Effectiveness and Safety of Guizhi Fuling Wan (Keishibukuryogan) on Prostate Diseases: A Systematic Review and Meta-Analysis.

Objective: Aiming at evaluating the effectiveness and safety of Guizhi Fuling Wan or Keishibukuryogan (GZFL) on prostate diseases, to provide available synthesized evidence for clinical application. Methods: Randomized controlled trials (RCTs) were identified from English, Chinese, Japanese, and Korean electronic databases, the search date ranged from the inception of databases to July 2024. Rev-Man 5.4.1 software was applied in the analysis of extracted data. Results: 23 studies were included in the meta-analysis, 12 studies on chronic prostatitis(CP) and 11 studies on benign prostatic hyperplasia (BPH). The synthesized results showed that GZFL had a significantly higher effective rate compared to the control group both in BPH (risk difference [RD] = 0.14, 95% confidence interval [CI] [0.10, 0.18], p < 0.00001) and CP (RD = 0.19, 95% CI [0.14, 0.23], p < 0.00001). It reduced the International Prostate Symptom score (mean difference [MD] = -3.19, 95% CI [-5.35, -1.02], p = 0.004) and NIH Chronic Prostatitis Symptom Index score (MD = -4.09, 95% CI [-5.04, -3.15], p < 0.00001), It also had a significant effect on reducing postvoid residual urine (MD = -6.73, 95% CI [-10.12, -3.33], p = 0.0001), prostate volume (MD = -2.59, 95% CI [-4.39, -0.80], p = 0.005), and increasing maximum urinary flow rate (MD = 1.61, 95% CI [1.11, 2.10], P < 0.00001). A few studies have also reported its therapeutic effects on prostate cancer. No severe adverse effects were reported. Conclusion: GZFL is effective and safe for BPH and CP in alleviating symptoms, improving scale scores. Rigorously designed clinical trials are necessary for further clinical application.