Chinese Herbal Medicine Treatment for Restless Legs Syndrome: A Protocol for a Systematic Review with Meta-Analysis

Background: Restless Legs Syndrome (RLS) significantly impairs sleep and daily life. Conventional treatments often cause side effects leading patients to seek alternative treatments like Chinese Herbal Medicine (CHM). A systematic review and meta-analysis of studies which used CHM treatment for RLS will facilitate the evaluation of its efficacy and safety.Methods: Randomized controlled trials will be retrieved systematically from electronic databases including PubMed, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang and Chongqing Value-added Information Platform. Comparisons between the effects of CHM (as monotherapy or adjunct therapy), placebos, and conventional interventions will be made. Two reviewers will independently perform study selection, data extraction, and risk of bias assessments using the Cochrane RoB 2.0 tool. The primary outcomes will be RLS symptom severity (e.g., IRLSSG rating scale), quality of life, and adverse events. Data will be pooled using a random-effects meta-analysis, and the overall certainty of evidence will be assessed for quality of evidence and strength of recommendation using the Grading of Recommendations, Assessment, Development, and Evaluation system.Conclusion: This review aims to synthesize high-quality evidence to determine the effectiveness and safety of CHM treatment for RLS, provide valuable insights for clinicians, patients, and policymakers, and identify gaps for future research.