Michal Tzadok1, Shimrit Uliel-Siboni2, Ilan Linder3, Uri Kramer2, Orna Epstein4, Shay Menascu2, Andrea Nissenkorn5, Omer Bar Yosef5, Eli Hyman4, Dorit Granot6, Michael Dor7, Tali Lerman-Sagie3, Bruria Ben-Zeev5. 1. Pediatric Neurology Units of Chaim Sheba Medical Center, Tel Hashomer. Electronic address: Michal.tzadok@gmail.com. 2. Pediatric Neurology Units of Tel Aviv Sourasky Medical Center, Tel Aviv. 3. Pediatric Neurology Units of Wolfson Medical Center, Holon. 4. Pediatric Neurology Units of Assaf Harofeh Medical Center, Zrifin. 5. Pediatric Neurology Units of Chaim Sheba Medical Center, Tel Hashomer. 6. Pediatric Neurology Units of Panaxia Medical Devices and Pharmaceuticals, Tel Aviv, Israel. 7. Pediatric Neurology Units of Medical Cannabis Unit, Ministry of Health, Tel Aviv, Israel.
Abstract
PURPOSE: To describe the experience of five Israeli pediatric epilepsy clinics treating children and adolescents diagnosed as having intractable epilepsy with a regimen of medical cannabis oil. METHODS: A retrospective study describing the effect of cannabidiol (CBD)-enriched medical cannabis on children with epilepsy. The cohort included 74 patients (age range 1-18 years) with intractable epilepsy resistant to >7 antiepileptic drugs. Forty-nine (66%) also failed a ketogenic diet, vagal nerve stimulator implantation, or both. They all started medical cannabis oil treatment between 2-11/2014 and were treated for at least 3 months (average 6 months). The selected formula contained CBD and tetrahydrocannabinol at a ratio of 20:1 dissolved in olive oil. The CBD dose ranged from 1 to 20mg/kg/d. Seizure frequency was assessed by parental report during clinical visits. RESULTS: CBD treatment yielded a significant positive effect on seizure load. 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. In addition, we observed improvement in behavior and alertness, language, communication, motor skills and sleep. Adverse reactions included somnolence, fatigue, gastrointestinal disturbances and irritability leading to withdrawal of cannabis use in 5 patients. CONCLUSIONS: The results of this multicenter study on CBD treatment for intractable epilepsy in a population of children and adolescents are highly promising. Further prospective, well-designed clinical trials using enriched CBD medical cannabis are warranted.
PURPOSE: To describe the experience of five Israeli pediatric epilepsy clinics treating children and adolescents diagnosed as having intractable epilepsy with a regimen of medical cannabis oil. METHODS: A retrospective study describing the effect of cannabidiol (CBD)-enriched medical cannabis on children with epilepsy. The cohort included 74 patients (age range 1-18 years) with intractable epilepsy resistant to >7 antiepileptic drugs. Forty-nine (66%) also failed a ketogenic diet, vagal nerve stimulator implantation, or both. They all started medical cannabis oil treatment between 2-11/2014 and were treated for at least 3 months (average 6 months). The selected formula contained CBD and tetrahydrocannabinol at a ratio of 20:1 dissolved in olive oil. The CBD dose ranged from 1 to 20mg/kg/d. Seizure frequency was assessed by parental report during clinical visits. RESULTS:CBD treatment yielded a significant positive effect on seizure load. 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. In addition, we observed improvement in behavior and alertness, language, communication, motor skills and sleep. Adverse reactions included somnolence, fatigue, gastrointestinal disturbances and irritability leading to withdrawal of cannabis use in 5 patients. CONCLUSIONS: The results of this multicenter study on CBD treatment for intractable epilepsy in a population of children and adolescents are highly promising. Further prospective, well-designed clinical trials using enriched CBD medical cannabis are warranted.
Authors: Shanna Babalonis; Margaret Haney; Robert J Malcolm; Michelle R Lofwall; Victoria R Votaw; Steven Sparenborg; Sharon L Walsh Journal: Drug Alcohol Depend Date: 2016-12-14 Impact factor: 4.492
Authors: Richard James Huntsman; Richard Tang-Wai; Bryan Acton; Jane Alcorn; Andrew William Lyon; Darrell David Mousseau; Blair Seifert; Robert Laprairie; Erin Prosser-Loose; Lumir Ondrej Hanuš Journal: Paediatr Child Health Date: 2018-04-05 Impact factor: 2.253