Shugan Yiyang capsule for the treatment of erectile dysfunction: A protocol for systematic review and meta-analysis of randomized controlled trials

BACKGROUND: Erectile dysfunction (ED) is a common disease. It affects the quality of life of both husband and wife and becomes an independent risk factor for cardiovascular events. In China, Shugan Yiyang (SGYY) capsule has been increasingly reported in clinical trials for the treatment of ED and reported inconsistent findings. Therefore, it is necessary to conduct a systematic review to evaluate the efficacy and safety of this drug for the treatment of ED. METHODS: Chinese and English literature of SGYY capsule for ED published before August 31, 2019 will be comprehensive searched in PubMed, Cochrane Library, EMBASE, WANFANG, China National Knowledge Infrastructure, VIP Chinese Science and Technology Journal Database, Chinese biomedical document service system, and Clinicaltrials.gov. All randomized controlled trials that meet the eligibility criteria will be included and other studies will be excluded. Two investigators will conduct literature screening, data extraction and assess risk of bias alone, and the third investigator will handle disagreements. Two outcomes involving the international index of erectile function 5 score and adverse events will be evaluated. RevMan 5.3 and Stata 14.0 will be used to conduct this systematic review. The preferred reporting items for systematic reviews and meta-analysis protocols (PRISMA-P) statement is followed in this protocol and the the PRISMA statement will be followed in the completed systematic review. CONCLUSION AND DISSEMINATION: The efficacy and safety of SGYY capsule for ED will be evaluated. We will publish the results of this systematic review in peer-reviewed journals to provide new evidence to clinicians. Registration information: PROSPERO CRD42019140903