[Efficacy of High-dose Dual Therapy for Helicobacter Pylori Infection Eradication in Servicemen: a Randomized Controlled Trial]

To assess the efficacy and cost-effectiveness of high-dose dual therapy compared with bismuth-containing quadruple therapy for treating Helicobacter pylori() infection in servicemen patients. A total of 160 -infected, treatment-naive servicemen, including 74 men and 86 women, aged from 20 years to 74 years, with a mean (SD) age of 43 (13) years, tested in the First Center of Chinese PLA General Hospital from March 2022 to May 2022 were enrolled in this open-label, randomized controlled clinical trial. Patients were randomly allocated into 2 groups: the 14-day high-dose dual therapy group and the bismuth-containing quadruple therapy group. Eradication rates, adverse events, patient compliance, and drug costs were compared between the two groups. The -test was used for continuous variables, and the Chi-square test for categorical variables. No significant difference in eradication rates were found between high-dose dual therapy and bismuth-containing quadruple therapy by ITT, mITT and PP analysis[ITT:90.0% (95% 81.2%-95.6%) vs. 87.5% (95% 78.2%-93.8%), =0.25, =0.617;mITT:93.5% (95% 85.5%-97.9%) vs. 93.3% (95% 85.1%-97.8%), <0.01, =1.000; PP: 93.5% (95% 85.5%-97.9%) vs. 94.5% (95% 86.6%-98.5%), <0.01, =1.000 ]. The dual therapy group exhibited significantly less overall side effects compared with the quadruple therapy group [21.8% (17/78) vs. 38.5% (30/78), =5.15,=0.023]. There were no significant differences in the compliance rates between the two groups [98.7%(77/78) vs. 94.9%(74/78), =0.83,=0.363]. The cost of medications in the dual therapy was 32.0% lower compared with that in the quadruple therapy (472.10 RMB vs. 693.94 RMB). The dual regimen has a favorable effect on the eradication of infection in servicemen patients. Based on the ITT analysis, the eradication rate of the dual regimen is grade B (90%, good). Additionally, it exhibited a lower incidence of adverse events, better compliance and significantly reduced cost. The dual regimen is expected to be a new choice for the first-line treatment of infection in servicemen but needs further evaluation.