Cannabis oil improved pain, anxiety, and depression in 17 patients with burning mouth syndrome
In a pilot study of 17 patients with burning mouth syndrome, a cannabis sativa oil applied for 4 weeks produced significant improvements in oral pain, anxiety, and depression, with benefits persisting through 24 weeks of follow-up.
Quick Facts
What This Study Found
All 17 patients showed statistically significant improvement in oral pain intensity over time (assessed by VAS, Present Pain Intensity, McGill Pain Questionnaire, and OHIP). Anxiety and depression levels also improved significantly. No serious adverse events occurred and no patients discontinued treatment.
Key Numbers
17 patients; 4-week treatment; 24-week follow-up; significant improvement in VAS, Present Pain Intensity, McGill Pain Questionnaire, OHIP scores; anxiety and depression improved; 0 serious adverse events; 0 treatment discontinuations
How They Did This
Prospective, open-label, single-arm pilot study. 17 patients with primary burning mouth syndrome received cannabis sativa oil extract (1g cannabis in 10g olive oil) for 4 weeks. Pain, neuropathic pain, anxiety, depression, and adverse events assessed at end of treatment and through 24 weeks follow-up.
Why This Research Matters
Burning mouth syndrome has limited treatment options and significantly affects quality of life. This pilot provides initial evidence that cannabis oil may address both the pain and the psychological burden of the condition.
The Bigger Picture
Burning mouth syndrome is often treatment-resistant, making any positive signal noteworthy. The simultaneous improvement in pain, anxiety, and depression aligns with cannabis acting on multiple symptom domains rather than just pain.
What This Study Doesn't Tell Us
Open-label with no placebo or control group. Very small sample (17 patients). Expectation effects likely significant given cannabis's cultural reputation. Single center. Cannabis extract composition may vary between preparations.
Questions This Raises
- ?Would benefits hold in a placebo-controlled trial?
- ?Which cannabinoid components (THC vs. CBD) drive the effect in burning mouth syndrome?
Trust & Context
- Key Stat:
- Significant pain improvement persisted through 24 weeks of follow-up
- Evidence Grade:
- Small, open-label pilot without controls. Provides a proof-of-concept signal but cannot establish efficacy.
- Study Age:
- Published in 2021.
- Original Title:
- Evaluating the Suitability and Potential Efficiency of Cannabis sativa Oil for Patients with Primary Burning Mouth Syndrome: A Prospective, Open-Label, Single-Arm Pilot Study.
- Published In:
- Pain medicine (Malden, Mass.), 22(1), 142-151 (2021)
- Authors:
- Gambino, Alessio, Cabras, Marco, Panagiotakos, Evangelos, Calvo, Federico, Macciotta, Alessandra, Cafaro, Adriana, Suria, Marco, Haddad, Giorgia El, Broccoletti, Roberto, Arduino, Paolo Giacomo
- Database ID:
- RTHC-03142
Evidence Hierarchy
A small preliminary study to test whether a larger study is feasible.
What do these levels mean? →Frequently Asked Questions
What is burning mouth syndrome?
Burning mouth syndrome is a chronic condition characterized by a burning sensation in the mouth without any visible abnormality. It is difficult to treat and often accompanied by anxiety and depression.
How was the cannabis oil prepared?
The extract was made from standardized cannabis plant material using the Romano-Hazekamp extraction method, diluted in olive oil (1g cannabis in 10g oil). It was prepared by specialized pharmacies, not commercially available products.
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Cite This Study
https://rethinkthc.com/research/RTHC-03142APA
Gambino, Alessio; Cabras, Marco; Panagiotakos, Evangelos; Calvo, Federico; Macciotta, Alessandra; Cafaro, Adriana; Suria, Marco; Haddad, Giorgia El; Broccoletti, Roberto; Arduino, Paolo Giacomo. (2021). Evaluating the Suitability and Potential Efficiency of Cannabis sativa Oil for Patients with Primary Burning Mouth Syndrome: A Prospective, Open-Label, Single-Arm Pilot Study.. Pain medicine (Malden, Mass.), 22(1), 142-151. https://doi.org/10.1093/pm/pnaa318
MLA
Gambino, Alessio, et al. "Evaluating the Suitability and Potential Efficiency of Cannabis sativa Oil for Patients with Primary Burning Mouth Syndrome: A Prospective, Open-Label, Single-Arm Pilot Study.." Pain medicine (Malden, 2021. https://doi.org/10.1093/pm/pnaa318
RethinkTHC
RethinkTHC Research Database. "Evaluating the Suitability and Potential Efficiency of Canna..." RTHC-03142. Retrieved from https://rethinkthc.com/research/gambino-2021-evaluating-the-suitability-and
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.