[Fushile: a safe and effective therapeutic for benign prostatic hyperplasia].

OBJECTIVE

To observe the efficacy and safety of Fushile, a compound preparation of several Chinese herbal drugs, in the treatment of benign prostatic hyperplasia (BPH).

METHODS

A multi-centered, open and self-controlled clinical trial was performed in 60 BPH patients, who were treated with Fushile for 12 weeks. The efficacy of the compound was evaluated by the International Prostate Syndrome Score (IPSS), maximum flow rate (Qmax), post void residual (PVR) and prostate volume as the primary indexes and by the quality of life (QOL) score and average urinary flow rate (Qave) as the secondary indexes.

RESULTS

After 12 weeks of Fushile treatment, IPSS, Qmax, PVR, QOL and Qave of the BPH patients were significantly improved (P < 0.01), but there was no significant difference in the volume of the prostate before and after the treatment (P > 0.05). No adverse events were observed in any of the patients.

CONCLUSION

Fushile can significantly improve voiding symptoms, increase urinary flow and reduce PVR in BPH patients. It is effective and safe in the treatment of BPH.