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ABM Clinical Protocol #9: Use of Galactogogues in Initiating Or Augmenting Maternal Milk Production, Second Revision 2018

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ABM Clinical Protocol #9: Use of Galactogogues in Initiating Or Augmenting Maternal Milk Production, Second Revision 2018 BREASTFEEDING MEDICINE Volume 13, Number 5, 2018 ABM Protocol ª Mary Ann Liebert, Inc. DOI: 10.1089/bfm.2018.29092.wjb ABM Clinical Protocol #9: Use of Galactogogues in Initiating or Augmenting Maternal Milk Production, Second Revision 2018 Wendy Brodribb and the Academy of Breastfeeding Medicine A central goal of the Academy of Breastfeeding Medicine is the development of clinical protocols for man- aging common medical problems that may impact breastfeeding success. These protocols serve only as guide- lines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient. Background of milk, so the terms drain, drainage, and draining are more appropriate. If the breasts are not drained regularly and thor- alactogogues (or lactagogues) are medications or oughly, milk production declines. Alternatively, more frequent other substances believed to assist initiation, mainte- G and thorough drainage of the breasts typically results in an nance, or augmentation of maternal milk supply. Because increased rate of milk secretion, with both immediate (per perceived or actual low milk supply is one of the most common feeding) and delayed (several days) effects.8,9 reasons given for discontinuing breastfeeding,1–4 both mothers and health professionals have sought medication(s), in addi- tion to other nonpharmacological interventions, to address this Potential Indications for Galactogogues concern. Human milk production is a complex physiological process Galactogogues have commonly been used to increase low involving physical and emotional factors and the interaction of (or perceived low) milk supply. Physiologically, low milk multiple hormones, the most important of which is believed to supply is often related to suboptimal milk removal with be prolactin. Despite the fact that prolactin is required for reasons including problems with infants draining the breast, lactation, once lactation is established, there is no direct cor- inappropriate breastfeeding management, maternal or infant relation between serum prolactin levels (either baseline levels illness and hospitalization, and regular mother–infant sepa- or percentage increase after suckling) and the volume of milk ration, for example, work or school. In addition, galactogo- produced in lactating women.5,6 However, most lactating gues have frequently been used in the neonatal intensive care women have a higher baseline prolactin level than nonlactating unit in mothers with preterm infants, where the aim has been Downloaded by Mary Ann Liebert, Inc., publishers from www.liebertpub.com at 09/11/18. For personal use only. women for a number of months and continue to experience to stimulate initial secretory activation or augment declining suckling-induced peaks when breastfeeding. milk secretion. Mothers who are not breastfeeding, but are Lactation is initiated with parturition, expulsion of the pla- expressing milk by hand or with a pump, often experience a centa, and falling progesterone levels in the presence of very decline in milk production after several weeks. Galactogo- high prolactin levels. Systemic endocrine control of other sup- gues have also been used in women inducing lactation when porting hormones (estrogen, progesterone, oxytocin, growth they have not been pregnant with the current child, in women hormone, glucocorticoids, and insulin) is also important.7 These relactating after weaning, or in transgender women.10 hormonal changes trigger secretory activation (lactogenesis II) Many breastfeeding medicine specialists and lactation con- of the mammary secretory epithelial cells, also called lactocytes. sultants have recommended various drugs and herbs when Prolactin secretion functions in a negative feedback system in other nonpharmacological measures have not resulted in an which dopamine serves as an inhibitor. Therefore, when dopa- increase in milk volume. However, some providers may in- mine concentration decreases, prolactin secretion from the an- appropriately recommend galactogogues before emphasizing terior pituitary increases.7 the primary means of increasing the overall rate of milk Once secretory activation has occurred and the mother’s synthesis (i.e., frequent and effective milk drainage at regular milk supply has been established, the rate of milk synthesis intervals) or evaluating other medical factors that may poten- is mainly controlled locally in the mammary gland by auto- tially be involved (see point 1 in the Practice Recommenda- crine control. Lactating breasts are never completely empty tions section). 