A Randomized, Double-blind, Placebo-controlled, Parallel-group, Pilot Study of Cannabidiol-rich Botanical Extract in the Symptomatic Treatment of Ulcerative Colitis.

Irving, Peter M, Iqbal, Tariq, Nwokolo, Chuka, Subramanian, Sreedhar, Bloom, Stuart, Prasad, Neeraj, Hart, Ailsa, Murray, Charles, Lindsay, James O, Taylor, Adam, Barron, Rachel and Wright, Stephen (2018) A Randomized, Double-blind, Placebo-controlled, Parallel-group, Pilot Study of Cannabidiol-rich Botanical Extract in the Symptomatic Treatment of Ulcerative Colitis. Inflammatory bowel diseases, 24 (4). pp. 714-724. ISSN 1536-4844.

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Abstract

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.

Item Type:	Article
Subjects:	WI Digestive system. Gastroenterology
Divisions:	Planned IP Care > Gastroentrology
Related URLs:	https://www.ncbi.nlm.nih.gov/pubmed/2953...
Depositing User:	Jennifer Manders
Date Deposited:	31 May 2019 10:19
Last Modified:	31 May 2019 10:19
URI:	http://www.repository.uhblibrary.co.uk/id/eprint/2125

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