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Clinical Outcome Measures in Patients with Multiple Sclerosis from the UK Medical Cannabis Registry

Published: 17/05/2024

What is Multiple Sclerosis?

Multiple sclerosis (MS) is a chronic disease affecting the brain and spinal cord, impacting over 120,000 people in the UK. In MS, the immune system mistakenly attacks the myelin sheath, which is the protective covering of the nerves. This damage causes inflammation and lesions, disrupting the nerve signals. The exact cause of MS is unknown, but it is believed to involve a combination of genetic and environmental factors.

MS causes a wide range of symptoms such as fatigue, difficulty walking, vision problems, muscle stiffness and spasms, pain, and cognitive issues. Additionally, MS patients often experience mental health challenges due to the physical toll of the disease.

What Treatments Are Available for Multiple Sclerosis?

MS treatments mainly focus on reducing inflammation and preventing flare-ups. Anti-inflammatory medications are commonly used for this purpose.

Symptom management is also crucial for improving the quality of life in MS patients. Pain, both neuropathic and musculoskeletal, is a frequent issue, and while treatments exist, evidence supporting their effectiveness specifically for MS is limited.

Spasticity, or muscle stiffness, is another common symptom, typically treated with medications like baclofen and clonidine. However, these drugs often have side effects and limited effectiveness, leading to poor adherence. There is also a form of medical cannabis called nabiximols (Sativex®) licensed for MS-associated spasticity. Therefore, as the authors of a recent analysis note, the development of effective novel therapeutics for the treatment of symptoms associated with MS is essential.

UK Medical Cannabis Registry & Multiple Sclerosis

In 2019, Curaleaf Clinic (formerly Sapphire Medical Clinics) launched the UK Medical Cannabis Registry, the first of its kind in the UK. This registry collects data on the outcomes of patients using cannabis-based medicinal products for various conditions, including MS. The current study analysed data from MS patients in the registry.

The study aimed to track changes in patient-reported outcomes using the Multiple Sclerosis Quality of Life-54 (MSQoL-54) scale, as well as anxiety (GAD-7), sleep quality (SQS scale), and overall health-related quality of life (EQ-5D-5L) measures. It also looked at the occurrence of adverse events in MS patients using medical cannabis.

Results of the Analysis

The study included 141 MS patients, with 78 (55.32%) currently using cannabis. Most patients (138 or 97.87%) were prescribed both tetrahydrocannabinol (THC) and cannabidiol (CBD). Data was collected at the start of treatment and then at 1, 3, and 6 months.

Changes were noted in health-related quality of life measures (GAD-7, SQS, and EQ-5D-5L) at each follow-up. The MSQoL-54 scale showed changes in various areas, including health perception, cognitive function, mental health, physical health, and social and sexual function.

A total of 146 adverse events were reported by 21 patients, with fatigue being the most common (9.93%). Most adverse events were mild (33.33%) or moderate (51.06%) in severity, consistent with findings from similar studies.

Conclusions

This study is the first to assess the long-term use (up to 6 months) of unlicensed cannabis-based medicinal products in MS patients, providing valuable insights into their potential use.

However, the authors caution that the study has limitations, and its conclusions should be considered preliminary. More research, particularly randomised controlled trials, is needed to further explore the effectiveness of cannabis-based medicines for MS symptoms.

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