Efficacy of Plantago major, chlorhexidine 0.12% and sodium bicarbonate 5% solution in the treatment of oral mucositis in cancer patients with solid tumour: A feasibility randomised triple-blind phase III clinical trial
Por:
Cabrera-Jaime, S, Martinez, C, Ferro-Garcia, T, Giner-Boya, P, Icart-Isern, T, Estrada-Masllorens, JM and Fernandez-Ortega, P
Publicada:
1 feb 2018
Resumen:
Purpose: Oral mucositis is one of the most common adverse effects of chemotherapy and radiotherapy. The aim of this study was to compare the efficacy of Plantago major extract versus chlorhexidine 0.12% versus sodium bicarbonate 5% in the symptomatic treatment of chemotherapy-induced oral mucositis in solid tumour cancer patients.
Method: Multicentre randomised controlled trial estimated sample of 45 solid tumour patients with grade II-III mucositis. The participants were randomised to one of three treatments, consisting of sodium bicarbonate 5% aqueous solution together with: an additional dose of sodium bicarbonate 5% aqueous solution, Plantago major extract, or chlorhexidine 0.12%. The primary outcomes were severity of mucositis, pain intensity, oral intake capacity and quality of life. The independent variable was treatment group, and confounders included socio-demographic data, neutrophil count, chemotherapy drug and dose received.
Results: Of the 50 patients enrolled, 68% (n = 34) achieved grade 0 mucositis (none), with those using the double sodium bicarbonate rinse healing in five days on average (95% CI 3.9, 6.5) versus seven days (95% CI 5.3, 9,0) for the chlorhexidine group and seven days (95% CI 5.3, 8.5) for the Plantago major group. The pain experienced by the participants lessened over the 14 days of treatment, but differences in pain intensity between the three groups did not show statistical significance (p = 0.762).
Conclusions: Healing time was shorter with the double sodium bicarbonate solution compared to the other two rinses, but the differences were not significant. Our results suggest it may be time to reconsider the use of Plantago major extract in the management of oral mucositis.
Filiaciones:
:
Catalan Inst Oncol ICO, Nursing Res, Barcelona, Spain
Univ Barcelona, Nursing Sch, GRIN Grp, IDIBELL,Inst Biomed Res, Campus Hlth Sci, Barcelona, Spain
Martinez, C:
Catalan Inst Oncol ICO, Tobacco Control Unit, Canc Control & Prevent Grp, Barcelona, Spain
Inst Invest Biomed Bellvitge IDIBELL, Canc Control & Prevent Grp, Barcelona, Spain
Univ Int Catalanya, Sch Med & Hlth Sci, Nursing Dept, Barcelona, Spain
Ferro-Garcia, T:
Univ Barcelona, Nursing Sch, GRIN Grp, IDIBELL,Inst Biomed Res, Campus Hlth Sci, Barcelona, Spain
Catalan Inst Oncol ICO, Nursing, Barcelona, Spain
Giner-Boya, P:
Hosp Badalona Germans Trias & Pujol, Pharm Dept, Barcelona, Spain
Icart-Isern, T:
Univ Barcelona, Nursing Sch, GRIN Grp, IDIBELL,Inst Biomed Res, Campus Hlth Sci, Barcelona, Spain
Estrada-Masllorens, JM:
Univ Barcelona, Nursing Sch, GRIN Grp, IDIBELL,Inst Biomed Res, Campus Hlth Sci, Barcelona, Spain
Fernandez-Ortega, P:
Catalan Inst Oncol ICO, Nursing Res, Barcelona, Spain
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