Barley malt-based composition as a galactagogue - a randomized, controlled trial in preterm mothers.

Abstract

Delayed or insufficient breast milk production, as well as low milk supply, is still a challenging problem to overcome, particularly in the case of preterm delivery. Herbal galactagogues might be a good way to increase milk supply, however, there is a lack of clinical studies confirming their efficacy and safety. The aim of this study was to verify the safety and effectiveness as a galactagogue of the unique galactagogue composition based on barley malt with β -glucan and lemon balm. The study included 117 mothers of preterm infants randomly divided into the Galactagogue Group given galactagogue and the Placebo Group. A complete data set was obtained for 80 participants, divided equally between two groups. Volume of milk expressed by mothers during the first two weeks after delivery was the primary outcome and safety of the product was the secondary outcome. Volume of milk recorded on participants' last visit in the Galactagogue Group was significantly higher than in the Placebo Group (95 mL vs 62.5 mL, p = 0.049). The total expressed milk volume during the study was 4209 ± 335 mL in the Placebo Group vs 6036 ± 498 mL (p = 0.003) in the Galactagogue Group. Supplementation with unique Galactagogue composition was safe and increased milk output which allowed achieving target minimal volume of 500 mL per day in first week of lactation in preterm mothers.