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Efficacy and safety of traditional Chinese medicine Qiaoshao Formula combined with Dapoxetine in the treatment of premature ejaculation in Chinese men: a real-world study

Guo, J1; Zhou, Q2; Zhang, R3; Zhang, CH4; Xuan, ZH5; Cai, J6; Zeng, XB7; BIN, B8; Chen, WT9; Wang, F10; Qiu, JF10; Yan, B10; Gao, QH10; Zhang, XJ10; Liu, Y10

1: Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing,China; 2: The First Hospital of Hunan University of Chinese Medicine,Changsha,China; 3: The Second Hospital Affiliated to Heilongjiang University of Chinese Medicine,Harbin,Heilongjiang ,China; 4: Yunnan Provincial Hospital of Traditional Chinese Medicine,Kunming,China; 5: Shunyi hospital of Beijing Chinese Medicine Hospital ,Beijing,China; 6: The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine,Chendu,China; 7: Sichuan Provincial People's Hospital,Chengdu,China; 8: The First Affiliated Hospital of Guangxi University of Chinese Medicine,Nanning,China; 9: Shenzhen Traditional Chinese Medicine Hospital,Shenzheng,China; 10: Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing,China

Objective: To make a real-world study on the efficacy and safety of Qiaoshao Formula (QSF) combined with Dapoxetine for the treatment of premature ejaculation (PE).

Methods: A total of 245 patients ,aged 20-50 years, duration of ≥ 6 months, stability partner, sex life frequency ≥ 4 times / month, diagnostic criteria with the 2014 guide of ISSM for PE ,were collected from April to July 2017 in multiple observation centers. According to patient's own choice, not random, the patients were divided into combination of Chinese and Western medicine group( n = 155,CWMG): QSF(consisted of Fructus Forsythiae 20 g, Radix Paeoniae Alba 15 g, Radix Bupleuri 15 g, Morinda offcinalis How 15 g, Rhizoma Dioscoreae 15 g, and so on , twice a day) combined with dapoxetine (Priligy,Menarini Co., Ltd) , and Western medicine group (dapoxetine, n =90,WMG) . There were no significant differences between the two groups in age, course of disease, premature ejaculation profile (PEP) and TCM syndrome scores (P> 0.05). But the intra-vaginal ejaculation latency time (IELT) in two groups was significant difference (P<0.05), WMG was longer. After treatment for 4 weeks and 8 weeks, the subjects were interviewed, and the IELT , PEP , clinical global impression change (CGIC) and adverse reactions (AEs) were recorded respectively; Then the drug was stopped and followed up again 4 weeks later.

Results: CWMG lost 15 cases, WMG lost 8 cases .After the treatment of 4 weeks, 8 weeks and 4 weeks after drug withdrawal, IELT of CWMG increased from1.51±0.63 min to 3.30±1.57 min,4.67±2.07 min,5.22±2.65min, and WMG were extended from 1.62±0.47 min to 6.64±3.59 min,8.11±4.58 min,5.9±3.39min; IELT of after treatment had no significant difference (P>0.05),but CWMG improved more; PEP of CWMG from before treatment 3.56±2.51 to 6.64±3.59,8.11±4.58,8.85±4.81, WMG from 5.79±3.02 to 6.63±2.18, 6.48±3.74, 6.17±4.03; CWMG was higher than the WMG after the 4 weeks treatment; There was significant difference (P<0.05), but 8 weeks and 4 weeks after drug withdrawal in two groups had no significant differences (P>0.05); The CGIC of CWMG and WMG were 88.12% and 86.67% respectively after treatment, and there was no significant difference between (P >0.05); In addition, no significant AEs were observed in both groups.

Conclusion: It is safe and effective for the treatment of PE with QSF combined with dapoxetine. Compared with dapoxetine only, QSF combined with dapoxetine can prolong IELT more and the effect is faster of PEP.

Disclosure:

Work supported by industry: no.

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