[Efficacy of Huang'e Capsules on benign prostatic hyperplasia with Qi-deficiency, blood stasis and damp heat block: A stratified analysis].

OBJECTIVE: To evaluate the efficacy and safety of Huang'e Capsules in the treatment of BPH with Qi-deficiency, blood stasis and damp heat block. METHODS: This study included 1 456 cases of BPH with Qi-deficiency, blood stasis and damp heat block from 40 hospitals of Zhejiang and Anhui Provinces between June 2014 and July 2017. The patients were aged 40－85 years and treated with Huang'e Capsules at a dose of 4 capsules, tid, for a course of 6 weeks. The IPSSs of the patients were obtained before and after 2, 4 and 6 weeks of medication, and a stratified analysis was made on the factors influencing the therapeutic effects, such as age, the stage of BPH, and concomitant medication of urogenital and reproductive hormone drugs. RESULTS: After 6 weeks of medication, the IPSS of the patients was decreased by 8.4 ± 5.4 (ï¼»42.9 ± 22.7ï¼½ %) as compared with the baseline (19.2 ± 6.8) (P < 0.05), with a total effectiveness rate of 71.9% and an excellence rate of 23.1%. After 6 weeks of medication, the IPSSs of the patients with stage-Ⅰ, -Ⅱ and -Ⅲ BPH were decreased by 7.3 ± 6.8, 6.6 ± 4.3 and 11.0 ± 5.5, with total effective rates of 69.5%, 70.1% and 74.7%, respectively, with statistically significant differences among the three stages (P < 0.05), and so were those in the patients aged ≤50 years (by 7.4 ± 5.8), 51－60 years (by 7.9 ± 5.3), 61－70 years (by 8.7 ± 5.6) and >70 years (by 8.6 ± 5.1), but with no statistically significant differences among different age groups (P > 0.05). At 6 weeks, the IPSS was reduced by 7.1 ± 5.9 by concomitant medication of urogenital and reproductive hormone drugs, 8.7 ± 5.4 by concomitant medication of other drugs, and 8.4 ± 5.3 by non-concomitant medication, with no statistically significant differences among the three types of medication (P > 0.05). CONCLUSIONS: Huang'e Capsules can evidently improve the symptoms of BPH, with the best effect on stage-Ⅲ BPH, and the effect does not differ significantly with age or drug concomitance.