Propolis (Bee Glue)

Propolis (Bee Glue)

PEP Topic 
Mucositis
Description 

Propolis, or bee glue, is a resin-like material made by bees to coat the inside of the hive. Propolis is derived from the buds of poplar and cone-bearing toma trees and is believed to have antioxidant and anti-inflammatory properties. Propolis has been studied in patients with cancer for treatment of mucositis.

Effectiveness Not Established

Research Evidence Summaries

Abdulrhman, M., El Barbary, N.S., Ahmed Amin, D., & Saeid Ebrahim, R. (2012). Honey and a mixture of honey, beeswax, and olive oil-propolis extract in treatment of chemotherapy-induced oral mucositis: A randomized controlled pilot study. Pediatric Hematology and Oncology, 29, 285–292.

doi: 10.3109/08880018.2012.669026
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Study Purpose:

To evaluate the effect of topical use of honey and a mixture of honey, olive oil-propolis extract, and beeswax (HOPE) as natural products in the treatment of chemotherapy-related oral mucositis

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to one of three groups, with 30 patients in each group. All patients used routine oral care, which included toothbrushing with a soft brush and normal saline rinses three times daily before topical treatment. All treatments were done three times daily to affected oral mucosa until healing or for 10 days, whichever came first. Topical treatments in each group were performed by the resident or nursing staff under researcher supervision.    

  • Group 1 (Honey group) applied 0.5 g honey/kg (maximum 15 g) topically to affected oral mucosa.            
  • Group 2 (HOPE group) used 0.25 g/kg (maximum 5 g) of a 4:2:1 mixture of honey, olive oil-propolis extract, and beeswax.                                                                 
  • Group 3 (control group) received benzocaine 7.5% gel.

Sample Characteristics:

  • The group consisted of 90 patients, ranging in age from 2–18 years old.
  • Mean patient age was 6.9 years. Mean patient age was 9 years (SD = 3.8 years).
  • The sample was 63% male and 37% female.
  • Patients were included in the study if they
    • Had an acute lymphoblastic leukemia (ALL) diagnosis.
    • Were undergoing the consolidation phase of treatment with methotrexate.
    • Had chemotherapy-related oral mucositis grades 2 and 3 based on the National Cancer Institute Common Toxicity Criteria (NCI-CTC).
  • Patients were excluded if they
    • Were diagnosed with diabetes mellitus.
    • Had received antiviral/antifungal therapy or any other treatment for oral mucositis before enrollment.
    • Were experiencing neutropenia with absolute neutrophil count (ANC) of more than 1,500.
    • Had advanced or severe periodontitis (periodontal pockets of 6 mm or greater).

Setting:

The study was conducted at a single site, inpatient setting at Hematology-Oncology of Children's Hospital of Ain Shams University in Egypt.

Phase of Care and Clinical Applications:

  • Patients were undergoing the active treatment phase of care.
  • This study has clinical applicability for pediatrics.

Study Design:

This was a randomized, non-blinded, controlled, clinical phase II trial.

Measurement Instruments/Methods:

  • The primary outcome measure was recovery time, defined as number of days from initiation of treatment to when complete healing of all ulcers occurred.    
  • The NCI-CTC was used.

Results:

  • In patients with grade 2 mucositis, recovery time was reduced in the honey group as compared with either the HOPE or control groups (p < 0.05).
  • In patients with grade 3 mucositis, recovery time did not differ significantly between honey and HOPE (p = 0.6).
  • Compared to controls, both the honey and HOPE groups had significantly faster healing (p < 0.01).
  • Comparing both grades, honey produced faster healing as compared with either control (p = 0.005; statistical power of 96.2%) or HOPE (p = 0.0056; statistical power of 81.9%).

Conclusions:

The superiority of topical honey alone may be related to the amount of honey used as well as better distribution in the oral cavity.

Limitations:

  • The sample size was small with fewer than 100 patients.
  • The study was not blinded to both researcher and patient.
  • The study only involved a select group (pediatrics).
  • The authors have a pending patent application for the mixture of honey, beeswax, and olive oil-propolis extract.
  • No description was provided regarding the management of mucositis in the control group.
  • No information was provided about other treatments for mucositis-related pain.

Nursing Implications:

Mucositis is a significant debilitating side effect of cancer therapy. Effective interventions to reduce or eliminate the severity of this symptom are needed. Further research is needed in all patient populations.

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.

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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.

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: 10.1016/j.ctim.2013.04.002
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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.


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