Comprehensive long-term outcome of best drug treatment with or without add-on vagus nerve stimulation for epilepsy: a retrospective matched pairs case-control study.

PURPOSE: In the treatment of epilepsy, the recommendation to add vagus nerve stimulation (VNS) to the best available drug therapy (BDT) mostly relies on uncontrolled studies which provide limited information about VNS-specific benefits. We report findings from a retrospective matched pairs case-control study comparing the long-term (>2 years) outcomes of BDT with or without VNS. METHODS: Included were adult patients with therapy-refractory epilepsy who had undergone the pre-surgical work-up (baseline) and subsequently received BDT with VNS (BDT+VNS) or BDT alone (BDT group). Patients were matched in pairs for age, gender and follow-up. Health outcomes were assessed at least 24 months after the baseline by comprehensive postal surveys and included established psychometric scales. RESULTS: We obtained data from 20 matched pairs of case and control patients. In both groups, seizures, health-related quality of life and mood improved over time. More BDT patients experienced a complete cessation of "major" seizures (12/20 vs. 4/20) whereas, in non-seizure free patients, BDT+VNS patients showed better seizure frequency reduction (>50% reduction: 12/19 vs. 7/16). BDT+VNS patients experienced equal drug related and additional VNS related side effects. No clinically relevant effect of VNS treatment was found on any psychological/psychosocial outcome measure. CONCLUSION: This retrospective study provided no positive evidence for therapeutic benefits of adding VNS to BDT. The follow-up health status of BDT+VNS patients was slightly worse than in patients receiving BDT alone. Despite minor group differences at baseline the two patient groups who had failed presurgical evaluation were comparable. Therapeutic improvements during long-term BDT alone are often underestimated resulting in a misattribution of positive changes to VNS in uncontrolled studies and reviews. Currently, there is no incontrovertible evidence for the clinical effectiveness of adding VNS to BDT.

Analysis of the initial ictal phenomenon in patients with temporal lobe epilepsy.

We aimed to assess the localizing value of the initial semiological element in temporal lobe epilepsy (TLE). Video-EEG-documented seizures of 97 adult TLE patients were studied in relation to seizure origin (left versus right; mesial versus extra-mesial). Strikingly, seizures with mesial onset started with very few ictal phenomena, while seizures of extra-mesial origin began with a larger variety of ictal elements. Furthermore, following noticeable distributions were observed for the mesial group: (i) aura was the most common initial ictal phenomenon in the total patient collective, occurring significantly more frequently in mesial than in extra-mesial seizure onset. Aura appeared most often in seizures of left mesial origin. (ii) Vocalization presented a trend towards mesial left seizure origin. (iii) Oral automatisms showed a trend towards mesial seizure origin. Following noticeable distribution was observed for the extra-mesial group: In patients without aura, restlessness as initial ictal phenomenon appeared exclusively in seizures of extra-mesial right origin. Finally, behavioral arrest showed a trend towards left-sided seizure origin. In conclusion, the initial ictal element may add useful information concerning differentiation of seizure onset in TLE.

The localizing value of hypersalivation and postictal coughing in temporal lobe epilepsy.

Analysis of ictal semiology is essential to presurgical evaluation of epilepsy patients providing information on seizure origin. To assess the significance of hypersalivation and postictal coughing for seizure origin in temporal lobe epilepsy (TLE), we analyzed video/EEG monitoring documented seizures of 107 adult patients for these seizure elements with respect to frequency and sequence of occurrence in relation to epileptogenic origin, comparing mesial versus extra-mesial and left versus right. Hypersalivation was rare, but occurred exclusively in seizures of mesial origin (9.4%). Comparison between left (11.4%) and right (6.9%) mesial origin was statistically insignificant. Postictal coughing also occurred exclusively in seizures of mesial onset (6.3%). Again, comparison between left (5.7%) and right (6.9%) mesial seizure onset was statistically insignificant. Thus, hypersalivation and postictal coughing are rare seizure phenomena in TLE, but their occurrence strongly support mesial seizure origin.

Lateralizing value of behavioral arrest in patients with temporal lobe epilepsy.

Analysis of ictal semiology is essential to presurgical evaluation of patients with epilepsy. To assess the localizing value of behavioral arrest in temporal lobe epilepsy (TLE), we analyzed 107 video/EEG monitoring-documented seizures of 107 adult patients with TLE for a set of defined seizure phenomena with respect to frequency and sequence of occurrence in relation to epileptogenic (mesial vs extramesial, left vs right) origin. Behavioral arrest was observed more frequently in left-sided temporal seizures: 25.7% of left-sided mesial seizures and 25.0% of left-sided extramesial seizures exhibited behavioral arrest, whereas only 3.4% of right-sided mesial seizures and 10.5% of right-sided extramesial seizures were associated with behavioral arrest. In addition, occurence of behavioral arrest within the sequence of seizure phenomena was remarkably consistent, being observed mainly as the first apparent feature of seizure onset. Thus, behavioral arrest is a valuable early indicator of a left-sided temporal epileptogenic focus in adult patients with TLE.

Bodyweight gain under pregabalin therapy in epilepsy: mitigation by counseling patients?

OBJECTIVE: To evaluate bodyweight gain during pregabalin therapy for epilepsy and the utility of a short counseling program to prevent this side effect. METHODS: Randomized controlled trial on the effects of extended versus standard patient counseling on the risk of bodyweight gain with 3- and 6-month follow-up including a consecutive sample of adult outpatients with epilepsy eligible for pregabalin add-on treatment (N=98). RESULTS: The seizure response rate was about 30%, the seizure freedom rate was 5% at the 6-month follow-up (intent-to-treat sample, N=98). The median bodyweight gain for the according-to-protocol sample (N=62) was 4.0 kg with no effect of extended counseling. Bodyweight gain was correlated with number of anticonvulsant drugs (r=.32, p<.05). CONCLUSIONS: Pregabalin treatment is associated with a high risk for bodyweight gain which in part depends on total anticonvulsant drug load. This side effect cannot be prevented by extended patient counseling within a standard clinical setting.