EXPERT REACTION: CBD gel may help to lower childhood seizures

Publicly released:
Australia; New Zealand; VIC
PHOTO: Kimzy Nanney/Unsplash
PHOTO: Kimzy Nanney/Unsplash

Australian and Kiwi children with a severe form of epilepsy had a 43.5 per cent drop in how many seizures they were having after taking a CBD gel twice daily for around six months, reports a new study. The researchers found adverse effects from the gel on the group of almost 50 children, aged 3 to 18, were either mild or moderate. The study team notes that the research was non-randomised and had no control group, so it’s not possible to know if the placebo effect may have had an impact.

News release

From:

Expert Reaction

These comments have been collated by the Science Media Centre to provide a variety of expert perspectives on this issue. Feel free to use these quotes in your stories. Views expressed are the personal opinions of the experts named. They do not represent the views of the SMC or any other organisation unless specifically stated.

Dr Marta Rychert, Senior Researcher in Drug Policy, Massey University

This is an interesting topic to explore, as prior research has shown promising outcomes from oral CBD as adjunctive therapy in children with Dravet and Lennox-Gastaut syndromes (serious epileptic conditions). The authors in this study report a reduction in seizures and disease burden, but their findings need to be read with limitations of research kept in mind.

The study was a nonrandomized, before-and-after design, therefore participant assignment was neither randomized nor masked; there was no control group so it’s impossible to know the extent that placebo effect contributed to the positive outcomes reported. Additionally, a number of authors report financial conflict of interest, including consultancy work, employment and stock ownership in the pharmaceutical company whose CBD formulation was used in the study. The sponsor (pharmaceutical company) was responsible for the design and conduct of the study, including involvement in data collection and analysis. We need more well-designed (double-blind placebo-controlled trials) and independent research in this space.

Last updated:  03 Sep 2021 11:13am
Contact information
Contact details are only visible to registered journalists.
Declared conflicts of interest I never worked, consulted or received funding from any pharmaceutical or medicinal cannabis company. I currently receive research funding from the NZ Health Research Council and Marsden Royal Society.

Dr Ali Seyfoddin, Associate Professor in Drug Delivery and Biological Engineering and head of AUT University’s cannabinoids research

Despite decades of negative publicity and propaganda against one of nature’s most mysterious plants, medicinal uses of cannabis are once again attracting attention largely thanks to the Marijuana legalisation movements. As more clinical data is being established around medicinal uses of cannabis, what is even more interesting is the consensus that as a medicine, cannabis is very well tolerated. If one carefully critiques the scientific manuscripts on harms of cannabis (1960-2018), it would be apparent that the studies were largely biased especially around inclusion criteria of participants/patients (eg predisposed health conditions) and types/dosages of cannabis used. Today, we know that unlike any other drug, patients develop tolerance to cannabis side effects but not to the actual therapeutic effect. That means that over time, a titrated dose can be maintained without the need to increase dose or frequency and that cannabis medicines are very well tolerated over time.

Dosage form and delivery route of cannabis are major factors which will influence the efficacy of proposed treatments as one could expect significantly different uptake (bioavailability) and pharmacological effect (eg oral cannabis causes 4 times more psychoactive side effects) from them. While oral administration of cannabis remains popular, alternative dosage forms of cannabis such as transdermal gels have been used to treat paediatric drug resistant seizures with some success. These patients also suffer from other comorbidities such as sleep disorders, autism, gut and movement problems and respiratory tract conditions all of which could also benefit from medicinal cannabis. 

Some limitations of the study are acknowledged by the authors in the article itself. With all the limitations in legislation and access to patients, it is not always possible to design the perfect experiment involving medicinal cannabis.

Last updated:  03 Sep 2021 11:11am
Contact information
Contact details are only visible to registered journalists.
Declared conflicts of interest Ali Seyfoddin has research collaboration with major medicinal cannabis companies.
Journal/
conference:
JAMA Network Open
Research:Paper
Organisation/s: The University of Melbourne, Murdoch Children's Research Institute (MCRI), University of Otago, Consultants, USA; The Griesser Group, USA; Zynerba Pharmaceuticals, USA
Funder: The study was supported by Zynerba Pharmaceuticals Inc. : The sponsor was responsible for the design and conduct of the study. The sponsor was involved with the collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript, and decision to submit the manuscript for publication. Dr Scheffer reported service on the editorial boards of the Annals of Neurology, Neurology, and Epileptic Disorders; she reported patents held or pending for therapeutic compounds, testing methods, and molecular diagnostic targets for infantile epilepsy, some of which are licensed and have paid royalties. She reported service on scientific advisory boards for UCB Pharmaceuticals, Eisai Co Ltd, GlaxoSmithKline, BioMarin Pharmaceutical, Nutricia, Rogcon Inc, Chiesi, Encoded Therapeutics, Xenon Pharmaceuticals, Zynerba Pharmaceuticals, and Knopp Biosciences; she reported receiving speaker honoraria from GlaxoSmithKline, UCB Pharmaceuticals, BioMarin, Athena Diagnostics, Liva Nova, Biocodex, and Eisai; she reported receiving funding for travel from UCB Pharmaceuticals, Biocodex, GlaxoSmithKline, Biomarin Pharmaceutical, National Research Foundation Singapore, and Eisai Co Ltd; she reported service as an investigator for Zogenix, Zynerba Pharmaceuticals, Ultragenyx, GW Pharmaceuticals, UCB Pharmaceuticals, Eisai Co Ltd, Anavex Life Sciences, Ovid Therapeutics, Epigenyx, Encoded Therapeutics, and Marinus; and she reported consulting work for Zynerba Pharmaceuticals, Athena Diagnostics, Atheneum Partners, Ovid Therapeutics, Care Beyond Diagnosis, Epilepsy Consortium, and UCB Pharmaceuticals. She reported receiving research support from the National Health and Medical Research Council of Australia, the Australian Medical Research Future Fund, Health Research Council of New Zealand, Citizens United for Research in Epilepsy, Australian Epilepsy Research Fund, and the National Institute of Neurological Disorders and Stroke outside the submitted work. Dr Sadleir reported consulting work for Zynerba Pharmaceuticals Inc, and reported receiving honoraria from Eisai Co Ltd. Drs Hulihan and Messenheimer and Mr Griesser reported consulting work for Zynerba Pharmaceuticals Inc. Dr Gutterman and Ms Sebree reported employment with Zynerba Pharmaceuticals Inc and reported stock options from Zynerba Pharmaceuticals Inc; they reported holding patents for treatment methods using cannabidiol and CBD. Ms Sebree reported stock ownership of Zynerba Pharmaceuticals Inc. No other conflicts were reported.
Media Contact/s
Contact details are only visible to registered journalists.