Effectiveness of auricular acupuncture in milk production of breastfeeding women: a randomized clinical trial

Abstract

The use of acupuncture to improve breastfeeding conditions, in particular to increase milk production has been used mainly in the East, with satisfactory results. Thus, the objective of this study is to evaluate the effectiveness of auricular acupuncture in milk production in lactating mothers. This is a controlled, randomized, with three parallel groups: intervention, placebo and control. The intervention group will receive Auricular Acupuncture; the placebo group will receive Auricular Sham Acupuncture; the control group will receive usual care, as well as the two previous groups. The auricular acupuncture sessions will be twice a week for a period of three weeks. The control group also have the same follow-up period. The study will be conducted in the Human Milk Bank (HMB), University Hospital of Ribeirão Preto Medical School, University of São Paulo. Will participate in the study mothers who attend at HMB with low milk production. The primary endpoint will be the milk production, measured by the volume of milk produced and the serum prolactin level, in the baseline, day-7 and day-15 after the beginning of the treatment. Initially, there will be a pilot study of 50 women and from the data obtained will be held the sample calculation for the second phase of study. The block randomization will be used in the proportion 1: 1: 1. Statistical analyses will be performed in STATA software, with a statistical significance level of ± = 0.05. (AU)