RESUMEN
BACKGROUND: The negative outcomes associated with painful and damaged nipples have been widely documented in the breastfeeding literature. Numerous studies have been conducted evaluating topical preparations to treat nipple pain and damage with equivocal findings. No studies have evaluated the effectiveness of the increasingly popular all-purpose nipple ointment (APNO). The purpose of this trial is to evaluate the effect of the APNO versus lanolin on nipple pain among breastfeeding women with damaged nipples. SUBJECTS AND METHODS: A double-blind, randomized controlled trial was conducted in a large single-site, tertiary-care hospital in Toronto, ON, Canada. Breastfeeding women (n=151) identified as having damage to one or both nipples were randomized to apply either APNO (intervention group) or lanolin (control group) to their nipples according to the trial protocol. The primary outcome was nipple pain at 1 week after randomization measured using the Short Form McGill Pain Questionnaire. Additional outcomes at 1 week after randomization and 12 weeks postpartum included nipple yeast symptoms and/or mastitis, rates of breastfeeding duration and exclusivity, and maternal satisfaction with infant feeding method and treatment ointment. RESULTS: There were no significant group differences in mean pain scores at 1 week after randomization. Women in the lanolin group reported significantly greater satisfaction with their infant feeding method and had nonsignificantly higher breastfeeding duration and exclusivity rates at 12 weeks postpartum. CONCLUSION: Results suggest that APNO is not superior to lanolin in treating painful, damaged nipples.