Safety and efficacy of a mucoadhesive phytomedication containing curcuminoids and Bidens pilosa L. extract in the prevention and treatment of radiochemotherapy-induced oral mucositis: Triple-blind, randomized, placebo-controlled, clinical trial.

Autor: Arantes DAC; Department of Stomatology (Oral Pathology), Federal University of Goiás, Goiânia, Brazil., da Silva ACG; Laboratory of Pharmacology and Cellular Toxicology, Federal University of Goiás, Goiânia, Brazil., Freitas NMA; Division of Radiotherapy, Araújo Jorge Hospital, Goiânia, Brazil., Lima EM; Laboratory of Pharmaceutical Technology, Federal University of Goiás, Goiânia, Brazil., de Oliveira AC; Laboratory of Nanosystems and Modified-Release Drugs Devices, Federal University of Goiás, Goiânia, Brazil., Marreto RN; Laboratory of Nanosystems and Modified-Release Drugs Devices, Federal University of Goiás, Goiânia, Brazil., Mendonça EF; Department of Stomatology (Oral Pathology), Federal University of Goiás, Goiânia, Brazil.; Division of Head and Neck, Araújo Jorge Hospital, Goiânia, Brazil., Valadares MC; Laboratory of Pharmacology and Cellular Toxicology, Federal University of Goiás, Goiânia, Brazil.
Jazyk: angličtina
Zdroj: Head & neck [Head Neck] 2021 Dec; Vol. 43 (12), pp. 3922-3934. Date of Electronic Publication: 2021 Oct 15.
DOI: 10.1002/hed.26892
Abstrakt: Background: Oral mucositis (OM) is the significant complication of radio/chemotherapy treatment. This study evaluated the safety and efficacy of a mucoadhesive phytomedication containing curcuminoids and Bidens pilosa L. (FITOPROT) in the prevention/treatment of OM.
Methods: Sixty-two patients were randomized into the group's intervention and placebo. Adverse effect assessment, OM grading, pain, and saliva collection were carried at the 1st, 15th, 21st, and final of radiotherapy (RT). Inflammatory salivary mediators were measured.
Results: FITOPROT decreased the severity of OM from the 15th to the final RT, while the placebo showed an increase in the severity (p < 0.05). Intervention group had a lower number of patients with ulcerated OM at the final RT (p < 0.05). Phytomedication prevented increases of IL-8 levels and reduced the salivary nitrite during RT.
Conclusions: FITOPROT does not promote adverse effects, it appears to be effective at reducing the severity of OM, and it controls the concentration of pro-inflammatory mediators.
(© 2021 Wiley Periodicals LLC.)
Databáze: MEDLINE
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