Still, Texas’s CBD law is considered “pretty restrictive” compared to those involving cannabis in other states, said Katharine Neill Harris, Ph.D., a drug policy fellow at Rice University’s Baker Institute for Public Policy.
Despite taking a slew of medications, and despite having a device implanted under the skin of his chest that sends electrical impulses to his brain to reduce the number and severity of his seizures, Trysten’s symptoms persisted.
“It’s kind of risky, but these parents and families are desperate for their kids,” said Gretchen Von Allmen, M.D., chief of pediatric epilepsy with McGovern Medical School at UTHealth and a pediatric neurologist at Memorial Hermann-TMC.
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Galveston resident Trysten Pearson, who has epilepsy, experienced his first seizure in 2013 when he was 12 years old. But last summer, his mother Shena Pearson explained, his condition began to deteriorate quickly.
He often felt nauseous and he’d vomit every few days. Because exercise triggered his seizures, his school stopped allowing him to participate in physical education, leading to weight gain. His grades were dropping and his memory was fading, too.
Meanwhile, the Texas law doesn’t permit people with any diagnosis besides intractable epilepsy to use CBD oil, even though some other states allow those with multiple sclerosis, late-stage cancer, Crohn’s disease and other conditions to access CBD oil or medical marijuana. That has frustrated some patients and advocates, but skeptics say more research must be done to evaluate whether and how CBD oil can treat those illnesses.
Zynerba Pharmaceuticals performed the only phase two clinical trial that we know of, using a CBD transdermal gel that the company developed in-house. The study involved 320 patients with knee osteoarthritis who received either 250 mg of ZYN002 4.2% CBD gel daily, 500 mg of ZYN002 daily, or a placebo, over 12 weeks. Although the study found some evidence of a reduction in pain and improvements in physical function, scores for measures of pain were not statistically different from placebos.
CBD (cannabidiol) products are all the rage right now, with countless companies and merchandisers offering a wide variety of options. While edibles are usually the products of choice, some prefer topical CBD products to avoid gastrointestinal problems or to reap potential pain reduction effects from local application to specific body parts, such as a sore shoulder or ankle. It is, however, extremely probable that there are significant differences in outcomes between oral and topical administration of CBD products.
However, while those results are encouraging, rat studies don’t always translate to humans, so such findings should be taken with a grain of salt. For instance, although many people anecdotally claim that topical CBD products help them manage their pain after a workout or injury, they might be experiencing reduced anxiety, which is known to interfere with how we manage pain. CBD topical products could also act like placebos. There is really no way to tell unless clinical trials are performed on humans, which are expensive and ethically challenging.
Edibles vs topicals
CBD is one of the many compounds found in Cannabaceae plants, or, as most people call them, cannabis plants. It can be extracted from both the marijuana and hemp plants; however, most US states require that CBD oil products come from hemp and do not contain more than 0.03% THC. CBD oil does not produce a high, but it does interact with brain chemistry, so saying it is completely non-psychoactive would be inaccurate.
The effects of CBD on the body can be pinned to the body’s endocannabinoid system, which regulates numerous processes such as appetite, pain, and mood. The body produces its own cannabinoids, but introducing CBD into the body amplifies the endocannabinoid system.
There is evidence that CBD may be effective in treating some very dangerous childhood epilepsy syndromes, including Lennox-Gastaut syndrome (LGS) and Dravet syndrome. CBD seems able to reduce the number of seizures or stop their incidence altogether, even in some patients who don’t respond to typical antiseizure medication. In 2018, the FDA approved the first ever cannabis-derived, medically certified drug for these conditions, Epidiolex, which is formulated with CBD.
The bottom line is that there is insufficient evidence demonstrating that topical CBD products are effective for managing pain, which is the main reason people buy them. We simply cannot come to definite conclusions until more clinical trials are performed. But are there any downsides to using CBD? CBD oil taken orally is known to cause side effects such as nausea, fatigue and irritability. CBD may also interact with blood thinner medication.
The researchers defined tolerance as either the necessity to increase dose by ≥30% after efficacy declined, or a response reduction of >30%. They saw tolerance in 30 patients, on an average dose of 12.6 mg/kg/day. The mean time until tolerance appeared was 7.3 months (range 1-24 months).
In the U.S., the FDA has approved a purified, pharmaceutical-grade formulation of cannabidiol (Epidiolex), a chemical component of the Cannabis sativa plant, for children with Lennox-Gastaut and Dravet syndromes. (The current study used a different product.)
In a study of 92 children and young adults with treatment-resistant seizures who used cannabis oil extract for an average of 19.8 months, tolerance to CBD emerged in 32.6% of patients, reported Shimrit Uliel-Sibony, MD, of Tel Aviv Sourasky Medical Center’s Dana Children’s Hospital, and colleagues at the American Epilepsy Society annual meeting.
— But the observation that two-thirds continued to benefit may be a key finding
NEW ORLEANS — About one-third of patients who used cannabidiol (CBD) to manage treatment-resistant epilepsy developed tolerance to it, researchers from Israel reported here.
“By definition, most patients with treatment-resistant epilepsy do not enjoy long-term benefits from a new anti-seizure therapy — that is, a ‘honeymoon effect,'” said Orrin Devinsky, MD, of New York University Langone Health in New York City, who was not involved with the study.
by Judy George, Contributing Writer, MedPage Today December 2, 2018
The researchers increased the CBD dose in most patients who developed tolerance; 12 patients achieved their previous response level and 15 did not.