OBJECTIVETo investigate the effect of Longbishu Capsule (, LBS), doxazosin, and combination therapy on benign prostatic hyperplasia (BPH).

METHODSA randomized, double-blind, multi-center parallel trial was conducted involving 360 patients in hospitals in Beijing (108 cases), Heilongjiang (90 cases), Sichuan (90 cases), Shanghai (72 cases), China. They were randomly assigned with central randomization method to group A (LBS placebo plus doxazosin), group B (LBS plus doxazosin) or group C (LBS plus doxazosin placebo), 120 cases for each group. The international prostate symptom score, maximum urinary flow rate, postvoid residual urine volume and prostate volume were measured for evaluating the efficacy of the three treatments.

RESULTSAt baseline, there was no significant difference in the measured variables among the three groups. After 12-month treatment, the three groups showed significant improvements in IPSS and maximum urinary flow rate from baseline (P<0.01). Although postvoid residual urine volume was not significantly different from the baseline in group A (P>0.05), it significantly decreased in group B and C (P<0.05). The incidence of adverse events were similar among the three groups.

CONCLUSIONSThe treatment of LBS alone or LBS plus doxazosin was able to significantly improve IPSS in patients with BPH. The treatments may reduce the increase in prostate volume and postvoid residual urine volume as well.