An observational study of clinical outcome measures in patients treated with cannabis-based medicinal products on the UK Medical Cannabis Registry
Simon Erridge 1 2, Ophilia Leung 1, Carl Holvey 2, Ross Coomber 2 3, Sushil Beri 1 2, Shaheen Khan 2 4, Mark W Weatherall 2 5, James J Rucker 2 6 7, Michael W Platt 2, Mikael H Sodergren 1 2
- 1Imperial College Medical Cannabis Research Group, Department of Surgery and Cancer, Imperial College London, London, UK.
- 2Sapphire Medical Clinics, London, UK.
- 3St. George’s Hospital NHS Trust, London, UK.
- 4Guy’s & St. Thomas’ NHS Foundation Trust, London, UK.
- 5Buckinghamshire Healthcare NHS Trust, Amersham, UK.
- 6Department of Psychological Medicine, Kings College London, London, UK.
- 7South London & Maudsley NHS Foundation Trust, London, UK.
Affiliationer
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). 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.