Study Results
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Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-09-04
2025-09-04
Brief Summary
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Main aim is to investigate a potential improvement in post-tonsillectomy pain control, with a low cost and freely available alternative to conventional analgesics. Recent systematic review and multidisciplinary consensus suggest a potential role for the inclusion of honey for this purpose. Clinical efficacy over placebo remains to be conclusively demonstrated in robust clinical trials.
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Detailed Description
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Beehive products such as honey and propolis have been mentioned as wound dressings in ancient writings across the world, thousands of years before the advent of modern medicine. Honey is a by-product of flower nectar produced in the aero-digestive tract of bees and propolis is produced from plant resins, enriched with salivary enzymatic secretions. Honey has been shown to possess anti-bacterial and anti-inflammatory properties. Manuka honey is a mono-floral honey with potential wound repair and antibacterial activities. It is produced by bees fed on the flowers of the New Zealand Manuka bush (Leptospermum scoparium) and contains a significantly higher concentration of the 1,2-dicarbonyl compound methylglyoxal, which may account for its antibacterial activity. Manuka honey has been reported to stimulate the formation of new blood capillaries and the growth of fibroblasts and epithelial cells when applied topically to wounds. It is now part of the routine armamentarium of products used in the treatment of burns and external skin wounds in NHS Plastic surgery departments in the United Kingdom (UK). The clinical efficacy of Manuka honey in the oral and oropharyngeal cavities is controversial and quality, placebo controlled, randomized clinical trials are lacking. There are a number of systematic reviews that have described some benefit of Manuka honey in the treatment of radiation induced oro-mucositis, particularly in reducing treatment interruptions, preventing weight loss and pain control.
The most recent PROSPECT (Procedure-specific postoperative pain management) guideline for tonsillectomy published in 2021 in the Anaesthesia journal, represented an international, multidisciplinary collaborative effort providing recommendations on the most effective pain management following tonsillectomy. The fourth of five summative recommendations, based on systematic review of the current literature, is that analgesic adjuncts such as postoperative honey is recommended. Honey could provide significant improvements in post-operative pain scores as well as provide opioid-sparing benefits. This is a powerful mandate for further research into the routine clinical usage of honey as an adjunct to post-tonsillectomy pain management. To date there have not been any placebo controlled, randomised clinical trials comparing the effectiveness of oral honey in post-tonsillectomy pain control in the UK.
The aim of this double-blind, randomised, placebo controlled clinical trial is to compare the effect of Manuka honey with standard of care compared to placebo with standard of care on post-tonsillectomy pain and postoperative outcomes. The hypothesis is that the addition of Manuka honey to standard of care will result in a significant reduction in post-tonsillectomy pain scores compared to the placebo control. The null hypothesis is that there is no significant difference between Manuka honey compared to placebo in post-tonsillectomy pain scores.
The primary endpoint/outcome are daily pain scores measured via Visual Analogue Scale (VAS). This is a continuous variable, which will be measured and recorded three times a day, every day for the first 14 days post-tonsillectomy.
The secondary endpoint/outcomes include the number and frequency of concurrent analgesia usage, the rate of readmission to hospital, the rate of secondary haemorrhage, the rate of infection requiring antibiotics treatment, the speed of return to work. These are a mixture of continuous and ordinal variables and will be collected retrospectively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Placebo - sugar-based syrup, thickened with sodium alginate and with honey flavouring, to be taken per-oral 15ml TDS for 14 days post-tonsillectomy.
TREATMENT
TRIPLE
Neither the patient nor the researcher collecting data will be aware of which arm the patient has been enrolled onto.
Study Groups
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Treatment
Manuka honey, 15ml, three times a day, for 14 days. To be kept on the tongue for at least 10 seconds prior to swallowing.
Manuka honey MGO 1000
Natural Manuka honey, produced in New Zealand. With MGO content ≥ 1000.
Placebo
Sugar-based syrup, thickened with sodium alginate and flavoured with honey flavouring, 15ml, three times a day, for 14 days.
To be kept on the tongue for at least 10 seconds prior to swallowing.
