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

Abstract

A central goal of the Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines 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

GALACTOGOGUES (OR LACTAGOGUS) are medications or other substances believed to assist initiation, maintenance, or augmentation of maternal milk supply. Because perceived or actual low milk supply is one of the most common reasons given for discontinuing breastfeeding, both mothers and health professionals have sought medication(s), in addition to other nonpharmacological interventions, to address this concern.

Human milk production is a complex physiological process involving physical and emotional factors and the interaction of multiple hormones, the most important of which is believed to be prolactin. Despite the fact that prolactin is required for lactation, once lactation is established, there is no direct correlation between serum prolactin levels (either baseline levels or percentage increase after suckling) and the volume of milk produced in lactating women. However, most lactating women have a higher baseline prolactin level than nonlactating women for a number of months and continue to experience suckling-induced peaks when breastfeeding.

Lactation is initiated with parturition, expulsion of the placenta, and falling progesterone levels in the presence of very high prolactin levels. Systemic endocrine control of other supporting hormones (estrogen, progesterone, oxytocin, growth hormone, glucocorticoids, and insulin) is also important. These hormonal changes trigger secretory activation (lactogenesis II) of the mammary secretory epithelial cells, also called lactocytes. Prolactin secretion functions in a negative feedback system in which dopamine serves as an inhibitor. Therefore, when dopamine concentration decreases, prolactin secretion from the anterior pituitary increases.

Once secretory activation has occurred and the mother’s milk supply has been established, the rate of milk synthesis is mainly controlled locally in the mammary gland by autocrine control. Lactating breasts are never completely empty of milk, so the terms drain, drainage, and draining are more appropriate. If the breasts are not drained regularly and thoroughly, milk production declines. Alternatively, more frequent and thorough drainage of the breasts typically results in an increased rate of milk secretion, with both immediate (per feeding) and delayed (several days) effects.

Potential Indications for Galactogogues

Galactogogues have commonly been used to increase low (or perceived low) milk supply. Physiologically, low milk supply is often related to suboptimal milk removal with reasons including problems with infants draining the breast, inappropriate breastfeeding management, maternal or infant illness and hospitalization, and regular mother–infant separation, for example, work or school. In addition, galactogogues have frequently been used in the neonatal intensive care unit in mothers with preterm infants, where the aim has been to stimulate initial secretory activation or augment declining milk secretion. Mothers who are not breastfeeding, but are expressing milk by hand or with a pump, often experience a decline in milk production after several weeks. Galactogogues have also been used in women inducing lactation when they have not been pregnant with the current child, in women relactating after weaning, or in transgender women.

Many breastfeeding medicine specialists and lactation consultants have recommended various drugs and herbs when other nonpharmacological measures have not resulted in an increase in milk volume. However, some providers may inappropriately recommend galactogogues before emphasizing the primary means of increasing the overall rate of milk synthesis (i.e., frequent and effective milk drainage at regular intervals) or evaluating other medical factors that may potentially be involved (see point 1 in the Practice Recommendations section).

Pharmaceutical Galactogogues

Human growth hormone (lB, llA) (quality of evidence [levels of evidence IA, IB, IIA, IIB, III, and IV] is based on levels of evidence used for the National Guidelines Clearing House and is noted in parentheses), sulpride (llB), and thyrotropin-releasing hormone (lB) may be helpful as galactogogues in some populations, but are not currently used in most countries. Domperidone and metoclopramide are the most commonly used pharmaceutical galactogogues at present. Both are dopamine antagonists that increase prolactin secretion. A number of older mainly observational or controlled studies documented increased baseline prolactin levels in lactating women who took metoclopramide or domperidone and provide some evidence for their effectiveness. (llA, lll)

However, high-quality evidence is lacking. The numbers of women in randomized, placebo-controlled blinded studies (RCTs) with each of these agents are small. Studies also tended to have high dropout rates, differed in patient selection (i.e., some were expressing for preterm infants, not all women had documented low milk supply), and differed in dose and duration of the galactogogue and application of other nonpharmacological measures before starting the galactogogue. Most studies also had limited follow-up.