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

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.

Manuka honey sinus irrigation for the treatment of chronic rhinosinusitis: a randomized controlled trial.

BACKGROUND: Manuka honey (MH) has been shown in vitro to be effective against biofilm-producing bacteria. This study assessed the effectiveness of MH for patients with active chronic rhinosinusitis (CRS) and prior sinus surgery. METHODS: This prospective single-blinded (clinician only) randomized controlled trial recruited patients with active CRS and prior sinus surgery. Patients received either MH or saline (SAL) sinus irrigations twice daily for 30 days and were offered oral antibiotics and/or oral/topical steroids as indicated. Outcomes were 22-item Sino-Nasal Outcome Test (SNOT-22) change score (primary), culture negativity, and Lund-Kennedy endoscopic change score. RESULTS: Forty-two patients were analyzed (MH, n = 20; SAL, n = 22). The SNOT-22 change score achieved a clinically significant improvement in both groups but was similar between MH (median [interquartile range]: -12 [-20, -1]) and SAL (-12.5 [-22, -6]) (p = 0.57). Culture negativity was better on MH (8/19, 42%) compared to SAL (4/21, 19%), nearing statistical significance (p = 0.11). Lund-Kennedy endoscopic change score improved in both groups but was not statistically better on MH (-3 [-5, 0]) compared to SAL (-1 [-2, 0]) (p = 0.20). For patients not receiving oral antibiotics/steroids, culture negativity was statistically better on MH (5/10, 50%) compared to SAL (0/6, 0%) (p = 0.04). MH was well-tolerated. No adverse events were reported. CONCLUSION: In patients with active CRS and prior sinus surgery, both MH and SAL improved outcomes, but there was no statistically significant difference between these groups. However, in the subset that did not receive oral antibiotics/steroids, culture negativity was statistically better on MH, suggesting that MH alone may be effective for acute exacerbations of CRS.