Efficacy Comparison and Analysis of Influencing Factors of High-Dose Dual Therapy vs. Bismuth-Containing Quadruple Therapy for Helicobacter pylori Infection in Elderly Patients in Hainan Province

Objective To compare the efficacy of high-dose dual therapy and bismuth-containing quadruple therapy in the treatment of Helicobacter pylori (H. pylori) infection in the elderly aged ≥ 60 years in Hainan Province, and to analyze the effects of gender, hypertension, diabetes mellitus, coronary heart disease, and anxiety status on therapeutic outcomes, so as to provide a reference for the precise treatment of H. pylori infection in the elderly population in Hainan. Methods Clinical data were retrospectively collected from the H. pylori infection database of the Gastroenterology Outpatient Department, the Second Affiliated Hospital of Hainan Medical University, from January 2024 to August 2025. Eligible patients were aged ≥ 60 years and had completed a follow-up ¹³C urea breath test at least 4 weeks after the end of initial treatment. Patients were divided into two groups according to the treatment regimen: • Experimental group (high-dose dual therapy): Esomeprazole 20mg / Ilaprazole 5mg / Vonoprazan 20mg, bid (twice daily) + Amoxicillin 1.0g, tid (three times daily); • Control group (bismuth-containing quadruple therapy): Esomeprazole 20mg / Ilaprazole 5mg, bid + Bismuth Potassium Citrate 240mg, bid + Amoxicillin 1.0g, bid + Furazolidone 100mg, bid. The treatment course for both groups was 14 days. The intention-to-treat (ITT) eradication rate, per-protocol (PP) eradication rate, and incidence of adverse reactions were compared between the two groups. Univariate analysis and multivariate Logistic regression analysis were used to evaluate the effects of gender, hypertension, diabetes mellitus, coronary heart disease, and anxiety status on treatment failure. Results A total of 230 patients were included, with 123 in the experimental group and 107 in the control group. In the experimental group, the ITT eradication rate was 71.54% (88/123) and the PP eradication rate was 74.58% (88/118); in the control group, the ITT eradication rate was 75.70% (81/107) and the PP eradication rate was 77.14% (81/105). There was no significant difference in eradication rates between the two groups (all P > 0.05). The incidence of adverse reactions in the experimental group was 9.32% (11/118), which was lower than that in the control group (12.38%, 13/105), though the difference was not statistically significant (χ² = 0.541, P = 0.462). Adverse reactions in the experimental group were mainly mild abdominal distension and diarrhea, while those in the control group were mainly oral odor, dizziness, and headache.Univariate analysis showed that diabetes mellitus (χ² = 6.44, P = 0.011), anxiety status (χ² = 5.66, P = 0.017), and gender (χ² = 4.239, P = 0.040) were associated with H. pylori treatment failure. Multivariate Logistic regression analysis revealed that diabetes mellitus (OR = 3.461, 95% CI = 1.559–7.684, P = 0.002), anxiety status (OR = 2.909, 95% CI = 1.438–5.886, P = 0.003), and gender (OR = 0.472, 95% CI = 0.246–0.905, P = 0.024) were independent risk factors for H. pylori treatment failure. Hypertension and coronary heart disease had no significant impact on therapeutic outcomes (all P > 0.05). Conclusion In the treatment of H. pylori infection in the elderly aged ≥ 60 years in Hainan Province, high-dose dual therapy has comparable efficacy to bismuth-containing quadruple therapy, but the former has fewer adverse reactions and a lower cost. Gender, diabetes mellitus, and anxiety status are independent risk factors for treatment failure. Clinical treatment should focus on these patients and strengthen targeted interventions.