Randomised controlled trial of topical kanuka honey for the treatment of rosacea.

Autor:	Braithwaite I; Medical Research Institute of New Zealand, Wellington, New Zealand., Hunt A; Medical Research Institute of New Zealand, Wellington, New Zealand., Riley J; Medical Research Institute of New Zealand, Wellington, New Zealand., Fingleton J; Medical Research Institute of New Zealand, Wellington, New Zealand., Kocks J; Medical Research Institute of New Zealand, Wellington, New Zealand., Corin A; Clinical Horizons, Tauranga, New Zealand., Helm C; Clinical Horizons, Tauranga, New Zealand., Sheahan D; Papamoa Pines Medical Centre, Tauranga, New Zealand., Tofield C; Cameron Medical Clinic, Tauranga, New Zealand., Montgomery B; Optimal Clinical Trials, Auckland, New Zealand., Holliday M; Medical Research Institute of New Zealand, Wellington, New Zealand., Weatherall M; University of Otago, Wellington, New Zealand., Beasley R; Medical Research Institute of New Zealand, Wellington, New Zealand.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2015 Jun 24; Vol. 5 (6), pp. e007651. Date of Electronic Publication: 2015 Jun 24.
DOI:	10.1136/bmjopen-2015-007651
Abstrakt:	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. (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.)
Databáze:	MEDLINE
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