Comparison of Cefuroxime-Based Dual Therapy With Quadruple Therapy in Helicobacter pylori-Infected Treatment-Naive Patients: A Prospective, Multicenter, Randomized Controlled Trial
Abstract
BACKGROUND: High-Dose Dual Therapy With Amoxicillin Has Shown Advantages to Eradicate Helicobacter pylori (H. pylori), but Not for Penicillin-Allergic Patients. It Is Recommended That Cefuroxime Could Be an Alternative, but Whether Cefuroxime Could Be Used in Dual Therapy Has Not Been Reported. This Study Aimed to Compare the Efficacy, Safety, and Compliance of Cefuroxime-Based Dual Therapy (CDT) With Cefuroxime-Based Bismuth Quadruple Therapy (CQT) to Treat H. pylori Infection.
MATERIALS AND METHODS: The Prospective, Multicenter, Open-Label, Randomized Controlled Trial Was Conducted to Enroll Patients With Treatment-Naive H. pylori Infection From 9 Institutions. Patients Were Randomly Assigned to CDT Group (Cefuroxime 500 Mg Three Times/Day and Vonoprazan 20 Mg Twice/Day) or CQT Group (Cefuroxime 500 Mg Twice/Day, Levofloxacin 500 Mg Once/Day, Vonoprazan 20 Mg Twice/Day, and Bismuth 220 Mg Twice/Day), both for 14 Days.
RESULTS: 700 Patients (350 per Group) Were Enrolled. In the Intention-To-Treat Analysis, Eradication Rates Were 76.0% and 86.3% in CDT Group and CQT Group (P = 0.001). In the Modified Intention-To-Treat Analysis, Eradication Rates Were 78.9% and 89.1% (P 0.025). Compliance Was Good in Both Groups (96.0% vs. 92.8%, P = 0.073). Poor Adherence Was a Risk Factor for Reducing the Efficacy in Both Groups.
CONCLUSIONS: CQT Was More Effective Than CDT for H. pylori Eradication, Which Might Be Recommended for Penicillin-Allergic Patients. If There Were…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 700 participants or records.
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