Efficacy and safety of traditional Chinese medicine combined with sildenafil in the treatment of ED in Chinese men: A real-world study
GUO Jun
CHANG De-gui
CHEN Lei
OU-YANG Bin
ZHANG Rui
GENG Qiang
YU Chao
WANG Fu
GAO Qing-he
YU Guo-jin
ZHANG Xiu-ju
Abstract：Objective:To make a real-world study on the efficacy and safety of traditional Chinese medicine (TCM) combined with sildenafil in the treatment of erectile dysfunction (ED) that failed to respond to TCM medication.Methods:This study included 1 038 ED patients with the International Index of Erectile Function-5 (IIEF-5) scores ≤21 and improvement ＜30％ after 4 weeks of TCM medication,differentially diagnosed with kidney-yang or kidney-yin deficiency syndrome.We administered TCM combined with sildenafil (Viagra,Pfizer Pharmaceutical Co.,Ltd) at 100 mg 1 hour before sexual intercourse.After 2 and 4 weeks of medication,we recorded the scores in IIEF-5,erection hardness,Sexual Encounter Profile question 2 (SEP-2:whether vaginal penetration is successful),SEP-3 (whether sexual intercourse is successful),and TCM Syndromes Scale as well as the indexes of routine blood,urine,liver function,and renal function of the patients,and compared them with those obtained before treatment.Results:No serious adverse reactions were observed in any of the patients.Compared with the baseline,the patients achieved significantly increased IIEF-5 scores after 2 and 4 weeks of medication (15.01 ± 2.25 vs 16.96 ± 2.55 and 19.41 ± 2.82,P ＜ 0.05),penileelectionhardness remarkably improved at 4 weeks (3.36％ vs 44.58％,P ＜ 0.05),and the positive answers to SEP-2 and SEP-3 both markedly increased at2 (38.11％ vs90.49％,P＜0.05;22.01％ vs63.77％,P＜0.05) and4 weeks (38.11％ vs96.95％,P＜0.05;22.01％ vs 89.73 ％,P ＜ 0.05).Conclusion:TCM combined with sildenafil is safe and effective in the treatment of ED in Chinese men,which can significantly improve the IIEF-5 score and erection hardness of the patients.
Keywords：real-world studyerectile dysfunctiontherapeutic effect evaluationsafety
Publication Date：2017-10-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：5( 917-921 )