scholarly journals 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 ◽  
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.

Gabapentin has little or no effect in the treatment of burning mouth syndrome - results of an open-label pilot study

2006 ◽  
Vol 13 (7) ◽  
pp. e6-e7 ◽  
Author(s):  
S. M. Heckmann ◽  
J. G. Heckmann ◽  
A. Ungethum ◽  
P. Hujoel ◽  
T. Hummel
Keyword(s):  
Pilot Study ◽  
Burning Mouth Syndrome ◽  
Open Label ◽  
Burning Mouth

Vortioxetine in the Treatment of Mood Disorders Associated with Burning Mouth Syndrome: Results of an Open-Label, Flexible-Dose Pilot Study

Pain Medicine ◽  
2019 ◽  
Author(s):  
Daniela Adamo ◽  
Giuseppe Pecoraro ◽  
Massimo Aria ◽  
Gianfranco Favia ◽  
Michele Davide Mignogna
Keyword(s):  
Pilot Study ◽  
Rating Scales ◽  
Nonparametric Test ◽  
Burning Mouth Syndrome ◽  
University Hospital ◽  
Open Label ◽  
Paired Samples ◽  
Total Pain ◽  
Burning Mouth ◽  
Flexible Dose

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.

Evaluating Thrombin Inhibition in Alzheimer’s Disease (The BEACON Trial): Protocol for a Pilot Study (Preprint)

2019 ◽  
Author(s):  
Cláudia Yang Santos ◽  
Christine Getter ◽  
John Stoukides ◽  
Brian Ott ◽  
Stephen Salloway ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Pilot Study ◽  
Cognitive Performance ◽  
Thrombin Inhibitor ◽  
Placebo Control ◽  
Open Label ◽  
Double Blind ◽  
Thrombin Inhibition ◽  
Approved Drugs

BACKGROUND The precise mechanisms whereby cardiovascular risk factors increase the risk of Alzheimer’s disease (AD) have not been delineated. We reported that microvessels isolated from AD brains overexpress a diverse array of neurotoxic and inflammatory proteins, which is consistent with the process of vascular activation. In pre-clinical studies using AD animal models we showed that a vascular activation inhibitor reduced vascular-derived neuroinflammation and improved cognitive performance. Thrombin is a key mediator of cerebrovascular activation in AD. OBJECTIVE This study aims to investigate the safety and potential efficacy of the direct thrombin inhibitor dabigatran, in patients with mild cognitive impairment (MCI) or mild AD to decrease vascular-derived neuroinflammation and improve cognitive performance. METHODS Participants will be enrolled then evaluated quarterly throughout the 24-month study. This is a 24-month randomized-control, double-blind, placebo-controlled, multicenter, delayed-start, pilot study evaluating thrombin inhibition in people with biomarker-confirmed MCI probably due to AD or mild AD. 40 - 60 participants will be recruited between 50 - 85 years old. In the initial 9-months of study, either dabigatran or placebo will be orally administered to patients at a dose of 150 mg per day. After 9 months of the placebo-control (Phase I), the placebo arm will cross-over to an active, open-label (Phase II) where all patients will be treated with a 150 mg daily dose of dabigatran orally for an additional 12 months. A 3-month non-treatment follow-up period will assess duration of effects. RESULTS Beginning in July 2019, and concluding in August 2022, this study is expected to publish final results in January 2023. CONCLUSIONS BEACON is a first-in-kind randomized clinical trial targeting thrombin activation in AD therapeutics. This trial will stimulate translational investigations of an FDA-approved drugs in a newly defined therapeutic areas. CLINICALTRIAL Clinicaltrials.gov NCT03752294

Vortioxetine versus other antidepressants in the treatment of burning mouth syndrome: An open‐label randomized trial

Oral Diseases ◽  
2020 ◽  
Author(s):  
Daniela Adamo ◽  
Giuseppe Pecoraro ◽  
Noemi Coppola ◽  
Elena Calabria ◽  
Massimo Aria ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Burning Mouth Syndrome ◽  
Open Label ◽  
Burning Mouth

Pilot Study: Alleviation of Pain in Burning Mouth Syndrome With Topical Sucralose

2011 ◽  
Vol 51 (3) ◽  
pp. 444-446 ◽  
Author(s):  
Alan R. Hirsch ◽  
Alhumayyd Ziad ◽  
Ah Young Kim ◽  
Navdeep Singh Lail ◽  
Sameer Sharma
Keyword(s):  
Pilot Study ◽  
Burning Mouth Syndrome ◽  
Burning Mouth

Pregabalin GAD-treatment in Different Patient Populations Under Clinical Practice Conditions

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
M. Brasser
Keyword(s):  
Adverse Events ◽  
Depression Scale ◽  
Anxiety And Depression ◽  
Hospital Anxiety ◽  
Open Label ◽  
Current Medication ◽  
Treatment Naïve ◽  
Post Marketing ◽  
Report Data ◽  
The One

Background:The safety and efficacy of pregabalin in Generalized Anxiety Disorder (GAD) has been confirmed based on the results of 7 large, placebo-controlled trials. We report data on different patient populations from an open-label non-interventional observational trial under naturalistic conditions.Methods:331 physicians (mainly psychiatrists) recruited 578 adult GAD patients and documented treatment with pregabalin over 4 weeks. GAD severity was rated by the patients using Hospital Anxiety and Depression Scale (HADS) and a 100mm daily Visual Analogue Scale (VAS-anxiety). Spontaneous Adverse Events (AEs) were collected.Results:Most patients received an initial dose of 150mg pregabalin per day, which was then increased to 300mg per day. Mean HADS-A Baseline Score (15.5 vs. 14.6) and Improvement (-5.9 vs. -6.1) was similar in younger (≤65 years, n=484) and older (>65 years, n=71) patients. Treatment naive patients had a lower HADS-A-Score (mean 14.2) than patients who got pregabalin add-on to their current medication (mean 15.8); both groups showed a similar improvement by 5.9 points over 4 weeks. A total of 26 AEs occured during this study, most of them rated mild to moderate in severity with no treatment related serious events. The pattern of events resembled the one known from clinical trials and post-marketing experience. 1.2% of subjects discontinued treatment due to adverse events.Conclusion:Data from this non-interventional study in GAD show that pregabalin demonstrates similar effectiveness in adults and older (≤65 years) patients, regardless of whether used as mono- or adjunctive therapy.

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