Abstract
BACKGROUND: Systemic lupus erythematosus (SLE) is an autoimmune disease that involves multiple systemic organs. Bushen Huoxue Method (BSHXM) is a traditional Chinese medicine treatment, which is used for the treatment of SLE combining with cyclophosphamide. However, no systematic review has been performed to describe its effectiveness. This study provides a protocol for systematic review and meta-analysis of currently published randomized controlled trials (RCTs) reporting the combination of BSHXM and cyclophosphamide for the treatment of SLE, thus providing evidences to support clinical practice. METHODS: RCTs reporting the combination of BSHXM and cyclophosphamide for the treatment of SLE before October 2022 will be searched in the online databases, including the PubMed, Cochrane, Embase, Web of Science, CNKI, Wanfang, VIP databases and CBM. The Cochrane Risk of Bias 2 (RoB2) tool will be used to evaluate the quality of included RCTs. Meta-analysis will be performed using Stata 14.0. RESULTS: Results to be published in a peer-reviewed journal providing evidence for the efficacy and safety of the combination of BSHXM and cyclophosphamide on the treatment of SLE. CONCLUSIONS: This study will provide a strong basis for the effectiveness and safety of the combination of BSHXM and cyclophosphamide on the treatment of SLE.