hemp extracted cbd oil for epilepsy

Whole-plant Cannabis Linked to Large Reduction in Seizures

Whole-plant cannabis is linked to a significant reduction in seizures in children with severe treatment-resistant epilepsy, early research suggests.

In a small case series, children with severe treatment-resistant epilepsy treated with a range of whole-plant extract cannabis-based medical products (CBMPs) reported an 86% reduction in monthly seizures.

All participants had no improvement with traditional antiepileptic drugs (AEDs).

The study adds to a small but growing body of research investigating whole-plant cannabis medicines containing tetrahydrocannabinol (THC) in pediatric epilepsies.

Rayyan Raja Zafar

“Although we have previously noted the superior efficacy of whole-plant medical cannabis is a previous group of children, to find that the effect of the treatment resulted in an 86% average reduction in seizures is remarkable and testament to the clear clinical value of this intervention,” lead author Rayyan Raja Zafar, a doctoral student with the Centre for Psychedelic Research and Neuropsychopharmacology, Imperial College London, United Kingdom, told Medscape Medical News.

The findings were published online December 14 in BMJ Paediatrics Open.

Superior to CBD?

The retrospective case series included 10 children under age 18 years who were recruited through MedCann Support and End Our Pain, charities that represent children who use medical cannabis to treat intractable epilepsies. Data were collected from patients’ parents or caregivers between January and May 2021.

Patients presented with a range of epilepsy etiologies and reported a mean of 7 (±4.58) AEDs prior to initiation of CBMPs. Two patients experienced no symptom improvement after taking Epidyolex, a purified cannabidiol (CBD) approved by the European Commission in 2019 for the treatment of rare forms of epilepsy. The formulation was approved by the US Food and Drug Administration in 2018 under the name Epidiolex.

All participants received CBMPs, including Bedrolite (<1% THC and 9% CBD), Bedica (14% THC and <1% CBD), Celixir 20 (<1% THC and 20% CBD), Sweet Pink CBD (<1% THC and 10.6% CBD), and Althea 100 (<1% THC and 10% CBD). Medications were prescribed to patients by clinicians in the National Health Service or by private medical practices.

Patients consumed a mean of 5.15 (±6.8) mg of THC a day and a mean of 171.8 (±153.3) mg of CBD daily.

All patients reported fewer seizures, ranging from a decrease in monthly seizure activity of 62.5% to 100%. The average decrease was 86%.

“It appears that whole-plant cannabis is superior to CBD alone, and the reasons for this are speculative,” Zafar said.

“It is known that THC does have independent antiseizure activity; however, much less is known of the role that other minor cannabinoids and terpenes in the cannabis plant play,” Zafar added.

“There has been some preclinical testing down to suggest they also have antiseizure activity, and so the compounded effects of whole-plant products seem to be working better than just an isolate.”

Selection Bias?

Commenting on the findings for Medscape Medical News, Tyler Allison, MD, associate professor of pediatrics at Children’s Mercy Kansas City, Missouri, noted that researchers chose patients based on their long-standing use of whole-plant medical cannabis oils, introducing a selection bias.

“The response is still interesting, and I think it needs to be studied further with better parameters in place to reduce bias, but I don’t think it’s fair to evaluate the amount of decrease in seizure frequency when the population studied was only patients who responded to the treatment,” said Allison, who was not involved with the research.

“How many patients tried whole-plant cannabis oil and didn’t find it to be effective or at least more effective than their other antiepileptic treatments?” he asked. “That information is missing and could significantly impact the significance of the study.”

The selection bias and small study group also make it difficult to compare the results to prior studies of isolated CBD that involved larger patient populations, Allison added.

An intention-to-treat, randomized study design that compared a control group treated with a form of isolated CBD product and a second group that received whole-plant cannabis oils would remove that bias, he noted. “Then they could analyze the frequency of seizures in the same way as they did and compare across groups to see if whole-plant cannabis oil shows a reduction in seizure frequency by comparison to a similar drug,” he said.

