Placebo-controlled study – Ulcerative colitis

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Placebo-controlled study – Cannabis is associated with clinical but not endoscopic remission in ulcerative colitis

PLOS ONE

Timna Naftali1,2, Lihi Bar-Lev Schleider3, Fabiana Benjaminov1,2, Fred M.Konikoff1,2, Shelly Tartakover Matalon1,2,Yehuda Ringel1,2

1Institute of Gastroenterology and Hepatology, Meir Medical Center, Kfar Saba; 2Sackler School of Medicine, Tel Aviv University, Tel Aviv; 3Soroka University Medical Centre and Faculty of Health Sciences, Ben-Gurion University of the Negev.

Ulcerative colitis is an inflammatory bowel disease characterized by inflammation of the large intestine. The disease poses a significant personal and socioeconomic burden due to its effects on patients’ quality of life, daily functioning and use of healthcare system. The most common symptoms in colitis patients are: multiple bowel movements, severe abdominal pain and blood in the stool. The current treatment carries many long-term risks including malignancies, infections, and decreased bone density. Therefore, it is not surprising that many patients with colitis seek alternative treatments for their illnesses. A common such alternative treatment is the use of cannabis. However, clinical studies in the field are lacking. The aim of this randomized, double-blind, placebo-controlled study, conducted in collaboration with Meir Medical Center, was to evaluate the effect of medical cannabis on the clinical condition of ulcerative colitis patients. Cannabis treatment induced clinical remission and improved quality of life in patients with mild to moderately active ulcerative colitis.

STUDY POPULATION: 32 patients with ulcerative colitis (18 males, mean age 30).

STUDY PRODUCT: Erez rolls compared to placebo (47% of patients received placebo).

RESULTS:

• No patient stopped treatment during the 8 weeks of follow-up. 17 patients (53%) continued treatment for another year after the study ended.

Overall improvement – a clinical response (considered to be above 3 points in the Lichtiger index score) was observed in the cannabis group more significantly than in the placebo group; Cannabis group patients improved from 10.9 to 5.0. There was also a decrease in the score of the placebo group, due to the placebo effect, but was more moderate from 11.0 to 8.0.

Decrease in the number of bowel movements per day – In the cannabis group, the number of bowel movements per day decreased from 2.6 to 1.0. In the placebo group, the number of bowel movements decreased from 2.6 to 2.

Decrease in abdominal pain – of the patients who reported severity of abdominal pain of ≥2 (on a scale of 1 to 10, with 10 being the highest level of pain), in the cannabis group the level of pain decreased from 10 to 1. In the placebo group, the level of pain decreased from 9 to 8.

Improvement in quality of life – The cannabis group observed a significant improvement in quality of life (from a score of 77 to a score of 98), compared to the placebo group whose quality of life remained at the same level (score of 78 all the way).

Symptomatic improvement – The cannabis group patients reported a significant improvement compared to the placebo group also in appetite, concentration, libido, pain, general satisfaction with the treatment (on a grade from 1 to 7, 1 = improved, 4 = no change, 7 = deteriorated).

Side effects – No significant differences were observed between the cannabis group and the placebo group.

FULL STUDY

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