Sugar-based syrup, thickened with sodium alginate and flavoured with honey flavouring
Sugar-based syrup, thickened with sodium alginate and flavoured with honey flavouring, 15ml, three times a day, for 14 days.
To be kept on the tongue for at least 10 seconds prior to swallowing.
Interventions
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Manuka honey MGO 1000
Natural Manuka honey, produced in New Zealand. With MGO content ≥ 1000.
Sugar-based syrup, thickened with sodium alginate and flavoured with honey flavouring
Sugar-based syrup, thickened with sodium alginate and flavoured with honey flavouring, 15ml, three times a day, for 14 days.
To be kept on the tongue for at least 10 seconds prior to swallowing.
Eligibility Criteria
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Inclusion Criteria
* Consented and listed for bilateral tonsillectomy or adenotonsillectomy
* Tonsillectomy performed within the trial study period
Exclusion Criteria
* Unilateral tonsillectomy
* Pregnancy
* Concurrent pharyngeal or upper aerodigestive tract biopsy
* Robotic tonsillectomy
* Previous H\&N malignancy
* Previous H\&N radiotherapy
* Type 1/2 diabetes mellitus
* Known allergy to bee related products
* Known allergy to golden syrup
* History of chronic pain
* History of fibromyalgia
* Current usage of chronic (\>6weeks) analgesia
* High-risk anaesthetic patients
* Children or adolescents \<18years old
* Adults unable to consent for themselves
18 Years
ALL
Yes
Sponsors
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Manuka Doctor UK Ltd
UNKNOWN
National Institute for Health Research, United Kingdom
OTHER_GOV
East and North Hertfordshire NHS Trust
OTHER_GOV
Responsible Party
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Principal Investigators
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Phillip Smith, PhD
Role: STUDY_DIRECTOR
East and North Hertfordshire NHS Trust
George Mochloulis, MD
Role: PRINCIPAL_INVESTIGATOR
East and North Hertfordshire NHS Trust
Locations
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Lister Hospital
Stevenage, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Aldamluji N, Burgess A, Pogatzki-Zahn E, Raeder J, Beloeil H; PROSPECT Working Group collaborators*. PROSPECT guideline for tonsillectomy: systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 Jul;76(7):947-961. doi: 10.1111/anae.15299. Epub 2020 Nov 17.
Nolan VC, Harrison J, Wright JEE, Cox JAG. Clinical Significance of Manuka and Medical-Grade Honey for Antibiotic-Resistant Infections: A Systematic Review. Antibiotics (Basel). 2020 Oct 31;9(11):766. doi: 10.3390/antibiotics9110766.
Carter DA, Blair SE, Cokcetin NN, Bouzo D, Brooks P, Schothauer R, Harry EJ. Therapeutic Manuka Honey: No Longer So Alternative. Front Microbiol. 2016 Apr 20;7:569. doi: 10.3389/fmicb.2016.00569. eCollection 2016.
Hawley P, Hovan A, McGahan CE, Saunders D. A randomized placebo-controlled trial of manuka honey for radiation-induced oral mucositis. Support Care Cancer. 2014 Mar;22(3):751-61. doi: 10.1007/s00520-013-2031-0. Epub 2013 Nov 13.
Yang C, Gong G, Jin E, Han X, Zhuo Y, Yang S, Song B, Zhang Y, Piao C. Topical application of honey in the management of chemo/radiotherapy-induced oral mucositis: A systematic review and network meta-analysis. Int J Nurs Stud. 2019 Jan;89:80-87. doi: 10.1016/j.ijnurstu.2018.08.007. Epub 2018 Aug 23.
Cho HK, Jeong YM, Lee HS, Lee YJ, Hwang SH. Effects of honey on oral mucositis in patients with head and neck cancer: A meta-analysis. Laryngoscope. 2015 Sep;125(9):2085-92. doi: 10.1002/lary.25233. Epub 2015 Mar 16.
Other Identifiers
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323188
Identifier Type: OTHER
Identifier Source: secondary_id
56974
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
RD2023-14 HONEY-POT
Identifier Type: -
Identifier Source: org_study_id
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