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
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;…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 115 participants or records.
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