Recently there have been several large, well-controlled studies of the use of Cannabidiol in children and adolescents but it was used as an adjunctive therapy, not in a standalone way. What would happen if patients were only taking a cannabinoid as some activists for the legalization of Cannabis are vociferously demanding in many American state capitals?
Emily Stockings et al., researchers at the National and Alcohol Research Centre at the University of South Wales in Sydney, reviewed the data of several clinical trials of Cannabidiol, focusing on 36 studies that studied the use of the drug in drug-resistant Epilepsy. Two double blind studies on the use of CBD—one with 120 patients with the Drayet syndrome and the other with 171 patients with Lenox-Gastaut syndrome—showed that CBD was 75% more likely than the placebo to reduce the number of seizures by more than half. In the largest pool of almost a thousand patients that were observed, almost half of them got some significant reduction of their seizure frequency.
The researchers admitted that the quality of the data was mixed as there is no reliable evidence of which preparation of Cannabis—either Cannabis sativa or CBD-THC extracts or oral cannabis extracts—is more suitable. Three randomized clinical trials studied the possibility of seizure-free by just taking CBD compared to placebo; even though they found an encouraging six-fold increase in the number of patients that ended up seizure-free, their data is not completely reliable. Half of the patients treated with CBD reported that the quality of their daily activities had improved. The overall data suggested that almost half of the patients reported some significant improvement.
The greatest gains were observed in patients with Drayet syndrome or Severe Myoclonic Epilepsy of Childhood (SMEC), a tragic condition that begins in the first year of life and produces constant seizures; we can understand the relief experienced by those parents when they noticed a change. However, all the studies with Drayet syndrome were case series with a 100% response, which should be interpreted with extreme caution. The Sydney researchers also studied the number of participants that dropped off the study, which could be an indicator of their tolerance to the drug; they found no real difference between the participants receiving CBD and those with placebo.
There was a significant increase in the rate of adverse events in patients receiving CBD compared to placebo, including the dangerous status epilepticus and elevated aminotransferase levels. The most common adverse effects were drowsiness, diarrhea, fatigue and lack of appetite. This fact should make clinicians ponder whether the addition of CBD is warranted in the med schedule. The use of Cannabis should not be taken lightly or “to see what happens. What’s there to lose anyway?”
Many policy pundits and media charlatans are jumping in the bandwagon of the medical benefits of Cannabis in the American states that have long approved it like Colorado and those like Florida that are just beginning to regulate its use. We should fund serious studies in prestigious centers; moreover, the parents of children with grave, chronic neurological diseases should have priority access to them. There is a fine blue line between the medical benefits of Cannabis and its purely recreational use. But sick children should not be taken as hostages by the perpetrators of this media driven-frenzy.
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