An open-label, dose escalation pilot study of the effect of clonazepam in burning mouth syndrome

Abstract Objective To evaluate the efficacy of a new multimodal antidepressant, vortioxetine (VO), in the management of burning mouth syndrome (BMS). Design Longitudinal single-assessment open-label pilot study. Setting University hospital. Subjects. Thirty BMS patients were enrolled. Methods BMS patients were treated with topical clonazepam and a flexible dose of VO (10 mg, 15 mg, or 20 mg). The visual analog scale (VAS), the Total Pain Rating Index (T-PRI), the Hamilton Rating Scales for Depression (HAM-D) and Anxiety (HAM-A), and the Pittsburgh Sleep Quality Index (PSQI) were performed at baseline (time 0) and after two (time 1), four (time 2), six (time 3), and 12 months (time 4) of treatment. Descriptive statistics and the Wilcoxon nonparametric test for two paired samples were used. Results The BMS patients showed a statistically significant improvement in VAS and T-PRI scores from baseline (median [interquartile range {IQR}] = 10.0 [10–10] and 22.0 [20–24], respectively) to time 4 (median [IQR] = 0.0 [0–0] and 8.0 [7–9], P < 0.001, respectively). Similarly, the HAM-A and HAM-D and PSQI scores showed an improvement from time 0 (median [IQR] = 20 [15.8–22], 19 [16–20.3], and 4.0 [4–7.3], respectively) to time 4 (median [IQR] = 6.0 [6–7], 6.0 [6–7], and 3.0 [3–4], respectively, P < 0.001). Conclusions VO is efficacious and well tolerated in the treatment of BMS in firstline therapy on account of its better receptor pharmacological profile and in second-line treatment for patients who have only partially responded or have reported adverse effects to previous treatments.

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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 ◽

10.1093/pm/pnaa318 ◽

2020 ◽

Author(s):

Alessio Gambino ◽

Marco Cabras ◽

Evangelos Panagiotakos ◽

Federico Calvo ◽

Alessandra Macciotta ◽

...

Keyword(s):

Pilot Study ◽

Adverse Events ◽

Pain Intensity ◽

Cannabis Sativa ◽

Burning Mouth Syndrome ◽

Anxiety And Depression ◽

Mcgill Pain Questionnaire ◽

Placebo Control ◽

Open Label ◽

Burning Mouth

Abstract Objective To evaluate the use of a Cannabis sativa oil in the management of patients diagnosed with primary burning mouth syndrome (BMS). Design Prospective, open-label, single-arm pilot study. Setting University hospital. Subjects Seventeen patients with diagnosed BMS were included. Methods Subjects were treated for 4 weeks with a full cannabis plant extract, which was prepared from standardized plant material (cannabis flos) in specialized pharmacies by means of Romano-Hazekamp extraction and was diluted in oil (1 g of cannabis in 10 g of olive oil). The primary outcome was the change in pain intensity (assessed by the visual analog scale, Present Pain Intensity scale, McGill Pain Questionnaire, and Oral Health Impact Profiles) at the end of the protocol and during the succeeding 24 weeks; the neuropathic pain was also investigated with a specific interview questionnaire (DN4-interview [Douleur Neuropathique en 4 Questions]). Levels of anxiety and depression were considered as secondary outcomes, together with reported adverse events due to the specified treatment. Results Subjects showed a statistically significant improvement over time in terms of a clinical remission of the oral symptoms. Levels of anxiety and depression also changed statistically, displaying a favorable improvement. No serious reactions were detailed. None of the patients had to stop the treatment due to adverse events. Conclusions In this pilot evaluation, the C. sativa oil provided was effective and well tolerated in patients with primary BMS. Further bigger and properly defined randomized controlled trials, with different therapeutic approaches or placebo control, are needed, however.

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