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Response to Treatment with Melatonin and Clonazepam versus Placebo in Patients with Burning Mouth Syndrome

Objective: to evaluate the efficacy of melatonin and clonazepam versus placebo in patients with burning mouth syndrome (BMS). Methods: a prospective double-blind study was carried out in patients with BMS and randomized to three groups: melatonin (1 mg once a day), clonazepam (0.5 mg/twice a day), o...

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Autores principales: Castillo-Felipe, Candela, Tvarijonaviciute, Asta, López-Arjona, Marina, Pardo-Marin, Luis, Pons-Fuster, Eduardo, López-Jornet, Pia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9101769/
https://www.ncbi.nlm.nih.gov/pubmed/35566642
http://dx.doi.org/10.3390/jcm11092516
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author Castillo-Felipe, Candela
Tvarijonaviciute, Asta
López-Arjona, Marina
Pardo-Marin, Luis
Pons-Fuster, Eduardo
López-Jornet, Pia
author_facet Castillo-Felipe, Candela
Tvarijonaviciute, Asta
López-Arjona, Marina
Pardo-Marin, Luis
Pons-Fuster, Eduardo
López-Jornet, Pia
author_sort Castillo-Felipe, Candela
collection PubMed
description Objective: to evaluate the efficacy of melatonin and clonazepam versus placebo in patients with burning mouth syndrome (BMS). Methods: a prospective double-blind study was carried out in patients with BMS and randomized to three groups: melatonin (1 mg once a day), clonazepam (0.5 mg/twice a day), or a placebo once a day, for 8 weeks. The clinical changes were evaluated, including xerostomia, the Oral Health Impact Profile 14 (OHIP-14) score, Pittsburg Sleep Quality Index, and the Hospital Anxiety and Depression Scale (HADS). Oxygen saturation and heart rate were recorded, with an analysis of salivary biomarkers in the forms of oxytocin, ferritin, adenosine deaminase (ADA), total proteins, and alpha-amylase. Results: a total of 64 patients were analyzed. A significant decrease in burning sensation was recorded with melatonin (7.8 ± 1.54 pre-treatment, 5.78 ± 2.54 post-treatment; p < 0.001) and clonazepam (8.75 ± 1.2 pre-treatment, 5.5 ± 3.6 post-treatment (p < 0.01). With regard to quality of life (OHIP-14), significant improvements were observed before and after the administration of melatonin (p < 0.001) and clonazepam (p = 0.001). On the other hand, with regard to the changes in salivary biomarkers following treatment, negative correlations were found between oxytocin and drainage (r = −0.410; p = 0.009) and between the HADS-D score and ferritin (r = −0.312; p = 0.05). While salivary amylase showed positive correlation with heart rate (r = 0.346; p = 0.029) and oxygen saturation (r = 0.419; p = 0.007). Conclusions: melatonin and clonazepam were shown to be effective at reducing the burning sensation and improving quality of life. Both drugs were found to be safe, with no major adverse effects in patients with BMS. Melatonin may be regarded as an alternative treatment for patients with BMS, though further studies are needed to confirm its effectiveness.
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spelling pubmed-91017692022-05-14 Response to Treatment with Melatonin and Clonazepam versus Placebo in Patients with Burning Mouth Syndrome Castillo-Felipe, Candela Tvarijonaviciute, Asta López-Arjona, Marina Pardo-Marin, Luis Pons-Fuster, Eduardo López-Jornet, Pia J Clin Med Article Objective: to evaluate the efficacy of melatonin and clonazepam versus placebo in patients with burning mouth syndrome (BMS). Methods: a prospective double-blind study was carried out in patients with BMS and randomized to three groups: melatonin (1 mg once a day), clonazepam (0.5 mg/twice a day), or a placebo once a day, for 8 weeks. The clinical changes were evaluated, including xerostomia, the Oral Health Impact Profile 14 (OHIP-14) score, Pittsburg Sleep Quality Index, and the Hospital Anxiety and Depression Scale (HADS). Oxygen saturation and heart rate were recorded, with an analysis of salivary biomarkers in the forms of oxytocin, ferritin, adenosine deaminase (ADA), total proteins, and alpha-amylase. Results: a total of 64 patients were analyzed. A significant decrease in burning sensation was recorded with melatonin (7.8 ± 1.54 pre-treatment, 5.78 ± 2.54 post-treatment; p < 0.001) and clonazepam (8.75 ± 1.2 pre-treatment, 5.5 ± 3.6 post-treatment (p < 0.01). With regard to quality of life (OHIP-14), significant improvements were observed before and after the administration of melatonin (p < 0.001) and clonazepam (p = 0.001). On the other hand, with regard to the changes in salivary biomarkers following treatment, negative correlations were found between oxytocin and drainage (r = −0.410; p = 0.009) and between the HADS-D score and ferritin (r = −0.312; p = 0.05). While salivary amylase showed positive correlation with heart rate (r = 0.346; p = 0.029) and oxygen saturation (r = 0.419; p = 0.007). Conclusions: melatonin and clonazepam were shown to be effective at reducing the burning sensation and improving quality of life. Both drugs were found to be safe, with no major adverse effects in patients with BMS. Melatonin may be regarded as an alternative treatment for patients with BMS, though further studies are needed to confirm its effectiveness. MDPI 2022-04-29 /pmc/articles/PMC9101769/ /pubmed/35566642 http://dx.doi.org/10.3390/jcm11092516 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Castillo-Felipe, Candela
Tvarijonaviciute, Asta
López-Arjona, Marina
Pardo-Marin, Luis
Pons-Fuster, Eduardo
López-Jornet, Pia
Response to Treatment with Melatonin and Clonazepam versus Placebo in Patients with Burning Mouth Syndrome
title Response to Treatment with Melatonin and Clonazepam versus Placebo in Patients with Burning Mouth Syndrome
title_full Response to Treatment with Melatonin and Clonazepam versus Placebo in Patients with Burning Mouth Syndrome
title_fullStr Response to Treatment with Melatonin and Clonazepam versus Placebo in Patients with Burning Mouth Syndrome
title_full_unstemmed Response to Treatment with Melatonin and Clonazepam versus Placebo in Patients with Burning Mouth Syndrome
title_short Response to Treatment with Melatonin and Clonazepam versus Placebo in Patients with Burning Mouth Syndrome
title_sort response to treatment with melatonin and clonazepam versus placebo in patients with burning mouth syndrome
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9101769/
https://www.ncbi.nlm.nih.gov/pubmed/35566642
http://dx.doi.org/10.3390/jcm11092516
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