2021
DOI: 10.1002/hed.26892
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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

Abstract: 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 med… Show more

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Cited by 8 publications
(7 citation statements)
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“…In the intervention groups, seven types of nonpharmacological interventions were identified. Specifically, two studies used oral wetting and cleaning agents (Lambrecht et al., 2013; Wong et al., 2017); 10 studies conducted honey treatment (Alvi et al., 2013; Amanat et al., 2017; Bardy et al., 2012; Biswal et al., 2003; Charalambous et al., 2018; Hawley et al., 2014; Jayalekshmi et al., 2016; Maiti et al., 2012; Motallebnejad et al., 2008; Rashad et al., 2009); 10 studies provided low‐level laser therapy (Antunes et al., 2013; Gautam et al., 2012; Gouvêa de Lima et al., 2012; Kauark‐Fontes et al., 2022; Kuhn et al., 2008; Legouté et al., 2019; Lopes Martins et al., 2021; Marín‐Conde et al., 2019; Nugent et al., 2022; Oton‐Leite et al., 2015); seven studies treated patients with natural plant‐based therapies, including natural plant extract mouthwashes (Aghamohammadi et al., 2018; Arantes et al., 2021; Kong et al., 2016; You et al., 2009), and natural plant extract capsules (Arun et al., 2020; Delavarian et al., 2019; Soni et al., 2022); 13 studies provided participants with nutritional supplements (Bakr et al., 2021; Büntzel et al., 2010; Chattopadhyay et al., 2014; Dastan et al., 2020; Demir Doğan et al., 2017; Ertekin et al., 2004; Fernandes et al., 2022; Hamstra et al., 2018; Huang et al., 2019; Lozano et al., 2021; Onseng et al., 2017; Sangthawan et al., 2013; Tsujimoto et al., 2015); six studies used microecological preparations (De Sanctis et al., 2019; Jiang et al., 2019; Manifar et al., 2022; Mirza et al., 2022; Sharma et al., 2012; Xia et al., 2021); and the rem...…”
Section: Resultsmentioning
confidence: 99%
“…In the intervention groups, seven types of nonpharmacological interventions were identified. Specifically, two studies used oral wetting and cleaning agents (Lambrecht et al., 2013; Wong et al., 2017); 10 studies conducted honey treatment (Alvi et al., 2013; Amanat et al., 2017; Bardy et al., 2012; Biswal et al., 2003; Charalambous et al., 2018; Hawley et al., 2014; Jayalekshmi et al., 2016; Maiti et al., 2012; Motallebnejad et al., 2008; Rashad et al., 2009); 10 studies provided low‐level laser therapy (Antunes et al., 2013; Gautam et al., 2012; Gouvêa de Lima et al., 2012; Kauark‐Fontes et al., 2022; Kuhn et al., 2008; Legouté et al., 2019; Lopes Martins et al., 2021; Marín‐Conde et al., 2019; Nugent et al., 2022; Oton‐Leite et al., 2015); seven studies treated patients with natural plant‐based therapies, including natural plant extract mouthwashes (Aghamohammadi et al., 2018; Arantes et al., 2021; Kong et al., 2016; You et al., 2009), and natural plant extract capsules (Arun et al., 2020; Delavarian et al., 2019; Soni et al., 2022); 13 studies provided participants with nutritional supplements (Bakr et al., 2021; Büntzel et al., 2010; Chattopadhyay et al., 2014; Dastan et al., 2020; Demir Doğan et al., 2017; Ertekin et al., 2004; Fernandes et al., 2022; Hamstra et al., 2018; Huang et al., 2019; Lozano et al., 2021; Onseng et al., 2017; Sangthawan et al., 2013; Tsujimoto et al., 2015); six studies used microecological preparations (De Sanctis et al., 2019; Jiang et al., 2019; Manifar et al., 2022; Mirza et al., 2022; Sharma et al., 2012; Xia et al., 2021); and the rem...…”
Section: Resultsmentioning
confidence: 99%
“…Of the included studies, 7 studies reported Curcuma longa [ 18 24 ], 6 studies reported honey [ 16 , 25 29 ] (including pure honey from tea plant Camellia sinensis [ 16 ], pure honey from Thymus and Astragale [ 25 ], pure honey (Dabur honey) [ 26 ], pure honey from the clover plant Trifoliumalexandrenum [ 27 ], manuka honey [ 28 ], and thyme honey [ 29 ]), 3 studies reported aloe vera [ 30 – 32 ], 2 studies reported black mulberry molasses [ 33 , 34 ], and 2 studies reported FITOPROT [ 18 , 24 ] (an adhesive herbal remedy that contains glycerinated extract of Bidens pilosa L. and curcuminoids from Curcuma longa L. [ 18 ]), 2 studies reported Silymarin [ 35 , 36 ], and 1 study reported essential oils of manuka and kanuka [ 37 ]. Seven studies reported on propolis [ 38 ], Zataria [ 39 ], green tea [ 17 ], Cystus® tea [ 40 ], Indigowood root [ 41 ], Plantago major L [ 42 ], and Kangfuxin solution [ 43 ].…”
Section: Resultsmentioning
confidence: 99%
“…Regarding the outcome of pain (mainly assessed by the visual analog scale (VAS)), eighteen trials reported results. Thirteen of these studies showed a significant reduction, including curcumin [ 22 ], FITOPROT [ 24 ], thyme honey [ 29 ], black mulberry molasses [ 34 ], SAMITAL® [ 45 , 46 ], essential oils [ 37 ], Payayor [ 32 ], Zataria [ 39 ], Shuanghuabaihe tablets [ 48 ], Plantago major L. [ 42 ], CHIN [ 49 ] and Kangfuxin solution [ 43 ]. Five studies [ 17 , 28 , 31 , 33 , 47 ] showed no significant effect.…”
Section: Resultsmentioning
confidence: 99%
“…For instance, the study by Hasheminasab et al, 2020 [ 55 ] is excluded because the herbal treatment used is not an essential oil. In addition, in the records of Aghamohammadi and collaborators (2018) [ 56 ] and of Arantes et al, 2021 [ 57 ], the intervention contains an extract, not an essential oil. The studies of Czakert [ 58 ] and of Ho [ 59 ] and coworkers are excluded because they perform a qualitative analysis.…”
Section: Resultsmentioning
confidence: 99%