Safety and Efficacy of Qianliean Suppository for Chronic Prostatitis of Damp-Heat and Blood-Stasis Syndrome: A Randomized, Single-Blind, Parallel Controlled,Multi-Centered Phase m Clinical Trial
XIE Jian-xing
HU Han-tang
XIAO Dong-ni
XIE He-zhi
ZHU Cheng-bin
YANG Wen-tao
HUANG Xian-xun
HE Xue-jun
LIANG Guo-rong
Wang Zhi-gang
Abstract：Objective: To evaluate the safety and effieaey of Qianliean Suppository in the treatment of chronie prostatitis of damp-heat and blood-stasis syndrome. Methods: We conducted a randomized, single-blind, parallel-controlled, multi-centered elinical 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, excellenee 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 NIHCPSI 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 bloodstasis syndrome.
Keywords：Qianliean Suppositorychronic prostatitis of damp-heat and blood-stasis syndromeefficacysafetyrandomized controlled trial
Publication Date：2009-10-26
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：4( 1049-1052 )