Clinical outcome data of anxiety patients treated with cannabis-based medicinal products in the United Kingdom: a cohort study from the UK Medical Cannabis Registry
Raphael Rifkin‑Zybutz1,2,3 · Simon Erridge1,4 · Carl Holvey4 · Ross Coomber4,5 · Jessica Gafney2 · Will Lawn3,6 · Daniela Barros4 · Urmila Bhoskar4 · Gracia Mwimba4 · Kavita Praveen4 · Chris Symeon4 · Simmi Sachdeva‑Mohan4 · James J Rucker2,4,7 · Mikael H Sodergren1,4
1 Imperial College Medical Cannabis Research Group,
Department of Surgery and Cancer, Imperial College
London, Academic Surgical Unit, 10th Floor QEQM, St
Mary’s Hospital, South Wharf Road, London W2 1NY, UK
2 Department of Psychological Medicine, King’s College
London, London, UK
3 Department of Psychology, IoPPN, KCL, London, UK
4 Sapphire Medical Clinics, London, UK
5 St. George’s Hospital NHS Trust, London, UK
6 Clinical Psychopharmacology Unit, Department of Clinical,
Educational and Health Psychology, UCL, London, UK
7 South London & Maudsley NHS Foundation Trust, London,
UK
Affiliationer
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.
