Clinical study on Kangquan Recipe (康泉方) for benign prostatic hyperplasia patients: a randomized controlled trial.

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.