Clinical outcomes and safety of Chinese herbal medicine in the treatment of hyperuricemia: A retrospective real-world study

Hyperuricemia (HUA) has become a bothersome health problem that cannot be ignored. An increasing number of patients with HUA seek Chinese herbal medicine (CHM) as an alternative or complementary treatment. However, there was a lack of real-world evidence on the long-term impact of CHM in HUA populations. This study aimed to explore the clinical outcomes and safety of CHM among individuals with HUA in mainland China. A population-based, active-comparator new-user designed cohort study of patients with HUA was performed using the Yinzhou Regional Health Care Database (YRHCD). A cox model with propensity score matching was applied to estimate the hazard ratio (HR) of the association between the use of CHM and gouty arthritis (GA). Various subgroup analyses and multiple sensitivity analyses were also performed to demonstrate the robustness of results. The secondary outcomes were drug-induced liver injury (DILI) risk and gouty nephropathy (GN) risk. A total of 40 653 patients with HUA were included from the YRHCD between 2015 and 2024, among whom 35 511 participants were CHM users and 5 142 were benzbromarone (BBR) users. In the primary analysis, the incidence of GA was 34.43 per 1 000 person-years for CHM users and 58.00 per 1 000 person-years for BRR users, respectively. CHM users appeared to have a 43 % reduction in risk of developing GA compared with BBR users with an HR of 0.57 [95 %CI 0.50, 0.65]. In addition, there was comparable safety in DILI between CHM users and BBR users (HR 1.18 [95 % CI 0.93, 1.49]). The results were generally consistent in various subgroup analyses and sensitivity analyses. CHM users improved clinical outcomes in patients with HUA and was safe, which can be a promising complementary therapy for HUA patients.