Abstract Background: Diabetes mellitus with erectile dysfunction (DMED) is one of the most common causes of disability in diabetic population, and its pathogenesis is related to a variety of factors. Because its pathogenesis is complex and the existing treatment methods have limitations, DMED is difficult to treat in clinical. Recently, some studies have shown that α-lipoic acid (ALA) is associated with DMED, but there is no systematic review and meta-analysis on the relationship between ALA and DMED. Methods: We will search each database from the built-in until July 2020. The English literature mainly searches Cochrane Library, PubMed, EMBASE, and Web of Science, while the Chinese literature comes from CNKI, CBM, VIP, and Wangfang database. Simultaneously we will retrieve clinical registration tests and grey literatures. This study only screen the clinical randomized controlled trials (RCTs) about ALA for DMED to assess its efficacy. The 2 researchers worked independently on literature selection, data extraction, and quality assessment. The dichotomous data is represented by relative risk (RR), and the continuous is expressed by mean difference (MD) or standard mean difference (SMD), eventually the data is synthesized using a fixed effect model (FEM) or a random effect model (REM) depending on whether or not heterogeneity exists. Erectile dysfunction (ED) will be diagnosed by the International Index of Erectile Function 5 (IIEF-5) score. Finally, meta-analysis was conducted by RevMan software version 5.3. Results: This study will synthesize and provide high quality to evaluate the effectiveness of ALA supplementation for the treatment of DMED. Conclusion: This systematic review aims to provide new options for ALA supplementation treatment of DMED in terms of its efficacy and safety. PROSPERO registration number: INPLASY202070130.

中文翻译：

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α-硫辛酸治疗糖尿病勃起功能障碍的疗效评估


摘要 背景：糖尿病伴勃起功能障碍（DMED）是糖尿病人群最常见的致残原因之一，其发病机制与多种因素有关。由于其发病机制复杂且现有治疗方法存在局限性，DMED在临床上治疗难度较大。近年来，有研究表明α-硫辛酸（ALA）与DMED存在相关性，但目前尚未对ALA与DMED之间的关系进行系统综述和荟萃分析。方法：检索自内置至2020年7月的各数据库。英文文献主要检索Cochrane Library、PubMed、EMBASE、Web of Science，中文文献来自CNKI、CBM、VIP、万方数据库。同时检索临床注册试验和灰色文献。本研究仅筛选ALA用于DMED的临床随机对照试验（RCT）以评估其疗效。 2名研究人员独立进行文献选择、数据提取和质量评估。二分数据用相对风险（RR）表示，连续数据用平均差（MD）或标准均差（SMD）表示，最终使用固定效应模型（FEM）或随机效应模型（FEM）合成数据（ REM）取决于异质性是否存在。勃起功能障碍 (ED) 将通过国际勃起功能指数 5 (IIEF-5) 评分进行诊断。最后利用RevMan软件5.3版进行荟萃分析。结果：本研究将综合并提供高质量的 ALA 补充剂治疗 DMED 的有效性评估。 结论：本系统评价旨在为DMED的ALA补充治疗的有效性和安全性提供新的选择。 PROSPERO 注册号：INPLASY202070130。