1. Efficacy of ultramicronized palmitoylethanolamide in burning mouth syndrome-affected patients: a preliminary randomized double-blind controlled trial
- Author
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Matteo Biasotto, Roberto Di Lenarda, Margherita Gobbo, V. Zoi, Katia Rupel, Augusto Poropat, Giulia Ottaviani, Michela Faraon, Ottaviani, Giulia, Rupel, Katia, Gobbo, Margherita, Poropat, Augusto, Zoi, Valentina, Faraon, Michela, Di Lenarda, Roberto, and Biasotto, Matteo
- Subjects
Male ,medicine.medical_specialty ,Side effect ,Palmitic Acids ,Placebo ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Double-Blind Method ,law ,Internal medicine ,medicine ,Humans ,Adverse effect ,General Dentistry ,Burning Sensation ,Aged ,Aged, 80 and over ,business.industry ,Burning mouth syndrome ,030206 dentistry ,Middle Aged ,Amides ,Ultramicronized palmitoylethanolamide ,Therapy ,Discontinuation ,Treatment Outcome ,Ethanolamines ,030220 oncology & carcinogenesis ,Inclusion and exclusion criteria ,Female ,medicine.symptom ,business - Abstract
OBJECTIVES: This preliminary randomized double-blind controlled trial was performed to test the efficacy of ultramicronized palmitoylethanolamide treatment in the burning mouth syndrome. MATERIALS AND METHODS: Patients with referred burning mouth intensity greater than 4, according to the Numeric Rating Scale, were included in the study according to established inclusion and exclusion criteria. Patients were randomized into two groups and received either placebo or ultramicronized palmitoylethanolamide 600 mg twice daily for 60 days. Patients were assessed at baseline, 30 and 60 days after treatment start, and 4 months after treatment discontinuation. In order to evaluate the change in the burning mouth sensation over time, the generalized linear mixed model was employed. RESULTS: A total of 35 patients were considered eligible, among which 6 withdrew prior to the end of treatment. A statistically significant reduction of burning mouth sensation (p
- Published
- 2019