title: Low-Dose Cannabidiol Is Safe but Not Effective in the Treatment for Crohn's Disease, a Randomized Controlled Trial.
abstract: 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.
  
  
  
  To assess the effects of cannabidiol on Crohn's disease in a randomized placebo-controlled trial.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Gastroenterology, Meir Medical Center, 59 Tchernihovsky st., 4441002, Kfar Saba, Israel. Timna.naftali@clalit.org.il.|Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. Timna.naftali@clalit.org.il.
authors.forename: Timna
authors.identifier: 0000-0002-8931-6524
authors.initials: T
authors.lastname: Naftali
authors.affiliation: School of Pharmacology, Hadassa Medical School, Hebrew University of Jerusalem, Jerusalem, Israel.|Faculty of Pharmacology, School of Medicine, Hebrew University, POB 1221, 9112102, Ein Karem, Jerusalem, Israel.
authors.forename: Refael
authors.initials: R
authors.lastname: Mechulam
authors.affiliation: Hilel Yafe Medical Center, Hshalom st., 38100, Hadera, Israel.
authors.forename: Amir
authors.initials: A
authors.lastname: Marii
authors.affiliation: Department of Gastroenterology, Meir Medical Center, 59 Tchernihovsky st., 4441002, Kfar Saba, Israel.|Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Gila
authors.initials: G
authors.lastname: Gabay
authors.affiliation: Department of Gastroenterology, Meir Medical Center, 59 Tchernihovsky st., 4441002, Kfar Saba, Israel.|Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Asaf
authors.initials: A
authors.lastname: Stein
authors.affiliation: Department of Gastroenterology, Meir Medical Center, 59 Tchernihovsky st., 4441002, Kfar Saba, Israel.|Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Miriam
authors.initials: M
authors.lastname: Bronshtain
authors.affiliation: Department of Gastroenterology, Meir Medical Center, 59 Tchernihovsky st., 4441002, Kfar Saba, Israel.|Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Ido
authors.initials: I
authors.lastname: Laish
authors.affiliation: Department of Gastroenterology, Meir Medical Center, 59 Tchernihovsky st., 4441002, Kfar Saba, Israel.|Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Fabiana
authors.initials: F
authors.lastname: Benjaminov
authors.affiliation: Department of Gastroenterology, Meir Medical Center, 59 Tchernihovsky st., 4441002, Kfar Saba, Israel.|Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Fred M
authors.initials: FM
authors.lastname: Konikoff
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002185:Cannabidiol / Q000008:administration & dosage* / Q000009:adverse effects; D002188:Cannabis; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy / Q000009:adverse effects; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects; D012720:Severity of Illness Index; D017211:Treatment Failure; D055815:Young Adult
chemical_list: D010936:Plant Extracts; D002185:Cannabidiol
keywords: Cannabidiol; Cannabis; Crohn’s disease; Inflammatory bowel disease