TY - JOUR
T1 - UK medical cannabis registry
T2 - assessment of clinical outcomes in patients with headache disorders
AU - Nicholas, Martha
AU - Erridge, Simon
AU - Bapir, Lara
AU - Pillai, Manaswini
AU - Dalavaye, Nishaanth
AU - Holvey, Carl
AU - Coomber, Ross
AU - Rucker, James J.
AU - Weatherall, Mark W.
AU - Sodergren, Mikael H.
N1 - Funding Information:
S Erridge, C Holvey, R Coomber, JJ Rucker, MW Weatherall & MH Sodergren are the founding clinicians of Sapphire Medical Clinics, which is the first clinic registered with the CQC to evaluate patients for medical cannabis in England. S Erridge is a junior doctor and undertakes paid consultancy work at Sapphire Medical Clinics. He is also an honorary clinical research fellow at Imperial College London. C Holvey is chief clinical pharmacist at Sapphire Medical Clinics. R Coomber is a consultant orthopedic surgeon at St George’s Hospital, London, and Head of Operations at Sapphire Medical Clinics. JJ Rucker is a consultant psychiatrist at Sapphire Medical Clinics (London). He is an honorary consultant psychiatrist at The South London & Maudsley NHS Foundation Trust, and an NIHR Clinician Scientist Fellow at the Centre for Affective Disorders at King’s College London. JJ Rucker is funded by a fellowship (CS-2017-17-007) from the National Institute for Health Research (NIHR). He also leads the Psychedelic Trials Group at King’s College London. King’s College London receives grant funding from COMPASS Pathways PLC to undertake phase 1 and phase 2 trials with psilocybin. COMPASS Pathways PLC has paid for JJ Rucker to attend trial-related meetings and conferences to present the results of research using psilocybin. JJ Rucker has also undertaken paid consultancy work for Beckley PsyTech and Clerkenwell Health. Payments for consultancy work are received and managed by King’s College London. M Weatherall is a consultant in neurology and a director at Sapphire Medical Clinics (London). MH Sodergren is a consultant hepatopancreatobiliary surgeon, a director at Sapphire Medical Clinics and a consultant at Imperial College NHS Trust, London. He is senior clinical lecturer at Imperial College London and Chief Medical Officer at Curaleaf International. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Publisher Copyright:
© 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
PY - 2023/2/3
Y1 - 2023/2/3
N2 - Objectives: Headache disorders are a common cause of disability and reduced health-related quality of life globally. Growing evidence supports the use of cannabis-based medicinal products (CBMPs) for chronic pain; however, a paucity of research specifically focuses on CBMPs’ efficacy and safety in headache disorders. This study aims to assess changes in validated patient-reported outcome measures (PROMs) in patients with headaches prescribed CBMPs and investigate the clinical safety in this population. Methods: A case series of the UK Medical Cannabis Registry was conducted. Primary outcomes were changes from baseline in PROMs (Headache Impact Test-6 (HIT-6), Migraine Disability Assessment (MIDAS), EQ-5D-5L, Generalized Anxiety Disorder-7 (GAD-7) questionnaire and Single-Item Sleep Quality Scale (SQS)) at 1-, 3-, and 6-months follow-up. P-values <0.050 were deemed statistically significant. Results: Ninety-seven patients were identified for inclusion. Improvements in HIT-6, MIDAS, EQ-5D-5L and SQS were observed at 1-, 3-, and 6-months (p < 0.005) follow-up. GAD-7 improved at 1- and 3-months (p < 0.050). Seventeen (17.5%) patients experienced a total of 113 (116.5%) adverse events. Conclusion: Improvements in headache/migraine-specific PROMs and general health-related quality of life were associated with the initiation of CBMPs in patients with headache disorders. Cautious interpretation of results is necessary, and randomized control trials are required to ascertain causality.
AB - Objectives: Headache disorders are a common cause of disability and reduced health-related quality of life globally. Growing evidence supports the use of cannabis-based medicinal products (CBMPs) for chronic pain; however, a paucity of research specifically focuses on CBMPs’ efficacy and safety in headache disorders. This study aims to assess changes in validated patient-reported outcome measures (PROMs) in patients with headaches prescribed CBMPs and investigate the clinical safety in this population. Methods: A case series of the UK Medical Cannabis Registry was conducted. Primary outcomes were changes from baseline in PROMs (Headache Impact Test-6 (HIT-6), Migraine Disability Assessment (MIDAS), EQ-5D-5L, Generalized Anxiety Disorder-7 (GAD-7) questionnaire and Single-Item Sleep Quality Scale (SQS)) at 1-, 3-, and 6-months follow-up. P-values <0.050 were deemed statistically significant. Results: Ninety-seven patients were identified for inclusion. Improvements in HIT-6, MIDAS, EQ-5D-5L and SQS were observed at 1-, 3-, and 6-months (p < 0.005) follow-up. GAD-7 improved at 1- and 3-months (p < 0.050). Seventeen (17.5%) patients experienced a total of 113 (116.5%) adverse events. Conclusion: Improvements in headache/migraine-specific PROMs and general health-related quality of life were associated with the initiation of CBMPs in patients with headache disorders. Cautious interpretation of results is necessary, and randomized control trials are required to ascertain causality.
KW - cannabidiol
KW - headache
KW - Medical cannabis
KW - migraine
KW - tetrahydrocannabinol
UR - http://www.scopus.com/inward/record.url?scp=85147660460&partnerID=8YFLogxK
U2 - 10.1080/14737175.2023.2174017
DO - 10.1080/14737175.2023.2174017
M3 - Article
C2 - 36722292
AN - SCOPUS:85147660460
SN - 1473-7175
VL - 23
SP - 85
EP - 96
JO - Expert Review of Neurotherapeutics
JF - Expert Review of Neurotherapeutics
IS - 1
ER -