Abstract
<jats:p>INTRODUCTION: Brain edema (BE) is a life-threatening condition that complicates various injuries of the central nervous system. The pharmacological treatment of BE is carried out using few drugs that are lacking a strong evidence base. OBJECTIVE: To evaluate the effectiveness of escin for conditions accompanied by BE, based on clinical trial data. MATERIALS AND METHODS: The review was conducted in compliance with the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) 2020 guidance. We identified 16 clinical trials that matched the criteria: patients with BE; escin as intervention; placebo, standard therapy, an active comparator, or combination therapy without escin as comparison; outcomes relevant to BE; prospective, interventional, controlled design. RESULTS: We reviewed 15 trials (n = 1016) with acceptable risk of bias, including participants with traumatic brain injury (10 trials; n = 574), stroke (6 trials; n = 356), and/or hypertensive encephalopathy (1 trial; n = 86). All trials were conducted at a single center, had a parallel-group design, and used standard therapy as control; 7 (43.7 %) of the trials were randomized, and 1 (6.3 %) were (single) blind. In all cases, the intervention was escin lysinate, administered intravenously at 10–25 mg (median — 20 mg) daily, over 3–14 days (median — 10 days). Addition of escin lysinate was associated with a reduction in brain lesion volumes, a faster improvement of intracranial hypertension and neurological symptoms, normalization of cerebral blood flow, and a higher overall survival rate. According to the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) system, we rated our confidence in all of these findings as low/very low for the entire trial set, and as moderate, for the randomized trial subset. CONCLUSIONS: Escin lysinate may accelerate BE resolution in traumatic brain injury and stroke, but its effectiveness and safety require further confirmation in randomized, blind, placebo-controlled clinical trials.</jats:p>