title: CBD-enriched medical cannabis for intractable pediatric epilepsy: The current Israeli experience.
abstract: OBJECTIVE
  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.affiliation: Pediatric Neurology Units of Chaim Sheba Medical Center, Tel Hashomer. Electronic address: Michal.tzadok@gmail.com.
authors.forename: Michal
authors.initials: M
authors.lastname: Tzadok
authors.affiliation: Pediatric Neurology Units of Tel Aviv Sourasky Medical Center, Tel Aviv.
authors.forename: Shimrit
authors.initials: S
authors.lastname: Uliel-Siboni
authors.affiliation: Pediatric Neurology Units of Wolfson Medical Center, Holon.
authors.forename: Ilan
authors.initials: I
authors.lastname: Linder
authors.affiliation: Pediatric Neurology Units of Tel Aviv Sourasky Medical Center, Tel Aviv.
authors.forename: Uri
authors.initials: U
authors.lastname: Kramer
authors.affiliation: Pediatric Neurology Units of Assaf Harofeh Medical Center, Zrifin.
authors.forename: Orna
authors.initials: O
authors.lastname: Epstein
authors.affiliation: Pediatric Neurology Units of Tel Aviv Sourasky Medical Center, Tel Aviv.
authors.forename: Shay
authors.initials: S
authors.lastname: Menascu
authors.affiliation: Pediatric Neurology Units of Chaim Sheba Medical Center, Tel Hashomer.
authors.forename: Andrea
authors.initials: A
authors.lastname: Nissenkorn
authors.affiliation: Pediatric Neurology Units of Chaim Sheba Medical Center, Tel Hashomer.
authors.forename: Omer Bar
authors.initials: OB
authors.lastname: Yosef
authors.affiliation: Pediatric Neurology Units of Assaf Harofeh Medical Center, Zrifin.
authors.forename: Eli
authors.initials: E
authors.lastname: Hyman
authors.affiliation: Pediatric Neurology Units of Panaxia Medical Devices and Pharmaceuticals, Tel Aviv, Israel.
authors.forename: Dorit
authors.initials: D
authors.lastname: Granot
authors.affiliation: Pediatric Neurology Units of Medical Cannabis Unit, Ministry of Health, Tel Aviv, Israel.
authors.forename: Michael
authors.initials: M
authors.lastname: Dor
authors.affiliation: Pediatric Neurology Units of Wolfson Medical Center, Holon.
authors.forename: Tali
authors.initials: T
authors.lastname: Lerman-Sagie
authors.affiliation: Pediatric Neurology Units of Chaim Sheba Medical Center, Tel Hashomer.
authors.forename: Bruria
authors.initials: B
authors.lastname: Ben-Zeev
mesh_terms: D000293:Adolescent; D000927:Anticonvulsants / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D000069279:Drug Resistant Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007223:Infant; D007557:Israel; D008297:Male; D064086:Medical Marijuana / Q000627:therapeutic use*; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D064086:Medical Marijuana
keywords: CBD-enriched medical cannabis; Intractable epilepsy