307 308 ABM PROTOCOL Pharmaceutical Galactogogues significant differences between the two groups, nor were there 27 Human growth hormone11–13(lB, llA) (quality of evidence differences at term or at 6 weeks post-term. (lB) The results n [levels of evidence IA, IB, IIA, IIB, III, and IV] is based on of one older very small study ( = 6) suggested that individual levels of evidence used for the National Guidelines Clearing women may be responders or nonresponders and that pri- 14 15,16 miparas may respond to domperidone with higher prolactin House and is noted in parentheses), sulpride (llB), and 28 thyrotropin-releasing hormone17,18(lB) may be helpful as levels than multiparas. (lB) galactogogues in some populations, but are not currently used With respect to potential risks, there is evidence that dom- in most countries. Domperidone and metoclopramide are the peridone increases the QTc interval and it has been implicated in ventricular arrhythmias and sudden cardiac death, particular most commonly used pharmaceutical galactogogues at pres- 29,30 ent. Both are dopamine antagonists that increase prolactin in older and unwell adults. (lA, lV) The risk for domper- secretion. A number of older mainly observational or con- idone to increase the incidence of arrhythmias in postpartum trolled studies documented increased baseline prolactin levels women with no other risk factors appears to be very small, but in lactating women who took metoclopramide or domperidone may increase with other factors such as a past history of 19,20 ventricular arrhythmias, high BMI, higher dosages, and con- and provide some evidence for their effectiveness. (llA, lll) 31 However, high-quality evidence is lacking. The numbers comitant use of medications that inhibit CYP3A4. (lll) In this of women in randomized, placebo-controlled blinded studies large study of more than 225,532 postpartum women, the only women who developed ventricular arrhythmias while taking (RCTs) with each of these agents are small. Studies also 32 tended to have high dropout rates, differed in patient selection domperidone had a past history of ventricular arrhythmias. (i.e., some were expressing for preterm infants, not all women See Table 1 for further information. had documented low milk supply), and differed in dose and duration of the galactogogue and application of other non- Metoclopramide pharmacological measures before starting the galactogogue. Five randomized, placebo-controlled blinded studies re- Most studies also had limited follow-up. searching the effect of metoclopramide have been published between 1980 and 2011.33–37(lB) Of these, participants in Domperidone three studies commenced metoclopramide within 4 days of 21 birth without a diagnosis of low milk supply,33,34,37 one study A Cochrane systematic review (lA) published in 2012 36 included two studies with a total of 59 mothers with preterm investigated women who were relactating, and one re- cruited women whose infants had not gained 500 g within the infants and found a moderate benefit (mean increase of 99 mL 35 per day) when using domperidone, 30 mg per day, for 7 or first month of life. None of these studies found differences 14 days. Other systematic reviews have similar findings,22 in milk volumes and/or breastfeeding duration between me- with the most recent review that included one finding a mean toclopramide and placebo groups, even with optimal breast expression and counseling.37 However, as mentioned above, increase of 88.3 mL per day (95% confidence interval 56.8– 26 119.8).23(lA) There have been four RCTs using domperidone Ingram et al. found similar positive effects with metoclo- since the Cochrane review. In one study of 45 women, 22 were pramide and domperidone. given domperidone, 30 mg per day, for 4 days postcesarean In addition, a number of older randomized controlled tri- als,38–41(lB, llA) controlled trials,42,43(llB) and observa- section and were found to have increased milk production 20,44–46 during that time compared with the control group.24(lB) tional studies (lll) reported a significant increase in In a second study of only 15 women with low milk supply milk yield using metoclopramide, 5–20 mg, three times a who were expressing for preterm infants, there was a 300-mL day for periods of 5 days to 4 weeks. The one study that per day difference in milk production for women given compared different doses of metoclopramide found no re- domperidone, 60 mg per day, for 4 weeks compared with sponse with 15 mg per day, but similar responses with 30 and women given domperidone, 30 mg per day, for a similar 45 mg per day. The scientific rigor of these older studies may length of time.25(lB) A third trial in the United Kingdom not be as strong as more recent studies, so their results should compared the effects of domperidone, 30 mg per day, with be interpreted with caution. As for potential risks, metoclo- Downloaded by Mary Ann Liebert, Inc., publishers from www.liebertpub.com at 09/11/18. For personal use only. metoclopramide, 30 mg per day. Women had 24-hour milk pramide may cause neurological side effects in the mother. production measured from 10 days before the commence- Further information can be found in Table 1. ment of medication administration and during the 10 days of medication administration.26 The 51 women were expres- Summary sing for their preterm infants and had documented low milk Despite the widespread use of these pharmaceutical ga- supply.
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