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

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.