A double blind randomised placebo controlled study of propolis (bee glue) effectiveness in the treatment of severe oral mucositis in chemotherapy treated children

Objectives: Chemotherapy-induced oral mucositis (OM) is a debilitating side effect. In addition to standard therapy, patients often use complementary and alternative medicine to treat OM. Design: Double blind randomised placebo controlled study assessing propolis (bee glue) efficacy for chemotherapy-induced severe OM treatment. Setting: University Children's Hospital, University Medical Centre Ljubljana, Ljubljana, Slovenia. Interventions: Paediatric patients undergoing chemotherapy were randomly assigned to propolis (n = 19) or placebo groups (n = 21). Patients were introduced to a unified oral care protocol and asked to apply propolis or placebo to vestibular mucosa twice daily. Oral mucosa was assessed with the Oral Assessment Guide (OAG) twice a week when the patients were in hospital. Patients were followed for the period of the chemotherapy or for the first 6 months of the chemotherapy. An OAG score of 3 was considered to be severe OM and analysed. Main outcome measurements: Three dependent variables (a) OM episode frequency, (b) mean number of assessment visits, at which an OAG 3 score was noted, expressing mean OM duration, (c) mean number of OAG 3 scores expressing mean OM severity) were reduced to a single variable using principal component analysis. A new variable (FDS) was used as the dependent variable in ANCOVA model analysis to show the differences between study groups. Results: Severe OM was seen in 42% and 48% of patients in the propolis and placebo group, respectively. FDS was not statistically significant between study groups (p = 0.59). Conclusions: According to our study results, propolis cannot be recommended for severe OM treatment. (c) 2013 Elsevier Ltd. All rights reserved.