Efficacy of a galactogogue containing silymarin-phosphatidylserine and galega in mothers of preterm infants: a randomized controlled trial.

BACKGROUND/OBJECTIVES: Human milk (HM) is the best possible food for all infants, especially for preterm ones, but lactation and breastfeeding are very difficult for mothers of preterm babies and high rates of breastfeeding difficulties have been reported. Our aim was to investigate the efficacy of a galactogogue containing silymarin-phosphatidylserine and galega in increasing milk production during the first month after delivery in a population of mothers of preterm infants. SUBJECTS/METHODS: Mothers of infants with gestational age (GA) between 27+0 and 32+6 weeks were enrolled in this prospective, double-blind, randomized trial and were randomly allocated to receive either the galactogogue containing silymarin-phosphatidylserine and galega, 5 g/day (galactogogue group, GG), or a placebo, 5 g of lactose per day (placebo group, PG) from the 3rd to the 28th day after delivery. RESULTS: Fifty mothers were included in each group. General characteristics of mothers and pregnancies were similar. Milk production was significantly greater in the GG at the 7th day of life and at the 30th day of life. Daily milk production from the 7th to the 30th day of life was 200 (110-380) ml in the GG vs 115 (60-245) ml in the PG (P<0.0001). The total production of milk during the study period was significantly higher in the GG (6523±5298 ml vs 4136±4093 ml; P<0.02). At the end of the study, 45 mothers of the GG were able to reach the target of milk supply of 200 ml/day compared with 25 mothers of the PG (P<0.01). No adverse reactions were noticed in the study groups. CONCLUSIONS: Silymarin-phosphatidylserine and galega increased milk production in mothers of preterm infants without any significant side effects.