Tomazevic, T., & Jazbec, J. (2013). A double blind randomised placebo controlled study of propolis (bee glue) effectiveness in the treatment of severe oral mucositis in chemotherapy treated children. Complementary Therapies in Medicine, 21, 306-312. 

DOI Link

Study Purpose

To assess the efficacy of propolis versus placebo for the treatment of chemotherapy-induced severe oral mucositis (OM) treatment as a complementary and alternative medicine to alleviate severe OM from cancer therapy in the pediatric population. Propolis is a resinous material collected by bees from various plant sources and mixed with the bee’s salivary enzymes and beeswax. Recent scientific evidence suggests that honeybee products include anti-inflammatory, antioxidant, and antimicrobial properties.

Intervention Characteristics/Basic Study Process

The pediatric patients randomly were assigned to two groups: propolis or placebo. The oral care protocol consisted of teeth brushing.

The propolis or placebo was applied twice a day—once in the morning and once in the evening. The patients' OM was assessed according to the modified Eilers Oral Assessment Guide (OAG) twice a week when the patients were in the hospital. Patients were followed for the period of the chemotherapy or the first six months of the chemotherapy. An average of 0.38 g of propolis or placebo was used for each application. Each patient was given an information folder to reinforce cooperation and help them remember the protocol. A protocol follow-up regarding side effects and efficacy was assessed by questionnaire.

Sample Characteristics

  • N = 40
  • AGE = 1–19 years
  • MALES: 20 (50%), FEMALES: 20 (50%)
  • KEY DISEASE CHARACTERISTICS: Variety of children’s cancer, no specific diagnosis given

Setting

  • SITE: Single site 
  • SETTING TYPE: Inpatient    
  • LOCATION: Division of Oncology and Haematology, University Children’s Hospital, Medical Centre, Ljubljana

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Pediatrics

Study Design

  • Double-blind, randomized, placebo-controlled study

Measurement Instruments/Methods

OM was clinically assessed using a dental mirror and portable head light. OM was scored according to the modified Eilers OAG twice a week.

Results

The study assessed OM episode frequency, duration, and severity. The OM episode frequency and OM mean duration were assessed. The frequency of severe OM and duration of OM were not statistically significant between the study groups. Thus, the findings found that severe OM was of slightly shorter duration and of a lesser extent in the propolis group. The study results demonstrated that almost half of the patients enrolled in the study suffered from severe OM. Severe OM was seen in 18 (45%) patients. In the propolis group, 8 of 19 (42%) patients had OM, while in the placebo group, the corresponding number was 10 of 21 (48%). Twenty-four episodes of severe OM were recorded—10 (42%) in the propolis group and 14 (58%) in the placebo group.

Conclusions

The authors do not recommend propolis in severe OM as a treatment plan. Because of the limitations in the study design, further clinical studies are needed to verify whether the use of propolis in OM treatment truly is not justified.

Limitations

  • Small sample (< 30)
  • Baseline sample/group differences of import
  • Measurement validity/reliability questionable
  • Findings not generalizable
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: Small sample size (50 patients and dropped 10 [20%]), key sample group differences that could influence results (the type of cancer might be important), measurement was discussed and appropriate but did not include validity/reliability of instrument used, the findings are not generalizable, less than optimal preparation of the propolis

Nursing Implications

The study was limited to the pediatric population in one hospital. Therefore, there is a need to replicate it with a different study population and multiple settings to establish regular use and guidelines.