Val Robson University Hospital Aintree. Liverpool U.K.

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1 Val Robson University Hospital Aintree. Liverpool U.K. Results of a Randomised Controlled Trial Comparing Antibacterial Honey (Medihoney ) to conventional treatment in wound care and the problems arising during the course of the trial.

2 Background There is increasing evidence to support the use of honey in wound care. Antibacterial properties Acidity ph low enough to slow down or prevent microbial growth (Molan 1992) Osmotic effect Inhibits microbial growth (Molan 1992) Hydrogen Peroxide (Allen et.al.1991; Cooper 1999, 2002, 2005; Blaser et.al 2007)

3 Understanding Honey Prof. Peter Molan MBE. PhD, B.Sc (Hons), University of Waikato, Hamilton, New Zealand Prof. Rose Cooper PhD, PGCE, BSc. University of Wales Institute, Cardiff

4 Honey in Wound Care Use in wound care Protective barrier Moist wound healing Debriding agent Removes malodour (Molan 1998 Cooper et.al 2005; Molan 2005; White et.al 2005)

5 Moore et al. Systematic Review RCT s Effects of honey compared to active controls, (conventional & unconventional) Evidence of bias, poor quality & validity, small sample sizes Honey shown to be superior for wound healing, maintenance of sterility & eradication of infection Conclusion Lack of high quality comparative evidence Limited evidence on honey and its uses Review would help in design of new, large randomised studies with conventional wound treatment More trials needed.

6 Aim of the Study Compare medical grade honey with conventional treatments in wounds healing by secondary intention. Honey used was Medihoney Antibacterial Honey Design Single centre open-label RCT Data Collection Collected between September 2004 & May 2007

7 Inclusion & Exclusion Criteria All patients with a wound healing by secondary intention. Exclusion Criteria Patients with diabetes Known allergy to bee/honey products Venous ulcers of less than 12 weeks Grade 1 or 4 pressure sores Wounds containing exposed tendon, muscle or bone or where malignancy was present or suspected. Wound infection requiring systemic antibiotics

8 Sample size calculation Conventional group: estimated 50% healing rate by 24 weeks Honey group: expected 20% increase (i.e. 70% healing rate by 24 weeks) 80% power, 5% significance level 93 patients required per group Aimed to recruit 200 (to allow for drop outs)

9 Outcomes Measures Primary Outcome Measure Time to healing (calculated as the number of days between randomisation and date of complete healing) Secondary Outcome Measure Time to 50% reduction in wound area. Wound Measurement Leg Ulcer Telemedicine System

10 Interventions Honey Wound covered with honey to a depth of approx 3mm followed by a NA dressing & absorbent dressing. Control Group Dressings or dressing system appropriate to the wound and available from the local dressing formulary

11 Randomization Blocked randomization Stratified by two factors Age <40 yrs >40 yrs Size of Wound <10cm >10cm

12 Data Analysis Intention to Treat Analysed in treatment groups to which originally randomised, regardless of actual treatment received Sensitivity analyses 1. Per protocol (PP): Analysed only those patients who received the randomized treatment (and censored at point of any deviation) 2. As treated (AT): Analysed patients according to the treatment they actually received

13 Results Time to healing The median time to healing in the honey group was 100 days compared to 140 in the control group. This was not statistically significant but clinically significant. Time to 50% reduction in wound area 32 days in the honey group compared to 46 days in the control group. Again, not statistically significant but clinically significant.

14 Results Men on average are 77% less likely to achieve healing than women. With each cm 2 increase in wound area the likelihood of the wound healing decreases by an average of 2% at any particular time point. Conclusions from the PP & AT analyses were similar to the ITT analyses

15 Study limitations Problems with over popularity of honey Media attention Availability on prescription Stratifying by wound type rather than age

16 Discussion Blinding Prevents Bias Double Blind Presentation of honey Active Preparation Caused Non adherence

17 Discussion Recruitment problems limited recruitment to 105 patients As with Jull et.al study (2008) insufficient numbers were recruited to reach statistical significance Data strongly suggests that healing times are reduced using honey compared with conventional treatment.

18 Conclusion Wound area at start of treatment and sex are both highly significant predictors of time to healing. Results of study gives further support to the use of honey in clinical practice. Further research should consider health economics.

19 Conclusion More research needed RCT s a gold standard?

20 Acknowledgements Mrs Susie Dodd. Medical Statistician. University of Liverpool Aintree Hospitals NHS Foundation Trust Medihoney Pty Mr. Simon Dodds, Good Hope Hospital Florence Nightingale Foundation Florence Nightingale Council Huntleigh Healthcare

21 References Allen, K. L., P. C. Molan, et al. (1991). A survey of the antibacterial activity of some New Zealand honeys. Journal of Pharmacy and Pharmacology 43: Molan P.C. (1999) The role of honey in the management of wounds. Journal of Wound Care, 8; 8: Blaser, G., K. Santos, et al. (2007). Effect of medical honey on wounds colonised or infected with MRSA. J Wound Care 16(8): Cooper, R. (2005). The antimicrobial activity of honey. In Honey: A modern wound management product. (R. White and R. Cooper., ed.) Aberdeen, Wounds UK Publishing: Cooper, R. A., E. Halas, et al. (2002). The efficacy of honey in inhibiting strains of Pseudomonas aeruginosa from infected burns. J Burn Care Rehabil 23(6): Cooper, R. A., P. C. Molan, et al. (1999). Antibacterial activity of honey against strains of Staphylococcus aureus from infected wounds. J R Soc Med 92(6):

22 References Molan P.C (1992) The antibacterial activity of honey. 1. The nature of the antibacterial activity. Bee World 1992, 73, 5-28 Cooper, R., K. Jones, et al. (2005). Mode of action of honey. Immunomodulatory properties of honey that may be relevant to wound repair. R. White and R. Cooper. Aberdeen, Wounds UK Publishing: Molan, P. C. (1998). A brief review of honey as a clinical dressing. Primary Intention 6(4): Molan, P. (2005). Mode of action of honey. In Honey: A modern wound management product. (R. White and R. Cooper., ed) Aberdeen, Wounds UK Publishing: White, R. and P. Molan (2005). Mode of action of honey. A summary of published clinical research on honey in wound management. R. White and R. Cooper. Aberdeen, Wounds UK Publishing: Moore O.A, Smith A, Campbell F, Seers k, McQuay H.J, Moore R.A (2001)Systematic review of the use of honey as a wound dressing. BMC Complementary and Alternative Medicine 1; 2: Jull, A., N. Walker, et al. (2008). Randomized clinical trial of honey-impregnated dressings for venous leg ulcers. Br J Surg 95(2):

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