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

• DOI: 10.1002/hed.26892
• Publication Date: 2021-10-20T19:13:02Z
• Authors: Diego Antônio Cos...; Artur Christian G...; Nilceana Maya Air...; Eliana Martins Lima; Aline Carlos de O...; Ricardo Neves Mar...; Elismauro Francis...; Marize Campos Val...
• Keywords: Mucositis

Abstract Background Oral mucositis (OM) is the significant complication of radio/chemotherapy treatment. This study evaluated safety and efficacy a mucoadhesive phytomedication containing curcuminoids Bidens pilosa L . (FITOPROT) in prevention/treatment OM. Methods Sixty‐two patients were randomized into group's intervention placebo. Adverse effect assessment, OM grading, pain, saliva collection carried at 1st, 15th, 21st, final radiotherapy (RT). Inflammatory salivary mediators measured. Results FITOPROT decreased severity from 15th to RT, while placebo showed an increase ( p < 0.05). Intervention group had lower number with ulcerated RT Phytomedication prevented increases IL‐8 levels reduced nitrite during RT. Conclusions does not promote adverse effects, it appears be effective reducing OM, controls concentration pro‐inflammatory mediators.