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.

Gambino, Alessio et al.·Pain medicine (Malden·2021·Preliminary EvidencePilot Study
RTHC-03142Pilot StudyPreliminary Evidence2021RETHINKTHC RESEARCH DATABASErethinkthc.com/research

Quick Facts

Study Type
Pilot Study
Evidence
Preliminary Evidence
Sample
N=17

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)
Database ID:
RTHC-03142

Evidence Hierarchy

Meta-Analysis / Systematic Review
Randomized Controlled Trial
Cohort / Case-Control
Cross-Sectional / ObservationalSnapshot without intervening
This study
Case Report / Animal Study

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.

Read More on RethinkTHC

Cite This Study

RTHC-03142·https://rethinkthc.com/research/RTHC-03142

APA

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.