The clinical effectiveness and safety of alprostadil combined with alpha lipoic acid in the treatment of diabetic peripheral neuropathy: A protocol for systematic review and meta-analysis

BACKGROUND: The pathogenesis of diabetic peripheral neuropathy is more complex and it is not yet clear, but studies have shown that microangiopathy and oxidative stress responses are closely related to their pathogenesis. At present, the treatment of improving microcirculation and antioxidant stress is mainly used in clinical. Alprostadil is a commonly used vasodilator, and alpha lipoic acid is an antioxidant, which can effectively reduce oxidative stress responses and delay the progression of diabetes mellitus and its complications. However, there is a lack of evidence-based medical evidence for alprostadil combined with alpha lipoic acid in the treatment of diabetic peripheral neuropathy, and this article aims to understand the clinical effectiveness and safety of alprostadil combined with alpha lipoic acid in the treatment of diabetic peripheral neuropath by a meta-analysis of published randomized controlled trials. METHODS: In this study, we obtain the relevant literature by retrieving 8 electronic databases, including PubMed, EMBASE, Web of Science, the Cochrane Library, CBM, CNKI, VIP, and WanFang Database. Retrieving a randomized controlled study of alprostadil combined with alpha lipoic acid in the treatment of diabetic peripheral neuropath, while the language of the literature is restricted and it only includes Chinese and English literature. For the publication of literature, the time is from the beginning of the database to August 31, 2020. In the English database, using the retrieval method of subject word combined free word. The two researchers read the titles and abstracts of all the literature independently based on the inclusion and exclusion criteria. If it cannot be determined whether the literature is included by reading the title and abstract, then download and read the full text of the literature. If there is a dispute between the two researchers about the literature, so it should discuss the dispute with the third researcher in order to reach a conclusion. Using the bias risk assessment tool of randomized controlled trials in Cochrane systematic review to evaluate the bias risk of the included literature; Using RevMan 5.3 software to conduct statistical analysis; Using funnel plot analysis to analyze the situation of literature publication bias. RESULTS: This study will provide a high-quality evidence on the effects of hydrolyzed protein formula milk on gastrointestinal diseases and physical development of premature infants. CONCLUSION: This study will draw reliable evidence-based medical evidence for alprostadil combined with Alpha lipoic acid in the treatment of diabetic peripheral neuropathy, thus providing help for the clinical treatment of diabetic peripheral neuropathy. REGISTRATION NUMBER: Open Science Framework (OSF), registration number: DOI 10.17605/OSF.IO/7S46G.