The first Latin American study on the effects of CBD oils in the treatment of pediatric refractory epilepsy has delivered its first conclusions.
Nearly 80% of patients responded positively to CBD and saw the number of seizures they suffered drastically reduced.
At the beginning of the year, the first results came out of an Argentinean clinical trial that started 15 months earlier on the effects of cannabis oils. It was the first research conducted under the control of the health authorities since a law of March 2017 had required the state to study the medicinal uses of the plant.
As a result, in 2018, the first clinical trial protocol for cannabis in Latin America was approved. The Garrahan Pediatric Hospital (Buenos Aires) commissioned to evaluate the efficacy of cannabidiol oils (CBD) in the treatment of refractory pediatric epilepsy.
Are they effective?
Today we know that they are,” proudly proclaims the hospital director, Carlos Kambourian. The patient’s reaction to the new treatment was indeed particularly satisfactory.
Trial participants ranged in age from 7 to 17 years and were from across the country. Before starting CBD treatment, they had an average of 959 seizures per month, or about 30 days, with some patients suffering up to 400 seizures daily.
Of the 49 participants, 39 (80%) had a positive response to treatment. The average number of seizures per month decreased from 959 to 381, or about 13 per day, which equates to a 60% reduction.
Two-thirds of the episodes, therefore, prevented. And five patients now appear to be completely free of seizures. Families have also reported improved cognitive and motor functions, resulting in a significant improvement in living conditions.
The side effects observed were mild to moderate. Most of them managed by adjusting cannabidiol doses or by adding antiepileptic drugs.
Significance of the Study
These results confirm those of other clinical trials conducted worldwide: administered in controlled quantities, CBD is a useful tool in the treatment of refractory pediatric epilepsy. Affirms Graciela Demirdjian, who is in charge of coordinating the project’s evaluation unit.
Among the clinical trials, several of them – notably in Canada – have sought to evaluate the effect of CBD on Dravet and Lennox-Gastaut syndromes, two particularly disabling types of childhood refractory epilepsy.
However, despite these precedents, the promoters of the study encountered several difficulties, particularly administrative ones. In total, more than 100 people had to work together to ensure the supply of CBD to patients in a country where medicinal cannabis is not always readily available.
Despite the legalization of this treatment, cannabis products are virtually impossible to find in Argentina, since strict procedures require quality tests to verify the product quality domestically.
The study demonstrated the shortcomings of this system and represented an essential step in the development of the local and regional cannabis industry.
The study will follow a total of 100 patients. But, impressed by the surprisingly convincing preliminary results, its promoters have already decided to publish the conclusions of the first stage. The clinical trial is, therefore, still ongoing, and the published data still await confirmation. With a total duration of 27 months and a sample size of 100 patients, this will be the world’s broadest program ever devoted to childhood refractory epilepsy.