The perception of insufficient milk production is a common problem in mothers and one of the main reasons for medical consultation in early months after giving birth. Maternal fear of providing insufficient nutrition to their infant can lead to early breastfeeding cessation and switch to infant formula even against recommendations. Especially mothers who experience stress or anxiety may fear that their milk production is insufficient and switch partially or completely to formula feeding (Wilinska & Schleußner, 2015).
Most mothers have enough milk to feed their infant. They may need coaching and encouragement to learn proper techniques and understand their infant's need (WHO & UNICEF, 1993, WHO, 2009). However, reduced breast milk production (hypogalactia) remains the most frequent reason for breastfeeding failure. Reasons for perceived or actual hypogalactia are manifold and include preterm birth (immaturity of the mammary gland tissue), illness of mother or infant and subsequent medication, separation of the dyad, re-lactation efforts after prolonged suspension, as well as the impact of emotional stress or anxiety (Zuppa et al., 2010, Wilinska & Schleußner, 2015). It can also be that infants have colics or other functional gastrointestinal disorders (FGID →) that may make the mother doubt about her milk and its quality. In these cases, a thorough examination and exclusion of physical causes is necessary. Non-physical or technical causes for low milk supply are also important. Their assessment should target education about breast milk and FGID. This includes education, observation, and assessment of breastfeeding techniques, latching of the infant, frequency and efficacy of breast emptying. Addressing maternal anxiety and mental health issues should not be forgotten. In many cases, teaching of proper breastfeeding technique and latching, reduction of stress and anxiety with the application of relaxation techniques and increasing comfort during a feeding session often resolve the difficulties (Brodribb, 2018, WHO, 2009).
Reassurance and support can help the mother as well as a coach or lactation expert, who evaluates the feeding process. If necessary, an HCP can also suggest milk inducers, so-called galactogogues, to support breast milk production and soothe the mothers' concerns (Brodribb, 2018, Wilinska & Schleußner, 2015, Brand et al., 2011).
Galactogogues are substances known to support lactation initiation, increase milk synthesis, milk release or volume. They are well known in the dairy industry and in traditional medicine and can be pharmacological (e.g. synthetic drugs like domperidone) but also plant-based (e.g. extracts from milk thistle fruit) (Penagos Tabares et al., 2014, Wilinska & Schleußner, 2015). Galactogogues affect different processes involved in milk production like prolactin synthesis (dopamine antagonists), milk ejection (oxytocin) or by exerting phytoestrogenic action (Penagos Tabares et al., 2014, Wilinska & Schleußner, 2015).
Some drugs are being used as milk inducers. These are mostly dopamine antagonists (metoclopramide, domperidone and sulpiride) that increase prolactin synthesis. However, these drugs are not indicated as galactogogues so they are used off-label and without regulatory approval. The Food and drug administration of the USA (FDA) has issued a warning against the use of domperidone as galactogogue and explicitly warns against its use due to safety concerns associated with severe adverse effects in some women (Brodribb, 2018, FDA, 2016).
Domperidone transfers into breast milk. Thus, adverse effects of dopamine antagonists can possibly not only affect the mother but the infant as well. Side effects in mothers include gastrointestinal disorders, cardiac arrhythmia, insomnia, depression, seizures and even sudden death. Side effects in infants receiving milk from treated mothers include intestinal discomfort, lethargy and sedation (Wilinska & Schleußner, 2015, FDA, 2016). Health care professionals should carefully weigh the risks before off-label use for these drugs as pharmacological galactogogues. In line with our mission on the unity of nature and science, the Institute NaturScience concentrates on current knowledge of natural galactogogues.
Natural galactogogues are derived from different plants and have a long history of use in many cultures. In traditional medicine well known plant-based galactogogues are teas or plant extracts from fennel (Foeniculum vulgare), caraway (Carum carvi), fenugreek (Trigonella foenumgraecum), galega (Galega officinalis) and milk thistle fruit and its phytocomplex silymarin (Silybum marianum) (Wilinska & Schleußner, 2015, Mortel & Mehta, 2013).
Most reports about their function are based on empirical traditions which have shown that these plants can beneficially influence milk production without serious adverse effects. Data from clinical trials regarding their efficacy but especially their mechanism of action are still largely lacking. It is assumed that their effects are mediated by phytoestrogenic action (Penagos Tabares et al., 2014). Some natural galactogogues may function like the human 17 beta-estradiol, which induces prolactin expression and promotes the proliferation of mammary epithelial cells lining alveoli (Wilinska & Schleußner, 2015). Another mechanism has been proposed that natural galactogogues affect prolactin concentrations by influencing dopamine receptors. This was suggested in a study with lactating rats where the administration of silymarin led to an increase in prolactin concentrations that could be reversed by a dopamine receptor agonist (Capasso et al., 2009). More information about lactation can be found here (→).
