Background: Sore nipples are common during lactation and remain the major reason for failing to establish successful breastfeeding. To formulate a peppermint gel and to evaluate its effect on the prevention of nipple crack associated with breast-feeding, a randomized double-blinded clinical trial comparing the above formulation with modified lanolin and a neutral ointment was carried out.
Material/Methods: Two hundred and sixteen primiparous participants were assigned randomly to three groups. Each group applied only one of the above three preparations on both breasts for 14 days. Each group consisted of 72 primiparous mothers and was seen for a maximum of four follow-up visits within 14 days and a final visit at week 6. The rate of nipple and areola crack and pain was evaluated.
Results: The study groups were comparable in mean age and route of delivery. Nipple crack were less in mothers who received peppermint gel than in those who received lanolin ointment or placebo (χ[sup]2[/sup]=16.8, df=6, P=0.01). Relative risk of nipple crack in the lanolin group (RR: 2.41, 95%CI: 1.20–3.01) was higher than in the peppermint group (RR: 1.85, 95%CI: 1.64–3.10).
Conclusions: Prophylactic peppermint gel in breastfeeding lactating women is associated with fewer nipple cracks and is more effective than lanolin and placebo. It could be recommended for preventing of nipple crack along with teaching better breastfeeding technique at the initiation of breastfeeding.

Keywords: Lanolin - pharmacology, Pregnancy, Placebos, Parity, Ointments - pharmacology, Nipples - drug effects, Mentha piperita - chemistry, Administration, Cutaneous, infant formula, Gels - pharmacology, Breast Feeding, Breast Diseases - prevention & control