Spasticity, including painful muscle spasms, is a major contributor to the disease burden of Multiple Sclerosis (MS). But conventional medications are not always effective at treating this symptom. A new review published in the Journal of Central Nervous System Disease looks at the effectiveness of a 1:1 THC and CBD mouth spray for treating spasticity in patients with MS.
The Impacts of Multiple Sclerosis
MS is a disease where the immune system attacks and degrades the protective covering of nerve cells. This makes it difficult for the brain to send signals to the rest of the body. As a result, many of the body’s basic functions are compromised.
One of the most debilitating symptoms of MS is spasticity. Spasticity refers to muscle stiffness and involuntary spasms in the limbs, most frequently the legs. These symptoms can be incredibly painful and interfere with day to day activities. It’s also one of the most common symptoms, occurring in about 80% of MS patients.
Spasticity doesn’t occur in isolation. Aside from pain, the spasms can cause a host of secondary symptoms including disrupted sleep and bladder problems. The loss of mobility brought about by muscle spasms also has a significant impact on patient quality of life.
Therefore, effective management of spasticity is critical for treating MS patients. Current treatments options include a combination of physiotherapy and anti-spasticity medications including:
However, not all patients respond to these medications. Many also suffer from adverse side effects, especially with prolonged use and high dosages.
Sativex: A Cannabis-Based Solution for MS
For patients who don’t respond or have bad reactions to traditional anti-spasticity medications, there’s another option. Researchers have shown that cannabis can be effective for treating MS symptoms including spasticity.
In some countries, there’s already an approved cannabis-based option called Sativex. Sativex is a mouth spray derived from the cannabis sativa plant. It contains a 1:1 ratio of THC (tetrahydrocannabinol) to CBD(cannabidiol).
Various government agencies around the world including in Canada and the European Union have approved Sativex as an add-on therapy. This means that doctors can prescribe Sativex to adults with MS who haven’t responded to other anti-spasticity medications and who respond well to Sativex during an initial trial period.
THC and CBD are the two most prominent cannabinoid compounds in the cannabis plant. THC acts on the cannabinoid receptors CB1 and CB2. Researchers believe that THC acts as a muscle relaxer and improves spasticity. Users usually think about THC as the psychoactive compound. CBD can complement the effects of THC. And when taken together, CBD reduces the psychoactive effects of THC including anxiety. Researchers confirmed these finding in several randomized controlled trials (RCTs) and long-term studies.
Confirming THC and CBD Effects with Real World Evidence
Researchers and doctors consider RCTs the gold standard when it comes to clinical evidence. That’s because they directly test a hypothesis and take many measures to reduce bias.
But it’s a double-edged sword. Because RCTs are so tightly controlled, they can’t always be generalized to everyday clinical practice. For this reason, real-world data offers a good complement to RCTs. This can include data from medical record reviews, case studies, databases, prospective or retrospective patient data collections, or observational cohort studies.
A group of researchers from the University Hospital Dresden in Germany set out to find more real-world data for Sativex. They wanted to confirm the results of the Sativex RCTs for MS spasticity. They scoured the research literature to find high-quality, real-world evidence for the benefits and safety of the THC and CBD spray for treating MS spasticity.
The researchers found 14 publications that fit their criteria for high-quality, observational studies. Patients in these studies took the THC/CBD spray according to the approved label recommendations. In all of the studies, the researchers used a quantitative and validated method to look at changes in spasticity symptoms.
In most of the studies, the patients also continued the use of their other anti-spasticity medications. However, some patients only used Sativex spray because they couldn’t tolerate other medications.
So how effective was Sativex under real-world conditions? The researchers found a consensus that the 1:1 THC:CBD spray, Sativex, significantly improved patient spasticity symptoms.
For example, in the largest study included in the review, researchers saw an initial positive response in 70% of patients. This is similar to the outcome for patients who participated in Sativex RCTs. In the RCT studies, initial response rates varied between 42% and 83%.
The observational studies also confirmed that Sativex improves secondary symptoms associated with spasticity. In one study, patients experienced significant decreases in sleep disturbances, pain, muscle stiffness, and restricted mobility after using the THC/CBD spray.
Additionally, some studies showed significant increases in quality of life for patients using Sativex. And similar to the RCTs, patients reported very few adverse side effects. Dizziness, drowsiness, and fatigue were the most commonly reported side effects.
Spasticity is the most prominent and debilitating symptom for patients suffering from MS. This study clearly shows that the real-world data is in agreement with the controlled clinical trials. A 1:1 combo of THC and CBD is an effective and well tolerated therapeutic option for MS patients who don’t respond well to conventional anti-spasticity drugs.