Download APPROPRIATE USE OF GALACTAGOGUES

APPROPRIATE USE OF GALACTAGOGUES:
A GUIDE FOR NURSE PRACTITONERS IN PRIMARY CARE
by
Sandra Lachapelle
BScN, University of Victoria, 2008
PROJECT SUBMITTED IN PARTIAL FULFILLMENT OF
THE REQUIREMENTS FOR THE DEGREE OF
MASTER OF SCIENCE
IN
NURSING
UNIVERSITY OF NORTHERN BRITISH COLUMBIA
August 2010
© Sandra Lachapelle, 201 0
UNiv. ,,
,•; :;)RTHERN
BRITISri COLUMBIA
LIBRARY
Prince George, B.C.
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Abstract
The short term and long term benefits to mother and baby with breastfeeding are welldocumented, however, the actual rates of exclusive breastfeeding to 6 months of age are less than
17% in Canada. The most often cited reason for discontinuation of breastfeeding is not enough
breastmilk, which has increased the use of galactagogues- substances used to induce or augment
lactation in breastfeeding women. There is a lack of guidance regarding the appropriate use of
galactagogues because at present there is only one clinical practice guideline from the American
Academy of Breastfeeding Medicine (ABM) which does not describe actual use in practice and
has not been updated since 2004. This has resulted in practice based on anecdotal evidence, with
a wide variation in indications, dosages, and duration of treatment among primary care
practitioners. A literature review of galactagogue use and research from 2000 to 2010 was
performed, grey literature such as presentations, theses and dissertations were included, and
practitioners were interviewed regarding their own use of galactagogues in practice. In Canada
the most widely used galactagogues are the herb fenugreek, and the medication domperidone.
Fenugreek has not had any randomized controlled trials (RCT) to support its safety or efficacy in
practice, which makes its recommendation more difficult, particularly because it has been
reported to have significant side effects such as hypoglycemia. Conversely, domperidone has
been shown to be safe and effective, with low incidence of side effects. Domperidone is used
widely in Canadian practice for this off-label purpose by physicians and nurse practitioners (NP).
When accompanied by assessment and treatment of underlying physiological causes of breast
milk insufficiency and or milk transfer issues such as poor infant latch, domperidone I 0 mg
three times daily with thorough assessment and follow up is a reasonable and safe galactagogue
choice.
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Acknowledgements
I would like to thank Dr. Lela Zimmer, PhD, RN, and Erin Wilson, MScN, NP-F for their
incredible support and encouragement, invaluable feedback, and for trudging through early drafts
of this project. They kept me on track when I was drifting, and helped to make this project a
much more-interesting read. I could not have done this without them.
I would also like to acknowledge my wonderful husband, who stepped up when needed,
read innumerable papers, and sat through too many presentations, all without complaint. And
finally I need to thank my amazing children, who were so positive and gave me tremendous
strength throughout this entire process .
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Table of Contents
Abstract .... ....... ..... ............................... .............. ............... .......... .... ................ ........ .. .. ......... 2
Acknowledgements ............... ................ ....... .......................... ............ ................................. 3
Table of Contents ................................................................................................................ 4
Introduction .......................................................................................................................... 5
Literature Review ............................................ ............................. .......... ... ............. .... ......... 7
Clarification ofTerms .................................. ....... ..................... ....................................... 8
Background .......................................................................................................................... 9
Benefits of Breastfeedin g .. ....... ........... ...... ... ................ ............. ....... ..... .......... ... ... .... ...... 9
Physiology of Breast Milk Production .. ... ............. ... ......... .... ..... ................... ....... ... ...... . II
Causes of [nsufficient Nutritional Status in Newborns .................................................. l3
Perceived Versus Actual Breast Milk Insuffic iency .... .. ..................................... .. ....... . 15
Herbal Galactagogues ............... .. .... .... .... .... ... ... .... .................................... ....... ................. 19
Fenugreek .. ................... ..... ... .. ...... .................. ....... .. ....... .... ...... .......................... ....... .... 19
Blessed Th istle ..... ........ ..... .... ........ ... ............................ .. ........................ ...... ..... ......... ... 21
Other Herbal Galactagogues .. ... ... .......... ............ .......... ..... ........... ... ... ................... ....... . 22
Alternative Non-Pharmaceutical Galactagogues .............................................................. 23
Alcohol ........................... ......... ........... ... .............. ..... ....... ... ........................... ....... ......... 23
Acupuncture ... ................ ........ ... ..... ... ........................................ .................. ...... .... ........ 24
Pharmace utica l Galactagogues .. .................... ..... ... .. .................... ... ...... ...... .... .................. 24
Metoclopramide ..... ............... ... .. ................... .. .. ........ ... ..................... ..... ......... .. ..... ... ... . 24
Domperidone .. ...... .. ...... ........ .. ... ... ......... ......... .... ................... ...... .. ...... .. ........................ 25
Less Commonl y-Used Medications .................................................. ... ......................... 30
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Summary of Present Research .. ............ ................... ..................... ..................... ... ...... ... .... 30
