Evaluation on curative effects of ethylene diamine tetra-acetic acid chelation therapy in treating with atherosclerotic cardiovascular disease: A protocol for systematic review and meta-analysis

BACKGROUND: Ethylene diamine tetra-acetic acid (EDTA) is a chelating agent which attach to metals such as calcium and enables their elimination. In particular, some researchers suggest chelation with EDTA to treat cardiovascular disease with the hypothesis of moderating calcium to decrease atherosclerotic calcification of arteries. However, chelation with EDTA therapeutic effects in atherosclerotic cardiovascular disease is still unclear. Therefore, we propose to undertake a meta-analysis to assess the curative effects of EDTA chelation therapy in patients with atherosclerotic cardiovascular disease. METHODS: In the current study, we set to perform a systematic literature search using the electronic databases of 4 most commonly used English databases (EMBASE, MEDLINE, Cochrane Library, and ClinicalTrials.gov trials register), as well as 3 most commonly employed Chinese databases (China Nation Knowledge Infrastructure, Wan Fang, and VIP), from the date of database inception until September 30, 2020 to identify relevant randomized controlled studies of the evaluation on curative effects of EDTA chelation therapy in patients with atherosclerotic cardiovascular disease. In the study, 2 authors worked independently to screen search results, chose studies for inclusion, then they extracted pertinent data to evaluate and study quality based on Cochrane Risk of Bias Tool V.2.0. Additionally, we will address discrepancies by consultation with a third author. We also intend to use pooled risk ratio (RR) and pooled mean difference (MD) or pooled standardized mean difference (SMD) with 95% confidence intervals (CI) to approximate the relative strength of curative effects of EDTA chelation therapy in patients with atherosclerotic cardiovascular disease. RESULTS: The results of the current study will systematically assess curative effects of EDTA chelation therapy in patients with atherosclerotic cardiovascular disease. CONCLUSION: The study will infer the currently published evidence to evaluate curative effects of EDTA chelation therapy in patients with atherosclerotic cardiovascular disease, which might be beneficial to these patients. ETHICS AND DISSEMINATION: The present study is a systematic review, hence the pooled results are founded upon the published evidence. Therefore, ethical approval is not necessary for the study. OPEN SCIENCE FRAMEWORK REGISTRATION NUMBER: October 20, 2020.osf.io/tvmk8. (https://osf.io/tvmk8/).