Liu Liting, Xie Rongfang, Wang Ruiqi, Huang Chunhua
Jiangxi University of Traditional Chinese Medicine Nanchang.
Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Nanchang, Jiangxi Province, China.
Medicine (Baltimore). 2020 Oct 30;99(44):e22831. doi: 10.1097/MD.0000000000022831.
Restless legs syndrome (RLS) is a sensory motor disorder. It mainly manifests as indescribable pain in the lower limbs at night or at rest, and the symptoms are reduced after activity or beating, which seriously affects the patients sleep. Nowadays, a large number of randomized controlled clinical studies have shown that Chinese medicine has the advantages of good curative effect and high safety in the treatment of RLS. However, due to the various treatment methods of Chinese medicine, its relative effectiveness and safety have not been verified. Therefore, this study will use a network meta-analysis method to verify the effectiveness and safety of different types of TCM therapies in the treatment of RLS.
Computer retrieval was conducted in PubMed, Cochrane Library, Web of Science, Embase, SinoMed, CNKI, WanFang-database, VIP. The retrieval period was until September 9, 2020, and all randomized controlled trials of TCM treatment of RLS were collected. To avoid omissions, we will manually search relevant references and conference papers. According to the inclusion and exclusion criteria, we conduct quality assessment and risk assessment of all retrieved documents. Methodological quality assessment and risk of bias will be assessed using Cochrane bias risk tool. All data analysis will use Revman5.3, WinBUGS 1.4.3, and Stata14.2 software.
This study will directly or indirectly compare the effectiveness of different interventions on RLS outcome indicators, and rank the effectiveness. The main outcome indicators include total effective rate (total effective rate = rocovery + obvious effective + effective/total number of cases × 100%), International Restless Legs Syndrome Score Scale, secondary outcome indicators include visual analog scale, Pittsburgh sleep quality indicators and adverse events.
Provide a basis for evidence-based medicine, and provide a basis for clinical researchers to choose more effective Chinese medicine treatment of RLS.
不安腿综合征（RLS）是一种感觉运动障碍。主要表现为夜间或休息时下肢难以形容的疼痛，活动或拍打后症状减轻，严重影响患者睡眠。目前，大量随机对照临床研究表明，中医在RLS治疗中具有疗效好、安全性高的优势。然而，由于中医治疗方法多样，其相对有效性和安全性尚未得到验证。因此，本研究将采用网络荟萃分析方法验证不同类型中医治疗RLS的有效性和安全性。
通过计算机检索PubMed、Cochrane图书馆、Web of Science、Embase、中国生物医学文献数据库、中国知网、万方数据库、维普数据库。检索截止到2020年9月9日，收集所有中医治疗RLS的随机对照试验。为避免遗漏，我们将手动检索相关参考文献和会议论文。根据纳入和排除标准，对所有检索到的文献进行质量评估和风险评估。采用Cochrane偏倚风险工具进行方法学质量评估和偏倚风险评估。所有数据分析将使用Revman5.3、WinBUGS 1.4.3和Stata14.2软件。
本研究将直接或间接比较不同干预措施对RLS结局指标的有效性，并对有效性进行排序。主要结局指标包括总有效率（总有效率 = 痊愈 + 显效 + 有效/病例总数×100%）、国际不安腿综合征评分量表，次要结局指标包括视觉模拟量表、匹兹堡睡眠质量指标和不良事件。
为循证医学提供依据，为临床研究人员选择更有效的中医治疗RLS提供依据。
