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.

Abstract

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. 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. <i>In vitro</i>, experiments using BPH-1 cells were conducted to assess cell proliferation, inflammatory cytokines levels, androgen receptor (<i>AR</i>)-related genes, and p38-JAK1-STAT3 signalling. Both groups showed significant improvements in IPSS, NIH-CPSI, Qmax, Qave, and QOL (all <i>p</i> &lt; 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 <i>p</i> &lt; 0.001), with reduced residual urine volume (<i>p</i> = 0.010). QOL improvement favoured XLQ before correction (<i>p</i> = 0.018) but did not survive multiple-comparison correction; prostate volume and IIEF-5 were unchanged. <i>In vitro</i>, XLQ inhibited BPH-1 proliferation, reduced interleukin (IL)-6, IL-1&#x3b2;, and tumour necrosis factor-&#x3b1; (TNF-&#x3b1;), suppressed AR-related gene expression, and decreased the phosphorylation of p38, JAK1, and STAT3 phosphorylation; these effects were partially reversed by p38 activation. XLQ improves urinary function in BPH patients, potentially by the inhibiting of inflammation and AR signalling via the p38-JAK/STAT axis. The study was registered at Clinicaltrial.gov (https://www.chictr.org.cn/showproj.html?proj=14405), registration number: (ChiCTR1900022393).