Authors :
Presenting Author: anilu Daza Restrepo, MD – Hospital El Cruce
Manuela Villanueva, MD – MD, Neurosciences, Epilepsy Unit, Hospital el Cruce; Gonzalez Silvia, Fellowship in Epilepsy – Fellowship in Epilepsy, Neurosciences, Epilepsy Unit, Hospital el Cruce; Ines Mintz, Fellowship in neuropsychology – Fellowship, Neurosciences, Epilepsy Unit, Hospital el Cruce; Silvia Oddo, MD – MD, Neurosciences, Epilepsy Unit, Hospital el Cruce; Julian Lamonarca, MD – Neurosciences, Epilepsy Unit – Hospital el Cruce; Brenda Giagante, MD – Neurosciences, Epilepsy Unit – Hospital el Cruce; Patricia Solis, MD – Neuropsychologist, Neurosciences, Epilepsy Unit, Hospital el Cruce; Florencia Andrieu, Fellowship in Epilepsy – Fellowship in Epilepsy, Epilepsy Unit, Hospital el Cruce; Roxana Matus, Fellowship in Epilepsy – Fellowship in Epilepsy, Epilepsy Unit, Hospital el Cruce; Julia Rivas, Fellowship – Fellowship, Neurosciences, Epilepsy Unit, Hospital el Cruce; Nuria Campora, MD – MD, Neurosciences, Epilepsy Unit, Hospital el Cruce; Alejandro Nasimbera, MD – Neurosciences, Epilepsy Unit – Hospital el Cruce; Juan Pablo Princich, MD – MD, Neurosciences, Epilepsy Unit, Hospital el Cruce; Silvia Kochen, MD – MD, Neurosciences, Epilepsy Unit, Hospital el Cruce
Rationale: This study aims to determine the effective dose, level of effectiveness, impact on the quality of life and mental health, and tolerability of purified cannabidiol as adjuvant treatment in drug-resistant focal epilepsy adults.
Methods:
An open observational prospective study was performed. We included 55 patients with focal drug-resistant epilepsy, with functional levels of writing and reading comprehension. All patients started cannabidiol treatment with a 100% CBD purified oil formula at 250 mg/day (mean: 4.1 mg/kg/day), titration progressively up to 20mg/kg/day according to clinical response and tolerability during 6 months.
The criterion used to assess efficacy was the monthly percentage change in the number of seizures. Tolerability was evaluated through the adverse effects registry. Tolerability was evaluated through the adverse effects registry. Beck Depression Inventory (BDI) and QOLIE 10 questionnaire were used for mental health and quality of life.
Results:
A total of 55 patients were included. Eleven patients did not complete the study, 9 dropped out and 2 patients were excluded due to protocol violation. The results analyzed are from the remaining 44 patients are: 87% of the patients (38) reduced 50% of their monthly seizures (5% (2) are seizure-free so far, and 32% (14) patients decreased more than 80% of their seizures), five patients (11%) presented a decrease of less than 50% of their usual seizure frequency, one patient presented an increase in his seizure frequency.
The average final dose was 335 mg/d (5 mg/kg/d), and 329 mg/d (4.7 mg/kg/d) in responding patients (≥50% seizure reduction). Fifteen patients (34%) did not report adverse events. The remaining 66% (29 patients) presented mild symptoms. Most of the patients presented only 1 type of adverse effect (41%), while the minority presented 2 (11%) and 3 types of adverse effects (14%). 60% of the patients who reported adverse effects were gastrointestinal, 16% drowsiness and 14% decreased appetite. Regarding depressive symptoms, 95.5% of patients with major depression diagnosed by BDI, responded favorably to CBD, and fifteen of them (71.5%) had minimal or no depression (score <=13). Similarly, it was found that 70.4% of the patients improved their quality of life through the QOLIE 10 questionnaire