Evaluating the efficacy and safety of transcutaneous vagus nerve stimulation for systemic lupus erythematosus: a protocol for a systematic review and meta-analysis.

Abstract

Conventional treatments, like immunosuppressants for systemic lupus erythematosus (SLE), are associated with many side effects. Transcutaneous vagus nerve stimulation (tVNS) emerges as a promising adjunctive therapy, potentially offering a more benign therapeutic avenue for patients with SLE. The increased number of clinical trials, including randomised clinical trials, highlights the importance of a systematic review and meta-analysis to evaluate the efficacy and safety of tVNS in treating SLE. Consequently, the aim of this systematic review and meta-analysis protocol is to synthesise the available evidence to elucidate the efficacy and safety of tVNS for the treatment of SLE. Databases include PubMed, Cochrane Library, Web of Science, Embase, Wanfang Database, China National Knowledge Infrastructure, VIP Database and Chinese BioMedical Literature Database. Data selection, extraction and quality assessment by two independent reviewers. Fatigue is the primary outcome, and secondary outcomes include pain, quality of life, negative emotions, adverse events and measures of SLE disease activity. We will use instruments appropriate for each study type to assess the risk of bias. The credibility of evidence will be evaluated using the grading of recommendation, assessment, development and evaluation system. For meta-analysis, we will use RevMan software to perform data synthesis (V.5.4.1). Besides, publication bias assessment, sensitivity, subgroup and meta-regression analyses will be conducted as appropriate. All data used in our study will be extracted from published clinical trials and, therefore, no ethical approval is required. Study results will be disseminated through peer-reviewed journals and relevant academic conferences. PROSPERO CRD42024525580.