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Vagus nerve stimulation for treatment of
partial seizures: 1. A controlled study of effect on seizures. First
International Vagus Nerve Stimulation Study Group.
Ben-Menachem E,
Manon-Espaillat
R, Ristanovic R,
Wilder BJ,
Stefan H,
Mirza W,
Tarver WB,
Wernicke JF.
University of Goteborg, Sweden.
Vagus
nerve stimulation (VNS) was shown to reduce seizure frequency in
refractory epilepsy patients in two pilot studies. Based on these
results, a multicenter, prospectively randomized, parallel,
double-blind study of patients with refractory partial seizures was
initiated. After a 12-week baseline period, identical vagus nerve
stimulators were implanted and patients randomized to either a high or
low 14-week VNS treatment paradigm. The primary objective was to
demonstrate that high VNS (therapeutic parameters) was more effective
in reducing partial seizure frequency than was low VNS (less or
noneffective parameters). Patients continued receiving antiepileptic
drugs (AEDs) with plasma concentrations held constant throughout the
study. We report results of the first 67 patients to exit the 14-week
acute phase. After 14 weeks of VNS, 31 patients receiving high VNS
experienced a mean seizure frequency percentage reduction of 30.9%,
which was statistically significant as compared with the mean seizure
frequency percentage reduction of 11.3% in 36 patients receiving low
VNS (p = 0.029, t test; p = 0.036, Wilcoxon rank-sum test). In addition
to the significant intragroup p-values, mean seizure frequency
percentage change reached statistical significance for high VNS (p <
0.001) but not low VNS (p = 0.072) as compared with baseline. Twelve of
31 (38.7%) patients receiving high VNS achieved at least 50% reduction
in seizure frequency whereas 7 of 36 (19.4%) patients receiving low VNS
experienced at least 50% reduction after 14 weeks. The implant
procedure and VNS therapy were well tolerated. Our study confirmed the
effectiveness of VNS as treatment for epilepsy patients with refractory
partial seizures.
PMID: 8026408 [PubMed - indexed for MEDLINE]
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