Both doses were nearly equivalent in effectiveness, he said, and “the new results hint that the lower dose CBD is better-tolerated.”
CBD products are derived from marijuana, but do not include THC, the active agent in pot that causes a “high.”
This study was led by Dr. Shimrit Uliel-Sibony, of Tel Aviv Sourasky Medical Center’s Dana-Dwek Children’s Hospital, and presented at the American Epilepsy Society’s annual meeting in December.
The FDA approved Epidiolex last fall for the treatment of Dravet syndrome and another rare but severe form of childhood epilepsy, Lennox-Gastaut syndrome. The new study was funded by GW Research Ltd., developer of Epidiolex.
The only big difference between the new trial and that 2017 New England Journal of Medicine study is in the dosages given, explained neurologist Dr. Fred Lado.
TUESDAY, April 30, 2019 (HealthDay News) — There’s new data supporting the use of Epidiolex — the first cannabidiol (CBD) medicine approved by the U.S. Food and Drug Administration — to help curb a form of epilepsy.
“Tolerance” to the drug developed in about one-third of those patients after an average of seven months, the researchers said. So doctors needed to increase the dose by 30% to get the same seizure-reducing benefit.
An Israeli study using a product that had 20 parts of CBD to 1 part of THC was performed in an open-label format for children up to age 18 years with hard to control epilepsy. A significant number of people reported seizure reduction with 7% stating seizures worsened.
Hemp traditionally contains lower concentrations of THC and higher levels of CBD. Cannabinoids extracted from hemp plants, including CBD, have until recently been classified as marijuana and considered Schedule I substances. Per the DEA, Schedule I substances currently have no accepted medical use and have a high potential for abuse. A federal law* enacted in December 2018, however, reclassifies hemp and hemp-derived CBD as an agricultural commodity and exempts it from the list of Schedule I Drugs.
Despite this change in the classification of hemp and hemp-derived CBD, the only CBD product that has been rigorously studied and approved to be used as a medical therapy for epilepsy is the drug Epidiolex. While more CBD products may come to market in the coming months, it is important to understand that not every CBD product is the same quality or uniform from batch to batch. Any drug or supplement that is being considered for use as a medical treatment should first be discussed with your doctor. The potential for benefit as well as the interaction with other seizure medications and possible side effects require careful review with your doctor.
Are there ongoing CBD clinical trials?
Summarized below are results from the May 2017 New England Journal of Medicine study examining the effectiveness of Epidiolex (CBD) in people with drug resistant seizures with Dravet syndrome.
There are some drug-to-drug interactions that have been revealed during the studies of CBD in epilepsy syndromes. More research continues to be done examining these interactions. We know from studies that have been done:
When conventional treatments do not work to control seizures, as is the case for roughly 30% of people with epilepsy, it is not unreasonable to consider CBD oil. However, this should only be considered after a thorough evaluation at a specialized epilepsy center to look at whether all possible treatments (including FDA-approved new and add-on medicines, dietary therapy, devices, and surgery) have been reasonably tried.
The Journal of Child Neurology hosted a special report podcast about cannabis on March 6, 2017. In the report, Dr. Alison Christy interviews Dr. Jackie Gofshteyn, a resident in pediatric neurology at Children’s Hospital of Philadelphia, about her article, “Cannabidiol as a Potential Treatment for Febrile Infection-Related Epilepsy Syndrome (FIRES) in the Acute and Chronic Phases.” Dr. Christy also speaks with epilepsy.com’s medical cannabis editor, Dr. Anup Patel of Nationwide Children’s Hospital, about his article, “Medical Marijuana in Pediatric Neurological Disorders.” Margo Roemeling, a third year medical student at Oregon Health and Sciences University, shares the learning topic on the history and use of marijuana in the treatment of pediatric neurologic conditions.