Randomized clinical trial of honey-impregnated dressings for venous leg ulcers

Abstract

Background: The efficacy of honey as a treatment for venous ulcers has not been evaluated, despite widespread interest. This trial aimed to evaluate the safety and effectiveness of honey as a dressing for venous ulcers. Methods: This community-based open-label randomized trial allocated people with a venous ulcer to calcium alginate dressings impregnated with manuka honey or usual care. All participants received compression bandaging. The primary outcome was the proportion of ulcers healed after 12 weeks. Secondary outcomes were: time to healing, change in ulcer area, incidence of infection, costs per healed ulcer, adverse events and quality of life. Analysis was by intention to treat. Results: Of 368 participants, 187 were randomized to honey and 181 to usual care. At 12 weeks, 104 ulcers (55·6 per cent) in the honey-treated group and 90 (49·7 per cent) in the usual care group had healed (absolute increase 5·9 (95 per cent confidence interval (c.i.) − 4·3 to 15·7) per cent; P = 0·258). Treatment with honey was probably more expensive and associated with more adverse events (relative risk 1·3 (95 per cent c.i. 1·1 to 1·6); P = 0·013). There were no significant differences between the groups for other outcomes. Conclusion: Honey-impregnated dressings did not significantly improve venous ulcer healing at 12 weeks compared with usual care. Registration number: ISRCTN 06161544 (http://www.controlled-trials.com).