OBJECTIVETo evaluate the efficacy and safety of the combination therapy of Xipayimaizipizi Capsules and Tamsulo- sin in the treatment of benign prostatic hyperplasia (BPH).

METHODSWe randomly assigned 60 BPH patients to a control and a combination group of equal number, the former aged 62.03 ± 10.19 years with a disease course of 3.24 ± 2.18 years and the latter aged 64.77 ± 10.33 years with a disease course of 4.09 ± 2.63 years. We treated the patients in the control group with Tamsulosin at 0.2 mg qd and those in the combination group with Tamsulosin at 0.2 mg qd plus Xipayimaizipizi at 0.5 g tid, respectively, both for 4 weeks. Then, we obtained the mean frequency of nocturnal urination, maximal urinary flow rate (Qmax), residual urine volume, International Prostate Symptom Score (IPSS) , and quality of life scores (QOL) of the patients, and recorded their adverse reactions.

RESULTSBefore treatment, the nocturnal urination frequency, Qmax, IPSS, and QOL were 3.60 ± 1.81, (10.40 ± 3.53) ml/min, 22.47 ± 8.58, and 4.43 ± 1.50 in the control group, as compared with 3.43 ± 1.61, (10.14 ± 3.43) ml/min, 21.93 ± 8.79, and 4.73 ± 1.31 in the combination group. After 4 weeks of medication, the combination group showed more significant improvement than the control in the nocturnal urination frequency (1.30 ± 1.18 vs 2.27 ± 1.60), Qmax ([13.85 ± 3.15] vs [14.36 ± 3.03] ml/min), IPSS (13.00 ± 1.53 vs 17.20 ± 8.43), and QOL (2.57 ± 1.61 vs 2.93 ± 1.68), all significantly better than the baseline (P < 0.05). The combination therapy achieved remarkable improvement as compared with the control in the nocturnal urination frequency (- [2.13 ± 1.11] vs -[1.73 ± 1.07]), IPSS (- [8.93 ?6.01] vs -[4.80 ± 3.87]), and QOL (- [2.17 ± 1.12] vs -[1.50 ± 1.01]) (P < 0.05), but exhibited no significant differences from the latter in Qmax ([3.72 ± 2.281 vs [3.95 ± 2.53] ml/min) and residual urine volume (- [34.30 ± 37.43] vs - [26.43 ± 30.49] ml) (P > 0.05). Adverse reactions were found in 5 cases in the combination group (16.67%) and 3 cases in the control (10%) , with no remarkable differences between the two groups (P > 0.05).

CONCLUSIONThe combination therapy of Xipayimaizipizi Capsules and Tamsulosin can improve the symptoms of BPH and the patients quality of life of.