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An initial analysis of the UK Medical Cannabis Registry: Outcomes analysis of first 129 patients

AIM: Cannabis‐based medicinal products (CBMPs) are prescribed with increased frequency, despite a paucity of high‐quality randomized controlled trials. The aim of this study is to analyze the early outcomes of the first series of patients prescribed CBMPs in the UK with respect to effects on health‐...

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Autores principales: Erridge, Simon, Salazar, Oliver, Kawka, Michal, Holvey, Carl, Coomber, Ross, Usmani, Azfer, Sajad, Mohammed, Beri, Sushil, Hoare, Jonathan, Khan, Shaheen, Weatherall, Mark W., Platt, Michael, Rucker, James J., Sodergren, Mikael H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8411316/
https://www.ncbi.nlm.nih.gov/pubmed/33988306
http://dx.doi.org/10.1002/npr2.12183
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author Erridge, Simon
Salazar, Oliver
Kawka, Michal
Holvey, Carl
Coomber, Ross
Usmani, Azfer
Sajad, Mohammed
Beri, Sushil
Hoare, Jonathan
Khan, Shaheen
Weatherall, Mark W.
Platt, Michael
Rucker, James J.
Sodergren, Mikael H.
author_facet Erridge, Simon
Salazar, Oliver
Kawka, Michal
Holvey, Carl
Coomber, Ross
Usmani, Azfer
Sajad, Mohammed
Beri, Sushil
Hoare, Jonathan
Khan, Shaheen
Weatherall, Mark W.
Platt, Michael
Rucker, James J.
Sodergren, Mikael H.
author_sort Erridge, Simon
collection PubMed
description AIM: Cannabis‐based medicinal products (CBMPs) are prescribed with increased frequency, despite a paucity of high‐quality randomized controlled trials. The aim of this study is to analyze the early outcomes of the first series of patients prescribed CBMPs in the UK with respect to effects on health‐related quality of life and clinical safety. METHODS: A prospective case series was performed using the UK Medical Cannabis Registry. Primary outcomes were change in patient‐reported outcomes measures (EQ‐5D‐5L, General Anxiety Disorder‐7 (GAD‐7) and Single‐Item Sleep Quality Scale (SQS)) at 1 and 3 months from baseline. The secondary outcome was the incidence of adverse events. Statistical significance was defined by a P‐value <.050. RESULTS: There were 129 patients included in the final analysis with a mean age of 46.23 (±14.51) years. The most common indication was chronic pain of undefined etiology (n = 48; 37.2%). The median initial cannabidiol and (−)‐trans‐Δ⁹‐tetrahydrocannabinol daily dose was 20.0 mg (Range: 0.0‐768.0 mg) and 3.9 mg (Range: 0.0‐660.0 mg), respectively. Statistically significant improvements in health‐related quality of life were demonstrated at 1 and 3 months in GAD‐7, SQS, EQ‐5D‐5L pain and discomfort subscale, EQ‐5D‐5L anxiety and depression subscale, EQ‐VAS and EQ‐5D‐5L index values(P < .050). There were 31 (24.03%) total reported adverse events. CONCLUSION: This study suggests that CBMP therapy may be associated with an improvement in health‐related quality‐of‐life outcomes as self‐reported by patients. CBMPs are also demonstrated to be relatively safe in the short to medium‐term. These findings must be treated with caution given the limited scope of this initial analysis, with no placebo or an active comparator, with further research required.
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spelling pubmed-84113162021-09-03 An initial analysis of the UK Medical Cannabis Registry: Outcomes analysis of first 129 patients Erridge, Simon Salazar, Oliver Kawka, Michal Holvey, Carl Coomber, Ross Usmani, Azfer Sajad, Mohammed Beri, Sushil Hoare, Jonathan Khan, Shaheen Weatherall, Mark W. Platt, Michael Rucker, James J. Sodergren, Mikael H. Neuropsychopharmacol Rep Original Articles AIM: Cannabis‐based medicinal products (CBMPs) are prescribed with increased frequency, despite a paucity of high‐quality randomized controlled trials. The aim of this study is to analyze the early outcomes of the first series of patients prescribed CBMPs in the UK with respect to effects on health‐related quality of life and clinical safety. METHODS: A prospective case series was performed using the UK Medical Cannabis Registry. Primary outcomes were change in patient‐reported outcomes measures (EQ‐5D‐5L, General Anxiety Disorder‐7 (GAD‐7) and Single‐Item Sleep Quality Scale (SQS)) at 1 and 3 months from baseline. The secondary outcome was the incidence of adverse events. Statistical significance was defined by a P‐value <.050. RESULTS: There were 129 patients included in the final analysis with a mean age of 46.23 (±14.51) years. The most common indication was chronic pain of undefined etiology (n = 48; 37.2%). The median initial cannabidiol and (−)‐trans‐Δ⁹‐tetrahydrocannabinol daily dose was 20.0 mg (Range: 0.0‐768.0 mg) and 3.9 mg (Range: 0.0‐660.0 mg), respectively. Statistically significant improvements in health‐related quality of life were demonstrated at 1 and 3 months in GAD‐7, SQS, EQ‐5D‐5L pain and discomfort subscale, EQ‐5D‐5L anxiety and depression subscale, EQ‐VAS and EQ‐5D‐5L index values(P < .050). There were 31 (24.03%) total reported adverse events. CONCLUSION: This study suggests that CBMP therapy may be associated with an improvement in health‐related quality‐of‐life outcomes as self‐reported by patients. CBMPs are also demonstrated to be relatively safe in the short to medium‐term. These findings must be treated with caution given the limited scope of this initial analysis, with no placebo or an active comparator, with further research required. John Wiley and Sons Inc. 2021-05-14 /pmc/articles/PMC8411316/ /pubmed/33988306 http://dx.doi.org/10.1002/npr2.12183 Text en © 2021 The Authors. Neuropsychopharmacology Reports published by John Wiley & Sons Australia, Ltd on behalf of the Japanese Society of Neuropsychopharmacology. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Articles
Erridge, Simon
Salazar, Oliver
Kawka, Michal
Holvey, Carl
Coomber, Ross
Usmani, Azfer
Sajad, Mohammed
Beri, Sushil
Hoare, Jonathan
Khan, Shaheen
Weatherall, Mark W.
Platt, Michael
Rucker, James J.
Sodergren, Mikael H.
An initial analysis of the UK Medical Cannabis Registry: Outcomes analysis of first 129 patients
title An initial analysis of the UK Medical Cannabis Registry: Outcomes analysis of first 129 patients
title_full An initial analysis of the UK Medical Cannabis Registry: Outcomes analysis of first 129 patients
title_fullStr An initial analysis of the UK Medical Cannabis Registry: Outcomes analysis of first 129 patients
title_full_unstemmed An initial analysis of the UK Medical Cannabis Registry: Outcomes analysis of first 129 patients
title_short An initial analysis of the UK Medical Cannabis Registry: Outcomes analysis of first 129 patients
title_sort initial analysis of the uk medical cannabis registry: outcomes analysis of first 129 patients
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8411316/
https://www.ncbi.nlm.nih.gov/pubmed/33988306
http://dx.doi.org/10.1002/npr2.12183
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