Clinical outcome data of first cohort of chronic pain patients treated with cannabis-based sublingual oils in the United Kingdom – analysis from the UK Medical Cannabis Registry
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
Cannabis-based medicinal products (CBMPs) are an emerging therapeutic option in the management of primary chronic pain, utilizing the role of the endocannabinoid system in modulating central and peripheral pain processes. Despite promising pre-clinical data there is a paucity of high-quality evidence to support the use of CBMPs for chronic pain. This study aimed to investigate the health-related quality of life outcomes of patients with chronic pain who were prescribed CBMP oil preparations (Adven®, Curaleaf International)
This study is a case-series of patients from the UK Medical Cannabis Registry, who were treated with CBMP oils for an indication of chronic pain. The primary outcomes were the changes in Brief Pain Inventory short-form (BPI), Short-form McGill Pain Questionnaire-2 (SF-MPQ-2), Visual Analogue Scale (VAS) Pain, General Anxiety Disorder-7 (GAD-7), Sleep Quality Scale (SQS), and EQ-5D-5L, at 1, 3, and 6 months.
110 patients were included. Significant improvements in SQS, EQ-5D-5L pain and discomfort subscale, and Brief Pain Inventory Interference Subscale (p<0.05) at 1, 3, and 6 months were demonstrated. There were no notable differences between cannabis naïve and previous cannabis users in quality-of-life outcomes. The adverse event incidence was 30.0%, with most (n=58, 92.1%) adverse events being mild or moderate in intensity.
Treatment of chronic pain with Adven® CBMP oils was associated with an improvement in pain-specific outcomes, HRQoL and self-reported sleep quality. Relative safety was demonstrated over medium-term prescribed use. Whilst these findings must be treated with caution considering the limitations of study design, they can inform future clinical trials.
This study is a case-series of patients from the UK Medical Cannabis Registry, who were treated with CBMP oils for an indication of chronic pain. The primary outcomes were the changes in Brief Pain Inventory short-form (BPI), Short-form McGill Pain Questionnaire-2 (SF-MPQ-2), Visual Analogue Scale (VAS) Pain, General Anxiety Disorder-7 (GAD-7), Sleep Quality Scale (SQS), and EQ-5D-5L, at 1, 3, and 6 months.
110 patients were included. Significant improvements in SQS, EQ-5D-5L pain and discomfort subscale, and Brief Pain Inventory Interference Subscale (p<0.05) at 1, 3, and 6 months were demonstrated. There were no notable differences between cannabis naïve and previous cannabis users in quality-of-life outcomes. The adverse event incidence was 30.0%, with most (n=58, 92.1%) adverse events being mild or moderate in intensity.
Treatment of chronic pain with Adven® CBMP oils was associated with an improvement in pain-specific outcomes, HRQoL and self-reported sleep quality. Relative safety was demonstrated over medium-term prescribed use. Whilst these findings must be treated with caution considering the limitations of study design, they can inform future clinical trials.
Date Issued
2021-09-02
Date Acceptance
2021-08-27
Citation
Journal of Clinical Pharmacology, 2021, 16 (12), pp.1545-1554
ISSN
1552-4604
Publisher
Wiley
Start Page
1545
End Page
1554
Journal / Book Title
Journal of Clinical Pharmacology
Volume
16
Issue
12
Copyright Statement
This article is protected by copyright. All rights reserved.
Sponsor
EMMAC U.K Limited
EMMAC Life Sciences Limited
Identifier
https://accp1.onlinelibrary.wiley.com/doi/10.1002/jcph.1961
Grant Number
WSSS_P78476
WSGG_P82054
Subjects
Science & Technology
Life Sciences & Biomedicine
Pharmacology & Pharmacy
cannabinoids
chronic pain
health-related quality-of-life
medical cannabis
CHARLSON COMORBIDITY INDEX
LOW-BACK-PAIN
OROMUCOSAL SPRAY
CB2 RECEPTOR
DOUBLE-BLIND
RISK
OSTEOARTHRITIS
TOLERABILITY
GABAPENTIN
ANALGESICS
cannabinoids
chronic pain
health-related quality-of-life
medical cannabis
1115 Pharmacology and Pharmaceutical Sciences
Pharmacology & Pharmacy
Publication Status
Published online
Date Publish Online
2021-09-02