Manuka honey sinus rinse study - V0.1
Research type
Research Study
Full title
A pilot study investigating the effects of a manuka honey sinus rinse on sino-nasal outcome test scores in cystic fibrosis patients
IRAS ID
209288
Contact name
Rowena Jenkins
Contact email
Sponsor organisation
Swansea University Medical School
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Research Summary
A pilot study investigating the effects of a manuka honey sinus rinse on sino-nasal outcome test (SNOT-22) scores (indicator of pain and infection severity), quality of life, bacterial amount and/or types within the sino-nasal cavity, and sputum composition in Cystic Fibrosis (CF) patients.
CF is a common hereditary disease that causes an excessive buildup of mucus within the respiratory tract. This buildup (which would normally be cleared away) becomes infected by bacteria which causes inflammation of surrounding lung tissue (with increased pain), congestion of the airway, and poor patient outcome. To help alleviate some of these symptoms, patients use a nasal rinse. Manuka honey has a strong track record as an antimicrobial agent, inhibiting a wide range of bacteria, many of which are found in the lung of CF patients. It is thought that by combining manuka honey with the nasal rinse, the symptoms described above could be improved.
Over an 18 month period, patients will be recruited from the All Wales Adult CF Centre (AWACFC) at University Hospital Wales, Llandough. During their annual review meeting, participants who have SNOT-22 scores ≥ 7 will be recruited into one of two groups; those that will use a standard nasal rinse, and those who will use the standard nasal rinse supplemented with manuka honey. During the participants annual review appointment patient responses to the SNOT-22 and quality of life will be recorded, a nasal swab, sputum sample, and sinus rinse sample will be taken. Participants will use their respective nasal rinse at home daily for 30 days (+/- 7 days) as well as completing a compliance diary. During the participants follow up meeting, a second set of samples/answers will be provided. Any effect manuka honey has on SNOT-22, quality of life, bacterial amount/types within the sino-nasal cavity, and sputum composition will be analysed.
Summary of Results
Short study title: Manuka honey sinus rinse.
Full title: A pilot study investigating the effects of a manuka honey sinus rinse on sino-nasal outcome test scores in cystic fibrosis patients.
REC reference: WalesRec7
Registered:https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5BcbW9wgc64X2JjNxW-2BqMpAM62ONAaYamrqN0vAuiRcyiA-3D-3DNL-2_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIMmeRBiYTFg19P8mb5NwG3M80E2JzX5f2I2JBscGwZyNx-2BUX7wcCTcUqt0vJfCtq-2BA8Yd2a8NvFtq44eHMcBP4l-2F-2Fw-2FrPREn7j73Nd8tVO6Ojp-2FI-2BATxs70IGMxS4oabZaKXWaVZBbAC4OIJPiPzAEe9hcLGAP10mJ0ZMnEY0isQ-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C428a2ae92ccf4d12b4df08da9d4fdca2%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637995263572496957%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=qFDaCqwV1TmFsvu1QICsCWFDhvSaTMxKmtXYgKXPRXs%3D&reserved=0The sponsor of this study was Swansea University (resgov@swansea.ac.uk) who would like to thank everyone who took part. The research was carried out by clinical staff at the All Wales Adult Cystic Fibrosis Centre at the University of Wales and researchers at Swansea University and Cardiff University. There were no competing interests for anyone involved in the study. The study team would like to thank all the study participants for taking part in the study.
The purpose of this study was to see whether the addition of manuka honey to a sinus rinse would improve sino-nasal symptoms in people with cystic fibrosis compared to the standard sinus rinse. Participants were randomised into two groups, one group had a sinus rinse with added manuka honey and another group had the standard sinus rinse. Eighteen people aged between 21-53 with cystic fibrosis took part in this study. Twelve participants withdrew before completing the study. Of the six who completed four were from group A and two were from group B. Group A participants all had improvement in their sino-nasal symptoms at the end of the study, group B participants all had worsening symptoms by the end of the study. There were no serious adverse events in this study. The numbers of participants who completed are too small to draw any conclusions. No further trials with a manuka honey sinus rinse are planned at this time.
REC name
Wales REC 7
REC reference
18/WA/0319
Date of REC Opinion
26 Sep 2018
REC opinion
Favourable Opinion