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National Multicenter Cohort Study: Adjunctive Cannabidiol-Enriched Cannabis Oil for Pediatric Drug-Resistant Epilepsy
Apasri Lusawat1, Chaiyos Khongkhatithum2, Sirorat Suwannachote3
1Pediatric Neurology Department, Neurological Institute of Thailand, Ministry of Public Health, Bangkok, Thailand.
Insights
Medical-grade cannabidiol (CBD)-enriched oil effectively reduced seizures in Thai children with drug-resistant epilepsy. The treatment was generally well-tolerated over 12 months, showing consistent improvements in seizure frequency.
Area of Science:
- Neurology
- Pharmacology
- Pediatrics
Background:
- Drug-resistant epilepsy (DRE) in children poses significant challenges.
- Cannabidiol (CBD)-enriched oil is an emerging adjunctive therapy for DRE.
- This study is the first multicenter investigation of medical-grade CBD in Thai pediatric DRE.
Purpose of the Study:
- To assess the effectiveness and tolerability of medical-grade CBD-enriched oil as adjunctive treatment.
- To evaluate outcomes in pediatric patients with drug-resistant epilepsy in Thailand.
- To determine the long-term efficacy and safety profile of CBD treatment.
Main Methods:
- Prospective observational multicenter cohort study across 19 Thai hospitals (2021-2023).
- Inclusion of pediatric patients with drug-resistant epilepsy and various etiologies.
- Minimum three-month follow-up, including early discontinuations.
Main Results:
- 101 pediatric patients with DRE, median age 10 years, high baseline seizure frequency (75/month), and prior treatment failure (avg. 7 antiseizure medications).
- Median follow-up of 15 months with CBD doses ranging from 1-15 mg/kg/day; significant seizure reduction rates (≥50%) observed consistently up to 12 months.
- High incidence of adverse events (92%), mostly mild (95%), including somnolence and elevated liver enzymes; 33 patients discontinued CBD due to adverse events, ineffectiveness, or noncompliance.
Conclusions:
- Medical-grade CBD-enriched oil demonstrates effectiveness and tolerability for at least 12 months in pediatric drug-resistant epilepsy in Thailand.
- Consistent seizure reduction and manageable adverse events support CBD as a viable adjunctive therapy.
- Further research may explore optimal dosing and management of specific seizure types and adverse events.
Background:
Several studies have reported the effectiveness and tolerability of cannabidiol (CBD)-enriched oil adjunctive treatment in children with drug-resistant epilepsy. This is the first multicenter cohort study of medical-grade CBD-enriched drugs in pediatric drug-resistant epilepsy in Thailand.
Methods:
A prospective observational study was conducted across 19 Thai government hospitals between 2021 and 2023. The study aimed to assess CBD-enriched adjunctive treatment in pediatric drug-resistant epileptic patients with various etiologies ensuring a follow-up period of at least three months including cases wherein the medication was discontinued before three months.
Results:
Of 101 patients, 42% were male with a median age of 10 years, experiencing a seizure frequency of 75 per month, and having failed treatment with an average of seven types of antiseizure medications. The median follow-up duration was 15 months with a median modal CBD dose of 6 mg/kg/day. The ≥50% seizure reduction rate and the median monthly total seizure reduction showed consistent improvement with reductions at three-, six-, nine-, and 12-month and the latest follow-up visits. Most seizure types responded positively to treatment, except for complex motor seizures. The effective CBD dose varied within a range of 1-15 mg/kg/day. Adverse events were reported in 92% of patients, predominantly mild (95%) and including somnolence, increased liver enzymes, anorexia, and irritability. Thirty-three patients discontinued CBD, with 57% due to intolerable adverse events, 30% ineffectiveness, and 12% noncompliance.
Conclusions:
The Thai medical-grade CBD-enriched oil is effective and tolerable for at least 12 months of adjunctive treatment in pediatric drug-resistant epilepsy in Thailand.
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