TY - JOUR
T1 - Clinical outcome data of anxiety patients treated with cannabis-based medicinal products in the United Kingdom
T2 - a cohort study from the UK Medical Cannabis Registry
AU - Rifkin-Zybutz, Raphael
AU - Erridge, Simon
AU - Holvey, Carl
AU - Coomber, Ross
AU - Gaffney, Jessica
AU - Lawn, Will
AU - Barros, Daniela
AU - Bhoskar, Urmila
AU - Mwimba, Gracia
AU - Praveen, Kavita
AU - Symeon, Chris
AU - Sachdeva-Mohan, Simmi
AU - Rucker, James J.
AU - Sodergren, Mikael H.
N1 - Funding Information:
Dr Raphael Rifkin-Zybutz (Academic Clinical Fellow, ACF-2021-17-018) is funded by Health Education England (HEE)/NIHR for this research project. The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR (Partner Name), NHS or the UK Department of Health and Social Care.
Funding Information:
James Rucker is a consultant psychiatrist, a former director at Sapphire Medical Clinics (London). James Rucker 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. James Rucker is funded by a fellowship (CS-2017-17-007) from the National Institute for Health Research (NIHR). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. James Rucker has no shareholdings in pharmaceutical companies. James Rucker reviewed this article and made comments.
Publisher Copyright:
© 2023, The Author(s).
PY - 2023/6/14
Y1 - 2023/6/14
N2 - Rationale: Cannabis-based medicinal products (CBMPs) have been identified as novel therapeutics for generalised anxiety disorder (GAD) based on pre-clinical models; however, there is a paucity of high-quality evidence on their effectiveness and safety. Objectives: This study aimed to evaluate the clinical outcomes of patients with GAD treated with dried flower, oil-based preparations, or a combination of both CBMPs. Methods: A prospective cohort study of patients with GAD (n = 302) enrolled in the UK Medical Cannabis Registry prescribed oil or flower-based CBMPs was performed. Primary outcomes were changes in generalised anxiety disorder-7 (GAD-7) questionnaires at 1, 3, and 6 months compared to baseline. Secondary outcomes were single-item sleep quality scale (SQS) and health-related quality of life index (EQ-5D-5L) questionnaires at the same time points. These changes were assessed by paired t-tests. Adverse events were assessed in line with CTCAE (Common Terminology Criteria for Adverse Events) v4.0. Results: Improvements in anxiety, sleep quality and quality of life were observed at each time point (p < 0.001). Patients receiving CBMPs had improvements in GAD-7 at all time points (1 month: difference −5.3 (95% CI −4.6 to −6.1), 3 months: difference −5.5 (95% CI −4.7 to −6.4), 6 months: difference −4.5 (95% CI −3.2 to −5.7)). Thirty-nine participants (12.9%) reported 269 adverse events in the follow-up period. Conclusions: Prescription of CBMPs in those with GAD is associated with clinically significant improvements in anxiety with an acceptable safety profile in a real-world setting. Randomised trials are required as a next step to investigate the efficacy of CBMPs.
AB - Rationale: Cannabis-based medicinal products (CBMPs) have been identified as novel therapeutics for generalised anxiety disorder (GAD) based on pre-clinical models; however, there is a paucity of high-quality evidence on their effectiveness and safety. Objectives: This study aimed to evaluate the clinical outcomes of patients with GAD treated with dried flower, oil-based preparations, or a combination of both CBMPs. Methods: A prospective cohort study of patients with GAD (n = 302) enrolled in the UK Medical Cannabis Registry prescribed oil or flower-based CBMPs was performed. Primary outcomes were changes in generalised anxiety disorder-7 (GAD-7) questionnaires at 1, 3, and 6 months compared to baseline. Secondary outcomes were single-item sleep quality scale (SQS) and health-related quality of life index (EQ-5D-5L) questionnaires at the same time points. These changes were assessed by paired t-tests. Adverse events were assessed in line with CTCAE (Common Terminology Criteria for Adverse Events) v4.0. Results: Improvements in anxiety, sleep quality and quality of life were observed at each time point (p < 0.001). Patients receiving CBMPs had improvements in GAD-7 at all time points (1 month: difference −5.3 (95% CI −4.6 to −6.1), 3 months: difference −5.5 (95% CI −4.7 to −6.4), 6 months: difference −4.5 (95% CI −3.2 to −5.7)). Thirty-nine participants (12.9%) reported 269 adverse events in the follow-up period. Conclusions: Prescription of CBMPs in those with GAD is associated with clinically significant improvements in anxiety with an acceptable safety profile in a real-world setting. Randomised trials are required as a next step to investigate the efficacy of CBMPs.
KW - Anxiety
KW - Cannabidiol
KW - Cannabis
KW - Generalised anxiety disorder
KW - Tetrahydrocannabinol
UR - http://www.scopus.com/inward/record.url?scp=85161858868&partnerID=8YFLogxK
U2 - 10.1007/s00213-023-06399-3
DO - 10.1007/s00213-023-06399-3
M3 - Article
C2 - 37314478
AN - SCOPUS:85161858868
SN - 0033-3158
VL - 240
SP - 1735
EP - 1745
JO - Psychopharmacology
JF - Psychopharmacology
IS - 8
ER -