Purified cannabidiol leads to improvement of severe treatment-resistant behavioral symptoms in children with autism spectrum disorder

Abstract

Objective

The aim of our study was to evaluate the efficacy and safety of purified cannabidiol as an add-on medication in pediatric patients with autism spectrum disorder (ASD) associated with treatment resistant repetitive behaviors, behavior disorders, and intellectual disability and unresponsive to conventional medications and behavioral interventions.

Material and methods

A prospective, observational, before-and-after study was conducted including 20 patients with severe ASD who initiated treatment with purified CBD. Patients were evaluated using different scales at baseline and at three-month intervals during followup.

Results

The median total CBD dose was 363.5 mg (range, 100–700), and the median follow-up was 11 months (range, 6–12). As to the primary outcome evaluating symptoms reported by parents, improvement in at least one was observed after CBD initiation in 18 patients (90 %) and no improvement in two (10 %) (1 worsening, 1 no response). In the responders, 83.5 % (n = 76) of all reported symptoms improved. Regarding the secondary outcomes based on the assessment with different scales, improvement of around 30 % was found in irritability, social withdrawal, hyperactivity. Restricted and repetitive behavior improved in nine (50 %), while no changes were seen in seven (38.8 %). Sleep patterns were found to be slightly improved. Adverse effects were reported in 13 patients (65 %), mainly consisting of increased irritability and decreased appetite, but were mild or moderate and transient in all. In 40 % of the children, concomitant medication could be reduced or partially discontinued.

Conclusion

Our results suggest that treatment with purified CBD is effective and safe and could benefit patients with severe ASD by improving some of the core symptoms, including repetitive behaviors and social interaction, as well as associated comorbidities. The families considered the quality of life to have improved.