CBD-rich cannabis oil showed no significant blood chemistry changes in 59 children with autism | Research

The takeaway

In an interim analysis of 59 children with autism taking CBD-rich cannabis oil (20:1 CBD:THC) for 3 months, no clinically significant changes were found in any blood chemistry measure.

Parents considering cannabis treatments for children with autism, pediatricians, and researchers conducting cannabis safety studies.

No clinically significant changes in any blood measure at 3 months

What the researchers found

No clinically significant differences were found in complete blood count, glucose, liver enzymes, kidney function, electrolytes, thyroid function, lipid profile, or hormones between baseline and 3 months of CBD-rich treatment. All statistically significant changes remained within normal ranges.

Why it matters

Safety data for cannabis products in children is limited. This study provides reassuring biochemical safety data for CBD-rich cannabis oil in a pediatric autism population over 3 months.

The numbers in context

59 participants (85% male). Mean daily dose 7.88 mg/kg. Follow-up 18 weeks. No clinically significant changes in any of dozens of blood analytes. Liver enzymes stable even in patients on concurrent medications (n=14). LDH decreased slightly. Small thyroid hormone changes remained within normal range.

How the study worked

Interim analysis from an ongoing single-arm, open-label, phase III study. 59 children and young adults (ages 5-25, 85% male) received Nitzan Spectrum Oil (CBD:THC 20:1 in MCT oil) for 6 months. Blood analysis performed at baseline and 3 months.

What this study cannot tell us

Open-label, single-arm design with no placebo comparison. Only 3 months of data. Small sample size. No long-term safety data. Only biochemical safety was assessed, not efficacy or behavioral outcomes.

How to read the evidence

Moderate: phase III interim data from 59 participants, but open-label single-arm design without placebo comparison.

When this study was published

Published in 2022.

The bigger picture

As families and clinicians increasingly consider cannabis-based treatments for autism, having pediatric safety data is essential. This interim analysis suggests CBD-rich oil has a favorable short-term biochemical safety profile in children.

Questions still open

Will the safety profile hold at 6 months and beyond? Would higher doses produce different results? Are there non-biochemical safety concerns (behavioral, developmental) not captured by blood tests?

Common questions

Were liver enzymes affected?

No. Liver enzymes (AST, ALT, GGT) remained stable, even in 14 patients who were also taking other medications. This is notable because liver enzyme elevation is a known concern with CBD use.

What dose were children receiving?

The mean total daily dose was 7.88 mg/kg body weight of CBD-rich cannabis oil with a CBD:THC ratio of 20:1.

Does this prove CBD is safe for children?

It provides encouraging short-term biochemical safety data, but the open-label design, lack of placebo, and 3-month timeframe mean longer and more rigorous studies are still needed.

Read the original research

Medical cannabis for the treatment of comorbid symptoms in children with autism spectrum disorder: An interim analysis of biochemical safety.

Frontiers in pharmacology, 13, 977484

View on PubMed ↗Publisher’s paper ↗

Citation

Stolar, Orit; Hazan, Ariela; Vissoker, Roni Enten; Kishk, Ibrahim Abu; Barchel, Dana; Lezinger, Mirit; Dagan, Adi; Treves, Nir; Meiri, David; Berkovitch, Matitiahu; Kohn, Elkana; Heyman, Eli. (2022). Medical cannabis for the treatment of comorbid symptoms in children with autism spectrum disorder: An interim analysis of biochemical safety.. Frontiers in pharmacology, 13, 977484. https://doi.org/10.3389/fphar.2022.977484