OBJECTIVETo evaluate the efficacy and safety of Ziyin Tongbi Decoction (ZTD) in treating benign prostatic hyperplasia (BPH).

METHODSAdopting randomized positive controlled clinical trial method, the 100 BPH patients were assigned to two groups equally. The treatment group was medicated with ZTD, one dose per day, consisting of wild weed 12 g, yellow cocktree bark 12 g, rehmannia root 10 g, Chinese yam 15 g, bitter cardamon 10 g, red sage root 10 g, burreed tuber 8 g, tumeric rhizome 8 g, mantis egg-case 8 g, ground beetle 8 g, Zhejiang fritillary bulb 10 g, and prunella spike 15 g, etc., by decocting with water, taking twice daily and 150 mL each time. The control group was treated by Longbishu Capsule, a product of Kedi Pharmaceutical Co., Ltd., consisting of psoralea fruit, motherwort, and lysimachia, etc., twice a day, 0.9 g each time. A course of 4 weeks was given to both groups. The therapeutic efficacy was evaluated by changes in TCM symptoms after treatment (including frequency of night urination, degree of dysuria, condition of urinary thread, soreness and weakness in loin and knees, lower abdominal distention, spiritless and general weakness), the International Prostate Syndrome Score (I-PSS), maximum flow rate (Qmax), residual urine volume and prostate volume.

RESULTSThe TCM symptoms were improved in the treatment group after treatment, showing significant as compared with those before treatment (P < 0.05); as compared with the control group, the difference in urinary thread and lower abdominal distention in treatment group was significant improved (P < 0.05). The total effective rate in the treatment group was 89.00% (43/48), while that in the control group was 73.46% (36/49), showing statistically significant difference between them (P < 0.01). The efficacy in the treatment group in aspect of improving I-PSS and Qmax was better than that in the control group (P < 0.05, P < 0.01). The residual urine volume was reduced in both group, as compared with that before treatment (P < 0.05), but showed no significant difference between the two groups (P > 0.05). No obvious change of the prostate volume was found in both two groups after treatment (P > 0.05). There are 4 patients in the treatment group and 5 in the control group complained of slight adverse reactions as gastric discomfort and dry mouth, but these were not attended and showed no affection on the treatment.

CONCLUSIONZTD is effective and safe for the treatment of benign prostatic hyperplasia.