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[Huang'e Capsules for BPH of the qi-deficiency blood-stasis and damp-heat stagnation type: An open-label single-arm multicenter phase-Ⅳ clinical study].

Objective
To evaluate the efficacy of Huang'e Capsules in the treatment of BPH of the qi-deficiency blood-stasis and damp-heat stagnation type under conditions of extensive use.


METHODS
Totally, 605 male patients with BPH of the qi-deficiency blood-stasis and damp-heat stagnation type received oral Huang'e Capsules, tid, 4 capsules per time, for 42 days. We recorded the IPSS, maximum urinary flow rate (Qmax), mean urinary flow rate (Qave), quality of life (QOL) score, and prostate volume of the patients before and after medication.


RESULTS
A total of 503 patients completed the whole trial. Compared with the baseline, the patients showed significant decreases after treatment in the IPSS (20.1 ± 5.5 vs 12.6 ± 5.0, P < 0.05), QOL score (4.19 ± 0.90 vs 2.50 ± 0.89, P < 0.05) and prostate volume (［36.6 ± 15.8］ vs ［34.0 ± 17.6］ ml, P < 0.05), but remarkable increases in Qmax (［12.2 ± 5.8］ vs ［14.2 ± 6.5］ ml/s, P < 0.05) and Qave (［5.91 ± 3.12］ vs ［6.95 ± 3.45］ ml/s, P < 0.05).


CONCLUSIONS
Huang'e Capsules had a good therapeutic effect on BPH of the qi-deficiency blood-stasis and damp-heat stagnation type.