CRx MAGAZINE

Summer 2021

Ask the Expert: Cannabinoid Treatment for Multiple Sclerosis

Multiple sclerosis (MS) is an autoimmune disease that affects nearly 3 million people around the globe.1 In MS, the immune system attacks itself, creating a cascade of inflammation that causes nerve breakdown. The myelin sheath that encases the nerve cells begins to degrade, exposing the nerves to damage, resulting in pain and loss of function. Variable symptoms include numbness, tingling, neuropathy, fatigue, bladder dysfunction, and vision loss. Mental health effects are common and include depression, anxiety, and mood imbalances.2

There are three classifications of MS. Most common is relapsing-remitting disease, which, as the name suggests, is characterized by periods of exacerbations followed by remissions. About one-half of patients who experience relapsing-remitting disease go on to experience secondary progressive disease—an ongoing worsening of symptoms which may or may not be relieved by remissions. Patients with primary progressive disease do not reach
remissions and experience worsening symptoms over time.2

There’s no cure for MS, but immunomodulation therapy, often called disease- modifying therapy (DMT), can help slow progression. Common DMTs in use today include interferons beta-1a and beta-1b, which are given by injection, and natalizumab and mitoxantrone, which are be given by IV administration.3 These drug interventions are targeted to halt symptoms in early diagnosed patients with relapsing-remitting MS to tamp down destructive inflammation by suppressing the immune system. Ideally, the DMT drugs will stave off the disease from worsening into the more serious progressive MS classification. Patients may take many other drugs to control their symptoms, and with the comorbidities of aging this can lead to a cocktail of pharmaceuticals. The negative effects of polypharmacy, such as changes to cognition, fatigue, and organ damage, may result.4

Patients want natural alternatives, and there’s interest in the role cannabinoids may play. In 2003, the US government patented cannabinoids as neuroprotective antioxidants. Because MS is a neurodegenerative illness, cannabinoids offer much promise in slowing the progression; many published studies have investigated the connection.5,6

A 2012 study by Corey-Bloom and colleagues compared a placebo to cannabis cigarettes containing about 4% THC provided by the National Institute of Drug Abuse (NIDA). There was a reduction in measures of spasticity and pain in participants smoking the cannabis cigarettes, but acute cognitive effects muted the gains, and some of the participants were uncomfortably high. The patients were asked to inhale the smoke of these cigarettes in a research environment that may not have been conducive to healing and relaxation.7 If the study were to be designed today, the parameters might include the use of CBD alongside THC, knowing how the addition of CBD tempers the unwanted side effects of THC.

Modern research goals should include study of the gamut of CBD, THC, their acid counterparts, and other cannabinoids in various potencies and ratios that might prevent nerves from dying, preserve functionality, provide energy, lift mood, and reduce the painful spasms—without the cognitive impairments seen from inhaled THC, especially in cannabis-naïve subjects.

Specific dosing protocols may be on the horizon with the GW Pharmaceuticals’ drug Sativex, a 1:1 oil of CBD to THC on the market in 25 countries worldwide to treat many MS symptoms.8 The efficacy of Sativex for MS has been explored in upwards of 200 studies, with some showing greater efficacy and fewer side effects compared with DMTs.9 Sativex has been suggested to work long-term without losing its power, and no tolerance or addiction problems have been documented in those using this 1:1 CBD to THC oil. In several Sativex studies, once patients titrated up to their minimum effective doses to control symptoms, they didn’t show evidence of intoxication, cognitive impairment, or even adverse effects on driving. Quality of life measures all trended upward.10

Sativex is being studied in a Phase 3 clinical trial in the United States—exciting news for suffering Americans looking for options. In this study of the safety and efficacy of Sativex, 446 participants will receive placebo or as many as 12 5-mg doses of Sativex spray, each spray comprising 2.5 mg CBD and 2.7 mg THC. Provided there are good study outcomes, Sativex likely will gain FDA approval; the medication presumably will be priced comparably to GW’s other drug, Epidiolex, which was approved in 2018 for refractory seizure conditions—$36,000 per year for a 100 mg/mL CBD formula.12 It’s a costly drug, but if it stops children from having seizures, which can number in the hundreds each week, it might be considered beneficial in light of the life-changing ramifications for those children and their families.

If the FDA approves Sativex, its price tag will be steep after approval. The botanical version of Sativex is already on shelves in American dispensaries, sold as a 1:1 CBD to THC tincture.13 Potency varies widely based on manufacturer, but bottles can contain 300 to 3,000 mg of cannabinoids per 30 mL, so patients must be taught how to calculate dosing. Pricing of 1:1 tinctures varies with potency but averages $100 to $300 per bottle for a good-quality product. This may be more affordable for MS patients than the coming FDA-approved Sativex. However, clinicians should ensure that any dispensary product they recommend has a certificate of analysis that assures it is tested for potency, purity, and contaminants, and that a new certificate of analysis is available for each batch of oil produced.

