Jingui Shenqi pill for nocturia due to nocturnal polyuria: A protocol for systematic review and meta-analysis

BACKGROUND: The incidence of nocturia is high and will seriously affect patients’ physical and mental health. Nocturnal polyuria is the most critical cause of nocturia, There are few drugs currently used to treat nocturia due to Nocturnal Polyuria (NP). The guide highly recommends only Desmopressin. There is an urgent need to find new drugs. Jingui Shenqi pill (JSP) is a Chinese patent medicine, it is widely used in China to treat NP. However, there is no evidence-based medical evidence to prove its safety and effectiveness. The purpose of this systematic review is to evaluate the efficacy and safety of JSP in the treatment of NP. METHODS: We will search the randomized controlled trials (RCTs) including JSP for NP and published from the inception of the database to Oct 2020 by the following eight databases: Embase, Cochrane Library, PubMed, MEDLINE, the China National Knowledge Infrastructure, Cqvip Database, and Wanfang Data, the Chinese Biomedical Literature Database. There is no language and publication status restriction. The primary outcomes will include Nocturnal urine volume, the number of nocturnal voids, Nocturnal polyuria index (Nocturnal total urine volume /24 h total urine volume). We will perform the data synthesis, sensitivity analysis, subgroup analysis, and bias assessment risk using RevMan V.5.3. The reporting bias will be assessed using a funnel plot and Egger test. RESULTS: This study may provide additional evidence of JSP for NP in the effectiveness and safety and alternative therapy for NP. CONCLUSIONS: In this systematic review, we will assess whether JSP is an effective and safe medicine for nocturia.