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

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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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Authors and Affiliations

  1. Department of Gastroenterology, Meir Medical Center, 59 Tchernihovsky st., 4441002, Kfar Saba, Israel

    Timna Naftali, Gila Gabay, Asaf Stein, Miriam Bronshtain, Ido Laish, Fabiana Benjaminov & Fred M. Konikoff

  2. Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel

    Timna Naftali, Gila Gabay, Asaf Stein, Miriam Bronshtain, Ido Laish, Fabiana Benjaminov & Fred M. Konikoff

  3. School of Pharmacology, Hadassa Medical School, Hebrew University of Jerusalem, Jerusalem, Israel

    Refael Mechulam

  4. Faculty of Pharmacology, School of Medicine, Hebrew University, POB 1221, 9112102, Ein Karem, Jerusalem, Israel

    Refael Mechulam

  5. Hilel Yafe Medical Center, Hshalom st., 38100, Hadera, Israel

    Amir Marii

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  1. Timna Naftali
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  2. Refael Mechulam
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Correspondence to Timna Naftali.

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Naftali, T., Mechulam, R., Marii, A. et al. Low-Dose Cannabidiol Is Safe but Not Effective in the Treatment for Crohn’s Disease, a Randomized Controlled Trial. Dig Dis Sci 62, 1615–1620 (2017). https://doi.org/10.1007/s10620-017-4540-z

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  • DOI: https://doi.org/10.1007/s10620-017-4540-z

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