An observational study of clinical outcome measures in patients treated with cannabis‐based medicinal products on the UK Medical Cannabis Registry
Simon Erridge, Ophilia Leung, Carl Holvey, Ross Coomber, Sushil Beri, Shaheen Khan, Mark W. Weatherall, James J. Rucker, Michael W. Platt, Mikael H. Sodergren - Pharmacology (medical)
- Psychiatry and Mental health
- Pharmacology
- Clinical Psychology
Abstract
Introduction
While there is increasing evidence of the effects of cannabis‐based medicinal products (CBMPs) on health‐related quality of life (HRQoL), a major limitation of the current literature is the heterogeneity of studied CBMPs. This study aims to analyze changes in HRQoL in patients prescribed a homogenous selection of CBMPs.
Methods
Primary outcomes were changes in patient‐reported outcomes (PROMs) at 1, 3, 6, and 12 months from baseline. The secondary outcome was an adverse events analysis. Statistical significance was defined as p < 0.050.
Results
1378 patients prescribed Adven® CBMPs (Curaleaf International, Guernsey, UK) were included in the final analysis. 581 (42.16%) participants were current users of cannabis at baseline. 641 (46.51%), 235 (17.05%), and 502 (36.43%) patients were treated with oils, dried flowers, or a combination of the two, respectively. Improvements were found in all PROMs in each route of administration at 1, 3, 6, and 12 months from baseline (p < 0.010). Those prescribed dried flower only or both oils and dried flower experienced greater improvements in GAD‐7, SQS, and EQ‐5D‐5L index values at 12 months (p < 0.050). There was no difference in outcomes between those prescribed dried flower only or dried flower with oils (p > 0.050). 3663 (265.82%) adverse events were reported by 297 (21.55%) patients.
Conclusion
There was an associated improvement in self‐reported anxiety, sleep quality, and HRQoL in patients treated with the CBMPs. Those prescribed treatment formulations including dried flower were most likely to show a clinical improvement. However, these results must be interpreted with caution given the limitations of study design.