Medical Cannabis for the Treatment of Comorbid Symptoms in Children with Autistic Spectrum Disorder: An Interim Analysis of Biochemical Safety
2Autism center/ALUT, Shamir (Assaf Harofeh) Medical Center Affiliated to Sackler School of Medicine, Tel-Aviv University, ישראל
3Pediatric Neurology Department, Shamir (Assaf Harofeh) Medical Center Affiliated to Sackler School of Medicine, Tel-Aviv University, ישראל
4Division of Clinical Pharmacy, Institute for Drug Research, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, ישראל
Background: Autistic Spectrum Disorder (ASD) is a common neurodevelopmental disorder and no effective treatment for the core symptoms is currently available. The present study is part of a larger clinical trial assessing the effects of cannabis oil on autism co-morbidities.
Objectives: The aim of the present study was to assess the safety of a CBD-rich oil treatment in children and adolescents with ASD.
Methods: Data from 59 children and young adults (ages 5-25 years) from a single-arm, ongoing, prospective, open-label, one center, phase III study was analyzed. Participants received medical cannabis extract oil with a CBD:THC ratio of 20:1 for six months. Blood analysis was performed before treatment initiation, and after 3 months. Complete blood count, glucose, urea, creatinine, electrolytes, liver enzymes (AST, ALT, GGT), bilirubin, lipid profile, TSH, FT4, thyroid antibodies, prolactin, and testosterone measurements were performed at baseline, prior to starting treatment and at study midpoint, after three months of treatment.
Results: 59 children (85% male and 15% female) were followed for 18± 8 weeks (mean ±SD). The mean total daily dose was 7.88±4.24 mg/kg body weight. No clinical or statistically significant differences were found in any of the analytes between baseline and 3 month follow up. A comparison of patients who received additional medications (n=14), to those who solely received medical cannabis (n=45) showed no differences in biochemical tests.
Conclusions: CBD-rich cannabis oil (CBD: THC 20:1), appears to have a good safety profile. Long-term monitoring with a larger number of participants is warranted.