Buyang huanwu decoction combined with probiotics or prebiotics for functional recovery from stroke: A meta-analysis protocol for systematic review

BACKGROUND: Stroke is a global disease that compromises human health. Considering the side effects of Western medicine, alternative medicine, such as Chinese medicine, is widely used. Concurrently, the research and development on the microbiota-gut-brain axis in recent years have made intestinal microflora the new target of treatment. We aim to scientifically evaluate the advantages and clinical guidance of using Buyang-Huanwu (BYHW) decoction combined with probiotics in the intestinal microflora. METHODS: The search will focus on published Randomized Controlled Trial (RCTs) that used BYHW decoction, probiotics, prebiotics, synbiotics, or similar microecological preparations to treat stroke. We will search for relevant studies in six databases: PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wanfang Data, and Chongqing VIP Information. The retrieval date will be limited to the period from inception to June 2021 and will not be restricted by language. The extracted data will be subjected to systematic review and meta-analysis to evaluate its clinical advantages and efficacy. Patient-centred and most responsive outcomes will be selected as major outcomes, including the Fugl-Meyer (FMA) and Barthel scales. Secondary outcomes will be clinically assessed factors, including inflammatory factors in serum, platelet aggregation, other laboratory parameters, and the number and distribution of flora in the gut. We will evaluate the bias of each included study using the latest version of the Cochrane Handbook and the RoB tool. The analysis of all data and the drawing of forest maps will be performed using STAT 15.1 SE software. Regardless of the I(2) values generated between the studies, we will perform a subgroup analysis. The grouping method will be based on all included research characteristics and factors that may cause heterogeneity, and may depend on differences in intervention methods, sources of subjects, and other relevant factors. RESULTS: We plan to present the results of this systematic review in a peer-reviewed scientific journal, conferences, and popular press. CONCLUSION: The efficacy and safety of Buyang-Huanwu decoction combined with probiotics for the treatment of stroke will be evaluated, and the conclusion will be published to provide medical evidence for a better clinical decision of patients with stroke.