National Multicenter Cohort Study: Adjunctive Cannabidiol-Enriched Cannabis Oil for Pediatric Drug-Resistant Epilepsy Treatment in Thailand
Apasri Lusawat MD a , Chaiyos Khongkhatithum MD b , Sirorat Suwannachote MD c , Kamornwan Katanyuwong MD d , Thitiporn Fangsa-ad MD e , Kingthong Anurat MD f , Siriporn Pattharathitikul MD g , Tipaporn Thongmak MD h , Rapeepat Thewamit MD b , Panisra Sudachan MD a , Apimid Rojanawatsirivej MD a , Lunliya Thampratankul MD b , Chanikhan Sattaporn MD a , Puangtong Bunyatumma MD i , Narong Auvichayapat MD j , Salin Laohasaran MD k , Krittawit Anuroj MD l , Sineenart Kontun MD m , Krit Cheawcharnprapan MD n , Sudathip Paticheep MD o , Watuhatai Paibool MD j , Pat Thirapote MD p , Chinnuwat Sanguansermsri MD d , Piradee Suwanpakdee MD q , Ornpreeya Woravimolvanich MD r , Piangor Watcharakuldilok MD s , Anannit Visudtibhan MD b on behalf of Thai Pediatric CBD-Epilepsy Study
- a
- Pediatric Neurology Department, Neurological Institute of Thailand, Ministry of Public Health, Bangkok, Thailand
- b
- Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
- c
- Division of Neurology, Department of Pediatrics, Queen Sirikit National Institute of Child Health, Ministry of Public Health, Bangkok, Thailand
- d
- Neurologic Division, Paediatrics Department, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
- e
- Division of Pediatric Neurology, Department of Pediatrics, Bhumibol Adulyadej Hospital, Bangkok, Thailand
- f
- Chakri Naruebodindra Medical Institute, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Samut Prakan, Thailand
- g
- Department of Pediatrics, Prapokklao Hospital, Ministry of Public Health, Chanthaburi, Thailand
- h
- Department of Pediatrics, Hat Yai Hospital, Ministry of Public Health, Songkhla, Thailand
- i
- Department of Pediatrics, Lerdsin Hospital, Ministry of Public Health, Bangkok, Thailand
- j
- Division of Neurology, Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
- k
- Department of Pediatrics, Surat Thani Hospital, Ministry of Public Health, Surat Thani, Thailand
- l
- Department of Pediatrics, Sunpasitthiprasong Hospital, Ministry of Public Health, Ubon Ratchathani, Thailand
- m
- Department of Pediatrics, Buddhachinaraj Phitsanulok Hospital, Ministry of Public Health, Phitsanulok, Thailand
- n
- Division of Neurology, Department of Pediatrics, Faculty of Medicine, Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand
- o
- Division of Neurology, Department of Pediatrics, Faculty of Medicine, Thammasat University, Pathum Thani, Thailand
- p
- Department of Pediatrics, Vachira Phuket Hospital, Ministry of Public Health, Phuket, Thailand
- q
- Division of Pediatric Neurology, Department of Pediatrics, Phramongkutklao College of Medicine, Bangkok, Thailand
- r
- Department of Pediatrics, King Taksin Memorial Hospital, Bangkok Metropolitan Administration, Bangkok, Thailand
- s
- Department of Pediatrics, Buri Ram Hospital, Ministry of Public Health, Buri Ram, Thailand
Affiliationer
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.
