Manuka honey sinus irrigations in recalcitrant chronic rhinosinusitis: phase 1 randomized, single‐blinded, placebo‐controlled trial

Abstract

Background Manuka honey (MH) has significant antibiofilm activity in vitro and in vivo against Staphylococcus aureus, methicillin‐resistant S aureus (MRSA), and Pseudomonas aeruginosa. This is the first randomized, single‐blinded, placebo‐controlled phase 1 clinical trial investigating the safety and preliminary efficacy of MH with augmented methylglyoxal (MGO) rinses in recalcitrant chronic rhinosinusitis (CRS). Methods Patients were included after previously undergoing endoscopic sinus surgery and presenting with signs and symptoms of sinus infection with positive bacterial cultures on sinus swabs. Patients were randomized to receive 14 days of twice‐daily 16.5% MH + 1.3 mg/mL MGO sinonasal rinses and concurrent 10 days of placebo tablets (MH), or 14 days of twice‐daily saline sinonasal rinses and concurrent 10 days of culture‐directed antibiotic therapy (CON). Safety observations included the University of Pennsylvania Smell Identification Test (UPSIT) and adverse‐event (AE) reporting. Efficacy was assessed comparing microbiology results, Lund‐Kennedy scores (LKSs), and symptom scores using the visual analog scale (VAS) and 22‐item Sino‐Nasal Outcome Test (SNOT‐22). Results Twenty‐five patients completed the study. MH demonstrated a good safety profile with no major AEs and no changes in UPSIT. Six of 10 (60%) MH patients had a reduction in bacterial culture rate with 1 of 10 of those having negative cultures, compared with 12 of 15 (80%) in the control group with 7 of 15 having negative cultures upon completion of the study. Conclusion This study concludes that twice‐daily 16.5% MH augmented with 1.3 mg/mL MGO sinonasal rinses alone for 14 days is safe but not superior to culture‐directed oral antibiotics and twice‐daily saline rinses.

International consensus statement on allergy and rhinology: rhinosinusitis 2021

“…Clinical studies assessing the efficacy of Manuka honey in treatment resistant post‐surgical patients have not demonstrated superior efficacy over saline alone 1227–1232 . Thamboo et al evaluated 34 AFRS patients, randomized to receive 30 days of atomized MH saline solution to 1 side and saline alone to the contralateral side.…”

“…However, during acute exacerbation of their CRS, culture negativity was statistically better in patients who irrigated with MH solution 1230 . A 2019 single‐blinded, placebo‐controlled trial by Ooi et al investigated MH with augmented MGO rinses in recalcitrant CRS patients 1232 . Twenty‐five patients with CRS and positive bacterial culture sinus swab after ESS were randomized to receive 14 days twice daily 16.5% MH + 1.3 mg/mL MGO sinonasal rinses or 10 days of culture‐directed oral antibiotic therapy with concurrent topical or oral placebo.…”

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

“…It needed to be above the minimum inhibitory concentration, but below the upper limit of tolerability and the level at which histological epithelial injury occurs, as ascertained by in vitro and unpublished data (N. Sorrel, personal communication, 28 July 2014; E. Leon, personal communication, 16 July 2014) 9,10,20,21 . Only a couple other studies have evaluated manuka honey for nasal use and none in the CF‐CRS population 22‐25 …”

“…9,10,20,21 Only a couple other studies have evaluated manuka honey for nasal use and none in the CF-CRS population. [22][23][24][25] This trial does provide data on preliminary effectiveness of manuka honey sinus irrigations in post-ESS subjects with CF-CRS.…”

Current Perspective on Nasal Delivery Systems for Chronic Rhinosinusitis

“…However, it is difficult to reach a consensus on its use owing to the lack of consistent efficacy data, Lee et al [73] found no significant difference between MH sinus irrigation group and saline sinus irrigation group in patients with CRS. The experimental results reported by Ooi et al [74] revealed that 6 of 10 (60%) patients sinonasal rinses MH demonstrated a reduced bacterial culture rate, with no major adverse events.…”