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. 2021 Sep;41(3):362-370.
doi: 10.1002/npr2.12183. Epub 2021 May 14.

An initial analysis of the UK Medical Cannabis Registry: Outcomes analysis of first 129 patients

Simon Erridge  1   2 , Oliver Salazar  1 , Michal Kawka  1 , Carl Holvey  2 , Ross Coomber  2   3 , Azfer Usmani  2   4 , Mohammed Sajad  2   5 , Sushil Beri  1   2 , Jonathan Hoare  1   2 , Shaheen Khan  2   6 , Mark W Weatherall  2   7 , Michael Platt  1   2 , James J Rucker  2   8   9 , Mikael H Sodergren  1   2
Affiliations

An initial analysis of the UK Medical Cannabis Registry: Outcomes analysis of first 129 patients

Simon Erridge et al. Neuropsychopharmacol Rep. 2021 Sep.

Abstract

Aim: Cannabis-based medicinal products (CBMPs) are prescribed with increased frequency, despite a paucity of high-quality randomized controlled trials. The aim of this study is to analyze the early outcomes of the first series of patients prescribed CBMPs in the UK with respect to effects on health-related quality of life and clinical safety.

Methods: A prospective case series was performed using the UK Medical Cannabis Registry. Primary outcomes were change in patient-reported outcomes measures (EQ-5D-5L, General Anxiety Disorder-7 (GAD-7) and Single-Item Sleep Quality Scale (SQS)) at 1 and 3 months from baseline. The secondary outcome was the incidence of adverse events. Statistical significance was defined by a P-value <.050.

Results: There were 129 patients included in the final analysis with a mean age of 46.23 (±14.51) years. The most common indication was chronic pain of undefined etiology (n = 48; 37.2%). The median initial cannabidiol and (-)-trans-Δ⁹-tetrahydrocannabinol daily dose was 20.0 mg (Range: 0.0-768.0 mg) and 3.9 mg (Range: 0.0-660.0 mg), respectively. Statistically significant improvements in health-related quality of life were demonstrated at 1 and 3 months in GAD-7, SQS, EQ-5D-5L pain and discomfort subscale, EQ-5D-5L anxiety and depression subscale, EQ-VAS and EQ-5D-5L index values(P < .050). There were 31 (24.03%) total reported adverse events.

Conclusion: This study suggests that CBMP therapy may be associated with an improvement in health-related quality-of-life outcomes as self-reported by patients. CBMPs are also demonstrated to be relatively safe in the short to medium-term. These findings must be treated with caution given the limited scope of this initial analysis, with no placebo or an active comparator, with further research required.

Keywords: UK registry; cannabinoids; medical cannabis; sapphire clinic.

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Conflict of interest statement

Simon Erridge is a junior doctor and undertakes paid consultancy work at Sapphire Medical Clinics. Simon Erridge is an honorary clinical research fellow at Imperial College London. The views expressed are those of the author(s) and not necessarily those of the NHS. Oliver Salazar and Michal Kawka is a medical student at Imperial College London. Carl Holvey is the chief clinical pharmacist at Sapphire Medical Clinics. Ross Coomber is a consultant orthopedic surgeon, a director, and a shareholder at Sapphire Medical Clinics and a consultant at St George's Hospital, London. The views expressed are those of the author(s) and not necessarily those of the NHS. Azfer Usmani is a pain specialist at Sapphire Medical Clinics (London) and a consultant at Dartford and Gravesham NHS Trust. The views expressed are those of the author(s) and not necessarily those of the NHS. Mohammed Sajad is a pain specialist at Sapphire Medical Clinics (London) and a consultant at Dudley Group of Hospitals NHS Trust. The views expressed are those of the author(s) and not necessarily those of the NHS. Sushil Beri is a consultant in pediatrics and a director and a shareholder at Sapphire Medical Clinics (London). The views expressed are those of the author(s) and not necessarily those of the NHS. Jonathan Hoare is a consultant in gastroenterology and a director and a shareholder at Sapphire Medical Clinics (London). The views expressed are those of the author(s) and not necessarily those of the NHS. Shaheen Khan is a consultant in palliative medicine and a director and a shareholder at Sapphire Medical Clinics (London). The views expressed are those of the author(s) and not necessarily those of the NHS. Mark Weatherall is a consultant in neurology and a director and a shareholder at Sapphire Medical Clinics (London). The views expressed are those of the author(s) and not necessarily those of the NHS. Michael Platt is a consultant in pain services and a director and a shareholder at Sapphire Medical Clinics (London). The views expressed are those of the author(s) and not necessarily those of the NHS. James Rucker is a consultant psychiatrist, a director, and a shareholder 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 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 James Rucker to attend trial related meetings and conferences to present the results of research using psilocybin. James Rucker has undertaken paid consultancy work for Beckley PsyTech and Clerkenwell Health. Payments for consultancy work are received and managed by King's College London and James Rucker does not benefit personally. James Rucker reviewed this article and made comments. Mikael Sodergren is a consultant hepatopancreatobiliary surgeon, a director, and a shareholder at Sapphire Medical Clinics and a consultant at Imperial College NHS Trust, London. He is an honorary senior clinical lecturer at Imperial College London. The views expressed are those of the author(s) and not necessarily those of the NHS. Mikael Sodergren is the research director at EMMAC Life Sciences. All authors have contributed to and approved the final manuscript. The authors confirm that the PI for this paper is Mikael H Sodergren and that he had direct clinical responsibility for patients. Simon Erridge, Oliver Salazar, Michal Kawka, Carl Holvey, Ross Coomber, Azfer Usmani, Mohammed Sajad, Sushil Beri, Jonathan Hoare, Shaheen Khan, Mark Weatherall, Michael Platt and James Rucker: had no shareholdings in pharmaceutical companies. SE, CH, RC, SB, JH, SK, MWW, MP, JJR, and MHS 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.

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