Effects and safety of Ophiocordyceps sinensis preparation in the adjuvant treatment for dialysis patients: A protocol for systematic review and meta-analysis.

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INTRODUCTION: Ophiocordyceps sinensis(O. sinensis), a genus of ascomycete fungi, has been intensively studied in various disease models, which is a rich source of various bioactive compounds and used in the treatment for end-stage renal disease patients. This systematic review highlights the therapeutic roles of O. sinensis as adjuvant treatment for dialysis patients with clinical evidence.

METHODS AND ANALYSIS: The systematic review will be performed according to the Cochrane Handbook for Systematic Reviews of Interventions. The protocol is being reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols Statement. An literature search strategy will be developed and adapted for 9 databases. Searches will be run from the database inception until the date of the search implementation and be updated before the review is completed. Randomized controlled trials that investigate the effects of O. sinensis for dialysis patients (peritoneal dialysis and hemodialysis) will be included. We will focus on outcomes recommended by the core outcome measures in effectiveness trials, including mortality, cardiovascular disease, infection, vascular access problems, dialysis adequacy, hyperkalaemia, life participation. Two researchers will independently screen the studies, extract data and evaluate study quality using the Risk of Bias 2 tool. Subgroup analysis will be performed according to peritoneal dialysis and hemodialysis. Sensitivity analyses will be conducted based on the Leave-1-Out Method. The Grading of Recommendations Assessment, Development, and Evaluation approach will be used to rate the quality of the evidence. Meta analysis will be performed using Review Manager 5.3 and R packages.

OBJECTIVES: Studies have reported positive results of O. sinensis as adjuvant treatment for patients with dialysis. This review will synthesis current evidence on how O. sinensis can improve dialysis. Thus, it is expected that robust and conclusive evidence of the effects of O. sinensis during or after treatment can be obtained. These findings can inform future research and the selection of O. sinensis to promote quality of life for people with dialysis.