Xia Li Qi Capsules Improve Symptoms and Urodynamic Parameters in Patients With Benign Prostatic Hyperplasia: A Randomised Controlled Trial With Evidence of p38-JAK/STAT Axis Inhibition.

OBJECTIVE: To evaluate the efficacy and safety of Xia Li Qi capsules (XLQ) for benign prostatic hyperplasia (BPH) and explore its mechanisms of action involving the p38-Janus kinase/signal transducer and activator of transcription (p38-JAK/STAT) pathway. METHODS: In this randomised controlled trial, 115 patients with BPH received XLQ (n = 58) or placebo (n = 57) for 8 weeks. The primary endpoint was change in International Prostate Symptom Score (IPSS) from baseline to Week 8; secondary endpoints included the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), maximum urinary flow rate (Qmax), mean urinary flow rate (Qave), prostate volume, post-void residual urine volume, quality of life (QOL), and the International Index of Erectile Function-5 (IIEF-5). Baseline-adjusted analysis of covariance (ANCOVA) was performed for between-group comparisons. In vitro, experiments using BPH-1 cells were conducted to assess cell proliferation, inflammatory cytokines levels, androgen receptor (AR)-related genes, and p38-JAK1-STAT3 signalling. RESULTS: Both groups showed significant improvements in IPSS, NIH-CPSI, Qmax, Qave, and QOL (all p < 0.001). No significant between-group differences in IPSS or NIH-CPSI after adjustment. At Week 8, Qmax and Qave were significantly higher in the XLQ group (both p < 0.001), with reduced residual urine volume (p = 0.010). QOL improvement favoured XLQ before correction (p = 0.018) but did not survive multiple-comparison correction; prostate volume and IIEF-5 were unchanged. In vitro, XLQ inhibited BPH-1 proliferation, reduced interleukin (IL)-6, IL-1β, and tumour necrosis factor-α (TNF-α), suppressed AR-related gene expression, and decreased the phosphorylation of p38, JAK1, and STAT3 phosphorylation; these effects were partially reversed by p38 activation. CONCLUSIONS: XLQ improves urinary function in BPH patients, potentially by the inhibiting of inflammation and AR signalling via the p38-JAK/STAT axis. CLINICAL TRIAL REGISTRATION: The study was registered at Clinicaltrial.gov (https://www.chictr.org.cn/showproj.html?proj=14405), registration number: (ChiCTR1900022393).