Effect of Shanhaidan Granules combined with tadalafil on erectile dysfunction: A multi-center clinical trial.
- Author:
Yan-Ping HUANG
1
;
Zheng-Mu WU
2
;
Nian-Qin YANG
3
;
Yu PENG
4
;
Wei-Jie CHEN
5
;
Li LI
6
;
Lei CHEN
7
;
Huai-Jin CHENG
2
;
Mu-Jun LU
1
Author Information
1. Department of Urology and Andrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200120, China.
2. International Peace Maternal and Child Health Hospital, China Welfare Institute, Shanghai 200030, China.
3. Department of Urology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
4. Department of Urology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Chinese Medicine, Shanghai 200437, China.
5. Shanghai Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Chinese Medicine, Shanghai 200071, China.
6. Academic Department, Hangzhou Strong Pharmaceutical Co. LTD, Hangzhou, Zhejiang 310000, China.
7. Longhua Hospital, Shanghai University of Chinese Medicine, Shanghai 200032, China.
- Publication Type:Multicenter Study
- Keywords:
IIEF-6;
Shanhaidan Granules;
tadalafil;
therapeutic effect;
traditional Chinese medicine syndromes;
erectile dysfunction
- MeSH:
Erectile Dysfunction/drug therapy*;
Humans;
Male;
Medicine, Chinese Traditional;
Penile Erection;
Syndrome;
Tadalafil/therapeutic use*
- From:
National Journal of Andrology
2021;27(9):819-824
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To observe the clinical effect and safety of Shanhaidan Granules (SHDG) combined with tadalafil tablets (TT) in the treatment of ED.
METHODS:In this open multi-center case-control clinical trial, we enrolled 247 ED patients according to the designed criteria, and treated them orally with SHDG at 10 g per time tid (n = 74), TT at 5 mg per time bid (n = 52), or SHDG + TT at the above doses (n = 121), all for 8 weeks. Before and after medication, we recorded the IIEF-6, erection hardness scores (EHS), traditional Chinese medicine syndromes (TCMS) scores, penile cavernous blood flow parameters and adverse reactions, and compared them between the 3 groups of patients.
RESULTS:After 8 weeks of treatment, all the patients showed significantly increased IIEF-6, EHS and TCMS scores in comparison with the baseline (P < 0.05). The total effectiveness rates in the SHDG, TT and SHDG + TT groups were 60.8%, 67.3% and 69.4% respectively based on the IIEF-6 scores, remarkably higher in the TT and SHDG + TT groups than in the SHDG group (P < 0.05), and 40.5%, 32.7% and 63.6% respectively according to the TCMS scores, markedly higher in the SHDG and SHDG + TT groups than in the TT group (P < 0.05). Single-center data manifested significantly increased peak systolic velocity (PSV) of the penile artery in the SHDG + TT and TT groups (P < 0.05). The improvement values of relevant parameters were remarkably higher in the SHDG + TT group than in the TT and SHDG groups, so were IIEF-6 scores in the TT than in the SHDG group, and TCM syndromes in the SHDG than in the TT group. No medication-related adverse events were found in any of patients after treatment, except for some mild side effects including muscle soreness and gastrointestinal reactions in a few cases, all soon relieved, none with abnormalities in blood and urine routine tests or hepatic and renal function indicators.
CONCLUSIONS:Shanhaidan Granules combined with tadalafil can significantly improve the erectile function and reduce TCM syndromes in ED patients, and therefore can be applied effectively and safely in clinical practice./.
