CBD-rich cannabis oil showed no significant blood chemistry changes in 59 children with autism
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.
Quick Facts
What This Study 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.
Key Numbers
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 They Did This
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.
Why This Research 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 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.
What This Study Doesn't 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.
Questions This Raises
- ?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?
Trust & Context
- Key Stat:
- No clinically significant changes in any blood measure at 3 months
- Evidence Grade:
- Moderate: phase III interim data from 59 participants, but open-label single-arm design without placebo comparison.
- Study Age:
- Published in 2022.
- Original Title:
- Medical cannabis for the treatment of comorbid symptoms in children with autism spectrum disorder: An interim analysis of biochemical safety.
- Published In:
- Frontiers in pharmacology, 13, 977484 (2022)
- Authors:
- Stolar, Orit(6), Hazan, Ariela(5), Vissoker, Roni Enten, Kishk, Ibrahim Abu, Barchel, Dana, Lezinger, Mirit, Dagan, Adi, Treves, Nir, Meiri, David, Berkovitch, Matitiahu, Kohn, Elkana, Heyman, Eli
- Database ID:
- RTHC-04244
Evidence Hierarchy
A small preliminary study to test whether a larger study is feasible.
What do these levels mean? →Frequently Asked 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.
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Cite This Study
https://rethinkthc.com/research/RTHC-04244APA
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
MLA
Stolar, Orit, et al. "Medical cannabis for the treatment of comorbid symptoms in children with autism spectrum disorder: An interim analysis of biochemical safety.." Frontiers in pharmacology, 2022. https://doi.org/10.3389/fphar.2022.977484
RethinkTHC
RethinkTHC Research Database. "Medical cannabis for the treatment of comorbid symptoms in c..." RTHC-04244. Retrieved from https://rethinkthc.com/research/stolar-2022-medical-cannabis-for-the
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkTHC research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.