High-dose dual therapy versus bismuth-containing quadruple therapy for Helicobacter pylori eradication: a systematic review and meta-analysis with trial sequential analysis.

IF 4.2 3区医学 Therapeutic Advances in Gastroenterology Pub Date : 2023-01-10 eCollection Date: 2023-01-01 DOI:10.1177/17562848221147756

Ben-Gang Zhou, Yu-Zhou Mei, Min Zhang, Xin Jiang, Yao-Yao Li, Yan-Bing Ding

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Abstract

Background and objective: Recently, a large number of trials on proton pump inhibitor-amoxicillin-containing high-dose dual therapy (HDDT) versus bismuth-containing quadruple therapy (BQT) for Helicobacter pylori (H. pylori) eradication have been published with controversial and inconsistent conclusions. The aim of this meta-analysis was to determine the effects of HDDT for H. pylori eradication compared to BQT.

Design: A systematic review and meta-analysis was conducted.

Methods: PubMed, Embase, and the Cochrane library database were searched to collect all randomized controlled trials (RCTs) assessing the effects of HDDT versus BQT to H. pylori eradication from inception to September 2022. Meta-analysis was conducted to estimate the pooled relative risk (RR) with 95% confidence intervals (CIs) using a random-effects model. Quality of evidence was appraised using Grading of Recommendations, Assessment, Development and Evaluation system. Trial sequential analysis (TSA) was performed to determine the reliability and conclusiveness.

Results: A total of 14 RCTs with 5121 patients were included. The results of meta-analysis showed that there was no statistical significance in the eradication rate between HDDT and BQT (intention-to-treat analysis: 86.7% versus 85.1%, RR = 1.01, 95% CI: 0.98-1.04; per-protocol analysis: 89.9% versus 89.4%, RR = 1.01, 95% CI: 0.98-1.03; moderate-quality evidence). The incidence of total adverse effects in HDDT group was significantly lower than in BQT group (5.9% versus 34.1%, RR = 0.42, 95% CI: 0.34-0.50; low-quality evidence). No statistical significance was observed in compliance between HDDT and BQT (RR = 1.01, 95% CI, 1.00-1.03, p = 0.07; low-quality evidence). The TSA result for H. pylori eradication rate indicated that the effect was conclusive.

Conclusions: Evidence from our updated meta-analysis suggests that HDDT is as effective as BQT in eradicating H. pylori, with fewer adverse effects and similar compliance.

Registration: Open Science Framework registries (No: osf.io/th4vd).

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根除幽门螺旋杆菌的大剂量双重疗法与含铋四联疗法：系统综述和荟萃分析以及试验序列分析。

背景和目的：最近，大量关于含质子泵抑制剂-阿莫西林的大剂量双重疗法（HDDT）与含铋四联疗法（BQT）根除幽门螺杆菌（H. pylori）的试验相继发表，但结论存在争议且不一致。本荟萃分析旨在确定 HDDT 与 BQT 相比在根除幽门螺杆菌方面的效果：设计：进行系统回顾和荟萃分析：方法：检索PubMed、Embase和Cochrane图书馆数据库，收集从开始到2022年9月所有评估HDDT与BQT根除幽门螺杆菌效果的随机对照试验（RCT）。采用随机效应模型进行了元分析，以估计汇总相对风险（RR）及95%置信区间（CI）。采用 "建议、评估、发展和评价分级 "系统对证据质量进行评估。进行了试验序列分析（TSA）以确定可靠性和结论性：结果：共纳入了 14 项 RCT，5121 名患者。荟萃分析结果显示，HDDT 和 BQT 的根除率没有统计学意义（意向治疗分析：86.7% 对 85.1%，RR = 1.01，95% CI：0.98-1.04；按协议分析：89.9% 对 89.4%，RR = 1.01，95% CI：0.98-1.03；中度质量证据）。HDDT 组的总不良反应发生率显著低于 BQT 组（5.9% 对 34.1%，RR = 0.42，95% CI：0.34-0.50；低质量证据）。HDDT 和 BQT 的依从性没有统计学意义（RR = 1.01，95% CI，1.00-1.03，p = 0.07；低质量证据）。幽门螺杆菌根除率的TSA结果表明效果是确定的：我们更新的荟萃分析证据表明，HDDT与BQT一样能有效根除幽门螺杆菌，且不良反应较少，依从性相似：开放科学框架注册表（编号：osf.io/th4vd）。

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来源期刊

Therapeutic Advances in Gastroenterology Medicine-Gastroenterology

自引率

2.40%

发文量

103

期刊介绍： Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area. The editors welcome original research articles across all areas of gastroenterology and hepatology. The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.