Evaluation of the effect of melatonin in patients with Burning mouth syndrome: a double-blind, placebo-controlled randomized clinical trial

Abstract The present study was carried out to evaluate the effect of Melatonin and Placebo in the patient with the Burning mouth (BMs). This double-blind, placebo-controlled randomized clinical trial study was carried out on 30 patients who were suffering from BMS. During this period patients were divided into 2 study and control groups. The study group used four 3 mg Melatonin daily and the control group received a placebo. Then the severity of the burning sensation was measured by the physician Sleep quality was measured using the VAS scale using the Petersburg questionnaire. Data in the application Enter SPSS 20 and then using T test or equivalent Nonparametric was analyzed, mean sleep score and mean severity of oral irritation before and after treatment in two the group was evaluated using T-test Independent. Level significance was considered 0.05. The results of the present study show that the use of melatonin and a placebo in patients with BMS reduces sensation and improves their sleep quality, although it may not reduce it completely. In this study severity of burning was 4.93±2.56 after treatment in the study group and 6.93±2.12 in the control group, which was statistically significant (P =0.036). No significant difference was observed between the two groups in the sleep quality score (P-value = 0.43). Using Melatonin can be a reliable way to treat pain for which there is no standard treatment to date. Although evidence suggests an association between sleep disorders and BMS, melatonin was not superior to a placebo in reducing BMS-induced burning in the present study. Identification of stressors and the ways to struggle with them, further studies with larger samples and higher oral doses, extended follow-up periods and control of psychological factors, and measurement of body mass index that may affect pharmacokinetics are recommended.

Análise de fatores clínico-demográficos, psicológicos, hormonais e genéticos na síndrome da ardência bucal e ardor bucal secundário / Analysis of clinical and demographic, psychological, hormonal and genetic factors in burning mouth syndrome and secondary burning mouth

A síndrome da ardência bucal (SAB) é uma condição clínica pouco esclarecida caracterizada por sensação espontânea de ardência, dor ou prurido na mucosa oral, sem alterações locais ou sistêmicas identificáveis. Sua etiopatogenia é incerta, não havendo até o momento uma padronização dos critérios utilizados para o seu diagnóstico. O presente estudo objetivou verificar a associação de fatores psicológicos, hormonais e genéticos com a SAB no sentido de propor uma melhor caracterização de sua natureza. Além de uma análise descritiva da amostra estudada, os aspectos analisados foram especificamente os níveis de estresse e sua fase, depressão, e ansiedade, compondo os fatores psicológicos; mensuração dos níveis séricos de cortisol e desidroepiandrosterona (DHEA); bem como a verificação sobre a ocorrência de polimorfismos no gene da Interleucina-6 (IL6). Foram realizadas análises comparativas entre um grupo de pacientes com SAB e um grupo composto por indivíduos com ardor bucal secundário (AB). Os resultados revelaram diferenças estatisticamente significativas entre os dois grupos com relação aos seguintes aspectos: xerostomia (p=0,01) e hipossalivação em repouso (p<0,001), que foram mais prevalentes no grupo SAB; sintomas de depressão (p=0,033), também mais presentes no grupo SAB; e dosagem de DHEA, que apresentou níveis mais reduzidos no grupo SAB (p=0,003). A dosagem desse hormônio mostrou-se amplamente sensível e específica para o diagnóstico da síndrome em estudo, sendo verificado que níveis séricos de DHEA abaixo de 0,37µg/mL para mulheres, utilizando-se os procedimentos propostos na pesquisa, possuem um Odds Ratio de 4,0 95 por cento IC (0,37 a 2,71)]. Foi verificado ainda que o alelo C do polimorfismo rs2069849 da IL-6 pode representar um alelo de risco para a ocorrência de ardor bucal em ambos os grupos, no entanto, não se pode garantir sua real implicação nos processos inflamatórios da SAB

Os presentes resultados sugerem uma provável influência da depressão, bem como de níveis diminuídos do hormônio DHEA na SAB. (AU)

The burning mouth syndrome (BMS) is a clinical condition characterized by spontaneous burning sensation, pain or itching in the oral mucosa without identifiable local or systemic changes. Its pathogenesis is uncertain, with no observable standardization in previous literature of the criteria used for its diagnosis. The present study aimed to determine demographic, psychological, hormonal and genetic factors in patients with BMS and secondary burning mouth to propose a better characterization of the nature and classification of this condition. Besides a descriptive analysis of the sample of 163 individuals, were analyzed the levels of stress and its phase, depression and anxiety; measurement of serum levels of cortisol and dehydroepiandrosterone (DHEA), as well as checking on the occurrence of polymorphisms in the gene of interleukin-6 (IL6). Comparative analysis between a group of patients with BMS and a group of individuals with secondary burning mouth (BM) were performed. The results revealed statistically significant differences between the two groups with respect to the following aspects: xerostomia (p=0.01) and hyposalivation at rest (p<0.001), which were more prevalent in the BMS group; symptoms of depression (p=0.033), more present in the BMS group, and dosage of DHEA, which showed lower levels in BMS patients (p=0.003). The dosage of this hormone was largely specific and sensitive for the diagnosis of the studied syndrome, and was verified that serum levels of DHEA below 0.37 pg/mL in women, using the procedures proposed in this research, have an Odds Ratio of 4.0 95 per cent Cl (0.37 to 2.71)]. These results suggest a possible influence of depression and decreased levels of the hormone DHEA in the pathogenesis of BMS. (AU)