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• W2312938963 abstract "1 DiPALS Writing Committee; DiPALS Study Group Collaborators; McDermott CJ, Bradburn MJ, Maguire C, et al. Safety and effi cacy of diaphragm pacing in patients with respiratory insuffi ciency due to amyotrophic lateral sclerosis (DiPALS): a multicentre, open-label, randomised controlled trial. Lancet Neurol 2015; 14: 883–92. 2 Assistance Publique–Hopitaux de Paris. Sclerose laterale amyotrophique (SLA)– maladie de Charcot: l’Assistance Publique– Hopitaux de Paris decide de mettre un terme a l’etude clinique RespiStim. http://www. aphp.fr/contenu/sclerose-lateraleamyotrophique-sla-maladie-de-charcotlassistance-publique-hopitaux-de (accessed March 1, 2016). An overall seizure reduction of almost 50% compared with baseline is reported in this study. The analysis suggests that about a third of participants had an increased seizure frequency during the treatment period, and another third had less than 50% seizure reduction. Patients often start or switch antiepileptic drugs at times of an exacerbation of seizure frequency. Figure 3 seems to show a regression to the mean that can partly be attributed to the natural course of the condition, and which is inadequately controlled for by the short baseline period of this study. A baseline period of 4 weeks seems too short, especially as the lowest seizure frequency was 11 motor seizures per month. A natural variation in seizure frequency of one or two seizures per month could explain a 10–20% change either way. Adverse events are reported in 78% and serious adverse events in 30% of the participants in the 12 week treatment period. The authors conclude that “cannabidiol has an adequate safety profi le”. Compared with other antiepileptic drugs in refractory epilepsy, the number of serious adverse events reported seems high. This high frequency might be explained by epilepsy severity in this population, but such an interpretation cannot be assessed with the design of this study. What this study does show is that, contrary to what many hope, cannabidiol is probably not the magic bullet for severe childhood epilepsy. Properly randomised controlled trials are urgently needed to assess the safety profi le and effi cacy of cannabidiol are similar to those of other antiepileptic drugs, or worse." @default.
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• W2312938963 date "2016-05-01" @default.
• W2312938963 modified "2023-10-17" @default.
• W2312938963 title "Cannabidiol in patients with treatment-resistant epilepsy" @default.
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• W2312938963 doi "https://doi.org/10.1016/s1474-4422(16)00118-6" @default.
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