This is a design Zafar noted he and colleagues are interested in pursuing.

“We are beginning research to understand further the role of minor cannabinoids and terpenes in the treatment of this condition, as we want to further understand why we see a superior clinical effect in whole-plant medicines,” he said.

He added that they also plan to partner with academic and commercial collaborators on additional retrospective and prospective studies on these issues.

The study was unfunded. Zafar has reported no relevant financial relationships. Disclosures for the other authors are listed in the original article. Allison report no relevant conflicts of interest.

BMJ Paediatr Open. Published online December 14, 2021. Full text

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UI expert believes marijuana extract could help reduce seizures in some patients

The University of Iowa’s top expert on childhood epilepsy plans to sign letters of support for families who want to try cannabis oil, but she warns them to beware of possible risks and disappointments.

Dr. Charuta Joshi said previous anti-seizure drugs have also caused great excitement and optimism, but then were found to cause unexpected side effects, including liver damage.

Although she urges caution, Joshi believes marijuana extract, known as cannabidiol, could help reduce seizures in some patients. That’s why she’s helping set up a scientific trial of a version of the drug made by a British pharmaceutical company.

The Iowa City arm of the trial is to get underway in March, and should include about 30 children. Joshi hopes it is successful and offers another choice of medication for patients. But she noted that the benchmark for success in such a trial is a 50 percent reduction in seizures.

It’s possible that a few children will see larger reductions, she said, and every parent hopes to see the medication end their children’s seizures altogether. Unfortunately, she said, “that’s not how life is.”

In the three-month trial, half of the participants will be given the cannabis oil and half will be given a placebo. Even the doctors won’t know who received which until after the research is done. However, once the trial is over, the patients all will be offered the cannabis oil, she said.

Patients in the scientific trial would not need new state cards to possess the cannabis oil, because the research has federal approval. Families that want to obtain such cards so they can legally possess oil from other sources would need a neurologist to sign off on their applications. Advocates have noted that most states allowing medical marijuana don’t allow sales to out-of-state residents.

But Joshi said if families can obtain it and want to try it, she would support them. “Put it this way: It’s not like my patients are seizure-free on my meds,” she said.

She is concerned about cannabis oil being produced by dispensaries in places like Colorado, where the strength and doses of the medication aren’t as tightly controlled and easily understood as are those made by pharmaceutical companies. In the long run, she said, she hopes someone develops medications that reverse epilepsy instead of minimizing the seizures it causes. Neither the cannabis oil nor the current pharmaceuticals do that, she said.

Colorado has been the focus of the issue nationally, because of reports that cannabis oil produced there has dramatically helped some children. But a Colorado physician who specializes in treating epilepsy said results of cannabis oil use there have been mixed.

Dr. Kevin Chapman, a neurology professor at the University of Colorado, helped study 58 children who had used “artisanal” versions of the oil. The study found that just a third of parents reported their children had seizure reductions of 50 percent or more. And parents who moved to Colorado from out of state were three times as likely to report such success as those who were from Colorado.

“We just didn’t quite find what the popular press is reporting — that everybody is having a great response,” Chapman said in a phone interview.

He speculated that families who have seen success with the cannabis oil are more likely to volunteer for media interviews than families who haven’t. Families that moved to Colorado for the chance to obtain the oil might be more emotionally invested in the outcome, and more inclined to see improvement, he said.

Chapman said he’s known families who have moved back home after finding the oil didn’t help their children, only to be harangued by supporters of it.

Chapman said he doesn’t recommend that patients’ families try locally produced versions of the oil, because he doesn’t believe there’s enough evidence in its favor yet. But he urges them to let him know if they do use it, because he wants to monitor the interaction of the oil with other medications. Some neurologists have said they won’t continue seeing patients who are using the oil, which Chapman thinks is the wrong stance.

Chapman hopes to help lead part of a study of a synthetic version of the medication made by an Arizona company. He said the results of such studies, including the one in Iowa City, should help settle whether cannabis oil can help reduce epileptic seizures. Those results won’t be available for a year or two, he said.