Objective To observe the efficacy and safety of Longbishu Capsule (LBS) com- bined Doxazosin Mesylate Tablet (DMT) in treating benign prostatic hyperplasia (BPH). Methods Total- ly 360 BPH with Shen deficiency blood stasis syndrome (SDBSS) were randomly assigned to group A, B, and C, 120 cases in each group. Patients in Group A took LBS placebos combined DMT. Those in Group B took LBS combined DMT. Those in Group C took LBS combined DMT placebos. The dose for LBS was 3 pills each time, 0. 3 g/pill, twice per day. The dose of DMT was 1 tablet each time, 2 mg/tablet, once per day. The therapeutic course for all was 12 months. A total of 113 cases in Group A were recruited in FAS analysis, 115 cases in Group B, and 116 cases in Group C. Main efficacy indicators [International Prostate Symptom Score (IPSS) , maximum urinary flow rate (Qmax) , Quality of Life (QOL) ] , and sec- ondary efficacy indicators [postvoid residual urine volume (PVR) and prostate volume (PV) , symptoms scores of Chinese medicine (CM) I were observed in each group. The efficacy was analyzed in the three groups by taking average age of subjects (66 years) as the hierarchy factor (50 ?age ?66 and <66 <age ?80). Results Compared with before treatment in the same group, IPSS, QOL score, and symptoms scores of CM all decreased, and Qmax increased in Group A, B, and C after treatment; PVR decreased in Group B and C (all P <0. 01). There was no statistical difference in main efficacy indicators or second- ary efficacy indicators among post-treatment groups (P >0. 05). There was no statistical difference in clinical efficacy among post-treatment groups (P >0. 05). The efficacy in subjects more than 66 years old of Group B was superior to that of Group A and C with statistical difference (P <0. 05). Conclusions LBS, DMT, or LBS combined DMT was safe and effective for treating BPH. LBS combined DMT was suit- able for patients complicated with abnormal PVR or aged over 66 years.
Aged Capsules