Long Awaited CBD Study Reveals Promising Results – And Groundbreaking FDA Approval

Findings from the 2015 landmark study on Cannabidol (CBD) have finally been released, and the results look promising. The study, which was conducted at the south’s research powerhouse, University of Alabama at Birmingham, was published in the journal, Epilepsy and Behavior. It focused on 72 children and 60 adults, all of whom had intractable epilepsy that did not respond to at least four other traditional treatment methods. Some patients had even tried surgery, only to see little or no progress.

Why was the CBD study conducted?

The study was considered groundbreaking at the time of its beginnings, when the Alabama legislature enacted “Carly’s Law.” “Carly” is the daughter of Dustin Chandler, who led the push for CBD research in 2013. Chandler’s daughter had been suffering from violent seizures, and after researching, he found a documentary suggesting CBD oil might help epileptic patients. As a result, he began pushing state leaders to research, as the substance was not legal in Alabama at the time. The result was Carly’s Law. Five years later, UAB’s research confirmed what Chandler suspected.

Prior to Carly’s Law, there was no legal authorization for those in Alabama to study the effects of CBD, which is a component of cannabis commonly thought to treat neurological conditions such as epilepsy. With the law enacted, the UAB Epilepsy Center began its work.

What were the results?

Researchers were able to determine that CBD caused significant improvements in seizure frequency, seizure severity and a reduction of adverse events in those studied.  In fact, across the study, there was a nearly two-thirds reduction of seizure frequency, with some seeing even more improvement. From the 132 patients studied, data was analyzed at baseline, and visits at 12, 24 and 48 weeks. At week 12, the mean number of seizures went from 144 every two weeks (baseline) to 52 seizures over two weeks. This reduction remained stable throughout the remainder of the study.

Researchers also scored patients on an AEP score (adverse events profile). For the entire study population, this number went from 40.8 (baseline) to 33.2 at week 12. Using the Chalfont Seizure Severity Scale, the severity of the seizures were scored, dropping from 80.7 (baseline) to 39.2 at week 12.

“We saw improvements between baseline and 12-week visits in the 30- to 40-point range for each group, as much as a 50 to 60 percent improvement, indicating results that are not only statistically significant, but also highly clinically significant for the group as a whole.” said Jerzy Szaflarski, M.D., Ph.D., director of the UAB Epilepsy Center and principal investigator of the adult section of the study.

Put simply, the use of CBD oil led to patients having both fewer and less intense seizures. In fact, some patients became completely seizure free.

The CBD oil used for the study was a pharmaceutical-grade CBD oil, known as Epidiolex®. The purified oil, produced by Greenwich Biosciences, only contains trace amounts of THC, the psychotropic part of cannabis that gives users a “high.”

Because controlled studies had already confirmed the drug’s safety, UAB’s study was able to focus on the adverse events profiles of the patients, noting the effects when anti-seizure medications were replaced or used in combination with CBD. Only four patients withdrew from the study due to adverse effects.

On June 25, the U.S. Food and Drug Administration approved Epidiolex® for seizures associated with two severe forms of rare epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. This marked the first FDA approval of a purified drug derived from cannabis.

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