Placebo-controlled study – Oral CBD-rich cannabis for Crohn’s disease
Timna Naftali1,2, Lihi Bar-Lev Schleider3, ShlomoAlmog2, David Meiri4, Fred M Konikoff1,2
1Institute of Gastroenterology and Hepatology, Meir Medical Center, Kfar Saba affiliated with Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Israel; 2Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; 3Research Department, Tikun-Olam Cannbit Pharmaceuticals, Tel Aviv, Israel; 4Department of Biology, Technion-Israel Institute of Technology, Haifa, Israel
The cannabis plant is known to have therapeutic effects, including improvement in inflammatory processes. However, no controlled studies have been published to date investigating the effect of cannabis as an anti-inflammatory in Crohn’s patients. The aim of this double-blind, placebo-controlled randomized study, conducted in collaboration with Meir Medical Center, was to evaluate the effect of Avidekel oil, a CBD-rich and low-THC cannabis extract, on Crohn’s disease activity.
Study participants underwent an eight-week follow-up in which each participant received Avidekel or placebo oil and an additional two weeks of wash-up to see what happens during consumption cessation, a total of ten weeks of follow-up. During the study, patients attended four visits and were evaluated by medical interview, physical examination, blood and stool tests. In addition, a colonoscopy was performed before the start of cannabis treatment and at the end of eight weeks of treatment.
STUDY POPULATION: 56 patients with Crohn’s disease (30 males, mean age 34.5).
STUDY PRODUCT: Avidekel oil with 16% CBD and 4% THC VS placebo (46% of patients received placebo).
• No patient stopped treatment during the 10 weeks of follow-up.
• Improvement in disease symptoms – The CDAI score (Crohn’s disease activity index) improved significantly in the cannabis group, compared to the improvement in the placebo group.
• Decrease in abdominal pain – there was a significant relief in the intensity of abdominal pain in the cannabis group (decrease in the CDAI score in the pain section), compared to the placebo group, in which the intensity of pain remained at the same level.
• Improvement in the quality of life – In the cannabis group, a significant improvement in the quality of life was observed (an increase in the SF-36 questionnaire score), compared with the placebo group whose quality of life remained at the same level.
• Positive overall effect of treatment – Patients were asked to rate from 1 to 7, where 1 = great improvement, 7 = severe deterioration, various aspects of life. In the cannabis group, a significant improvement was observed in the various areas.
• Side effects – No significant differences were observed between the cannabis group and the placebo group.