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

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 rega...

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Autores principales: Nimalan, Devaki, Kawka, Michal, Erridge, Simon, Ergisi, Mehmet, Harris, Michael, Salazar, Oliver, Ali, Rayyan, Loupasaki, Katerina, Holvey, Carl, Coomber, Ross, Platt, Michael, Rucker, James J., Khan, Shaheen, Sodergren, Mikael H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8725528/
https://www.ncbi.nlm.nih.gov/pubmed/34980282
http://dx.doi.org/10.1186/s42238-021-00114-9
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author Nimalan, Devaki
Kawka, Michal
Erridge, Simon
Ergisi, Mehmet
Harris, Michael
Salazar, Oliver
Ali, Rayyan
Loupasaki, Katerina
Holvey, Carl
Coomber, Ross
Platt, Michael
Rucker, James J.
Khan, Shaheen
Sodergren, Mikael H.
author_facet Nimalan, Devaki
Kawka, Michal
Erridge, Simon
Ergisi, Mehmet
Harris, Michael
Salazar, Oliver
Ali, Rayyan
Loupasaki, Katerina
Holvey, Carl
Coomber, Ross
Platt, Michael
Rucker, James J.
Khan, Shaheen
Sodergren, Mikael H.
author_sort Nimalan, Devaki
collection PubMed
description 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.
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spelling pubmed-87255282022-01-06 UK Medical Cannabis Registry palliative care patients cohort: initial experience and outcomes Nimalan, Devaki Kawka, Michal Erridge, Simon Ergisi, Mehmet Harris, Michael Salazar, Oliver Ali, Rayyan Loupasaki, Katerina Holvey, Carl Coomber, Ross Platt, Michael Rucker, James J. Khan, Shaheen Sodergren, Mikael H. J Cannabis Res Letter to the Editor 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. BioMed Central 2022-01-04 /pmc/articles/PMC8725528/ /pubmed/34980282 http://dx.doi.org/10.1186/s42238-021-00114-9 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Letter to the Editor
Nimalan, Devaki
Kawka, Michal
Erridge, Simon
Ergisi, Mehmet
Harris, Michael
Salazar, Oliver
Ali, Rayyan
Loupasaki, Katerina
Holvey, Carl
Coomber, Ross
Platt, Michael
Rucker, James J.
Khan, Shaheen
Sodergren, Mikael H.
UK Medical Cannabis Registry palliative care patients cohort: initial experience and outcomes
title UK Medical Cannabis Registry palliative care patients cohort: initial experience and outcomes
title_full UK Medical Cannabis Registry palliative care patients cohort: initial experience and outcomes
title_fullStr UK Medical Cannabis Registry palliative care patients cohort: initial experience and outcomes
title_full_unstemmed UK Medical Cannabis Registry palliative care patients cohort: initial experience and outcomes
title_short UK Medical Cannabis Registry palliative care patients cohort: initial experience and outcomes
title_sort uk medical cannabis registry palliative care patients cohort: initial experience and outcomes
topic Letter to the Editor
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8725528/
https://www.ncbi.nlm.nih.gov/pubmed/34980282
http://dx.doi.org/10.1186/s42238-021-00114-9
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