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|2019||Slovenian experience with the use of cannabis and domestic cannabis products in the treatment of persistent epilepsy, certain epileptic syndromes, and encephalopathies of the childhood period||Abstract|
Refractory epilepsies, resistant to regular antiepileptic drugs (AEDs) in paediatric population continue to be a challenge worldwide. Despite an increasing number of new AEDs approximately 1 in 3 patients continues to have seizures. Cannabidiol (CBD), one ofmany constituentsof the Cannabis sativa or marijuana plant, has received renewed interest in the treatment of epilepsy. Cannabis has being used as treatment of seizure disorders nearly 5000 years ago in Asia and during 18th and 19th centuries also in Europe and United States and was also found in pharmacopeas. However it has been moved into Schedule I class after Marijuana Act in 1937.
After nearly 80 years of prohibition today highly purified CBD has already got Food and Drug Administration (FDA) approval, while still waiting for EMA approval in Europe, and was moved as a substance to Schedule V class. On the other hand artisanal formulations of CBDare readily available and are seeing increased use in our patient population as well. We are presenting our own data of treatment of resistant epilepsies/encephalopathies with pure CBD, where we got excellent results: in a group of retrospectively studied children with severe forms of epilepsy, treated by cannabidiol alone there was 77 % reduction of seizures and 21% of children were even seizure free. Later studies, especially some systematic reviews, reported similar data from other retrospective, non-randomized studies using cannabidiol alone, but including also some studies using cannabis plant extracts with similar outcome. When studying retrospectively those children whose parents admitted that they were using different artisanal products of cannabis for their children epilepsy is posing additional problems: potential benefits of artisanal cannabis preparations in the treatment of epilepsy are difficult to quantify due to the lack of controlled trials, variability in artisanal cannabis preparations which represents a key challenge and concern for the use of artisanal products for medical treatment of epilepsy, given the lack of both regulation and verification of such products. However the comparisson between those studies using purified/isolated cannabis products and those using artisanal product has many challenges. As shown by Sulak et al. response to artisanal cannabis is promising: uncontrolled observational data of 272 patients, have shown some degree of seizure reduction in 86% of cases and 10% had complete cessation of seizures. Our own data on small group of children useing atisanal cannabis are aslo promising.After half a year the parents were given the questionnaire and the Caregiver Global Impression of Change Scale (CGIC) to fulfill. The responses were low – 59% of all questionnaires sent, posing another possible bias, that those parents where artisanal cannabis was not effective did not want to report this as was the case also in some other studies. However we were surprised with the findings on the CGIC, which showed excellent results of 93% improvement. In a recent study of cannabidiol use in Lennox-Gastaut syndrome patients the results of CGIC scores were 57% in the 20 mg/kg/d group and 66% in the 10 mg/kg/d group, compared with 44% in the placebo group, reporting overall improvement. Further studies comparing eficiency of isolated cannabinoids and products made form the whole plant are in process and the results will be available shortly.