P358. Tetrahydrocannabinol (THC) induces clinical and biochemical improvement with a steroid sparing effect in active inflammatory bowel disease
T. Naftali1, L. Barlev2, G. Gabay1, Y. Chowers3, I. Dotan4, A. Stein1, M. Bronstein1, F.M. Konikoff1, 1Meir General Hospital, Gastroenterology, Kfar Saba, Israel, 2Tel aviv University, pschology, Tel Aviv, Israel, 3Rambam Health care campus, Gastroenterology, Haifa, Israel, 4Tel Aviv Sorasky Medical center, Gastroenterology, Tel Aviv, Israel
The anecdotally observed effects of cannabis on IBD were never investigated in a controlled trial.
Aim: To assess the effects of THC on IBD in a randomized placebo controlled trial.
Patients and Methods: Patients aged 18–75 years with a Crohn's Disease Activity Index (CDAI) >200 or Simple Ulcerative Colitis Activity Index (UCAI) >3 who did not respond to steroids (6 CD, 3 UC patients), immunomodulators (18 CD, 3 UC) or TNF antagonists (14 CD) were randomized to receive 2 cigarettes of medical cannabis or placebo daily. Each cigarette contained 0.5 g of cannabis, corresponding to 11.5 mg Tetrahydrocannabinol (THC) or placebo. Disease activity and laboratory testing were assessed during 8 weeks of treatment and 2 weeks post treatment. All other medical treatment remained unchanged.
Ten patients with UC and 22 with CD were recruited. 10 UC and 20 CD patients respectively, completed the study, mean age 40 (±13), 15 males. One patient was lost to follow up and one withdrew consent. The average CDAI before cannabis consumption was 358±99 and 373±94 in the THC and placebo groups, respectively. After 8 weeks of treatment, the CDAI dropped to 139±111 in the THC group but remained 306±143 in the placebo group (p < 0.05). Two weeks after cessation of treatment the CDAI in the THC group returned to 333±167. Five patients in the THC group but only one in the placebo group went into complete remission (CDAI <100). Four steroid-dependent patients in the THC group stopped steroids during the study. The mean CRP before treatment was 1.3 mg/dl and 2.6 in the study and control groups, respectively, and decreased to 0.9 and 2.1 (p = 0.05) after 8 weeks. In the UC group, average UCAI before cannabis was 11±2 and 11±1.5 in the THC and placebo groups, respectively. After 8 weeks of treatment the index was 4.±3 and 8±3 in the THC and placebo groups, respectively. Two patients in the treatment group but none in the placebo group went into complete remission. Three patients in the treatment group had endoscopy before and after treatment with significant improvement in edoscopic score.
Hemoglobin, albumin, kidney and liver function tests remained unchanged. No serious side effects were observed.
Tetrahydrocannabinol is safe and has beneficial effects, including steroid sparing, in moderately active inflammatory bowel disease. Further larger studies are needed to assess efficacy, optimal dose and mode of action.