[Tonglong Kaibi Prescription for the treatment of severe benign prostate hyperplasia: A clinical study]

To evaluate the clinical effect of the traditional Chinese medicine (TCM) Tonglong Kaibi Prescription (TKP) in the treatment of severe BPH with kidney deficiency and blood stasis combined with damp heat syndrome.

We randomly divided 120 cases of severe BPH with kidney deficiency and blood stasis combined with damp heat syndrome into three groups of equal number, treated with TKP, doxazosin mesylate sustained-release tablets (the DM control), and TKP + DM, all for 8 weeks. We obtained the IPSS, TCM symptoms scores, quality of life (QOL) scores, maximum urinary flow rate (Qmax) and postvoid residual urine volume (PVR) from the patients before and after treatment and compared them among the three groups.

After 8 weeks of treatment, the effectiveness rate was significantly higher in the TKP + DM than in the DM control group (P < 0.05). The IPSS, TCM symptoms scores, QOL scores and PVR decreased (P < 0.01), while the Qmax increased dramatically (P < 0.01) in all the three groups. Pairwise comparison showed that the IPSS and QOL scores were lower in the TKP + DM than in the TKP and DM control groups (P < 0.05 or 0.01), and so were the TCM syndrome scores in the TKP + DM and TKP groups than in the DM control (P < 0.01). There were no statistically significant differences in PVR and Qmax among the three groups after treatment (P> 0.05), and no serious adverse events during the treatment.

TKP is safe and effective in the treatment of severe BPH, which can improve the TCM symptoms, reduce the IPSS, QOL scores and PVR and increase the Qmax of the patients. TKP is evidently superior to DM alone in improving TCM symptoms of BPH and combined medication of TKP and DM produces even better clinical efficacy.