To explore the clinical efficacy of a modified bismuth triple regimen in eradicating H.pylori infection.

A total of 360 eligible patients with H.pylori infection were selected from the Gastroenterology & Hepatology Clinic, West China Hospital of Sichuan University from April 2019 to December 2020. They were equally randomized into a modified bismuth triple regimen group〔EBA group, esomeprazole 40 mg/time, colloidal bismuth pectin capsules 300 mg/time, and amoxicillin 1 g/time, twice a day for 14 days) , and a standard bismuth quadruple regimen group〔EBAT group, esomeprazole (strength: 20 mg, produced by AstraZeneca) 20 mg/time, colloidal bismuth pectin capsules 300 mg/time, amoxicillin 1g/time, and tetracycline 750 mg/time, twice a day for 14 days〕. The ¹³C- or ¹⁴C-urea breath test was performed 4-8 weeks after the treatment, and the negative result was defined as successful eradication treatment of H.pylori infection. The eradication rate of H.pylori infection and the improvement of related symptoms were compared between two groups.

259 newly treated patients with H.pylori infection (138 in EBA group and 121 in EBAT group) and 101 retreated patients (42 in EBA group and 59 in EBAT group) were included. The treatment completion rate of EBA group was 83.3% (150/180, including 112 cases of newly treated, and 38 retreated) , and that of EBAT group was 86.7% (156/180, including 104 newly treated patients and 52 retreated) . No statistical difference in completion rate was found between the two groups (χ²=0.784, P=0.376) . Intention-to-treat analysis revealed that, the eradication rate of H.pylori infection in newly treated patients in EBA group was not statistically different from that of those in EBAT group〔69.6% (96/138) vs 80.2% (97/121) 〕 (χ²=4.313, P=0.116) . Furthermore, per-protocol analysis found that, the eradication rates in newly treated patients in EBA group and EBAT group were 85.7% (96/112) and 93.3% (97/104) , respectively, demonstrating no statistically significant intergroup difference (χ²=3.235, P=0.072) .For retreated patients, intention-to-treat analysis indicated that, the eradication rates for those in EBA group and EBAT group were 54.8% (23/42) , and 72.9% (43/59) , respectively, showing no statistically significant intergroup difference (χ²=5.678, P=0.058) . However, based on the per-protocol analysis, the eradication rates for those in EBA group and EBAT group were 60.5% (23/38) and 82.7% (43/52) , respectively, manifesting statistically significant intergroup difference (χ²=5.516, P=0.019) . The rates of symptom improvements in newly treated patients with pre-treatment symptoms in EBA and EBAT groups showed no statistically significant difference〔88.3% (83/94) vs 92.0% (80/87) 〕 (χ²=0.897, P=0.639) . And the rates of symptom improvements in retreated patients with pre-treatment symptoms in EBA and EBAT groups also showed no statistically significant difference〔88.6% (31/35) vs 75.0% (33/44) 〕 (χ²=2.353, P=0.308) .

For newly treated patients with H.pylori infection, the modified bismuth triple regimen had effects similar to those of the standard bismuth quadruple regimen in terms of eradication rate of H.pylori infection and symptoms improvement rate, which could be used as a new treatment option. However, this modified triple regimen was not suitable for retreated patients, although the symptoms improvement rate was similar to that of the quadruple regimen, the eradication rate of H.pylori infection was too lower.