Low-Dose CBD Did Not Help Active Crohn's Disease in This Small Trial
In a randomized trial of 20 patients with moderately active Crohn's disease, CBD at 10 mg twice daily was safe but produced no clinical benefit over placebo.
Quick Facts
What This Study Found
This randomized, placebo-controlled trial tested oral CBD (10 mg twice daily) in 20 patients with moderately active Crohn's disease who had not responded to standard treatments.
After 8 weeks of treatment, both the CBD and placebo groups showed similar improvements in disease activity (CDAI decreased from 337 to 220 in CBD group vs. 308 to 216 in placebo), with no statistically significant difference between them.
CBD was safe: no side effects were observed, and liver function, kidney function, hemoglobin, and albumin all remained unchanged.
The authors acknowledged several possible explanations for the null result: CBD may genuinely not help Crohn's disease, or the dose may have been too low, the sample too small, or the lack of synergism with other cannabinoids (like THC) may have limited effectiveness.
Key Numbers
20 patients (19 completed). CDAI before: 337 vs. 308 (CBD vs. placebo). CDAI after 8 weeks: 220 vs. 216 (p = NS). CBD dose: 10 mg twice daily. No side effects.
How They Did This
Randomized, placebo-controlled trial of 20 patients aged 18-75 with CDAI >200 (moderately active Crohn's). Oral CBD 10 mg or placebo twice daily for 8 weeks plus 2 weeks follow-up. Patients had failed standard treatments (steroids, thiopurines, TNF antagonists). ClinicalTrials.gov: NCT01037322.
Why This Research Matters
This is one of the few randomized controlled trials testing CBD specifically (without THC) for inflammatory bowel disease. The null result at low dose is important because it tempers the enthusiasm generated by preclinical studies showing CBD's anti-inflammatory effects.
The Bigger Picture
The discrepancy between strong preclinical anti-inflammatory data and this negative clinical trial highlights the challenge of translating laboratory findings to patient outcomes. The dose-response question is critical: 10 mg twice daily may be far below the doses used in successful animal studies.
What This Study Doesn't Tell Us
Very small sample (20 patients). Very low CBD dose (10 mg BID, far below doses used in epilepsy trials of 10-20 mg/kg/day). No THC component, which may be necessary for entourage effects. Short treatment duration.
Questions This Raises
- ?Would higher CBD doses (100-300 mg/day) show efficacy for Crohn's?
- ?Would CBD combined with THC be more effective?
- ?Is the placebo response in IBD trials too strong for small studies to overcome?
Trust & Context
- Key Stat:
- CBD 10 mg twice daily showed no benefit over placebo in 20 Crohn's patients
- Evidence Grade:
- Randomized controlled trial with adequate methodology. Moderate despite small size because the RCT design provides relatively strong evidence for the null finding.
- Study Age:
- Published in 2017.
- Original Title:
- Low-Dose Cannabidiol Is Safe but Not Effective in the Treatment for Crohn's Disease, a Randomized Controlled Trial.
- Published In:
- Digestive diseases and sciences, 62(6), 1615-1620 (2017)
- Authors:
- Naftali, Timna(8), Mechulam, Refael, Marii, Amir, Gabay, Gila, Stein, Asaf, Bronshtain, Miriam, Laish, Ido, Benjaminov, Fabiana, Konikoff, Fred M
- Database ID:
- RTHC-01462
Evidence Hierarchy
Participants are randomly assigned to treatment or placebo groups to test cause and effect.
What do these levels mean? →Frequently Asked Questions
Does CBD help Crohn's disease?
This trial found CBD at 10 mg twice daily was no more effective than placebo for moderately active Crohn's. However, the dose was very low compared to doses used in other conditions, so higher doses might produce different results.
Is CBD safe for Crohn's patients?
Yes. No side effects were observed and all safety laboratory tests remained normal throughout the 8-week trial. CBD at this dose appears safe even if it was not effective.
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Cite This Study
https://rethinkthc.com/research/RTHC-01462APA
Naftali, Timna; Mechulam, Refael; Marii, Amir; Gabay, Gila; Stein, Asaf; Bronshtain, Miriam; Laish, Ido; Benjaminov, Fabiana; Konikoff, Fred M. (2017). Low-Dose Cannabidiol Is Safe but Not Effective in the Treatment for Crohn's Disease, a Randomized Controlled Trial.. Digestive diseases and sciences, 62(6), 1615-1620. https://doi.org/10.1007/s10620-017-4540-z
MLA
Naftali, Timna, et al. "Low-Dose Cannabidiol Is Safe but Not Effective in the Treatment for Crohn's Disease, a Randomized Controlled Trial.." Digestive diseases and sciences, 2017. https://doi.org/10.1007/s10620-017-4540-z
RethinkTHC
RethinkTHC Research Database. "Low-Dose Cannabidiol Is Safe but Not Effective in the Treatm..." RTHC-01462. Retrieved from https://rethinkthc.com/research/naftali-2017-lowdose-cannabidiol-is-safe
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkTHC research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.