TY - JOUR
T1 - Low-Dose Cannabidiol Is Safe but Not Effective in the Treatment for Crohn’s Disease, a Randomized Controlled Trial
AU - Naftali, Timna
AU - Mechulam, Refael
AU - Marii, Amir
AU - Gabay, Gila
AU - Stein, Asaf
AU - Bronshtain, Miriam
AU - Laish, Ido
AU - Benjaminov, Fabiana
AU - Konikoff, Fred M.
N1 - Publisher Copyright:
© 2017, Springer Science+Business Media New York.
PY - 2017/6/1
Y1 - 2017/6/1
N2 - 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.
AB - 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.
KW - Cannabidiol
KW - Cannabis
KW - Crohn’s disease
KW - Inflammatory bowel disease
UR - http://www.scopus.com/inward/record.url?scp=85016113978&partnerID=8YFLogxK
U2 - 10.1007/s10620-017-4540-z
DO - 10.1007/s10620-017-4540-z
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AN - SCOPUS:85016113978
SN - 0163-2116
VL - 62
SP - 1615
EP - 1620
JO - Digestive Diseases and Sciences
JF - Digestive Diseases and Sciences
IS - 6
ER -