Timna Naftali1,2, Lihi Bar-Lev Schleider3,4, Fabiana Scklerovsky Benjaminov1,2, Fred Meir Konikoff1,2, Shelly Tartakover Matalon1,2, Yehuda Ringel1,2. 1. Institute of Gastroenterology and Hepatology, Meir Medical Center, Kfar Saba, Israel. 2. Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. 3. Research Department, Tikun-Olam - Cannbit Pharmaceuticals, Tel-Aviv, Israel. 4. Clinical Research Center, Soroka Medical Center and Faculty of Health Sciences, Ben-Gurion University of the Negev, Be'er-Sheva, Israel.
Abstract
BACKGROUND:Cannabis is often used by patients with ulcerative colitis, but controlled studies are few. We aimed to assess the effect of cannabis in improving clinical and inflammatory outcomes in ulcerative colitis patients. METHODS: In a double-blind, randomized, placebo-controlled trial, patients received either cigarettes containing 0.5 g of dried cannabis flowers with80mgTetrahydrocannabinol (THC)or placebo cigarettes for 8 weeks. Parameters of disease including Lichtiger disease activity index, C reactive protein (CRP), calprotectin, Mayo endoscopic score and quality of life (QOL) were assessed before, during and after treatment. RESULTS: The study included 32 patients. Mean age was 30 years, 14 (43%) females. Lichtiger index improved in the cannabis group from 10.9 (IQR 9-14) to5 (IQR 1-7), (p<0.000), and in the placebo group from 11 (IQR 9-13) to 8 (IQR 7-10)(p = 0.15, p between groups 0.001). QOL improved in the cannabis group from 77±4 to 98±20 (p = 0.000) but not in the placebo group (78±3 at week 0 and 78±17 at week 8;p = 0.459; p between groups 0.007). Mayo endoscopic score changed in the cannabis group from 2.13±1 to 1.25±2 (p = 0.015) and in the placebo group from 2.15±1to 1.69±1 (p = 0.367, p between groups 0.17). CONCLUSION: Short term treatment with THC rich cannabis induced clinical remission and improved quality of life in patients with mild to moderately active ulcerative colitis. However, these beneficial clinical effects were not associated with significant anti-inflammatory improvement in the Mayo endoscopic score or laboratory markers for inflammation.(clinicaltrials.gov NCT01040910).
RCT Entities:
BACKGROUND:Cannabis is often used by patients with ulcerative colitis, but controlled studies are few. We aimed to assess the effect of cannabis in improving clinical and inflammatory outcomes in ulcerative colitispatients. METHODS: In a double-blind, randomized, placebo-controlled trial, patients received either cigarettes containing 0.5 g of dried cannabis flowers with80mgTetrahydrocannabinol (THC)or placebo cigarettes for 8 weeks. Parameters of disease including Lichtiger disease activity index, C reactive protein (CRP), calprotectin, Mayo endoscopic score and quality of life (QOL) were assessed before, during and after treatment. RESULTS: The study included 32 patients. Mean age was 30 years, 14 (43%) females. Lichtiger index improved in the cannabis group from 10.9 (IQR 9-14) to5 (IQR 1-7), (p<0.000), and in the placebo group from 11 (IQR 9-13) to 8 (IQR 7-10)(p = 0.15, p between groups 0.001). QOL improved in the cannabis group from 77±4 to 98±20 (p = 0.000) but not in the placebo group (78±3 at week 0 and 78±17 at week 8;p = 0.459; p between groups 0.007). Mayo endoscopic score changed in the cannabis group from 2.13±1 to 1.25±2 (p = 0.015) and in the placebo group from 2.15±1to 1.69±1 (p = 0.367, p between groups 0.17). CONCLUSION: Short term treatment with THC rich cannabis induced clinical remission and improved quality of life in patients with mild to moderately active ulcerative colitis. However, these beneficial clinical effects were not associated with significant anti-inflammatory improvement in the Mayo endoscopic score or laboratory markers for inflammation.(clinicaltrials.gov NCT01040910).
Authors: Matthew N Newmeyer; Madeleine J Swortwood; Allan J Barnes; Osama A Abulseoud; Karl B Scheidweiler; Marilyn A Huestis Journal: Clin Chem Date: 2016-10-10 Impact factor: 8.327
Authors: Triana Lobatón; Talat Bessissow; Gert De Hertogh; Bart Lemmens; Chelsea Maedler; Gert Van Assche; Séverine Vermeire; Raf Bisschops; Paul Rutgeerts; Alain Bitton; Waqqas Afif; Victoria Marcus; Marc Ferrante Journal: J Crohns Colitis Date: 2015-06-26 Impact factor: 9.071
Authors: S Lichtiger; D H Present; A Kornbluth; I Gelernt; J Bauer; G Galler; F Michelassi; S Hanauer Journal: N Engl J Med Date: 1994-06-30 Impact factor: 91.245
Authors: Shelly Tartakover Matalon; Shahar Azar; David Meiri; Rivka Hadar; Alina Nemirovski; Narjes Abu Jabal; Fred Meir Konikoff; Liat Drucker; Joseph Tam; Timna Naftali Journal: Front Endocrinol (Lausanne) Date: 2021-08-31 Impact factor: 5.555