Objective: The aim of this study was to evaluate the efficacy, safety and tolerability of medical cannabis for the treatment of refractory epilepsy in children and adolescents.
Methods: We conducted a prospective open-label follow-up analysis on pediatric patients with severe, intractable, treatment -resistant epilepsy treated with cannabis oil extract with a CBD/THC ratio of 20:1. Patients who had been followed-up for less than three months were excluded. Efficacy analysis was by modified intention to treat. Response to treatment was evaluated according to parental reports on clinic visits.
Results: Fifty-seven patients (age 1-20 years) with epilepsy of various types and etiologies, were recruited in a single pediatric epilepsy outpatient clinic. Twenty three percent had normal intelligence. All patients failed at least 3 anti-epileptic drugs (AEDs) prior to cannabis treatment. The follow-up period ranged from 3-33 months (average 15.6 months). Improvement in seizure control was reported in 40 (70%) of patients. 12 (21%) had 50-74% seizure reduction, 14 (24.5%) had 75-99% seizure reduction and two (3.5%) were seizure-free. Adverse events were reported in 35 (61%) patients, of whom 17 discontinue treatment. Response rate did not differ between different epilepsy etiologies, patients with or without ID, and cannabis strain used. There was a correlation between age at treatment onset and CBD dose.
Conclusions: Our findings suggest that the use of high CBD oil extract in patients with refractory epilepsy may result in a significant reduction of seizure frequency and therefore should be considered as an additional treatment option.
