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Cannabidiol in Patients with Intractable Epilepsy Due to TSC: A Possible Medication but Not a Miracle

Commentary Cannabis has been used for more than 100 years as a potential treatment for epileptic seizures. Cannabidiol (CBD) is one of the nonpsychoactive components of the cannabis plant. In recent years, the use of CBD has gained popularity in social media as a treatment for multiple diseases and symptoms, including intractable epilepsy, especially the early onset epileptic encephalopathies. However, the pharmacologic mechanisms are not yet fully understood (1). This has led to multiple studies to determine the safety and efficacy of CBD in children and adults with intractable epilepsy. Thus far, the clinical data are somewhat limited. The reports demonstrating the greatest efficacy were surveys of parents with children treated with CBD and were wrought with bias. Prospective studies overall have demonstrated >50% reduction in seizures in 32 to 84 percent of participants (1). An open-label trial of CBD in patients with treatment-resistant epilepsy showed a median reduction in monthly motor seizures of 36.5% (2). Cannabidiol has yet to gain FDA approval. In the open-label trial of CBD in children and adults with severe, intractable, childhood-onset epilepsy published earlier this year, 214 patients were enrolled: 162 continued in the study long enough to be included in the safety and tolerability analysis and 137 in the efficacy analysis. The most common epilepsy syndromes were Lennox-Gastaut syndrome and Dravet syndrome, although other epilepsies were also included. Overall, CBD was well-tolerated; although adverse events occurred in more than 79% of patients, only 3% discontinued treatment because of adverse events. The median reduction in motor seizures was 36.5%, and the median reduction in all seizures was 34.6%. For all seizure types, 37% of patients had a >50% reduction. In patients with Lennox-Gastaut syndrome, 37% had a >50% reduction in seizures, although there was no reduction in generalized tonic-clonic seizures. In patients with Dravet syndrome, 50% had a >50% reduction in seizures. Furthermore, efficacy was greater in patients taking concomitant clobazam or valproCannabidiol as a New Treatment for Drug-Resistant Epilepsy in Tuberous Sclerosis Complex.