Augusto Souza Noronha, V.R., Araujo, G.S., Gomes, R.T., Iwanaga, S.H., Barbosa, M.C., Abdo, E.N., ... Santos, V.R. (2014). Mucoadhesive propolis gel for prevention of radiation-induced oral mucositis. Current Clinical Pharmacology, 9(4), 359–364.

Study Purpose

To determine the efficacy of propolis gel on radiation-induced oral mucositis

Intervention Characteristics/Basic Study Process

Patients applied a coffee spoon (10 g) of propolis gel 5.0% three times a day (every 8 hours) beginning 24 hours before radiation began, continuing throughout radiation treatment, and two weeks post-treatment. The propolis gel was created following Brazilian safety guidelines. Propolis gel was applied on the tongue and then spread on the oral mucosa. Patients could use a swab or a finger covered with a latex glove to spread the gel if they had difficulty moving their tongue. Mucositis, food intake, and pain were measured at a weekly follow-up. Exfoliative cytology of buccal mucosa, palate, and tongue was performed to confirm the absence of Candida-related mucositis.

Sample Characteristics

  • N = 24
  • MEAN AGE: 56.9 years (range 38–72 years)
  • MALES: 19, FEMALES: 5
  • KEY DISEASE CHARACTERISTICS: Oral squamous cell carcinoma

Setting

  • SITE: Irradiated Head and Neck Patient Clinic
  • SETTING TYPE: Academic
  • LOCATION: School of Dentistry of Federal University of Minas Gerais-UFMG, Belo Horizonte, Brasil

Phase of Care and Clinical Applications

  • PHASE OF CARE: Treatment
  • APPLICATIONS: Population receiving radiotherapy treatment for squamous cell cancer of the head and neck

Study Design

  • Prospective, open label

Measurement Instruments/Methods

  • World Health Organization (WHO) criteria for oral mucositis

Results

83.33% of patients did not develop oral mucositis; 8.33% developed grade I and 8.33% developed grade II oral mucositis. Patients reported no pain associated with the propolis gel. More than 80% of patients who participated in the study were satisfied with the product and would recommend its use.

Conclusions

Mucoadhesive propolis gel could be a useful topical alternative for prevention of radiation-induced oral mucositis. In this study, no participants developed severe mucositis. Patients found the propolis gel used in this study to be acceptable and did not report pain or discomfort associated with the application of this product.

Limitations

  • Single institution
  • Small sample (< 100)
  • No mention was made of who did the mucositis evaluations, how they were trained, and how consistency was maintained between evaluators.
  • No control, non-blinded, non-randomized
  • Patients in the study received anywhere from 5040 cGy to 7020 cGy of radiation in daily fractions between five and seven weeks. No details were given as to where the patients fell in this continuum and the numbers. Total dose of radiation delivered can influence occurrence of mucositis.
  • Nine patients died during radiation treatment.

Nursing Implications

At this time, evidence is limited for the use of propolis/bee glue in the prevention and treatment of oral mucositis. In this study, patients found the mixture of propolis gel 5.0% to be an acceptable intervention. The majority of patients in this study did not develop severe mucositis; however, the study has many flaws, including a lack of randomization, no control group, and a small sample size. Additionally, the dose of radiation varied among participants. More research is needed to determine the effectiveness of propolis/bee glue on the prevention and treatment or oral mucositis.