The central mechanism of tadalafil vs Chaihu-Shugan-San capsule for psychogenic erectile dysfunction: a magnetic resonance imaging study protocol of a randomized placebo-controlled trial
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. We design this study to provide both an enhanced level of evidence of central mechanism research and an evidence-based treatment option for 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.
Method and Analysis: This study is designed as a multi-center, three-arms, randomized trial. From the perspective of psychogenic ED, we will divide patients into three groups, which are placebo group, tadalafil group and CHSGS group. 135 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 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. Apart from brain MRI from baseline, we will also attach great importance to other changes in the follow-up four weeks.
Discussion: We expect that the results of this trial can provide both an enhanced level of evidence for central mechanism research and an evidence-based treatment option for patients suffering from ED, as well…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 135 participants or records.
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