Wesolowska Aleksandra, Pietrzak Bronislawa, Kociszewska-Najman Bozena, Wielgos Miroslaw, Czajkowski Krzysztof, Wietrak Ewa, Karzel Katarzyna, Borszewska-Kornacka Maria K
Laboratory of Human Milk and Lactation Research at Regional Human Milk Bank in Holy Family Hospital, Medical University of Warsaw, Department of Neonatology, Warsaw, Poland.
1st Department of Obstetrics and Gynecology,Faculty of Medicine, Medical University of Warsaw, Poland, Poland.
Ginekol Pol. 2021;92(2):118-125. doi: 10.5603/GP.a2020.0107.
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.
母乳分泌延迟或不足以及乳汁供应少仍是一个难以克服的挑战性问题，尤其是在早产的情况下。草药催乳剂可能是增加乳汁供应的一个好方法，然而，缺乏临床研究证实其有效性和安全性。本研究的目的是验证基于含有β-葡聚糖的大麦芽和香蜂草的独特催乳剂组合物作为催乳剂的安全性和有效性。
该研究纳入了117名早产婴儿的母亲，她们被随机分为接受催乳剂的催乳剂组和安慰剂组。80名参与者获得了完整的数据集，两组人数相等。母亲在分娩后前两周挤出的乳汁量是主要结局，产品的安全性是次要结局。
催乳剂组参与者最后一次访视时记录的乳汁量显著高于安慰剂组（95毫升对62.5毫升，p = 0.049）。研究期间，安慰剂组挤出的乳汁总量为4209±335毫升，而催乳剂组为6036±498毫升（p = 0.003）。
补充独特的催乳剂组合物是安全的，并且增加了乳汁分泌量，这使得早产母亲在哺乳期第一周能够达到每天500毫升的目标最低量。
