Effectiveness and safety of traditional Chinese medicineShaoyao Gancao Tangfor the treatment of restless leg syndrome A protocol for systematic review and meta-analysis

Background: A growing body of clinical trials has demonstrated that traditional Chinese medicineShaoyao Gancao Tangmay improve restlessness leg syndrome (RLS). This review aims to systematically assess its effectiveness and safety in the treatment of patients with RLS. Methods: Eight databases will be searched from the inception to 31 August 2020, including the Chinese Biological Medicine Database, China National Knowledge Infrastructure, Wanfang Database, VIP Information Database, the Cochrane Library, PubMed, EMBASE, and the Web of Science. All published randomized controlled trials that meet the prespecified eligibility criteria will be included. The primary outcomes include the changes in the International Restless Legs Syndrome Rating Scale and the restless sensation assessed by visual analog scales, and the secondary outcomes include effective rate, adverse event rate, quality of life measures, and improvement in the sleep quality index. Study selection, data extraction, and assessment of bias risk will be conducted independently by 2 reviewers. Data synthesis will be carried out with RevMan software (V.5.3.5). Subgroup and sensitivity analysis will be performed when necessary. The strength of the evidence will be assessed by the Grading of Recommendations Assessment, Development and Evaluation System. Results: A high-quality synthesis of current evidence ofShaoyao Gancao Tang's effectiveness and safety for patients with RLS will be provided. Conclusion: This systematic review will provide evidence of whetherShaoyao Gancao Tangis an effective and safe intervention for RLS.