Study register · detailRCT · Ulcerative Colitis · 2021
Cannabis is associated with clinical but not endoscopic remission in ulcerative colitis: A randomized controlled trial
Naftali et al.·PLOS ONEImpact 2.8
MixedGRADELow51 citations
Samplen = 32 Pat.
Duration8 weeks
ControlPlacebo cigarettes
EndpointLichtiger Disease Activity…
Blindingdoppelblind
DesignRCT
Cannabinoidthc
Routeinhalativ
”Key finding
Cannabis led to clinical remission and improved quality of life, but not to significant improvement in endoscopic scores or inflammation markers.
Summary
n=32 active ulcerative colitis, cannabis cigarettes (23% THC, 0.5% CBD) vs. placebo over 8 weeks; clinical remission higher in cannabis group (28% vs. 26%, n.s.), no differences in endoscopic remission, symptom score improvement in both groups; primary endpoint not met.
P
PopulationAdults with mild to moderately active ulcerative colitis, n=32, mean age 30 years, 43% female
I
InterventionSmoked cannabis (0,5 g dried cannabis flowers with 80 mg THC per cigarette) over 8 weeks
C
ControlPlacebo cigarettes
O
OutcomeLichtiger Index: cannabis group 10,9→5 (p<0,001) vs. placebo 11→8 (p=0,15), p between groups=0,001; QOL significantly improved (p=0,007); Mayo endoscopy score not significantly different between groups (p=0,17)
Confidence in the evidence
Very lowLowModerateHigh
Low
The second of four GRADE levels, the effect estimate is of limited reliability.
Downgraded for
IndirectnessImprecision
Quality profile
Sample size★★★★★
BlindingDouble-blind
Effect sizeMixed
Citations / year★★★★★
Authors
Naftali T, Bar-Lev Schleider L, Scklerovsky Benjaminov F et al.
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). interests:- Author Lihi Bar Lev Schlieder is an employee of Tikun Olam, A cannabis manufacturing company, The cannabis used in the study was supplied by Tikun Olam All other authors have no conflicts to declare. F.M.K. was supported, in part, by the Josefina Maus and Gabriela Cesarman Chair for Research in Liver Diseases, Sackler Faculty of Medicine, Tel Aviv University. This does not alter our adherence to PLOS ONE policies on sharing data and materials.