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 13 C 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.