- Fecal Incontinence
|A Randomized, Double-blind, Placebo-controlled, Parallel-group, Pilot Study of Cannabidiol-rich Botanical Extract in the Symptomatic Treatment of Ulcerative Colitis
Irving PM1, Iqbal T2, Nwokolo C3, Subramanian S4, Bloom S5, Prasad N6, Hart A7, Murray C8, Lindsay JO9, Taylor A10, Barron R10, Wright S10. Inflamm Bowel Dis. 2018 Mar 19;24(4):714-724. doi: 10.1093/ibd/izy002.
1 Guy's and St Thomas' NHS Foundation Trust, London, UK.
2 University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
3 University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
4 The Royal Liverpool and Broadgreen University Hospitals NHS Foundation Trust, Liverpool, UK.
5 University College Hospitals NHS Foundation Trust, London, UK.
6 Wrightington, Wigan and Leigh NHS Foundation Trust, Wigan, UK.
7 The North West London Hospitals NHS Foundation Trust, Middlesex, UK.
8 Royal Free London NHS Foundation Trust, London, UK.
9 The Royal London Hospital, Barts Health NHS Trust, London, UK.
10 GW Research Ltd, Cambridge, UK.
BACKGROUND: Cannabidiol (CBD) exhibits anti-inflammatory properties that could improve disease activity in inflammatory bowel disease. This proof-of-concept study assessed efficacy, safety and tolerability of CBD-rich botanical extract in ulcerative colitis (UC) patients.
METHODS: Patients aged 18 years or older, with left-sided or extensive UC, Mayo scores of 4-10 (endoscopy scores ≥1), and on stable 5-aminosalicylic acid dosing, were randomized to 10-weeks' CBD-rich botanical extract or placebo capsules. The primary endpoint was the percentage of patients in remission after treatment. Statistical testing was 2-sided, using a 10% significance level.
RESULTS: Patients were less tolerant of CBD-rich botanical extract compared with placebo, taking on average one-third fewer capsules, and having more compliance-related protocol deviations (principally insufficient exposure), prompting identification of a per protocol (PP) analysis set. The primary endpoint was negative; end of treatment remission rates were similar for CBD-rich botanical extract (28%) and placebo (26%). However, PP analysis of total and partial Mayo scores favoured CBD-rich botanical extract (P = 0.068 and P = 0.038, respectively). Additionally, PP analyses of the more subjective physician's global assessment of illness severity, subject global impression of change, and patient-reported quality-of-life outcomes were improved for patients taking CBD-rich botanical extract (P = 0.069, P = 0.003, and P = 0.065, respectively). Adverse events (AEs) were predominantly mild/moderate with many in the CBD-rich botanical extract group potentially attributable to the ∆9-tetrahydrocannabinol content. A greater proportion of gastrointestinal-related AEs, indicative of UC worsening, was seen on placebo.
CONCLUSION: Although the primary endpoint was not reached, several signals suggest CBD-rich botanical extract may be beneficial for symptomatic treatment of UC.