What is new in treatment of children with medicinal cannabis?

Date: 04.01.2019

''Nearly at the same time papers were published confirming that the whole plant extracts are even more efficient than CBD alone.''

Neubauer

Prof. dr. David Neubauer.
Co-authors: Mirjana Perkovič-Benedik, Ph.D., Assist., Damjan Osredkar, Ph.D., Assist. Prof., PeK Lj.

In 2018 a lot of papers were published confirming the efficacy and safety of cannabidiol (CBD) as well as medicinal grade cannabis (MGC) products and even artisanal cannabis for treatment of drug-resistant epilepsies and some severe epileptic syndromes, cerebral palsy and autism – especially for autism–associated behavioral problems such as aggressive and hyperactive behavior. There is compeling evidence of the efficacy and safety, and some of the studies were randomized, placebo-controlled (and double - blind) clinical trial (1).
 
The results of these studies have also proven that add-on treatment with CBD/MGC products in resistant epilepsies and encephalopathies matches well with some of the standard antiepileptic drugs used for treatment of this conditions (2). 
 
Even authorities in the field of pharmacological treatment of resistant epilepsies have had to admit that there exists convincing evidence of successful treatment with CBD and that led also to the registration of first such drug within EU at the beginning of next year (3). Latter article also quotes that there are multiple high-profile reports of the response of children taking cannabis derived medication, meaning that neurologists are commonly asked questions about these treatments and should learn something from the experiences of child neurologists.
 
Nearly at the same time papers were published confirming that the whole plant extracts are even more efficient than CBD alone. This is expected, especially if we are aware of the fact that the whole plant contains also other beneficial substances such as terpenes, flavonoids, long-chain fatty acids and other cannabinoids (until now more than 140 were isolated from the whole plant) which support our own endocannabinoid system (4).
 
In 2018 papers were published, that undoubtedly prove the efficacy and advantages of using whole plant extracts (e.g. same efficacy with lower dosages and consequently less side-effects and even more beneficial effects, especially regarding cognition, behavior, sleep and appetite). We cite 2 of these articles which deserve further reading (5). 
Even more – there are also papers which prove even better results with the use of artisanal cannabis enabling even much lower dosing (below 0.5 mg/kg/d) and better end-results regarding reduction of the seizures and improvement of quality of life (6). This article also mentions that in the near future the treating doctors will soon be in a situation when they will need to analyze, supervise and monitor the treatment of their patients using artisanal products of cannabis. All these facts and experiences led us to write the first recommendations for the use of cannabinoids and cannabis products in pediatrics which will soon be validated and approved by the Medical Chamber of Slovenia for use to all pediatricians in Slovenia. 
There are also many proofs about the efficacy of the use of whole plant extracts for the spasticity in children with severe forms of cerebral palsy. Statistically significant decrease of spasticity, dystonia and hence pain, with improved quality of life were cited in papers, reporting very mild and rare side effects (7). A similar study is to be undertaken in Slovenia with a whole plant extract (ratio of CBT:THC of 10:1) and is currently waiting for approval.
 
And finally there are preliminary results on the positive effects of cannabis products in treatment of children with autism, especially regarding the improvement of associated behavioral problems, that is in the final phases in Israel. The results are promising and show an improvement of 61% in behavioral outbursts (8).

 

In conclusion we can say that today:

  • there exists compelling evidence of efficacy of cannabidiol and medicinal (also artisanal) cannabis products in certain epileptic syndromes;
  • we also know that there are other types of severe epilepsies and encephalopathies that respond very well to their use;
  • the whole plant extracts (MGC) are proven to be much more efficient (and with less side effects) than isolated CBD;
  • side effects are rare, mild and well tolerated; 
  • long-term efficacy and safety have been proven in Class I evidence studies in children with drug-resistant epilepsies;
  • however, the introduction and monitoring of such therapies (with the consideration of the rule “start low and go slow”) should be in the hands of those pediatricians and/or neurologists (and other relevant specialists) as well as general practitioners who are well educated in medicinal cannabis products, and aware of all positive effects as well as all possible adverse effects;
  • We are proactive in the use of cannabinoids in the treatment of drug-resistant epilepsies also in Slovenia, among other we are hosting the international symposium CannaPaed 2019 in Ljubljana on the 25th January. 

  1. Szaflarski JP, in sod. Long-term safety and treatment effects of cannabidiol  Epilepsia. 2018 Aug; 59(8):1540–1548.
  2. Gaston TE, Szaflarski JP. Cannabis for the Treatment of Epilepsy: an Update. CurrNeurolNeurosci Rep. 2018 Sep 8;18(11):73 in Neubauer D, Perković, Benedik M, Osredkar D. Cannabidiol for treatment of refractory childhood epilepsies: Experience from a single tertiary epilepsy center in Slovenia. Epilepsy Behav. 2018Apr; 81:79–85.
  3. Gaston TE, Szaflarski JP. Cannabis for the Treatment of Epilepsy: an Update. CurrNeurolNeurosci Rep. 2018 Sep 8;18(11):73 in Neubauer D, PerkovićBenedik M, Osredkar D. Cannabidiol for treatment of refractory childhood epilepsies: Experience from a single tertiary epilepsy center in Slovenia. Epilepsy Behav. 2018Apr; 81:79–85.
  4. More about this on: www.institut-icanna.com.
  5. Hausman-Kedem M, in sod.Efficacy of CBD-enriched medical cannabis for treatment of refractory epilepsy in children and adolescents – An observational, longitudinal study. Brain Dev. 2018 Aug;40(7): 544-551 in McCoy B, in sod. A prospective open-label trial of a CBD/THC cannabis oil in Dravet syndrome. Ann ClinTransl Neurol. 2018 Aug 1;5(9): 1077–1088.
  6. Porcari GS in sod. Efficacy of artisanal preparations of cannabidiol for the treatment of epilepsy: Practical experiences in a tertiary medical center. Epilepsy Behav. 2018 Mar;80: 240–246 in Sulak D in sod. The current status of artisanal cannabis for the treatment of epilepsy in the United States. Epilepsy Behav. 2017: 328–333.
  7. Porcari GS in sod. Efficacy of artisanal preparations of cannabidiol for the treatment of epilepsy: Practical experiences in a tertiary medical center. Epilepsy Behav. 2018 Mar;80: 240–246 in Sulak D in sod. The current status of artisanal cannabis for the treatment of epilepsy in the United States. Epilepsy Behav. 2017: 328–333.
  8. Aran A in sod.Cannabidiol-Rich Cannabis in Children with Autism Spectrum Disorder and Severe Behavioral Problems-A Retrospective Feasibility Study. J Autism Dev Disord. 2018 Oct 31.

I.CANNA.BLOG

Josipina Ana Červek, MD Cannabinoids in Oncology MAY 2019
Silvija Zeman, Ph.D. Hemp: a plant with many names APRIL 2019
Amra Šabić, Ph.D., Assist. When prejudices dominate rights MARCH 2019