Chen Yunhui, Huang Wei, Liu Lizhou, Tumilty Steve, Liu Dan, You Yanyan, Zheng Chuan, Baxter George David
College of Basic Medicine/Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Centre for Health, Activity, and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, New Zealand.
Medicine (Baltimore). 2020 Oct 2;99(40):e22401. doi: 10.1097/MD.0000000000022401.
A growing body of clinical trials has demonstrated that traditional Chinese medicine Shaoyao Gancao Tang may improve restlessness leg syndrome (RLS). This review aims to systematically assess its effectiveness and safety in the treatment of patients with RLS.
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.
A high-quality synthesis of current evidence of Shaoyao Gancao Tang's effectiveness and safety for patients with RLS will be provided.
This systematic review will provide evidence of whether Shaoyao Gancao Tang is an effective and safe intervention for RLS.
越来越多的临床试验表明，中药芍药甘草汤可能改善不安腿综合征（RLS）。本综述旨在系统评估其治疗RLS患者的有效性和安全性。
检索自建库至2020年8月31日的八个数据库，包括中国生物医学数据库、中国知网、万方数据库、维普资讯数据库、考克兰图书馆、PubMed、EMBASE和科学引文索引。纳入所有符合预先设定的纳入标准的已发表随机对照试验。主要结局包括国际不安腿综合征评分量表的变化以及通过视觉模拟量表评估的不安感，次要结局包括有效率、不良事件发生率、生活质量指标以及睡眠质量指数的改善情况。由两名审阅者独立进行研究选择、数据提取和偏倚风险评估。使用RevMan软件（V.5.3.5）进行数据合成。必要时进行亚组分析和敏感性分析。证据的强度将通过推荐分级评估、制定和评价系统进行评估。
将提供关于芍药甘草汤治疗RLS患者有效性和安全性的当前证据的高质量综合分析。
本系统综述将提供芍药甘草汤是否为RLS有效且安全干预措施的证据。
