Efficacy and safety of Qingwei Zhitong pellets combined with bismuth quadruple therapy for Helicobacter pylori eradication: A randomized controlled trial

IF 1.7 4区医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE

European Journal of Integrative Medicine Pub Date : 2025-09-16 DOI:10.1016/j.eujim.2025.102557

Zhen Li , Xiaolin Zhao , Kun Huang , Yong Cai , Chanjuan Fan , Dongling Xie , Lili Zhai , Sheng Li , Xiaomei Zhang , Haiou Ding , Pan Wang , Jianping Cheng

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引用次数: 0

Abstract

Introduction

We previously reported that Qingwei Zhitong pellets (QZP)-containing quadruple therapy was safe and effective for Helicobacter pylori (H. pylori) eradication. However, it remains unclear whether QZP adjunctive to bismuth-based quadruple therapy (BQT) enhances H. pylori eradication rates and reduces adverse events. The aim of this study was to investigate the effect of adding QZP to BQT on the eradication rate of H. pylori.

Methods

In this single-center, randomized controlled trial, 336 patients were randomized 1:1:1 to receive 14-day therapy with either BQT (compound bismuth aluminate 1.3 g three times daily, rabeprazole 20 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily), BQT plus QZP (3.2 g three times daily), or triple therapy (rabeprazole, amoxicillin, clarithromycin at aforementioned doses) plus QZP (3.2 g three times daily). The primary endpoint was the eradication rate of H. pylori. Secondary endpoints included symptom improvement, adverse effects, and treatment compliance.

Results

In intention-to-treat analysis, eradication rates were significantly higher with BQT-QZP (85.7 %) than with TT-QZP (73.2 %) or BQT (74.1 %) (RR 0.85, 95 % CI 0.76–0.96 and RR 0.86, 95 % CI 0.78–0.96, respectively). BQT-QZP showed superior symptom outcomes, with higher rates of complete resolution (13.4 % vs. 6.3 % and 4.5 %) and overall improvement (86.6 % vs. 63.4 % and 53.6 %). BQT-QZP also resulted in the highest total effective rate (71.4 % vs. 54.5 % and 60.7 %) and healing rate (19.6 %). The three groups demonstrated comparable rates of overall adverse events, and treatment compliance rates were high, with comparable levels between the groups.

Conclusions

A 14-day BQT combined with QZP quintuple therapy achieves an acceptable eradication rate as first-line anti-H. pylori therapy.

Registration

ChiCTR2300077090.

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清胃止痛丸联合铋四联疗法根除幽门螺杆菌的疗效和安全性：一项随机对照试验

我们曾报道含清胃止痛丸四联疗法对幽门螺杆菌（h.p ypylori）根除安全有效。然而，尚不清楚QZP辅助以铋为基础的四联疗法（BQT）是否能提高幽门螺杆菌根除率并减少不良事件。本研究的目的是探讨在BQT中加入QZP对幽门螺杆菌根除率的影响。方法在该单中心随机对照试验中，336例患者按1:1∶1随机分组，接受BQT（复方铝酸铋1.3 g每日3次，雷贝拉唑20 mg每日2次，阿莫西林1 g每日2次，克拉霉素500 mg每日2次）、BQT + QZP （3.2 g每日3次）或三联治疗（雷贝拉唑、阿莫西林、克拉霉素按上述剂量）+ QZP （3.2 g每日3次）。主要终点是幽门螺杆菌的根除率。次要终点包括症状改善、不良反应和治疗依从性。结果在意向治疗分析中，BQT- qzp的根除率（85.7%）显著高于TT-QZP（73.2%）和BQT (74.1%) （RR分别为0.85,95% CI 0.76 ~ 0.96和0.86,95% CI 0.78 ~ 0.96）。BQT-QZP表现出优越的症状结局，具有更高的完全缓解率（13.4%比6.3%和4.5%）和总体改善率（86.6%比63.4%和53.6%）。BQT-QZP组总有效率（71.4%比54.5%和60.7%）和治愈率（19.6%）最高。三组总体不良事件发生率相当，治疗依从率高，组间水平相当。结论14天BQT联合QZP五联疗法作为一线抗h抗体根除率可接受。螺杆菌therapy.RegistrationChiCTR2300077090。

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来源期刊

European Journal of Integrative Medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-

CiteScore

4.70

自引率

4.00%

发文量

102

审稿时长

33 days

期刊介绍： The European Journal of Integrative Medicine (EuJIM) considers manuscripts from a wide range of complementary and integrative health care disciplines, with a particular focus on whole systems approaches, public health, self management and traditional medical systems. The journal strives to connect conventional medicine and evidence based complementary medicine. We encourage submissions reporting research with relevance for integrative clinical practice and interprofessional education. EuJIM aims to be of interest to both conventional and integrative audiences, including healthcare practitioners, researchers, health care organisations, educationalists, and all those who seek objective and critical information on integrative medicine. To achieve this aim EuJIM provides an innovative international and interdisciplinary platform linking researchers and clinicians. The journal focuses primarily on original research articles including systematic reviews, randomized controlled trials, other clinical studies, qualitative, observational and epidemiological studies. In addition we welcome short reviews, opinion articles and contributions relating to health services and policy, health economics and psychology.