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A randomized placebo-controlled trial of manuka honey for radiation-induced oral mucositis.

  • 2013-11-13
  • Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 22(3)
    • Philippa Hawley
    • Allan Hovan
    • Colleen E McGahan
    • Deborah Saunders

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 81
Population
106 head and neck cancer patients from the Vancouver and Sudbury Cancer Centers in Canada
Methods
randomized to swish, hold, and swallow either 5 ml of irradiated organic manuka honey or a placebo gel, four times a day throughout radiation treatment, plus seven more days
Blinding
Double-blind
Duration
throughout radiation treatment, plus seven more days
Funding
Independent

Background

Few treatments have the potential to reduce the severity of radiation-induced mucositis in head and neck cancer patients. Some small studies have suggested that organic honey may be a useful preventive treatment.

Methods

This investigator-initiated double-blind randomized placebo-controlled trial investigated whether honey reduced the severity of radiation-induced oral mucositis (ROM). One hundred six head and neck cancer patients from the Vancouver and Sudbury Cancer Centers in Canada were randomized to swish, hold, and swallow either 5 ml of irradiated organic manuka honey or a placebo gel, four times a day throughout radiation treatment, plus seven more days. Severity of oral mucositis according to the Radiation Therapy Oncology Group (RTOG), World Health Organization (WHO), and Oral Mucositis Assessment Scale scales, weight, and subjects' symptom severity and quality of life were assessed weekly. Sialometry was performed at baseline and at the last study visit.

Results

One hundred six patients were recruited. Twenty-four did not attend any mucositis assessments. One was removed from the study because of off-study consumption of store-bought manuka honey. The remaining 81 patients had at least one mucositis assessment and were included in the analysis. Sixty-two percent of subjects received concurrent chemotherapy; 81 % were male. The groups were well-matched, and blinding was excellent. Dropouts were mostly due to nausea and were similar in both arms, with 78 % being able to tolerate the study products for more than 1 week. The dropout rate was 57 % in those who received honey and 52 % in those who received placebo gel. The dropout rate in those who had concurrent chemotherapy was 59 % and in those who only received radiation was 47 %. There was no statistically significant difference between the honey and placebo arms in any of the outcome indicators. Those who completed the study in both treatment arms had low rates of RTOG greater than or equal to grade 3 mucositis; 35 % in the honey group and 43 % in the placebo group.

Conclusion

Despite promising earlier reports, manuka honey was not tolerated well by our patients and, even when used as directed, did not have a significant impact on the severity of ROM.

Research Insights

  • Manuka Honey→Improved Quality of Life

    There was no statistically significant difference between the honey and placebo arms in any of the outcome indicators.

    Effect
    Neutral
    Effect size
    Small
    Dose
    5 ml four times a day
  • Manuka Honey→Improved Symptom Severity

    There was no statistically significant difference between the honey and placebo arms in any of the outcome indicators.

    Effect
    Neutral
    Effect size
    Small
    Dose
    5 ml four times a day
  • Manuka Honey→Reduced Oral Mucositis Severity

    There was no statistically significant difference between the honey and placebo arms in any of the outcome indicators.

    Effect
    Neutral
    Effect size
    Small
    Dose
    5 ml four times a day
  • Manuka Honey→Reduced Severity of Oral Mucositis

    There was no statistically significant difference between the honey and placebo arms in any of the outcome indicators.

    Effect
    Neutral
    Effect size
    Small
    Dose
    5 ml four times a day
  • Manuka Honey→Reduced Weight Loss

    There was no statistically significant difference between the honey and placebo arms in any of the outcome indicators.

    Effect
    Neutral
    Effect size
    Small
    Dose
    5 ml four times a day

Adverse Events Reported

  • Manuka Honey→Overall tolerability

    manuka honey was not tolerated well by our patients

    Finding
    Reported
  • Manuka Honey→nausea

    Dropouts were mostly due to nausea and were similar in both arms

    Finding
    Reported
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