Feiqiang Ren1, Ziyang Ma1, Yifeng Shen1, Guangsen Li2, Yaodong You2, Xujun Yu3, Zhengjie Li4, Degui Chang2, Peihai Zhang2. 1. Hospital of Chengdu University of Traditional Chinese Medicine and Chengdu University of Traditional Chinese Medicine. 2. The Urology and Andrology Department, Hospital of Chengdu University of Traditional Chinese Medicine. 3. The Andrology Department, The School of Medical and Life Sciences, Chengdu University of Traditional Chinese Medicine. 4. Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, PR China.
Abstract
BACKGROUND: Erectile dysfunction (ED) affects many adult men worldwide. Many studies on the brain of psychogenic ED have shown significant cerebral functional changes and reduced volume of gray matter and white matter microstructural alterations in widespread brain regions. Chaihu-Shugan-San (CHSGS) capsule has been used to treat ED from the 20th century in China. However, clinical research of CHSGS capsule in the treatment of ED was lack. We design this study to evaluate the efficacy and safety of CHSGS capsule in the treatment of patients suffering from psychogenic ED. Furthermore, we also aim to provide a new evidence as well as an innovation of the clinical treatment in psychogenic ED. METHODS: This study is designed as a multi-center, 3-arms, randomized trial. From the perspective of psychogenic ED, we will divide patients into 3 groups, which are placebo group, tadalafil group and CHSGS group. One hundred thirty-five patients will be randomly allocated to receive placebo, CHSGS capsule or tadalafil oral pharmacotherapy. After the period of 4-week treatment, the outcome of primary assessment changes in the brain MRI, IIEF-5, EHS, and QEQ total scores from baseline. Secondary assessments include the SEAR, HAMA-14, HAMD-17 scores, response rate of the patients and their partners. DISCUSSION: We designed this study based on previous research about psychogenic erectile dysfunction (ED). This study will provide objective evidences to evaluate the effects of CHSGS capsule as an adjuvant treatment for psychogenic ED. TRIAL REGISTRATION NUMBER: chictr.org.cn, ChiCTR-IOR-1800018301.
BACKGROUND: Erectile dysfunction (ED) affects many adult men worldwide. Many studies on the brain of psychogenic ED have shown significant cerebral functional changes and reduced volume of gray matter and white matter microstructural alterations in widespread brain regions. Chaihu-Shugan-San (CHSGS) capsule has been used to treat ED from the 20th century in China. However, clinical research of CHSGS capsule in the treatment of ED was lack. We design this study to evaluate the efficacy and safety of CHSGS capsule in the treatment of patients suffering from psychogenic ED. Furthermore, we also aim to provide a new evidence as well as an innovation of the clinical treatment in psychogenic ED. METHODS: This study is designed as a multi-center, 3-arms, randomized trial. From the perspective of psychogenic ED, we will divide patients into 3 groups, which are placebo group, tadalafil group and CHSGS group. One hundred thirty-five patients will be randomly allocated to receive placebo, CHSGS capsule or tadalafil oral pharmacotherapy. After the period of 4-week treatment, the outcome of primary assessment changes in the brain MRI, IIEF-5, EHS, and QEQ total scores from baseline. Secondary assessments include the SEAR, HAMA-14, HAMD-17 scores, response rate of the patients and their partners. DISCUSSION: We designed this study based on previous research about psychogenic erectile dysfunction (ED). This study will provide objective evidences to evaluate the effects of CHSGS capsule as an adjuvant treatment for psychogenic ED. TRIAL REGISTRATION NUMBER: chictr.org.cn, ChiCTR-IOR-1800018301.
Authors: Michael Lowy; Suzanne Collins; Mark Bloch; Michael Gillman; Douglas Lording; Peter Sutherland; Hao Wang; Vera Stecher Journal: J Sex Med Date: 2007-01 Impact factor: 3.802
Authors: Stephen M Smith; Mark Jenkinson; Heidi Johansen-Berg; Daniel Rueckert; Thomas E Nichols; Clare E Mackay; Kate E Watkins; Olga Ciccarelli; M Zaheer Cader; Paul M Matthews; Timothy E J Behrens Journal: Neuroimage Date: 2006-04-19 Impact factor: 6.556