Background: 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.
Methods: 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.
Results: 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.
Conclusion: Provide a basis for evidence-based medicine, and provide a basis for clinical researchers to choose more effective Chinese medicine treatment of RLS.