Vagus nerve stimulation is an empirically based method for treatment of epi
lepsy by repeated stimulation of the left vagus nerve through implanted ele
ctrodes. Despite studies in animals and man, which show changes in brain el
ectrophysiology, metabolism and neurochemistry, the mode of action remains
unknown.
Clinical testing has presented methodological challenges, as it is difficul
t to assess under double blind conditions a treatment which requires surger
y and produces a sensation every time the stimulator comes on. This has nev
ertheless been successfully addressed in parallel design, controlled trials
comparing high and low stimulation schedules. These have been performed in
adults with medically intractable partial seizures, and demonstrated effic
acy, safety and good tolerability. Efficacy, both in the controlled trials
and in numerous reports arising from the considerable post-marketing experi
ence is modest. Some 30% of patients achieve a 50% seizure reduction after
3 months of treatment, but this proportion progressively increases to about
50% after 18 months.
Side-effects comprise: discomfort in the face or neck when the stimulator i
s activated, coughing, breathlessness on exertion and hoarseness of voice.
All are related to intensity of stimulation and rapidly habituate in most s
ubjects. Ln those patients who respond, a stimulus level can therefore gene
rally be found which is acceptable to the subject.
No indication other than refractory partial seizures in adults has been the
subject of controlled trials, but post-marketing experience and uncontroll
ed reports indicate comparable efficacy and safety in a wide range of epile
psies, partial and generalized, idiopathic, cryptogenic, or symptomatic, in
patients of all ages. (C) 2000 BEA Trading Ltd.