Real‐World Effectiveness and Safety of Modified Huangqi Xiayuxue Decoction as Adjunctive Therapy for
MASLD
With
qi
Deficiency and Blood‐Stasis Syndrome:
Yuting Liu, Wenzhuo Hu, Honghao Wu, Yang Cheng ABSTRACT
Aim
To evaluate the real‐world effectiveness and safety of modified Huangqi Xiayuxue decoction (HXD) in patients with metabolic dysfunction‐associated steatotic liver disease (MASLD) and qi deficiency and blood‐stasis syndrome.
Methods
In this retrospective cohort study, data from 127 patients with MASLD (65 HXD and 62 conventional hepatoprotective therapy) at Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine (TCM) were analyzed. Propensity score overlap weighting balanced baseline characteristics. Primary endpoints were changes in controlled attenuation parameter (CAP) and liver stiffness measurement (LSM) at 24 weeks. Key secondary endpoints included liver enzymes, metabolic parameters, and TCM symptom scores.
Results
After weighting, baseline characteristics were well‐balanced. HXD group showed greater mean reduction in CAP than controls (−26.8 ± 22.1 dB/m vs. −17.5 ± 19.3 dB/m; mean difference −9.3 dB/m, 95% CI: −16.4 to −2.2; p = 0.012). A higher proportion of HXD patients achieved steatosis response (50.8% vs. 37.1%; aOR = 1.89, 95% CI: 1.01–3.65; p = 0.049). Positive trends favoring HXD for fibrosis improvement were observed (LSM change: −1.1 ± 1.4 kPa vs. −0.7 ± 1.1 kPa, p = 0.055; responder rate: 41.5% vs. 29.0%, aOR = 1.74, 95% CI: 0.96–3.88; p = 0.064). The HXD group also demonstrated superior improvements in ALT, triglycerides, BMI, all TCM symptom scores, and TCM syndrome efficacy rate (all p < 0.05). Adverse event incidence was low and similar between groups (HXD: 10.8%, control: 8.1%, p = 0.652).
Conclusion
HXD was an effective and safe treatment for MASLD patients with qi deficiency and blood‐stasis syndrome, improving liver steatosis, metabolic parameters, and clinical symptoms in a real‐world setting.
Trial Registration
ITMCTR2026000961