INTRODUCTION: The aim of this research was to evaluate changes in cognitive performances, mood and quality of life in drug-resistant epileptic patients, after the introduction of Vigabatrin (VGB) as additional treatment. MATERIAL AND METHODS: A four-step evaluation was carried out in two groups of 20 patients each, randomly assigned to VGB or placebo treatment. A battery of neuropsychological tests investigating attention, memory and adaptive abilities, associated with inventories concerning depression, quality of life and the concern of families upon patient behaviour, were utilised. For each subject, four evaluations were performed, two before and two after VGB/placebo administration. RESULTS: No relevant side-effects regarding cognition and behavior were detected in the VGB group. The intra-group comparison between pre- and post-treatment phases showed a slight improvement in cognitive performances of VGB patients and a positive change in their overall psychological status. The inter-group comparison confirmed the selective improvement occurring in the trend of a few neuropsychological test scores in the VGB group. CONCLUSION: Such results help to reject the hypothesis that the addition of VGB to the current antiepileptic treatment may affect cognitive performances and behaviour.
RCT Entities:
INTRODUCTION: The aim of this research was to evaluate changes in cognitive performances, mood and quality of life in drug-resistant epilepticpatients, after the introduction of Vigabatrin (VGB) as additional treatment. MATERIAL AND METHODS: A four-step evaluation was carried out in two groups of 20 patients each, randomly assigned to VGB or placebo treatment. A battery of neuropsychological tests investigating attention, memory and adaptive abilities, associated with inventories concerning depression, quality of life and the concern of families upon patient behaviour, were utilised. For each subject, four evaluations were performed, two before and two after VGB/placebo administration. RESULTS: No relevant side-effects regarding cognition and behavior were detected in the VGB group. The intra-group comparison between pre- and post-treatment phases showed a slight improvement in cognitive performances of VGB patients and a positive change in their overall psychological status. The inter-group comparison confirmed the selective improvement occurring in the trend of a few neuropsychological test scores in the VGB group. CONCLUSION: Such results help to reject the hypothesis that the addition of VGB to the current antiepileptic treatment may affect cognitive performances and behaviour.