For several years, I’ve treated a patient with MS who had severe pain; trigeminal neuralgia; terrible spasticity in her legs, which made it difficult for her physical therapist to work with her; a flat affect with few facial movements in conversation; anxiety with any change; depression; and insomnia. For years, she relied on a long list of pharmaceuticals, cycling through different drugs with each new doctor. She began a daily regimen of 3:1 CBD to THC at breakfast and a THC indica for sleep, adding in tetrahydrocannabinolic acid in the afternoon to provide pain relief and energy. She also used a topical 1:1 CBD to THC oil an hour before physical therapy and was able to move her limbs again. Every benchmark improved and, working with her physician, she slowly weaned herself off one-half of her medications. After a year using CBD, she was pleased to have lost 20 lbs, and, as her HgbA1c normalized, even her metformin was discontinued.

Millions of MS patients around the globe are using cannabinoids as medicine today. The website Multiple Sclerosis News Today has a set of links that detail its articles on the subject that can be shared with patients.14 Cannabinoids are medicine, and once cannabis is descheduled, researchers can study it using not only NIDA cigarettes but also the actual variations of products available to patients in dispensaries today. Clinicians and other experts in cannabis medicine have a role to play in educating others on the principles of medical cannabis and its promise for treating the symptoms of MS.

— Elisabeth Mack, RN, BSN, BA, MBA, is the founder of Holistic Caring (holisticcaring.com), a provider of educational programs and services for patients and professionals that include medical cannabis as part of an integrative treatment plan. She’s been a registered nurse for 34 years, and her MBA in health care administration led her to create systems to bridge the gap between conventional and cannabis medicine.

References

1. Wexler M. MS prevalence at over 2.8 million worldwide, update to Atlas reports. Multiple Sclerosis News Today website. https://multiplesclerosisnewstoday.com/news-posts/2020/09/21/ms-prevalence-2-8-million-worldwide-atlas-ms-third-edition/. Published September 21, 2020.

2. Multiple sclerosis overview. Multiple Sclerosis News Today website. https://multiplesclerosisnewstoday.com/multiple-sclerosis-overview/

3. Silva P. Multiple sclerosis treatment. Multiple Sclerosis News Today website. https://multiplesclerosisnewstoday.com/multiple-sclerosis-treatment/

4. Haughn Z, Bainbridge J. Recognize and prevent polypharmacy in MS patients. Practical Neurology website. https://practicalneurology.com/articles/2010-sept-oct/recognize-and-prevent-polypharmacy-in-ms-patients. Published September/October 2010.

5. Cannabinoids as antioxidants and neuroprotectants. PubChem website. https://pubchem.ncbi.nlm.nih.gov/patent/US6630507#section=Abstract  

6. Search results for “cannabis and multiple sclerosis”. PubMed.gov website. https://pubmed.ncbi.nlm.nih.gov/?term=cannabis+and+multiple+sclerosis. Accessed June 11, 2021.

7. Corey-Bloom J, Wolfson T, Gamst A, et al. Smoked cannabis for spasticity in multiple sclerosis: a randomized, placebo-controlled trial. CMAJ. 2012;184(10):1143-1150.

8. Vermersch P. Sativex(®) (tetrahydrocannabinol + cannabidiol), an endocannabinoid system modulator: basic features and main clinical data. Expert Rev Neurother. 2011;11(4 Suppl):15-19.

9. Search results for “Sativex and multiple sclerosis”. PubMed.gov website. https://pubmed.ncbi.nlm.nih.gov/?term=sativex+and+multiple+sclerosis. Accessed June 11, 2021.

10. Russo EB. The solution to the medicinal cannabis problem. In: Schatman ME, ed. Ethical Issues in Chronic Pain Management. Boca Raton, FL: CRC Press; 2007:165-194.

11. Carvalho J. Phase 3 trial of Sativex, cannabis extract treatment for MS spasticity, opens in US. Multiple Sclerosis News Today website. https://multiplesclerosisnewstoday.com/news-posts/2020/11/05/sativex-nabiximols-phase-3-trial-cannabis-extract-treatment-ms-spasticity-opens-us/. Published November 5, 2020.

12. FDA expands GW Pharma’s Epidiolex label. New Cannabis Ventures website. https://www.newcannabisventures.com/fda-expands-gw-pharmas-epidiolex-label/. Published August 3, 2020.

13. Search results for “1:1 cbd thc tincture”. Weedmaps website. https://weedmaps.com/search?filter[match]=1:1%20cbd%20thc%20tincture

14. Search results for “cannabis”. Multiple Sclerosis News Today website. https://multiplesclerosisnewstoday.com/?s=cannabis&header-search-submit=Search

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