reaction rate, and patient compliance were similar among the three groups (P >0.05).
The efficacy of berberine triple therapy for H. pylori initial treatment was comparable to that of vonoprazan quadruple therapy and rabeprazole quadruple therapy, and it was well tolerated. It could be used as one choice of H. pylori initial treatment.
随着中医药研究的发展，小檗碱在根除幽门螺杆菌（H. pylori）方面显示出良好的疗效和安全性。本研究旨在评估含小檗碱、阿莫西林和沃诺拉赞三联疗法在 H. pylori 初始治疗中的疗效和安全性。
这是一项单中心、开放标签、平行、随机对照临床试验。将 H. pylori 感染患者随机（1:1:1）分为三组接受治疗：小檗碱三联疗法（小檗碱 500mg、阿莫西林 1000mg、沃诺拉赞 20mg，A 组）、沃诺拉赞四联疗法（沃诺拉赞 20mg、阿莫西林 1000mg、克拉霉素 500mg、胶体次枸橼酸铋 220mg，B 组）或雷贝拉唑四联疗法（雷贝拉唑 10mg、阿莫西林 1000mg、克拉霉素 500mg、胶体次枸橼酸铋 220mg，C 组）。所有药物均每日两次，疗程为 14 天。主要结局是 H. pylori 根除率。次要结局是症状改善率、患者依从性和不良反应发生率。此外，还进一步分析了影响 H. pylori 根除率的因素。
本研究共纳入 300 例 H. pylori 感染患者，263 例完成研究。意向治疗（ITT）分析显示，小檗碱三联疗法、沃诺拉赞四联疗法和雷贝拉唑四联疗法的 H. pylori 根除率分别为 70.0%（70/100）、77.0%（77/100）和 69.0%（69/100）。按方案（PP）分析显示，三组的 H. pylori 根除率分别为 81.4%（70/86）、86.5%（77/89）和 78.4%（69/88）。ITT 分析和 PP 分析均显示三组间 H. pylori 根除率无显著差异（P>0.05）。此外，三组的症状改善率、总体不良反应发生率和患者依从性均相似（P>0.05）。
小檗碱三联疗法治疗 H. pylori 初治的疗效与沃诺拉赞四联疗法和雷贝拉唑四联疗法相当，且耐受性良好。可作为 H. pylori 初治的一种选择。
