Efficacies of different proton pump inhibitor-based 14-day bismuth–furazolidone quadruple regimens for the initial eradication of Helicobacter pylori in the southeast coastal region of China: an open-label, randomized clinical trial
To evaluate potency and safety of 14-day bismuth–furazolidone quadruple regimens and to compare efficacies of five proton pump inhibitors (PPIs) for the initial eradication of Helicobacter pylori (H. pylori), 175 eligible patients were enrolled and randomly assigned to 14-day quadruple regimens consisting of bismuth (400 mg), amoxicillin (1 g), furazolidone (100 mg), and a PPI, twice a day. PPIs used were Group A (pantoprazole capsules, 40 mg), Group B (pantoprazole tablets, 40 mg), Group C (lansoprazole, 30 mg), Group D (esomeprazole, 20 mg), and Group E (rabeprazole, 10 mg). H. pylori status was reassessed by 13C urea breath test on day 56 as the primary outcome. Gastrointestinal symptoms, parenteral side effects, compliance, and stool type were recorded simultaneously. The total eradication rates were 86.9% (152/175 [95% CI 80.9–91.5%]) and 95.6% (152/159 [91.1–98.2%]) by intention-to-treat (ITT) and per-protocol (PP) analysis. The efficacies of Group A, B, C, D, and E by ITT analysis were 91.4% (32/35 [76.9–98.2%]), 85.7% (30/35 [69.7–95.2%]), 88.6% (31/35 [73.3–96.8%]), 85.7% (30/35 [69.7–95.2%]), and 82.9% (29/35 [66.4–93.4%]) (p > 0.05). In the PP analysis, the efficacies were 97.0% (32/33), 93.8% (30/32), 93.9% (31/33), 100% (30/30), and 93.5% (29/31) (p > 0.05). Gastrointestinal symptoms and stool type were improved significantly (p < 0.05). Total side effects rate and poor compliance rate were 15.7% (25/159) and 5.0% (8/159). Fourteen-day bismuth–furazolidone quadruple regimens are of high potency and safety for the initial eradication of H. pylori. Efficacies of different PPIs and different dosages (9–32 mg omeprazole equivalents) showed no significant difference. The appropriate PPI can thus be chosen by clinicians.
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We thank our patients and colleagues at Sir Run Run Shaw Hospital, Zhejiang University. This study was funded by Zhejiang Province Key Science and Technology Innovation Team (2013TD13), Science Foundation of Zhejiang Traditional Medicine Bureau (2012ZB098, 2017ZB063) and Natural Science Foundation of Zhejiang Province (LY18H160011).
SC and AL contributed to the study design. LC and JH organized the study, enrolled participants and performed the writing of the manuscript. LW and QG performed the data entry and statistical analysis. XC, YL, YD and HH performed the preliminary screening of participants. HC and YC conducted the 13C urea breath test. All authors have participated in the discussion of the manuscript and approved the final version of the manuscript.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interests.
This study was approved by the Ethics Committee of Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University (20161206-21).
Written informed consent was obtained from all participants before enrollment.
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