Background Use of medical cannabis in pediatrics is increasing. A number of trials have investigated the efficacy and safety of medical cannabis for the treatment of co-morbid symptoms in children with ASD (Autistic Spectrum Disorder). Many of these children are treated with conventional medications.

Objective To compare the efficacy of cannabis monotherapy vs cannabis with concomitant conventional medications in children with ASD.

Methods Children with ASD were treated with cannabis oil at Shamir Medical Center. They underwent evaluation with trained speech therapist (ADOS) and psychologist (WPPSI). Parents and teachers filled questionnaires (Vineland, Conners, sleep, eating) at baseline and after 6 months of treatment.

During biweekly telephone follow-up, dosage was adjusted as per parents’ report, which included physical and behavior parameters- appetite, anxiety, aggression, sleep and compulsive behavior.

Laboratory values, efficacy and dosage of medical cannabis were compared between both groups of children.

Results Out of 81 patients, 30 received concomitant medications. Cannabis dose did not differ significantly between both groups. There were no significant differences in the laboratory values for both groups. Parents of children with cannabis monotherapy reported a significant improvement in aggressive behavior (p=0.027), anxiety (p=0.023) and coping with changes (p=0.036). In the group of patients with concomitant treatment, there was a significant improvement in sleep quality (p=0.029).

Conclusions Medical cannabis is probably effective in reducing co-morbid symptoms in children with ASD. However, whether treatment with cannabis as monotherapy is superior to treatment with conventional drugs for co-morbidities warrants further investigation.