Pilot, comparative, randomized, controlled trial assessing the safety and efficacy of manuka honey in the treatment of sinonasal bacterial infections in chronic rhinosinusitis

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000136404
• Date of registration: 05/02/2016
• Prospective Registration: Yes
• Primary sponsor: Adelaide University
• Public title: Pilot, comparative, randomized, controlled trial assessing the safety and efficacy of manuka honey in the treatment of sinonasal bacterial infections in chronic rhinosinusitis
• Scientific title: Pilot, comparative, randomized controlled trial assessing the safety and efficacy of manuka honey augmented with methylglyoxal targeting bacterial infections and biofilms in patients with Chronic Rhinosinusitis in a clinical setting
• Date of first enrolment: 08/02/2016
• Target sample size: 20
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616000136404.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Sarah Vreugde

• Name: Prof Peter-John Wormald

Key inclusion & exclusion criteria

Inclusion criteria: (1) Those who have had symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure, lack of sense of smell) that has been previously persistent for greater than 3 months
(2) Have had at least one operation for their chronic rhinosinusitis
(3) Continue to have ongoing symptoms despite surgical management
(4) Have a positive sinonasal swab that indicates a bacterial infection
(5) Over 18 years of age
(6) Are able to give written informed consent
(7) Are local patients who will be returning to this centre for postoperative follow-up care

Exclusion criteria: (1) A diagnosis of cystic fibrosis
(2) Pregnant or breastfeeding
(3) Immunocompromised patients
(4) Patients actively taking oral steroids
(5) Patients who have used antibiotics within 1 month prior to the trial.
(6) Fructose intolerance/allergy


Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Chronic rhinosinusitis;
Chronic rhinosinusitis

Infection - Studies of infection and infectious agents

Intervention(s)

Patients in the treatment group will receive 28 pre-prepared sinonasal flush bottles containing 240mL of 16.5% manuka honey and 1.3mg/mL methylglyoxal. They will be asked to utilize the flushes twice daily for 14 days. They will also receive 20 encapsulated dextrose tablets and will be requested to take these orally twice a day for 10 days in parallel with the honey flushes.

Patients are asked to return any unused bottles and/or tablets at the end of the study to monitor treatment adherence.

Primary Outcome(s)

Assessing the safety of the manuka honey flushes. This will be done by having patients self report any discomfort, pain or health problems that occur during the treatment period. [Immediately post-treatment]

Removal of active infection. This will be assess through endoscopic evaluation of the nose as well as by taking a swab from the patients nose to identify if any pathogenic bacteria are present.[Immediately post-treatment ]

Assessment of endoscopic score. This will be assessed by endoscopically examining the nasal passage of the patients and recording this examination. The video will then be scored by a blinded observer using the Lund-Kennedy scoring system.[Immediately post-treatment]

Secondary Outcome(s)

Long term assessment of endoscopic score. This will be assessed by endoscopically examining the nasal passage of the patients and recording this examination. The video will then be scored by a blinded observer using the Lund-Kennedy scoring system.[3 and 6 months post-treatment
]

Assessment of symptom scores. This will be assessed by asking patients to fill in two questionnaires regarding their symptoms. This will utilize the two validated questionnaires the SNOT-22 and Visual Analogue Scale.[Immediately post-treatment]

Long term assessment of symptom scores. This will be assessed by asking patients to fill in two questionnaires regarding their symptoms. This will utilize the two validated questionnaires the SNOT-22 and Visual Analogue Scale.[3 and 6 months post-treatment]

Prevention of future bacterial infections. This will be assessed by having patients attend clinics 3 and 6 months post-treatment to assess if they have continued to experience active infections. The nasal passage will be visualised using endoscopic techniques and if signs of an active infection are present, a swab will be taken and sent for microbiological analysis.[3 and 6 months post-treatment
]

Secondary ID(s)

Nil

Source(s) of Monetary Support

University of Adelaide

Secondary Sponsor(s)

Department of Otolaryngology, The Queen Elizabeth Hospital

Ethics review

Status: Approved
Approval date:
Contact:

The Queen Elizabeth Hospital, Lyell McEwin Hospital and Modbury Hospital HREC