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Published in: Digestive Diseases and Sciences 6/2017

01-06-2017 | Original Article

Low-Dose Cannabidiol Is Safe but Not Effective in the Treatment for Crohn’s Disease, a Randomized Controlled Trial

Authors: Timna Naftali, Refael Mechulam, Amir Marii, Gila Gabay, Asaf Stein, Miriam Bronshtain, Ido Laish, Fabiana Benjaminov, Fred M. Konikoff

Published in: Digestive Diseases and Sciences | Issue 6/2017

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Abstract

Background

Cannabidiol (CBD) is an anti-inflammatory cannabinoid shown to be beneficial in a mouse model of IBD. Lacking any central effect, cannabidiol is an attractive option for treating inflammatory diseases.

Aim

To assess the effects of cannabidiol on Crohn’s disease in a randomized placebo-controlled trial.

Patients and Methods

Twenty patients aged 18–75 years with a Crohn’s disease activity index (CDAI) >200 were randomized to receive oral (10 mg) CBD or placebo twice daily. Patients did not respond to standard treatment with steroids (11 patients), thiopurines (14), or TNF antagonists (11). Disease activity and laboratory parameters were assessed during 8 weeks of treatment and 2 weeks thereafter. Other medical treatment remained unchanged.

Results

Of 20 patients recruited 19 completed the study. Their mean age was 39 ± 15, and 11 were males. The average CDAI before cannabidiol consumption was 337 ± 108 and 308 ± 96 (p = NS) in the CBD and placebo groups, respectively. After 8 weeks of treatment, the index was 220 ± 122 and 216 ± 121 in the CBD and placebo groups, respectively (p = NS). Hemoglobin, albumin, and kidney and liver function tests remained unchanged. No side effects were observed.

Conclusion

In this study of moderately active Crohn’s disease, CBD was safe but had no beneficial effects. This could be due to lack of effect of CBD on Crohn’s disease, but could also be due to the small dose of CBD, the small number of patients in the study, or the lack of the necessary synergism with other cannabinoids. Further investigation is warranted.

ClinicalTrials.gov

NCT01037322.
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Metadata
Title
Low-Dose Cannabidiol Is Safe but Not Effective in the Treatment for Crohn’s Disease, a Randomized Controlled Trial
Authors
Timna Naftali
Refael Mechulam
Amir Marii
Gila Gabay
Asaf Stein
Miriam Bronshtain
Ido Laish
Fabiana Benjaminov
Fred M. Konikoff
Publication date
01-06-2017
Publisher
Springer US
Published in
Digestive Diseases and Sciences / Issue 6/2017
Print ISSN: 0163-2116
Electronic ISSN: 1573-2568
DOI
https://doi.org/10.1007/s10620-017-4540-z

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