Herbal teas, powders, and extracts pose a challenge because their active compounds are often poorly solubilised or are very large molecules, lack specific intestinal transporters or other absorptive mechanisms and therefore have low bioavailability. As consequence, their intake shows low efficacy and subsequently induces the need of high intake to achieve biologic activity. High intake quantities bear a high(er) risk of adverse effects. Accounting for these limitations that affect bioactive compounds from plant extracts in general, preparation and purification methods are being continuously improved to overcome the low bioavailability of these natural galactogogues (Wilinska & Schleußner, 2015).
Another difficulty in the purification of plant extracts is the lack of standardisation and quality assurance in many of these products. Concentrations of active compounds may vary batch-to-batch due to natural and external influences like seasonal changes. Therefore, conscious manufacturers standardise the processes and extractions to guarantee stable concentrations and subsequent safety and efficacy (Gupta et al., 2014).
Even though several plants have been used as galactogogues throughout history in many cultures without severe side effects, some authors raised concerns regarding their safety. These include possible presence of environmental contaminants in teas and plant extracts, potential allergic reactions to the plant compound and possible extract‑drug interactions and side effects, which are known to happen for drugs and some plant extracts. These concerns can and should be addressed by conducting good clinical safety trials (Brodribb, 2018, Penagos Tabares et al., 2014). To date, few high-quality studies exist that evaluate the safety of plant extracts in general and natural galactogogues in particular. Those that exist are often limited by small sample size, varying treatment periods, terminology, dosages and product characteristics (Tamayo & Diamond, 2007, Mortel & Mehta, 2013).
Brand E, Kothari C, Stark MA. Factors related to breastfeeding discontinuation between hospital discharge and 2 weeks postpartum. The Journal of Perinatal Education 2011; 20(1):36–44. at: www.ncbi.nlm.nih.gov/pmc/articles/PMC3209743/
Brodribb W. ABM Clinical Protocol #9: Use of Galactogogues in Initiating or Augmenting Maternal Milk Production, Second Revision 2018. Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine 2018; 13(5):307–14. at: pubmed.ncbi.nlm.nih.gov/29902083
Capasso R, Aviello G, Capasso F, Savino F, Izzo AA, Lembo F, Borrelli F. Silymarin BIO-C, an extract from Silybum marianum fruits, induces hyperprolactinemia in intact female rats. Phytomedicine : international journal of phytotherapy and phytopharmacology 2009; 16(9):839–44. at: pubmed.ncbi.nlm.nih.gov/19303749/
FDA. FDA Warns Against Women Using Unapproved Drug, Domperidone, to Increase Milk Production: FDA Talk Paper: U. S. Food and Drug Administration; 2016 [status of: 2019 Dec 10]. at: www.fda.gov/drugs/information-drug-class/fda-talk-paper-fda-warns-against-women-using-unapproved-drug-domperidone-increase-milk-production
Gupta PD, Daswani PG, Birdi TJ. Approaches in fostering quality parameters for medicinal botanicals in the Indian context. Indian journal of pharmacology 2014; 46(4):363–71. at: www.ncbi.nlm.nih.gov/pmc/articles/PMC4118527/
Mortel M, Mehta SD. Systematic review of the efficacy of herbal galactogogues. Journal of human lactation : official journal of International Lactation Consultant Association 2013; 29(2):154–62. at: pubmed.ncbi.nlm.nih.gov/23468043
Tamayo C, Diamond S. Review of clinical trials evaluating safety and efficacy of milk thistle (Silybum marianum L. Gaertn.). Integrative cancer therapies 2007; 6(2):146–57. at: pubmed.ncbi.nlm.nih.gov/17548793/
WHO. Infant and Young Child Feeding. Model Chapter for textbooks for medical students and allied health professionals. Geneva, Switzerland: World Health Organization (WHO) press; 2009. at: www.who.int/maternal_child_adolescent/documents/9789241597494/en/
WHO, UNICEF. Breastfeeding counselling: a training course - Participant's Manual: Maternal, newborn, child and adolescent health: WHO; 1993. at: www.who.int/maternal_child_adolescent/documents/who_cdr_93_3/en/
Wilinska M, Schleußner E. Galactogogues and breastfeeding. Nutrafoods 2015; 14(3):119–25. at: link.springer.com/article/10.1007/s13749-015-0034-9
Zuppa AA, Sindico P, Orchi C, Carducci C, Cardiello V, Romagnoli C. Safety and efficacy of galactogogues: substances that induce, maintain and increase breast milk production. Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques 2010; 13(2):162–74. at: pubmed.ncbi.nlm.nih.gov/20816003back