OBJECTIVE: To observe the effectiveness and safety of Kangquan Recipe (康泉方, KQR) for benign prostatic hyperplasia (BPH) patients. METHODS:One hundred and six BPH patients were randomly assigned to the treatment group (53 cases) and the control group (53 cases) according to a random number table. The treatment group was given KQR orally; the control group was given cernilton orally. After 24-week treatment, the clinical effect and safety were evaluated using the International Prostatic Symptom Score (I-PSS), quality of life (QOL), maximum flow rate (Qmax), average flow rate (Qave), residual urine volume (RUV), total prostatic volume (TPV), etc. RESULTS: After treatment, the score of I-PSS was decreased from 16.9±5.6 to 12.5±4.6 in the treatment group, significantly lower compared with the control group; the levels of Qmax and Qave were from 10.9±3.5 to 15.6±4.5 and 5.4±2.1 to 7.3±2.5 (mL/s) in the treatment group, significantly higher compared with the control group; the levels of RUV and TPV were from 70.8±28.2 to 35.2±21.8 and 37.2±16.9 to 30.1±10.8 (mL) in the treatment group, significantly lower compared with the control group (all P<0.05). The incidence rate of adverse reaction was similar between the two groups (P>0.05). CONCLUSION:KQR is effective and safe for the treatment of BPH.
RCT Entities:
OBJECTIVE: To observe the effectiveness and safety of Kangquan Recipe (康泉方, KQR) for benign prostatic hyperplasia (BPH) patients. METHODS: One hundred and six BPH patients were randomly assigned to the treatment group (53 cases) and the control group (53 cases) according to a random number table. The treatment group was given KQR orally; the control group was given cernilton orally. After 24-week treatment, the clinical effect and safety were evaluated using the International Prostatic Symptom Score (I-PSS), quality of life (QOL), maximum flow rate (Qmax), average flow rate (Qave), residual urine volume (RUV), total prostatic volume (TPV), etc. RESULTS: After treatment, the score of I-PSS was decreased from 16.9±5.6 to 12.5±4.6 in the treatment group, significantly lower compared with the control group; the levels of Qmax and Qave were from 10.9±3.5 to 15.6±4.5 and 5.4±2.1 to 7.3±2.5 (mL/s) in the treatment group, significantly higher compared with the control group; the levels of RUV and TPV were from 70.8±28.2 to 35.2±21.8 and 37.2±16.9 to 30.1±10.8 (mL) in the treatment group, significantly lower compared with the control group (all P<0.05). The incidence rate of adverse reaction was similar between the two groups (P>0.05). CONCLUSION: KQR is effective and safe for the treatment of BPH.