CBD-enriched Medical Cannabis for Intractable Pediatric Epilepsy
Michal Tzadok1, Shimrit Uliel-Siboni2, Ilan Linder3, Uri Kramer2, Orna Epstein4, Shay Menascu2, Andrea Nissenkorn1, Omer Bar Yosef1, Eli Hyman4, Dorit Granot5, Michael Dor6, Tali Lerman-Sagie3, Bruria Ben-Zeev1
1Pediatric Neurology Units of Chaim Sheba Medical Center, Tel Hashomer; 2Pediatric Neurology Units of Tel Aviv Sourasky Medical Center, Tel Aviv; 3Pediatric Neurology Units of Wolfson Medical Center, Holon; 4Pediatric Neurology Units of Assaf Harofeh Medical Center, Zrifin; 5Pediatric Neurology Units of Panaxia Medical Devices and Pharmaceuticals, Tel Aviv, Israel; 6Pediatric Neurology Units of Medical Cannabis Unit, Ministry of Health, Tel Aviv, Israel.
About one-third of patients with epilepsy suffer from drug resistant disease (patients with treatment failure of more than 7 antiepileptic drugs). Therefore, there is great interest in the development of new medications which may have antiepileptic properties. The aim of this retrospective cohort study, conducted by the Pediatric Neurology Unit at Sheba Medical Center in Tel Hashomer, was to examine the effect of CBD-rich medical cannabis oil in children and adolescents diagnosed with treatment-resistant epilepsy.
STUDY POPULATION: 74 children with intractable epilepsy (between the ages of 1-18, half of them under the age of 10).
STUDY PRODUCT: About half of the patients in the study received the company’s products regularly (CBD-enriched, mostly avidekel 30%).
• 5 (6.7%) children discontinued treatment during 10 months of follow-up.
• Overall improvement – CBD treatment had a positive and significant effect on the frequency and intensity of seizures.
• Decrease in seizures – Most of the children (66/74, 89%) reported reduction in seizure frequency: 13 (18%) reported 75–100% reduction, 25 (34%) reported 50–75% reduction, 9 (12%) reported 25–50% reduction, and 19 (26%) reported <25% reduction. Five (7%) patients reported aggravation of seizures which led to CBD withdrawal.
• Improvement in various aspects – there improvement in behavior and alertness, language, communication, motor skills and sleep.
• Side effects included somnolence, fatigue, gastrointestinal disturbances and irritability leading to withdrawal of cannabis use in 5 patients.