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Manuka honey versus saline sinus irrigation in the treatment of cystic fibrosis-associated chronic rhinosinusitis: A randomised pilot trial.

  • 2020-10-02
  • Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery 46(1)
    • Victoria S Lee
    • Ian M Humphreys
    • Patricia L Purcell
    • Greg E Davis

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 13
Population
13 subjects with recalcitrant cystic fibrosis sinusitis and previous sinus surgery
Methods
Prospective, single-blinded (clinician only), randomised, parallel two-arm pilot trial; manuka honey or saline sinus irrigations twice daily for 30 days
Blinding
Single-blind
Duration
30 days
Funding
Unclear

Objectives

Manuka honey attacks biofilms, which contribute to bacterial persistence in cystic fibrosis sinusitis. The primary objective was to determine feasibility of investigating manuka honey as an irrigation treatment for cystic fibrosis sinusitis and secondarily to assess the treatment's preliminary effectiveness.

Design

Prospective, single-blinded (clinician only), randomised, parallel two-arm pilot trial.

Setting

Tertiary rhinology clinic.

Participants

Subjects had recalcitrant cystic fibrosis sinusitis and previous sinus surgery. They received manuka honey or saline sinus irrigations twice daily for 30 days.

Main outcome measures

Main outcomes were recruitment/retention rates and tolerability. Preliminary effectiveness was assessed based on quality-of-life Sinonasal Outcome Test-22 and Lund-Kennedy endoscopic change scores and post-treatment culture negativity.

Results

Over 10 months, 13 subjects were enrolled, and 77% (10/13) were included in the analysis. Manuka honey irrigations were well-tolerated. The quality-of-life change score was clinically significant for manuka honey (-9 [-14,-6]) but not saline (-5 [-9,-1]), although the difference was not statistically significant (P = .29). Lund-Kennedy endoscopic change score was significantly better for manuka honey (-3 [-5,-3]) versus saline (0 [0,0]) (P = .006). There was no difference in post-treatment culture negativity between manuka honey (1/5, 20%) and saline (0/5, 0%) (P = 1.00).

Conclusions

Manuka honey irrigations were well tolerated, and retention rates were high. Preliminary data showed that manuka honey achieved a clinically important difference in quality-of-life score and a significantly better endoscopic outcome. Microbiological control was difficult to achieve. A future definitive trial would require multi-institutional recruitment.

Research Insights

  • Manuka Honey→Achieved Culture Negativity

    There was no difference in post-treatment culture negativity between manuka honey (1/5, 20%) and saline (0/5, 0%) (P = 1.00).

    Effect
    Neutral
    Effect size
    Small
    Dose
    twice daily for 30 days
  • Manuka Honey→Reduced Lund-Kennedy Endoscopic Score

    Lund-Kennedy endoscopic change score was significantly better for manuka honey (-3 [-5,-3]) versus saline (0 [0,0]) (P = .006).

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    twice daily for 30 days
  • Manuka Honey→Reduced Sinonasal Outcome Test-22 Score

    The quality-of-life change score was clinically significant for manuka honey (-9 [-14,-6]) but not saline (-5 [-9,-1]), although the difference was not statistically significant (P = .29).

    Effect
    Neutral
    Effect size
    Small
    Dose
    twice daily for 30 days

Adverse Events Reported

  • Manuka Honey→Overall tolerability

    Manuka honey irrigations were well-tolerated.

    Finding
    Reported
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