Can transcutaneous auricular vagus nerve stimulation be considered a viable adjuntive therapy in drug-resistant epilepsy? A systematic review and meta-analysis of randomized controlled trials
Pierludovico Moro , Marco Antonnio Rocha dos Santos , Abner Lucas Balduino de Souza , Thaís Pereira Mendes , Laura de Lima Xavier , Carlo Di Bonaventura , Emanuele Cerulli Irelli
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引用次数: 0
Abstract
Objective
Transcutaneous auricular vagal nerve stimulation (tVNS) has been investigated as a potential non-invasive therapy in addition to standard medical care in patients with drug-resistant epilepsy (DRE). This meta-analysis evaluates the efficacy and safety of tVNS compared to sham stimulation in patients with DRE.
Methods
A systematic search was conducted in three electronic databases (PubMed, Scopus, Cochrane) to identify randomized controlled trials (RCTs) comparing tVNS versus sham stimulation for the treatment of DRE. The Cochrane risk of bias tool for randomized trials was utilized for quality assessment.
Results
Four RCTs, comprising 368 patients, with 232 patients in the tVNS group, were included. The meta-analysis revealed that tVNS significantly reduces seizure frequency, as expressed by mean monthly seizure number (mean difference [MD] −3.01, 95 % confidence interval [CI] [−5.37 to −0.65], p < 0.01, I2 = 0 %) and percentage seizure reduction (MD 17.57 %, 95 % CI [1.90 to 33.25], p = 0.03, I2 = 0 %) at the end of treatment. The analysis also indicated a potential effect on responder rate (odds ratio 2.00, 95 % CI [0.98 to 4.05], p = 0.06, I2 = 42 %), although not statistically significant. No significant differences between groups were found regarding seizure freedom, depression, and QOL. Adverse events reported were mostly mild and transient, with no significant differences between groups and comparable discontinuation rates.
Conclusions
This meta-analysis supports the efficacy and safety of tVNS as an adjunctive therapy for the treatment of DRE. Due to significant methodological concerns in some of the included studies, well-designed RCTs are needed to investigate the efficacy of tVNS on seizure and non-seizure outcomes in patients with DRE.
期刊介绍:
Epilepsy & Behavior is the fastest-growing international journal uniquely devoted to the rapid dissemination of the most current information available on the behavioral aspects of seizures and epilepsy.
Epilepsy & Behavior presents original peer-reviewed articles based on laboratory and clinical research. Topics are drawn from a variety of fields, including clinical neurology, neurosurgery, neuropsychiatry, neuropsychology, neurophysiology, neuropharmacology, and neuroimaging.
From September 2012 Epilepsy & Behavior stopped accepting Case Reports for publication in the journal. From this date authors who submit to Epilepsy & Behavior will be offered a transfer or asked to resubmit their Case Reports to its new sister journal, Epilepsy & Behavior Case Reports.