title: Cannabis induces a clinical response in patients with Crohn's disease: a prospective placebo-controlled study.
abstract: OBJECTIVE
  The marijuana plant Cannabis sativa has been reported to produce beneficial effects for patients with inflammatory bowel diseases, but this has not been investigated in controlled trials. We performed a prospective trial to determine whether cannabis can induce remission in patients with Crohn's disease.
  
  
  METHODS
  We studied 21 patients (mean age, 40 ± 14 y; 13 men) with Crohn's Disease Activity Index (CDAI) scores greater than 200 who did not respond to therapy with steroids, immunomodulators, or anti-tumor necrosis factor-α agents. Patients were assigned randomly to groups given cannabis, twice daily, in the form of cigarettes containing 115 mg of Δ9-tetrahydrocannabinol (THC) or placebo containing cannabis flowers from which the THC had been extracted. Disease activity and laboratory tests were assessed during 8 weeks of treatment and 2 weeks thereafter.
  
  
  RESULTS
  Complete remission (CDAI score, <150) was achieved by 5 of 11 subjects in the cannabis group (45%) and 1 of 10 in the placebo group (10%; P = .43). A clinical response (decrease in CDAI score of >100) was observed in 10 of 11 subjects in the cannabis group (90%; from 330 ± 105 to 152 ± 109) and 4 of 10 in the placebo group (40%; from 373 ± 94 to 306 ± 143; P = .028). Three patients in the cannabis group were weaned from steroid dependency. Subjects receiving cannabis reported improved appetite and sleep, with no significant side effects.
  
  
  CONCLUSIONS
  Although the primary end point of the study (induction of remission) was not achieved, a short course (8 weeks) of THC-rich cannabis produced significant clinical, steroid-free benefits to 10 of 11 patients with active Crohn's disease, compared with placebo, without side effects. Further studies, with larger patient groups and a nonsmoking mode of intake, are warranted. ClinicalTrials.gov, NCT01040910.
authors: Department of Gastroenterology and Hepatology, Meir Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Kfar Saba, Israel. Electronic address: naftali@post.tau.ac.il.
authors: Timna
authors: T
authors: Naftali
authors: Lihi
authors: L
authors: Bar-Lev Schleider
authors: Iris
authors: I
authors: Dotan
authors: Ephraim Philip
authors: EP
authors: Lansky
authors: Fabiana
authors: F
authors: Sklerovsky Benjaminov
authors: Fred Meir
authors: FM
authors: Konikoff
mesh_terms: D000328:Adult; D002186:Cannabinoids / Q000008:administration & dosage*; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D002186:Cannabinoids; D005765:Gastrointestinal Agents; D010919:Placebos
keywords: C-reactive protein; CBD; CDAI; CRP; Cannabinoids; Crohn's Disease; Crohn's Disease Activity Index; Endocannabinoid; IBD; Inflammation; Inflammatory Bowel Disease; SF-36; Short-Form 36; THC; TNF; cannabidiol; inflammatory bowel disease; tumor necrosis factor; Δ9-tetrahydrocannabinol