Efficacy of cannabidiol: clinical trials of cannabidiol

18/05/2022

Using international research and studying the literature, publications of clinical studies and other scientific projects, we can now understand the aspects of the effectiveness of CBD or CBD-rich extracts.

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Scientific background

Tetrahydrocannabinol (THC) and cannabidiol (CBD) are the most prominent active ingredients from the flowers and leaves of the female hemp plant. The compounds belonging to the group of cannabinoids are mainly present in the plant as acids. Unlike THC, CBD has no psychotropic effects.

While the combination of THC and CBD-rich extracts has established itself for its analgesic and antispastic effects in patients with multiple sclerosis (MS), the application profile of CBD is still in its infancy. So far, only the antiepileptic effect has been recognized and is clinically relevant – especially in children with Dravet syndrome.

According to “Clinical Trials.gov”, a service of the US National Institutes of Health, over 150 clinical studies are currently running, so the level of knowledge on the clinical effectiveness of CBD will change several times over the next few years.

CBD and epilepsy

In a double-blind study, 120 children with Dravet syndrome were treated with 20 mg/kg body weight or placebo combined with existing medication. While 43% of patients on CBD had a reduction in seizures by at least 50%, the figure was 27% in the placebo group. In addition, while 5% of the patients in the verum group did not have a seizure, it was 0% in the placebo group.

This confirmed the positive results of various open studies with patients with therapy-resistant epilepsy. In a study, 214 patients between the ages of 1 and 30 were treated with up to 50 mg CBD/kg body weight for 12 weeks in combination with existing medication (clobazam, valproate, stiripentol and others). In a retrospective study with 74 patients between the ages of 1 and 18, they were treated with CBD at a dosage of 1-20 mg CBD/kg body weight in a CBD-rich extract for at least 3 months (average: 6 months). A study based on a survey of parents of therapy-resistant epileptic children treated with CBD also showed a positive effect.

In an older, placebo-controlled, double-blind study with 18 patients with Huntington’s disease, neither effects nor adverse effects could be demonstrated with an average dose of 700 mg per day for 6 weeks. A partial improvement was observed in a placebo-controlled, double-blind study with 15 epilepsy patients and 200 or 300 mg CBD daily. The first open and first controlled studies with healthy volunteers were conducted in the 1970s.

CBD is also used for a rare syndrome that affects children with fever and infection – Febrile Infection-Related Epilepsy Syndrome (FIRES). A retrospective analysis of 7 cases indicates a possible effect of this syndrome.

There are also previously unpublished controlled studies with the CBD product Epidiolex. A study of 120 patients with Dravet syndrome has shown a significant reduction in seizures by 39% with 20 mg/kg body weight and by 13% in the placebo group. A study of 171 patients with Lennox-Gastaut syndrome reported a 44% reduction in seizures at the same dose compared to 22% in the placebo group. In a dose-finding study with 225 patients with Lennox-Gastaut syndrome, 10 and 20 mg CBD per kg and placebo were examined. 42% of seizures were prevented with 20 mg/kg, 37% with 10 mg/kg and 17% with placebo.