The approval of Epidiolex in June 2018 signified a turning point in the treatment and management of seizures. Since the FDA-approved drug has CBD as its major component, its inclusion into the medical space as a prescription drug convinced even CBD’s skeptics of its potential
However, are Epidiolex and CBD Oil the same?
Proponents assume that since both products contain Cannabidiol, they must have the same uses. However, ongoing research does not support this claim.
This article seeks to spell out the differences between Epidiolex and CBD Oil, their principal pharmacological effects, side effects, and how best to increase the former and subdue the latter.
Epilepsy is a chronic non-communicable disease of the nervous system that affects about 50 million people worldwide. The condition is marked by unprovoked seizures, during which an individual loses voluntary control of the entire body or just a part of the body.
One seizure does not make an epileptic. According to the World Health Organisation, an individual must have had at least two seizures in his lifetime to be diagnosed with epilepsy. Epilepsy is a sensitive condition; the risk of premature death in epileptics is three times that of an average person. Statistics declare that 70% of epileptics can live seizure-free with proper management.
Common medications used to manage epilepsy include anti-epileptic drugs (AEDs) such as Clonazepam, Diazepam, Valproic acid, which usually present with side effects like lack of energy, drowsiness, tremors, headaches, and hair loss.
CBD is a potent anti-seizure medication that has found its use in some particular kinds of epilepsy; the drug-resistant Dravet Syndrome, Lennox-Gastaut Syndrome which plagues infants, and in Tuberculosis Sclerosis Complex. CBD products present with milder side effects than typical AEDs and are much more tolerable.
The only FDA-approved brand of CBD for managing seizures is Epidiolex. Nonetheless, other formulations containing organically-sourced CBD will have similar effects on seizures. The potency of CBD Oil against a seizure is dependent on its dose, form, and preparation.
What is CBD?
CBD stands for cannabidiol. It’s one of the cannabinoids found in the Cannabis Sativa plant. CBD is not psychoactive like tetrahydrocannabinol (THC), its sister component. This makes it more appealing when it comes to relieving pain and other symptoms without psychoactive side effects, and is suitable for children above the age of two.
Cannabidiol is one of the most active ingredients of medical cannabis, second only to THC. You can derive it directly from the marijuana flowers, or by using larger amounts of hemp plants. It can also be manufactured in a laboratory. Cannabidiol comes in different forms such as oils, vapes, creams, extracts, and capsules.
Research on human and animals have suggested some benefits of CBD such as:
- Anti-seizure properties
- Neuroprotective effects
- Anti-acne and Anti-inflammatory
- Fights anxiety disorders
- Lowers cravings for tobacco and heroin
- Lowers high blood pressure
- Improves sleep
What is Epidiolex?
Epidiolex is an extract from cannabis that contains 99% CBD that has been purified and is prescribed for medical purposes.
Although it contains no THC, as of 2018, it was placed on the list of controlled drugs and classified as a Schedule V prescription drug. This means that the regulatory body suspected that the drug may be subject to misuse by individuals seeking the psychoactive effects of THC.
As of 2020, Epidiolex was taken off the controlled drugs list, and pharmacists were free to dispense without retaining the prescription. Epidiolex remains a prescription-only drug. However, this legislation makes it easier to refill when it runs out.
Ingredients of Epidiolex
The formula of Epidiolex includes the following ingredients:
- Cannabidiol: the exact mechanism through which cannabidiol halts seizures remain unknown to scientists. One proposed mechanism involves the activation of the CB1 receptors of the endocannabinoid system, which are concentrated in the brain, and sparsely distributed in the periphery.
- Sucralose: Sucralose is an artificial sweetener. It has almost no calories and is 600 times sweeter than real sugar. Sucralose is used in ice cream and yogurt.
- Sesame seed oil: Sesame oil is edible vegetable oil. It is derived from sesame seeds. Sesame oil contains omega-3 and omega-6 fatty acids. It provides the benefit of protecting skin from sunburn and managing inflammation.
What is CBD Oil?
CBD oil is a viscous extract with high concentrations of CBD. The extract is diluted in a carrier oil, such as MCT oil or hemp seed oil to improve its bioavailability and speed up absorption. People use it for daily supplementation as well as to treat or manage the aforementioned health conditions.
Ingredients of CBD Oil
These are the following main ingredients:
- Hemp: A hemp flower is an unprocessed bud from the hemp plant. Hemp has a higher concentration of cannabidiol and a lower level of tetrahydrocannabinol.
- MCT Oil: MCT oil is a supplement made from medium-chain triglycerides. It is easily oxidized and breaks down rapidly to release energy. The oil, which can be found in coconut and palm oil, is rich in antioxidants and anti-inflammatory effects by activating neutrophils and mitochondrial reprogramming.
Comparing CBD Oil and Epidiolex: Epilepsy Treatment
Epidiolex in the Treatment of Epilepsy
Epidiolex is the first FDA-approved drug that is a CBD-derived medication for the treatment of epilepsy.
The FDA approved Epidiolex for the treatment of two severe and rare forms of epilepsy in patients two years of age and older — Lennox-Gastraut syndrome and Dravet syndrome. Epidiolex is also approved to treat seizures associated with tuberous sclerosis complex.
The job of the FDA is to protect public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical services. First of all, the manufacturers of a product conduct laboratory, animal, and clinical testing. Then, the FDA reviews the results of the testing and grants approval.
Three clinical trials involving 516 patients with Lennox-Gastaut syndrome and Dravet syndrome studied the effectiveness of Epidiolex. In one of these trials, Epidiolex was combined with other anti-seizure medications. Compared to a placebo, Epidiolex was more effective in the reduction of seizures.
