Objective:To investigate the clinical efficacy and safety of heat-clearing and spleen-invigorating method in the treatment of Helicobacter pylori (Hp) initial treatment failure population.Methods:The clinical data of 155 patients with initial Hp failure in our hospital from January 2021 to December 2022 were retrospectively analyzed. According to the treatment plan, they were divided into TCM group (66 cases) and Western medicine group (89 cases). Python 3.70 was used for bias score matching (PSM) to obtain samples with balanced covariates between groups. Finally 66 pair of cases were successfully matched according to the propensity score and the 1:1 matching principle.The TCM group was given Yiqing Capsule + Jianpi Pills (4 weeks) as a course of treatment. The Western medicine group was given four anti-Hp remedial regimen, 2 weeks for 1 course. 2 groups were treated for 1 course. Hp was detected by 14C breath test and its clearance rate was calculated. The overall symptoms of functional dyspepsia (FD) were evaluated from four aspects: postprandial fullness, early satiety, middle and upper abdominal pain, and middle and upper abdominal burning sensation. The adverse reactions during treatment were observed and the clinical efficacy was evaluated. Results:After treatment, the Hp clearance rate was 75.76% (50/66) in the TCM group and 83.33% (55/66) in the Western medicine group, which was significantly improved compared with that before treatment, without statistical significance ( χ2=1.16, P=0.281). After treatment, the scores of fullness and discomfort after meal [1 (0,2) vs. (2,4), Z=-6.85], early satiety [2 (0,2) vs. 4 (4, 6), Z=-8.02], middle and upper abdominal pain [2 (2, 4) vs. 4 (4, 6), Z=-4.48] in the TCM group were lower than those in Western medicine group ( P<0.01). The total effective rate was 75.76% (50/66) in the TCM group and 69.70% (46/66) in the Western medicine group, without statistical significance ( χ2=2.00, P=0.573). No adverse reactions occurred in the 2 groups during treatment. Conclusion:In terms of heat-clearing and spleen-invigorating method for Hp initially failed patients, its Hp clearance rate and clinical total effective rate are comparable to Western medicine, and can effectively improve the clinical symptoms of patients with Hp initial treatment failure.