[Safety and efficacy of QianlieanSuppository for chronic prostatitis of damp-heat and blood-stasis syndrome: a randomized, single-blind, parallel controlled, multi-centered phase III clinical trial].

OBJECTIVE

To evaluate the safety and efficacy of Qianliean Suppository in the treatment of chronic prostatitis of damp-heat and blood-stasis syndrome.

METHODS

We conducted a randomized, single-blind, parallel-controlled, multi-centered clinical trial among 467 subjects, who were assigned to a trial group (n = 349) and a control group (n = 118), the former treated with Qianliean Suppository anally one pill per night for 28 days and the latter given Yejuhua Suppository in the same way. The efficacy was evaluated by the TCM syndrome, NIH-CPSI, main clinical symptoms and WBC count in EPS.

RESULTS

After the treatment, the total rates of recovery, excellence and effectiveness for the TCM syndrome were 4.4%, 58.0% and 90.7% respectively in the trial group, significantly higher than 0.9%, 33.1% and 70.4% in the control group (P < 0.025). Remarkable decreases were observed in the NIH-CPSI total score and the scores on pain and discomfort, voiding symptoms and quality of life in the former group compared with the latter (P < 0.025). The trial group also showed a marked alleviation of such main chronic prostatitis symptoms as urgent micturition and perineal pain and discomfort (P < 0.05), as well as an obvious improvement (55.2%) of the WBC count in EPS as compared with 32.4% in the control group (P < 0.05). No serious adverse events occurred in either of the two groups (0.56% [2/349 ] vs 0.83% [1/118]).

CONCLUSIONS

Qianliean Suppository is safe and effective for the treatment of chronic prostatitis of damp-heat and blood-stasis syndrome.