UK Medical Cannabis Registry palliative care patients cohort: initial experience and outcomes

Abstract

Introduction Palliative care aims to improve quality of life through optimal symptom control and pain management. Cannabis-based medicinal products (CBMPs) have a proven role in the treatment of chemotherapy-induced nausea and vomiting. However, there is a paucity of high-quality evidence with regards to the optimal therapeutic regimen, safety, and effectiveness of CBMPs in palliative care, as existing clinical trials are limited by methodological heterogeneity. The aim of this study is to summarise the outcomes of the initial subgroup of patients from the UK Medical Cannabis Registry who were prescribed CBMPs for a primary indication of palliative care, cancer pain and chemotherapy-induced nausea and vomiting, including effects on health-related quality of life and clinical safety. Methods A case series from the UK Medical Cannabis Registry of patients, who were receiving CBMPs for the indication of palliative care was undertaken. The primary outcome consisted of changes in patient-reported outcome measures including EQ-5D-5L, General Anxiety Disorder-7 (GAD-7), Single-Item Sleep Quality Scale (SQS), Pain Visual Analog Scale (VAS) and the Australia-Modified Karnofsky Performance Scale at 1 and 3 months compared to baseline. Secondary outcomes included the incidence and characteristics of adverse events. Statistical significance was defined by p-value< 0.050. Results Sixteen patients were included in the analysis, with a mean age of 63.25 years. Patients were predominantly prescribed CBMPs for cancer-related palliative care (n = 15, 94%). The median initial CBD and THC daily doses were 32.0 mg (Range: 20.0–384.0 mg) and 1.3 mg (Range: 1.0–16.0 mg) respectively. Improvements in patient reported health outcomes were observed according to SQS, EQ-5D-5L mobility, pain and discomfort, and anxiety and depression subdomains, EQ-5D-5L index, EQ-VAS and Pain VAS validated scales at both 1-month and 3-months, however, the changes were not statistically significant. Three adverse events (18.75%) were reported, all of which were either mild or moderate in severity. Conclusion This small study provides an exploratory analysis of the role of CBMPs in palliative care in the first cohort of patients since CBMPs legalisation in the UK. CBMPs were tolerated with few adverse events, all of which were mild or moderate and resolved spontaneously. Further long-term safety and efficacy studies involving larger cohorts are needed to establish CBMPs role in palliative care, including comparisons with standard treatments.

Topical cannabidiol is well tolerated in individuals with a history of elite physical performance and chronic lower extremity pain

“…Nevertheless, topical CBD was well tolerated within these populations with minimal adverse effects. Nimalan et al studied the use of cannabis-based medicinal products, which included both CBD and THC, in a case series of cancer-related palliative care patients and, similar to the current study, determined them to be tolerated with few mild (12.5%) or moderate (6.25%) adverse events reported as lethargy, ataxia, and dysgeusia each affecting 6.25% of participants and resolving spontaneously (Nimalan et al 2022 ).…”

An overview of global monitoring systems for the side effects and adverse events associated with medicinal cannabis use: A scoping review using a systematic approach

“…The Australian Emyria database does not implement a formal causality assessment, however possible causal relationships are guided by clinicians' medical judgement (47). (47,(49)(50)(51)(52)(53)(54)(55)(56)(57)(58)(59)(60)(61)(62)(63)(64)(65)(66)(67). Emyria Limited maintains full ownership of the Australian Emyria Clinical e-Registry (47).…”

“…Prescribers were identified and invited to participate in data collection by GW Pharmaceuticals, and nominally compensated for completing Case Report Forms (44). UKMCR is maintained by Sapphire Medical Clinics, inviting patients from a private healthcare setting not representative of the broader population of CBM consumers (47,(49)(50)(51)(52)(53)(54)(55)(56)(57)(58)(59)(60)(61)(62)(63)(64)(65)(66)(67). Similarly, the Australian Emyria Clinical e-Registry sources participation from Emerald Clinics, a network of clinics specialising in use of currently unregistered medicines and commercialisation of collected clinical evidence with Spectrum Therapeutics, the medical division of a cannabis company known as Canopy Growth (47,96).…”

“…WHO VigiBase(28,42,43) Australian Emyria Clinical Registry (47) Eudravigilance European Database of Suspected Adverse Drug Reaction Reports (EDSADR) (48) Project TwentyOne (28,51,67,78,79) Drug Commission of the German Medical Association database (DCGMA) (68) TGA Database of Adverse Event Notifications (DAEN) (47,73) Italian Medicines Agency (AIFA) Registry (32,76,77)German Pain e-registry(29)(30)(31)(32)(33) UK Medicinal Cannabis Registry (UKMCR)(47,(49)(50)(51)(52)(53)(54)(55)(56)(57)(58)(59)(60)(61)(62)(63)(64)(65)(66)(67) ToxIC registry (69-72)…”

Preliminary findings from project Twenty21 Australia: An observational study of patients prescribed medicinal Cannabis for chronic pain, anxiety, posttraumatic stress disorder and multiple sclerosis

“…For example, there are several studies in the UK, many described as cannabis registries (e.g. Ergisi et al, 2022a, 2022b; Erridge et al, 2021; Harris et al, 2022; Kawka et al, 2021; Nimalan et al, 2021; Sakal et al, 2021) and at least one other study being conducted in Australia (e.g. Vickery et al, 2022).…”