Research Study on Efficacy And Safety Of Cannabinoid Oromucosal Spray For Multiple Sclerosis Spasticity

CBD or cannabidiol is one of the few hundred extracts of the plant Cannabis sativa L. This plant belongs to the botanical family of flowering plants called Cannabaceae.

In November 2017, the WHO committee established that CBD does not cause any psychoactive effects on the body.

THC, or 9-δ-tetrahydocannabinol is the main psychoactive substance in Cannabis sativa L.

What is Multiple Sclerosis?

Multiple sclerosis (MS) is a disease of the brain and the spinal cord. It has the potential to permanently disable the person.

Multiple sclerosis is an autoimmune disease. This means, the body’s immune system turns on the body itself and ends up destroying healthy cells.

In MS, the immune system attacks the myelin sheath (the protective covering on nerve cells) and this results in loss of transfer of messages or incorrect transfer of messages between the brain and the rest of the body.

Symptoms of Multiple sclerosis vary from person to person, and on the site of the affected nerve fibers. They include –

  • Tremors
  • Unsteady gait
  • Speech slurs
  • Weakness or numbness in one or more limbs
  • Fatigue
  • Bowel and bladder problems

What happened in the study

The oromucosal spray that contained both THC and CBD in a specific ratio (Sativex) opened up many new possibilities for patients suffering from Multiple sclerosis.

The aim of the study was to evaluate Sativex effectiveness and adverse events profile in a large population of Italian patients with MS in the daily practice setting.

Data of all patients starting Sativex between January 2014 and February 2015 was collected from the mandatory Italian medicines agency (AIFA) e-registry.

AIFA, or the Italian Medicines Agency is the national authority which is responsible for drugs regulation in Italy. AIFA guarantees access to medicines and their safe and appropriate use as means to protect public health.

The spasticity was measured by the 0-10 numerical rating scale (NRS) scale is available at baseline, after 1 month of treatment (trial period), and at 3 and 6 months.

The NRS (Numerical Rating Scale) is a system where the patients are asked to circle a number from 0-10 or 0-20 or 0-100 that best describes the intensity of their pain.

Zero will mean no pain, while the upper limit (10/20/100) means the worst pain imaginable.

From 30 MS centers in Italy, 1615 patients were recruited. There was a trial period (treatment period) of one month. After the trial period, it was observed that 70.5% of patients reached an improvement greater than or equal to 20% (This was their initial response).

28.2% of the total patients had reached a ≥ 30% improvement (this response was clinically relevant). The mean NRS score had reduced by 22.6% (the mean went from 7.5 to 5.8).

After analysing all the various results, it was observed that there was an increased probability to reach the initial response at the first month among patients with primary and secondary progressive MS, ie 1169 patients, OR 1.4; 95% confidence interval- ranging from 1.04 to 1.9, maintaining a p value of 0.025.

A confidence interval is constructed at a confidence level, such as 95 %. This means, if the same population is sampled on several occasions, using various criteria, similar results would be obtained in 95% of the population.

A similar conclusion was drawn regarding patients with a NRS score more than 8 at baseline (OR 1.8 95% confidence interval ranging from 1.3-2.4; p<0.001).

631 ie 39.5% of patients discontinued treatment in the 6 month observation period. Main reasons stated for discontinuation were lack of effectiveness which was felt by 375 patients, ie 26.2%, and/or adverse events which were felt by 268 patients, ie 18.7%.

What did the study conclude?

Sativex can be a useful and safe option for patients suffering from Multiple sclerosis with moderate to severe spasticity, who are resistant to common antispastic drugs.

Though this oromucosal spray did not work on few patients, the majority showed a good response to it.

What does this mean?

Autoimmune diseases can be dangerous as the body own immune system turns on itself. So when the body is destroying itself, it becomes tricky to find a solution.

Discoveries like Sativex spray and more can help the affected people live their lives a little better.

Read the research paper here-