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Randomised controlled trial of topical kanuka honey for the treatment of rosacea
OBJECTIVE: To investigate the efficacy of topical 90% medical-grade kanuka honey and 10% glycerine (Honevo) as a treatment for rosacea. DESIGN: Randomised controlled trial with blinded assessment of primary outcome variable. SETTING: Outpatient primary healthcare population from 5 New Zealand sites....
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4480029/ https://www.ncbi.nlm.nih.gov/pubmed/26109117 http://dx.doi.org/10.1136/bmjopen-2015-007651 |
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author | Braithwaite, Irene Hunt, Anna Riley, Judith Fingleton, James Kocks, Janwillem Corin, Andrew Helm, Colin Sheahan, Davitt Tofield, Christopher Montgomery, Barney Holliday, Mark Weatherall, Mark Beasley, Richard |
author_facet | Braithwaite, Irene Hunt, Anna Riley, Judith Fingleton, James Kocks, Janwillem Corin, Andrew Helm, Colin Sheahan, Davitt Tofield, Christopher Montgomery, Barney Holliday, Mark Weatherall, Mark Beasley, Richard |
author_sort | Braithwaite, Irene |
collection | PubMed |
description | OBJECTIVE: To investigate the efficacy of topical 90% medical-grade kanuka honey and 10% glycerine (Honevo) as a treatment for rosacea. DESIGN: Randomised controlled trial with blinded assessment of primary outcome variable. SETTING: Outpatient primary healthcare population from 5 New Zealand sites. PARTICIPANTS: 138 adults aged ≥16, with a diagnosis of rosacea, and a baseline blinded Investigator Global Assessment of Rosacea Severity Score (IGA-RSS) of ≥2. 69 participants were randomised to each treatment arm. 1 participant was excluded from the Honevo group, and 7 and 15 participants withdrew from the Honevo and control groups, respectively. INTERVENTIONS: Participants were randomly allocated 1:1 to Honevo or control cream (Cetomacrogol), applied twice daily for 8 weeks. MAIN OUTCOME MEASURES: The primary outcome measure was the proportion of participants who had a ≥2 improvement in the 7-point IGA-RSS at week 8 compared to baseline. Secondary outcomes included change in IGA-RSS and subject-rated visual analogue score of change in severity (VAS-CS) on a 100 mm scale (0 mm ‘much worse’, 100 mm ‘much improved’) at weeks 2 and 8. RESULTS: 24/68 (34.3%) in the Honevo group and 12/69 (17.4%) in the control group had a ≥2 improvement in IGA-RSS at week 8 compared to baseline (relative risk 2.03; 95% CI 1.11 to 3.72, p=0.020). The change in IGA-RSS for Honevo compared to control at week 2 minus baseline was −1 (Hodges-Lehman estimate, 95% CI −1 to 0, p=0.03), and at week 8 minus baseline was −1 (Hodges-Lehman estimate, 95% CI −1 to 0, p=0.005). The VAS-CS at week 2 was 9.1 (95% CI 3.5 to 14.7), p=0.002, and at week 8 was 12.3 (95% CI 5.7 to 18.9)¸ p<0.001 for Honevo compared to control. CONCLUSIONS: Honevo is an effective treatment for rosacea. TRIAL REGISTRATION NUMBER: This trial was registered in the Australian and New Zealand Clinical Trials Registry ACTRN12614000004662. |
format | Online Article Text |
id | pubmed-4480029 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-44800292015-07-02 Randomised controlled trial of topical kanuka honey for the treatment of rosacea Braithwaite, Irene Hunt, Anna Riley, Judith Fingleton, James Kocks, Janwillem Corin, Andrew Helm, Colin Sheahan, Davitt Tofield, Christopher Montgomery, Barney Holliday, Mark Weatherall, Mark Beasley, Richard BMJ Open Complementary Medicine OBJECTIVE: To investigate the efficacy of topical 90% medical-grade kanuka honey and 10% glycerine (Honevo) as a treatment for rosacea. DESIGN: Randomised controlled trial with blinded assessment of primary outcome variable. SETTING: Outpatient primary healthcare population from 5 New Zealand sites. PARTICIPANTS: 138 adults aged ≥16, with a diagnosis of rosacea, and a baseline blinded Investigator Global Assessment of Rosacea Severity Score (IGA-RSS) of ≥2. 69 participants were randomised to each treatment arm. 1 participant was excluded from the Honevo group, and 7 and 15 participants withdrew from the Honevo and control groups, respectively. INTERVENTIONS: Participants were randomly allocated 1:1 to Honevo or control cream (Cetomacrogol), applied twice daily for 8 weeks. MAIN OUTCOME MEASURES: The primary outcome measure was the proportion of participants who had a ≥2 improvement in the 7-point IGA-RSS at week 8 compared to baseline. Secondary outcomes included change in IGA-RSS and subject-rated visual analogue score of change in severity (VAS-CS) on a 100 mm scale (0 mm ‘much worse’, 100 mm ‘much improved’) at weeks 2 and 8. RESULTS: 24/68 (34.3%) in the Honevo group and 12/69 (17.4%) in the control group had a ≥2 improvement in IGA-RSS at week 8 compared to baseline (relative risk 2.03; 95% CI 1.11 to 3.72, p=0.020). The change in IGA-RSS for Honevo compared to control at week 2 minus baseline was −1 (Hodges-Lehman estimate, 95% CI −1 to 0, p=0.03), and at week 8 minus baseline was −1 (Hodges-Lehman estimate, 95% CI −1 to 0, p=0.005). The VAS-CS at week 2 was 9.1 (95% CI 3.5 to 14.7), p=0.002, and at week 8 was 12.3 (95% CI 5.7 to 18.9)¸ p<0.001 for Honevo compared to control. CONCLUSIONS: Honevo is an effective treatment for rosacea. TRIAL REGISTRATION NUMBER: This trial was registered in the Australian and New Zealand Clinical Trials Registry ACTRN12614000004662. BMJ Publishing Group 2015-06-24 /pmc/articles/PMC4480029/ /pubmed/26109117 http://dx.doi.org/10.1136/bmjopen-2015-007651 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ |
spellingShingle | Complementary Medicine Braithwaite, Irene Hunt, Anna Riley, Judith Fingleton, James Kocks, Janwillem Corin, Andrew Helm, Colin Sheahan, Davitt Tofield, Christopher Montgomery, Barney Holliday, Mark Weatherall, Mark Beasley, Richard Randomised controlled trial of topical kanuka honey for the treatment of rosacea |
title | Randomised controlled trial of topical kanuka honey for the treatment of rosacea |
title_full | Randomised controlled trial of topical kanuka honey for the treatment of rosacea |
title_fullStr | Randomised controlled trial of topical kanuka honey for the treatment of rosacea |
title_full_unstemmed | Randomised controlled trial of topical kanuka honey for the treatment of rosacea |
title_short | Randomised controlled trial of topical kanuka honey for the treatment of rosacea |
title_sort | randomised controlled trial of topical kanuka honey for the treatment of rosacea |
topic | Complementary Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4480029/ https://www.ncbi.nlm.nih.gov/pubmed/26109117 http://dx.doi.org/10.1136/bmjopen-2015-007651 |
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