Real-Life Experience With Purified Cannabidiol Treatment for Refractory Epilepsy: A Multicenter Retrospective Study
Michal Tzadok 1, Rotem Gur-Pollack 2, Hadar Florh 3, Yael Michaeli 4, Tal Gilboa 5, Mirit Lezinger 3, Eli Heyman 3, Veronika Chernuha 6, Irina Gudis 4, Andreea Nissenkorn 4, Tally Lerman-Sagie 4, Bruria Ben Zeev 7, Shimrit Uliel-Sibony 6
- 1Pediatric Neurology Unit, Edmond and Lily Safra Children’s Hospital, Sheba Medical Center, Ramat Gan, Israel; Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: Michal.Tzadok@sheba.health.gov.il.
- 2Neopharm Israel, Medical Unit, Petah Tikva, Israel.
- 3Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Pediatric Neurology and Development Center, Shamir Medical Center (Assaf Harofeh), Be’er Ya’akov, Israel.
- 4Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Pediatric Neurology Unit, Wolfson Medical Center, Holon, Israel.
- 5Faculty of Medicine, The Hebrew University of Jerusalem, Jerusalem, Israel; Pediatric Neurology Unit, Hadassah University Hospital, Jerusalem, Israel.
- 6Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Pediatric Neurology Institute, Dana-Dwek Children’s Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
- 7Pediatric Neurology Unit, Edmond and Lily Safra Children’s Hospital, Sheba Medical Center, Ramat Gan, Israel; Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Affiliationer
Background: Drug-resistant epilepsy (DRE) affects the development and quality of life of children and young adults. We analyzed the effectiveness and safety of purified CBD in this population.
Methods: A retrospective analysis of medical records of 139 children and young adults (54.7% female, median age 12.0 years) with DRE treated with purified CBD from 2018 to 2022 at five medical centers in Israel.
Results: The most common diagnosis was Lennox-Gastaut syndrome (37.4%) followed by Dravet syndrome (16.5%) and tuberous sclerosis complex (16.5%). Median purified CBD dose was 12.5 mg/kg (range 2.5 to 20.0), and median treatment duration was 9.0 months (range 0.5 to 48.0). Most patients (92.2%) had a reduced seizure frequency following treatment initiation; 41.1% had >50% reduction. Fifty-three patients (38.1%) had positive effects: improved alertness (31.7%), improved speech (10.1%), and achievement of new developmental milestones (2.2%). A multivariate linear model assessing predictive factors for seizure reduction demonstrated that patients previously treated with CBD oils, especially those with >50% seizure reduction on prior treatment, were also more likely to have a reduced seizure frequency while they were treated with purified CBD (P = 0.01, P < 0.0001). Development, diagnosis, age, purified CBD dose (0 to 10 mg/kg/day vs 10 to 20 mg/kg/day), and concomitant treatment with clobazam, valproic acid, or everolimus did not affect seizure reduction by purified CBD. The most common adverse events were irritability (20.9%) and drowsiness (12.9%). Conclusion: Purified CBD is well-tolerated and effective in reducing seizure frequency in children and young adults with DRE.
Keywords: Children; Drug-resistant epilepsy; Purified cannabidiol; Seizure reduction; Young adults.
