title: A controlled trial of transcutaneous vagus nerve stimulation for the treatment of pharmacoresistant epilepsy.
abstract: This study explored the efficacy and safety of transcutaneous vagus nerve stimulation (t-VNS) in patients with pharmacoresistant epilepsy. A total of 60 patients were randomly divided into two groups based on the stimulation zone: the Ramsay-Hunt zone (treatment group) and the earlobe (control group). Before and after the 12-month treatment period, all patients completed the Self-Rating Anxiety Scale (SAS), the Self-Rating Depression Scale (SDS), the Liverpool Seizure Severity Scale (LSSS), and the Quality of Life in Epilepsy Inventory (QOLIE-31). Seizure frequency was determined according to the patient's seizure diary. During our study, the antiepileptic drugs were maintained at a constant level in all subjects. After 12 months, the monthly seizure frequency was lower in the treatment group than in the control group (8.0 to 4.0; P=0.003). This reduction in seizure frequency was correlated with seizure frequency at baseline and duration of epilepsy (both P>0.05). Additionally, all patients showed improved SAS, SDS, LSSS, and QOLIE-31 scores that were not correlated with a reduction in seizure frequency. The side effects in the treatment group were dizziness (1 case) and daytime drowsiness (3 cases), which could be relieved by reducing the stimulation intensity. In the control group, compared with baseline, there were no significant changes in seizure frequency (P=0.397), SAS, SDS, LESS, or QOLIE-31. There were also no complications in this group.
authors.affiliation: The Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45, Changchun Street, Xicheng District, Beijing 100053, China.
authors.forename: Liu
authors.initials: L
authors.lastname: Aihua
authors.affiliation: The Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45, Changchun Street, Xicheng District, Beijing 100053, China.
authors.forename: Song
authors.initials: S
authors.lastname: Lu
authors.affiliation: The Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45, Changchun Street, Xicheng District, Beijing 100053, China.
authors.forename: Li
authors.initials: L
authors.lastname: Liping
authors.affiliation: The Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45, Changchun Street, Xicheng District, Beijing 100053, China.
authors.forename: Wang
authors.initials: W
authors.lastname: Xiuru
authors.affiliation: The Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45, Changchun Street, Xicheng District, Beijing 100053, China.
authors.forename: Lin
authors.initials: L
authors.lastname: Hua
authors.affiliation: The Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45, Changchun Street, Xicheng District, Beijing 100053, China. Electronic address: wangyuping01@sina.cn.
authors.forename: Wang
authors.initials: W
authors.lastname: Yuping
mesh_terms: D000293:Adolescent; D000328:Adult; D004351:Drug Resistance; D004827:Epilepsy / Q000628:therapy*; D006801:Humans; D008875:Middle Aged; D012640:Seizures / Q000628:therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055536:Vagus Nerve Stimulation / Q000379:methods*; D055815:Young Adult
keywords: Parasympathetic nervous system; Quality of life; Refractory epilepsy; Seizure; Transcutaneous vagus nerve stimulation