Efficacy and safety of Chinese tonic medicines for treating sepsis or septic shock: a protocol for a systematic review and Bayesian network meta-analysis of randomized controlled trials

Abstract

Background Sepsis is a life-threatening organ dysfunction with high morbidity and mortality. Various studies have demonstrated the effectiveness of Chinese tonic medicines (CTMs) in treating sepsis or septic shock. However, trials direct comparing the efficacy and safety of different CTMs for sepsis or septic shock are still lacking. To identify the most optimal CTMs for treating sepsis or septic shock, we plan to perform a systematic review and network meta-analysis of various CTMs used for sepsis or septic shock patients. Methods Randomized controlled trials (RCTs) that investigated the efficacy and safety of CTMs for patients with sepsis or septic shock will be systematically searched in Pubmed, Embase, Cochrane Central Register of Controlled Trials, CBM, CNKI, Wanfang, and VIP database from inception to November 2023. The quality of the included studies will be assessed using the Cochrane Risk of Bias V.2.0. tool. The confidence of evidence will be evaluated through the CINeMA (Confidence in Network Meta-Analysis) web application. Primary outcomes include the delta Sequential Organ Failure Assessment (△SOFA) score at day 7 after interventions and 28-day mortality. Secondary outcomes comprise delta serum lactate levels (△Lac) and delta mean arterial pressure (△MAP) at day 7 after interventions as well as total dose and duration of vasoactive drugs. Safety outcome includes adverse drug reactions or adverse drug events (ADRs/ADEs). The Bayesian network meta-analysis will be conducted using the “BUGSnet” package in R version 4.2.2. The surface under the cumulative ranking curve (SUCRA) values will be used to rank each treatment. Statistical inconsistency assessment, publication bias assessment, heterogeneity analysis, sensitivity analysis, and subgroup analysis will be performed. Discussion This study will provide new insights into the efficacy and safety of various CTMs used in sepsis or septic shock patients, providing help for future clinical practice and research. Systematic review registration CRD42023482572