CBD Oil in the Treatment of Epilepsy
CBD oil is a mixture of Cannabidiol with a carrier oil. CBD oils that contain other compounds such as supportive cannabinoids, terpenes, and traces of THC are labeled as full-spectrum by manufacturers. The presence of these supporting compounds boosts the effect of CBD, a mechanism called the entourage effect. This phenomenon doesn’t occur in the highly purified Epidiolex.
CBD oil may help in treating some seizure symptoms but it has some side effects. CBD Oil typically comes as a tincture, with a dosage of 25-50mg of CBD per ml. The CBD market isn’t regulated like the pharmaceutical industry, so there’s no standardization among products, both when it comes to potency and purity. Therefore, it’s difficult to evaluate the efficacy of specific dosages.
More research still needs to be carried out to understand the risks and benefits of CBD oil.
Which is Better in the Treatment of Epilepsy?
The option of Epidiolex and CBD Oil gives patients and caretakers a chance to individualize their regimen. The best pick would depend on each patient’s individual circumstances.
CBD oil has a broader spectrum of activity and fewer side effects. It may treat other coexisting conditions such as acne and inflammation, as opposed to the rash occasionally associated with Epidiolex use. Even so, always consider the effect of seizure relief. At the appropriate dosage, CBD Oil is just as potent as Epidiolex.
What to Consider When Choosing Between Epidiolex vs CBD Oil
The FDA is yet to approve any commercial CBD brands for the treatment of epilepsy. Epidiolex is a prescribed drug that has gone through well-controlled clinical trials, has been reviewed and approved by the Food and Drug Administration (FDA) to treat Lennox-Gastraut and Davet syndrome. You may get a prescription for Epidiolex, and purchase it at the nearest pharmacy.
CBD oils are recommended by doctors and can be purchased from online or physical stores. You don’t need a prescription for such products.
FDA studies suggest Epidiolex has been proven to be safe. Epidiolex is a cannabis extract made up of 99% CBD that has been purified. It also contains no tetrahydrocannabinol. THC is a principal psychoactive component of cannabis with a “high” effect.
CBD oil may contain other cannabinoid compounds and some contaminants. The FDA does not regulate CBD products, so CBD oils are not proven to be safe. The concentration of THC may vary with the brand.
According to Dr. Devinsky, a professor of neurology, neurosurgery, and psychiatry at the NYU Grossman school of medicine and director of NYU Langone’s Comprehensive Epilepsy Center, “The approval of Epidiolex or cannabidiol is a landmark in medicine. It is the first time such a medication, based on a cannabis plant, has been approved and scientifically established to be an effective treatment in the United States.” The pharmacological actions of CBD are not fully understood. However, Dr. Devinsky says, “We do understand some of how it helps to control seizures (by working) on a receptor system that no other drug touches.”
More research still needs to be carried out to understand the effectiveness of CBD oil.
Clinical trials carried out on Epidiolex suggest significant side effects were experienced by some of the participants like fever, vomiting, diarrhea, lethargy, fatigue, and drowsiness. Epidiolex may also lead to a change in liver function, jaundice, unusual darkening of the urine, and right upper abdominal pain.
CBD, the main component of CBD oil, is well-tolerated and its effects are considered mild Some of these adverse reactions include abnormalities in liver function, drowsiness, diarrhea, and dry mouth. In some studies, some patients experienced an increase in seizures with CBD. CBD Oil may interact with other medications, such as blood thinners.
It can be expensive to purchase Epidiolex. However, insurance may cover it in certain regions. The Epidiolex Copay Savings Program is eligible to legal residents of the United States or Puerto Rico. Some people who lack access to these privileges opt to buy CBD products from stores as an OTC alternative.
How to Use Epidiolex vs CBD oil
How to Use Epidiolex
Epidiolex is a liquid pharmacological drug. It is administered orally. The required dosage of Epidiolex depends on body weight and symptom severity.
The dosage based on a child’s body weight:
- Starting dosage: 2.5 milligrams per kilogram (mg/kg) taken twice daily per oral.
- Maintenance dosage: 5 mg/kg taken twice daily per oral.
- Maximum dosage: 10 mg/kg taken twice daily per oral.
How to use CBD oil
Most CBD oils come in bottles with a dropper. There are no guidelines for the proper administration but there are methods of using CBD oil. CBD oil is administered sublingually. place a few drops under the tongue and retain for 30 to 60 seconds without swallowing. The dose may be 5mg-25mg daily depending on what you are treating.
Interactions Between CBD and Medications
Certain side effects may occur when CBD is used with other drugs and medications such as:
- Calcium channel blockers
CBD inhibits some enzymes of the large family of CYP450 and alters the way they metabolize certain drugs. It’s a similar mechanism to the one demonstrated by grapefruit juice. When taken together with other medications, CBD may either decrease or increase its concentration in the bloodstream — leading to toxicity or subtherapeutic effects depending on the type of interaction.
If you take any medications, talk to your doctor before adding CBD oil to your routine. Doing so will help you find the right timing for both compounds, as well as the dose to avoid interactions.
Key Takeaways on CBD vs Epidiolex
The major difference between the purified and FDA-approved Epidiolex and CBD Oil brands is that Epidiolex contains 99% CBD and no other cannabinoids. CBD oils, on the other hand, contain supportive cannabinoids that enhance their pharmacological activity. On the flip side, CBD Oils may contain contaminants and psychoactive compounds if they’re improperly manufactured and not tested by a third-party laboratory.
CBD oils also vary in terms of potency, appearance, and taste, based on brand. This may be desirable when a wider range of options positively affects treatment results.
People now have the choice of using Epidiolex or CBD oil to treat epilepsy. You need to know what they are and how they work before choosing your treatment option. If you would like to explore the prescribed medication, Epidiolex, or store-bought CBD oil, talk to your doctor first.
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