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], < 0.00001) and CP (RD = 0.19, 95% CI [0.14, 0.23], < 0.00001). It reduced the International Prostate Symptom score (mean difference [MD] , 95% CI [-5.35, -1.02], = 0.004) and NIH Chronic Prostatitis Symptom Index score (MD , 95% CI [-5.04, -3.15], < 0.00001), It also had a significant effect on reducing postvoid residual urine (MD , 95% CI [-10.12, -3.33], = 0.0001), prostate volume (MD , 95% CI [-4.39, -0.80], = 0.005), and increasing maximum urinary flow rate (MD = , 95% CI [1.11, 2.10], < 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.