Outcomes for Inflammatory Bowel Disease from the UK Medical Cannabis Registry

Inflammatory bowel disease – also known as IBD – is the name given to a category of conditions that affect the gastrointestinal tract. It refers to two distinct disorders: Crohn’s disease and ulcerative colitis. Inflammatory bowel disease is characterised by various symptoms, including persistent diarrhoea, abdominal pain, weight loss, malnutrition, and fatigue. 

While Crohn’s disease and ulcerative colitis may share common symptoms, they differ in pathophysiology, part of the gastrointestinal tract affected, clinical presentation, complications, disease course, and management. The symptoms of IBD can have significant implications for the health and social aspects of patients’ lives, with diagnosis also presenting a potential financial burden owing to career limitations and lifetime expenses that are comparable to other major chronic diseases.

Current Treatment Options for IBD

IBD is now thought to affect around 1 in 200 people in Western countries, with an increasing incidence being reported in newly industrialised countries across Asia, Africa, and South America. Effective management of symptoms and disease progression is, therefore, an important consideration. Current treatments for IBD aim to induce and maintain disease remission, promote mucosal healing, and enhance patient quality of life. 

The therapeutic approach adopted can depend on several factors, including the severity of the disease, the extent of inflammation, and its evolution over time. However, common treatments include long-term treatment with medications such as aminosalicylates or mesalazines, immunosuppressants, and in some cases, surgery. Despite improvements in the rates of remission and the need for surgical intervention, a significant proportion of patients remain unresponsive or unable to tolerate current IBD treatments. There is, therefore, a need to develop further therapies for both the treatment of IBD and related complications.

Medical Cannabis and IBD

In recent years, cannabis-based medicinal products (CBMPs) have gained growing interest in the context of IBD. In particular, the cannabinoids cannabidiol (CBD) and tetrahydrocannabinol (THC) have increasingly become the subject of various studies in this area. Both of these compounds have been found to interact with the endocannabinoid system (ECS), particularly cannabinoid 1 (CB1) and cannabinoid 2 (CB2) receptors. CB1 and CB2 receptors are located throughout the enteric nervous system, suggesting that the ECS may play a critical role in the regulation of multiple aspects of gastrointestinal function. 

However, clinical evidence remains limited on the effects of CBMPs in IBD. Current clinical studies in this area have yielded conflicting results, highlighting the need for additional high-quality evidence from both clinical and real-world settings. A recent analysis of data collected through the UK Medical Cannabis Registry (UKMCR) aimed to assess multiple domains of health-related quality of life (HRQoL) outcomes and the incidence of adverse effects in patients with IBD.

Data Collection for the UK Medical Cannabis Registry

The UK Medical Cannabis Registry (UKMCR), which was set up by Sapphire Medical Clinics in 2019, is the first UK patient registry to collect data regarding CBMP prescription formulations, patient demographics, patient-reported outcome measures (PROMs) and adverse events (AEs). 

Patient-Reported Outcome Measures (PROMs)

The data assessed in this study was reported electronically by patients or contemporaneously by clinicians during initial clinical consultations. Primary outcome measures were changes in PROMs from baseline to 1-, 3-, and 6-month follow-up. Secondary outcomes were the incidence and severity of AEs. PROMs were measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), General Anxiety Disorder 7 (GAD-7), EQ-5D-5L, Single-Item Sleep Quality Scale (SQS), and Patient Global Impression of Change (PGIC).

The SIBDQ is a validated assessment for measuring clinically significant changes in HRQoL among IBD patients. It consists of 10 questions grouped into four domains of health and function: bowel symptoms, systemic symptoms, social function, and emotional function. Lower total SIBDQ scores are indicative of poorer HRQoL, whereas higher SIBDQ scores indicate better HRQoL.

The EQ-5D-5L is the HRQoL measure recommended by the National Institute for Health and Care Excellence (NICE). The SQS utilises a numerical rating scale rating from 0 (terrible) to 10 (excellent) to assess sleep quality over the past 7 days. GAD-7 evaluates seven aspects of generalized anxiety by the number of days they were experienced in the past fortnight. The PGIC assesses perceived change since starting treatment in terms of activity limitations, symptoms, emotions, and overall quality of life, through two parts.

Adverse Events (AEs)

The incidence of adverse events (AEs) and changes to prescribed opiate medications were both recorded as secondary outcomes. AE data were collected alongside completion of PROMs or during routine clinical follow-up. Patient medications were recorded at baseline and changes were recorded via patient self-reporting or during clinical assessment.

Results of Analysis

A total of 76 patients with Crohn’s disease (n=51; 67.11%) and ulcerative colitis (n=25; 32.89%) were included in the study. The majority (n=62; 84.93%) of participants were prescribed both THC and CBD; four (5.48%) were prescribed CBD only; seven (9.59%) were prescribed THC only. 

Health-Related Quality of Life (HRQoL)

The data collected through the UKMCR indicated changes in IBD-specific HRQoL, measured by the SIBDQ score, after 1 month and 3 months of follow-up. Changes in generalised anxiety and depression symptoms were also demonstrated by GAD-7 scores at 3-month follow-up. Furthermore, sleep quality changed across the study period. 

Adverse Events (AEs) 

A total of 122 AEs were reported by 16 patients. The majority of these were reported as mild (n=53; 69.74%) or moderate (n=56; 73.68%), with none reported as disabling or life-threatening. The most commonly reported AEs were fatigue (11.84%), abdominal pain (10.53%), nausea (9.21%), and lethargy (9.21%), which are common clinical manifestations of IBD. 

In this patient sample, medical cannabis treatment was not associated with any significant change in oral morphine equivalent (OME) between baseline and 1- and 3-month follow-ups.

Conclusions

The authors conclude that this study is an important step forward in understanding the outcomes of patients who receive care through Sapphire Medical Clnics and are enrolled on the UK Medical Cannabis Registry. However, they caveat this with the fact that further randomised placebo-controlled trials are required to evaluate the safety and efficacy of CBMPs more accurately.