In children with a complex motor disorder, cannabidiol (CBD)-enriched formulations comprised of CBD:d-9-tetrahydrocannabinol (THC) ratio of 20:1 and a CBD:THC ratio of 6:1 improves dystonia and other quality of life (QOL) indicators, according to a small pilot study published in the Journal of Child Neurology.
Children with a complex motor disorder, characterized by a combination of movement and posture abnormalities (eg, spasticity and dystonia), were enrolled (n=25). In this patient population, the investigators compared the efficacy of 2 CBD-enriched 5% oil formulations for improving dystonia and spasticity, sleep, mood, constipation, and appetite. Participants received either a CBD:THC formulation of a 20:1 or 6:1 ratio, representing a minimal amount and higher amount of THC, respectively. The findings are reported from the intention-to-treat analysis.
In the 6:1 group, the maximal doses of CBD and THC were 90 mg/d and 14.85 mg/d, respectively, whereas maximal respective doses of CBD and THC were 210 mg/d and 10.50 mg/d in the 20:1 group.
Improvements on the Cerebral Palsy Child questionnaire for QOL were seen in both groups by the end of the 5-month study. In the 20:1 group, both dystonia and QOL improved with an average THC dosage of 3.67+3.61 mg/day, 0.28+0.24 mg/kg/day and mean cannabidiol dosage of 91.75+69.11 mg/day, 5.53+4.85 mg/kg/day. Improvements in QOL in the 6:1 group occurred under an average THC dosage of 6.27+7.20 mg/day, 0.61+0.69 mg/kg/day, and cannabidiol dosages of 38+43.67 mg/day and 3.73+4.18 mg/kg/day.
Improvements in mood (P <.018), constipation (P <.021), sleep (P <.002), and appetite (P <.027) also improved at 5 months in both groups, based on findings on a numeric rating scale. Somnolence was reported in 1 patient in the 6:1 group at a CBD and THC dose of 18 mg/d (1.8 mg/kg/d) and 2.97 mg/d (0.3 mg/kg/d), respectively. Alertness was improved following dose reduction, with the lower dose resulting in successful maintenance of the patient.
Slow titration time as well as the relatively small sample size represent the primary limitations of the analysis.
Further research studies with “concurrent, non-cannabis-treated controls are needed to more comprehensively assess the efficacy of medical cannabis in children with complex motor disorder,” the researchers concluded.
Libzon S, Schleider LB, Saban N, et al. Medical cannabis for pediatric moderate to severe complex motor disorders [published online January 1, 2018]. J Child Neurol. doi:10.1177/0883073818773028