CBD-enriched Medical Cannabis Product for Pediatric Drug Resistant Epilepsy Treatment in Thailand : Experiences from 2 Centers in Department of Medical Services, Ministry of Public Health
Keywords:CBD enriched, Pediatric drug resistant epilepsy
Background: Since 2019, Thailand has legalized medical cannabis use in special access scheme.
Objective: To study the efficacy and safety of CBD-enriched medical cannabis product (MCP) for pediatric drug resistant epilepsy patients (PDREs) in Thailand.
Methods: Retrospective descriptive study was conducted at Neurological Institute of Thailand and Queen Sirikit National Institute of Child Health in PDREs treated with CBD enriched MCP, CBD: THC ≥ 20:1.
Results: Of 14 PDREs, 7 were male. Median age was 9 years (range 3-27). Median seizure frequency was 300 times per month. Median number of concomitant antiepileptic drugs was 4 (range2-6). Median CBD and THC dosage was 5.6 and 0.12 mg/kg/day (mkd). Five patients (35%) withdrew MCP, mostly due to seizure aggravation (28%) during the first 3 months. Median treatment duration of the remaining 9 patients was 18 months. The 50% responder rate in convulsive and total seizures was 50% and 43%. The % median monthly seizure reduction in convulsive and total seizures after 12 month-treatment was 57.5% and 67%. Adverse drug events (ADEs) were found in all patients but in 47% of 138 visits. The most common ADEs were somnolence (64%), seizure aggravation (43%), irritable (42%), and decreased appetite (28%). Serious ADEs were seizure aggravations leading to MCP withdrawal (28%), admissions due to seizure and drowsiness (14%), hepatitis (7%). The higher dose CBD starting group tended to have more seizure aggravation and drop out during titration (p= 0.086) but at 12th month the higher dose group had more seizure reduction rate than lower dose group with statistical significance (p=0.027)
Conclusion: CBD-enriched MCP had potential efficacy and could be continuously used more than 12 months in Thai PDREs. ADEs were very common but mostly tolerated. Low dose initiation, slowly titration and closely monitoring for serious ADEs during the first 3 months are suggested.
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