With the rise in popularity and use of cannabidiol (CBD) for its many health benefits, CBD products have entered the mainstream market of health and wellness products. People are using it to treat various health conditions like pain, inflammations, minor wounds and burns etc. It is also used as a major ingredient in skincare products due to therapeutic effects and lack of or minimal side effects compared to synthetic compounds. One rising trend is paediatricians are asked by parents about using CBD for treating the ailments of their children. The purpose of this article is to examine CBD clinical trials into the therapeutic benefits in children.
What Is Cannabidiol (CBD)?
Cannabidiol is the cannabinoid derived from the cannabis plant and legally available products are made from the hemp plant because of the low amounts of THC i.e. 0.3%. CBD imparts its psychoactive effects by influencing various neurotransmitters that are part of the endocannabinoid system (ECS). It can also reduce the adverse effects of THC by inhibiting the effectiveness of CB1 receptors of the ECS through allosteric modulation.
The US food and Drug Administration (FDA) has approved only one CBD derived medication, Epidiolex. It is used for the treatment of epileptic seizures in children above 2 years old and the CBD used in it is synthetic. This is one of the very few cases where extensive CBD clinical trials for epilepsy had been conducted and provides insight into how cannabidiol works, as well as about its side effects.
What Does Epidiolex Trials Reveal?
In the clinical trials, Epidiolex was administered to children above 2 years who were diagnosed with Dravet syndrome or Lennox-Gastaut syndrome. They were given a dose of 5 to 2 mg/kg per day and it showed a reduction in the frequency of seizures by 36% to 41%.
However, there are side effects in 10%, like elevated liver enzymes, diarrhea, malaise, somnolence, fatigue, reduced appetite and sleep issues. Apart from this, the drug was shown to interfere with the metabolism of drugs like clobazam, propofol, lorazepam, morphine, phenytoin and bupropion. Also, there was an increase in liver transaminase in 13% of paediatric patients treated with Epidiolex. So, on the package of the medicine they make it mandatory to do bilirubin levels and liver function tests before administering it. This should also be continued at 1 month, 3 months, 6 months intervals, as well as after change in dosage.
These CBD clinical trials for epilepsy for the drug Epidiolex prove that when appropriate doses are administered, it is effective in reducing seizures in children.