PMID- 35950052 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220813 IS - 2504-3889 (Electronic) IS - 2504-3889 (Linking) VI - 5 IP - 1 DP - 2022 Jan-Dec TI - Medicinal Cannabis for the Treatment of Chronic Refractory Pain: An Investigation of the Adverse Event Profile and Health-Related Quality of Life Impact of an Oral Formulation. PG - 20-31 LID - 10.1159/000521492 [doi] AB - INTRODUCTION: Medicinal cannabis is prescribed in Australia for patients with chronic refractory pain conditions. However, measures of safety and effectiveness of different cannabinoids are lacking. We designed an observational study to capture effectiveness, adverse events (AEs), and health-related quality of life (HRQoL) measures in patients prescribed an oral medicinal cannabis formulation at Cannabis Access Clinics through the Cannabis Access Clinics Observational study (CACOS). OBJECTIVES: We aimed to evaluate effectiveness, reported AEs, and change in patient-reported outcomes in individuals prescribed a cannabinoid oil formulation for management of chronic pain. METHODS: A cross-sectional analysis was conducted on patients prescribed an oil formulation of Delta9-tetrahydrocannabinol and cannabidiol for pain symptoms of at least 3-month duration. Clinician-reported AEs were organized by system, organ, class, and frequency. Analysis of patient-reported responses to a questionnaire was conducted using published minimal clinically important differences to determine meaningful change in HRQoL over time. RESULTS: More than half (n = 91/151, 60.3%) of the participants experienced at least one AE during the observation period (mean 133 +/- 116 days). No serious AEs were reported. Patient-reported pain impact scores were significantly reduced across the cohort (p = 0.034), and pain intensity scores verged on significance (p = 0.053). The majority of patients saw meaningful improvements in sleep (49.3%) and fatigue (35.6%). CONCLUSION: This analysis presents real-world data collected as part of standard of care. More than one-third of patients benefited from oral medicinal cannabis, which is impactful given the refractory nature of their pain. Amelioration of the impact of pain confirms continued prescribing of this formulation and validates our observational methodology as a tool to determine the therapeutic potency of medicinal cannabinoids. CI - Copyright (c) 2022 by S. Karger AG, Basel. FAU - Abelev, Sarah AU - Abelev S AD - Applied Cannabis Research, Sydney, New South Wales, Australia. FAU - Warne, Leon N AU - Warne LN AD - Little Green Pharma, Perth, Washington, Australia. AD - College of Science, Health, Engineering and Education, Murdoch University, Perth, Washington, Australia. AD - School of Pharmacy and Biomedical Sciences, Curtin Health Innovation Research Institute, Curtin University, Perth, Washington, Australia. FAU - Benson, Melissa AU - Benson M AD - Applied Cannabis Research, Sydney, New South Wales, Australia. FAU - Hardy, Mark AU - Hardy M AD - CA Clinics, Sydney, New South Wales, Australia. FAU - Nayee, Sunny AU - Nayee S AD - Pain Management Department, Charing Cross Hospital, Imperial College Healthcare Trust, London, United Kingdom. FAU - Barlow, John AU - Barlow J AD - Applied Cannabis Research, Sydney, New South Wales, Australia. LA - eng PT - Journal Article DEP - 20220209 PL - Switzerland TA - Med Cannabis Cannabinoids JT - Medical cannabis and cannabinoids JID - 101765665 PMC - PMC9235063 OTO - NOTNLM OT - Adverse events OT - Cannabinoids OT - Improved pain impact OT - Improved pain intensity OT - Medicinal cannabis COIS- L.N.W. reports personal fees from Little Green Pharma, outside the submitted work. All other authors have no conflicts of interest to declare. EDAT- 2022/08/12 06:00 MHDA- 2022/08/12 06:01 PMCR- 2022/02/09 CRDT- 2022/08/11 02:24 PHST- 2021/11/22 00:00 [received] PHST- 2021/12/10 00:00 [accepted] PHST- 2022/08/11 02:24 [entrez] PHST- 2022/08/12 06:00 [pubmed] PHST- 2022/08/12 06:01 [medline] PHST- 2022/02/09 00:00 [pmc-release] AID - mca-0005-0020 [pii] AID - 10.1159/000521492 [doi] PST - epublish SO - Med Cannabis Cannabinoids. 2022 Feb 9;5(1):20-31. doi: 10.1159/000521492. eCollection 2022 Jan-Dec.