Study register · detailKohortenstudie · Epilepsy · 2025
National Multicenter Cohort Study: Adjunctive Cannabidiol-Enriched Cannabis Oil for Pediatric Drug-Resistant Epilepsy Treatment in Thailand.
Lusawat et al.·Pediatric neurologyImpact 1.5
Clear benefitGRADELow4 citations
Samplen = 101 Pat.
DurationMedian follow-up duration of 15…
EndpointSeizure reduction rate
Blindingn.a.
DesignKohortenstudie
Cannabinoidcbd
Routeoral
”Key finding
CBD-enriched oil showed consistent improvements with ≥50% seizure reduction across most seizure types over 12 months, however with a high adverse event rate (92% of patients) and 33% discontinuation rate.
Summary
Prospective multicenter cohort study (n=101, 19 Thai hospitals) on CBD-enriched cannabis oil in pediatric drug-resistant epilepsy. Median age 10 years, median 75 seizures/month at baseline, failure of an average of 7 antiepileptic drugs. Median CBD dose 6 mg/kg/day, median follow-up 15 months. ≥50% seizure reduction consistently improved at 3, 6, 9, 12-month and last follow-up time points; median monthly overall seizure reduction consistently positive. Effective CBD dose 1-15 mg/kg/day. Adverse events in 92% of patients (predominantly mild 95%): somnolence, elevated liver enzymes, anorexia, irritability. 33 patients discontinued (57% due to intolerable adverse events, 30% ineffectiveness, 12% non-compliance).
P
PopulationPediatric patients with drug-resistant epilepsy of various etiologies, n=101, medication failure with an average of 7 antiepileptic drugs, seizure frequency median 75/month
I
InterventionCBD-enriched cannabis oil (medical grade) as adjunct therapy, median 6 mg/kg/day (range 1–15 mg/kg/day), oral
O
Outcome≥50% seizure reduction rate and median monthly overall seizure reduction showed consistent improvement over 3, 6, 9 and 12 months; adverse events in 92% of patients (95% mild); 33 patients discontinued treatment
Confidence in the evidence
Very lowLowModerateHigh
Low
The second of four GRADE levels, the effect estimate is of limited reliability.
Quality profile
Sample size★★★★★
Blinding—
Effect sizeClear benefit
Citations / year★★★★★
Authors
Lusawat A, Khongkhatithum C, Suwannachote S, Katanyuwong K, Fangsa-Ad T, Anurat K, Pattharathitikul S, Thongmak T, Thewamit R, Sudachan P
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.