Analysis of Clinical Practice Guidelines ... .. ........ .. ............ ................... .. .. ................... .... .. 32
Implications for Practice ........................................... ......... ...................... ... ...................... 34
Assessment of Maternal Milk Supply ........................................ ............ .......... ............. 35
NP Scope of Practice .................................................................................................... 3 8
Recommendations ........................................................................... ....................... ........ .. . 39
Conclusion ........................................................................................................................ 44
References ..................................................... ......... .... ..... .. ........ ..... .......... .............. ....... .... 4 7
Appendix A: Algorithm for Assessment of Breast Milk Insufficiency in Newborn
Period ................................................................................................................................. 62
Appendix 8 : Herbal Galactagogues ..................................................... .. .... .. ............ ... ....... 63
Appendix C: Alternative Galactagogues .......................................................................... 64
Appendix D : Pharmaceutical Galactagogues ...... .... ................................ ........ .. .......... ...... 64
Appendix E: The LATCH Breastfeeding Assessment Tool ........................................ ..... 66
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Research that clearly demonstrates the benefits and superiority of breastfeeding over
breast milk substitutes has led in recent years to an increase in the number of women who choose
to breastfeed their babies, and has increased societal pressure on all women to do the same.
Breastfeeding has become more of an infants ' rights issue than a choice for women, an almost
complete reversal of the women's rights movements only five decades ago that viewed
breastfeeding as tying women down, and glamorized the modern household in which babies were
bottle-fed (Thulier, 2009). "Baby-Friendly" initiatives now encourage hospitals to ban all breast
milk substitutes and artificial nipples from their premises, and the slogan "Breast is Best" are
seen on posters everywhere mothers and babies are likely to be found. While there is no denying
the benefits of breastfeeding for both mother and baby, this increased pressure to succeed at
breastfeeding has created a niche market of herbal, alternative, and pharmaceutical treatments
that claim to increase maternal breast milk production through a variety of mechanisms . Despite
the increasing demand for these products from breastfeeding mothers, the development of
evidence-based guidance regarding how to safely prescribe galactagogues has not kept pace with
this demand , and anecdotal evidence is often used as the only resource for practitioners.
Galactagogues are not a new concept, and cultures around the world have a variety of methods to
increase maternal breast milk production. However, based on my own experience, and from
speaking with primary care providers, nurse practitioners (NP) frequently find themselves in the
position of being asked for their advice regarding herbal or alternative galactagogues, and
responsible for prescribing pharmaceutical galactagogues.
NPs have only been legislated to practice in Briti sh Columbia (BC) since 2005 (Canadian
Institute For Health Information, 2006), and as relatively new primary care providers, often
access guidelines to ensure that they provide the best poss ible care using the latest evidence.
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NPs working in primary care certainly may have patients who request treatment for insufficient
milk supply. The lack of up-to-date information and direction regarding appropriate assessments
and treatment for this condition, including the use of such commonly prescribed treatments as
galactagogues, is a concern. This paper will include a review and critique of the latest research
findings on galactagogues that are commonly used in Canada, as well as the guidelines that are
currently available. Recommendations for practice will be presented based on these findings in
an attempt to provide that missing guidance for appropriate and safe prescribing of
galactagogues by NPs.
Literature Review
Information for this project was found using the search engines Medline, CINAHL, and
Google Scholar. The key words used to search for information were galactagogues,
galactogogues, breast feeding, lactation, augmentation, and gal act*. Terms of exclusion were
adoption, as the focus of this project was on the augmentation rather than the induction of
breastfeeding and maternal milk supply. Only papers published from 2000 to 2010 were
included in the literature search, and only those that were available in English whether translated
or not, with the intent of including only the most current information and research. The
reference lists of all accepted articles were used to find additional evidence. This process was
continued until the results became repetitive, with several key articles becoming apparent.
Personal communications in the form of email and personal interviews were used when
no published information was available, and dissertations and theses were accepted. The wide
range of acceptable literature for this project was a result of the difficulty in finding current
research on this topic. The idea for this project arose from previous paper written in which the
clinical practice guideline for galactagogue use were analyzed and critiqued. This critique
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brought to light the lack of consensus regarding galactagogue use, and the fact that anecdotal
rather than research-based evidence was being used to guide clinicians in their decisions
regarding when and how to prescribe galactagogues.
The supporting literature for breastfeeding self-efficacy, which is defined as maternal
confidence in the ability to breastfeed (Dennis, 1999), was found during research for a previous
paper, and the physiology of breastfeeding information was gleaned from the galactagogue
literature, as well as current textbooks that were frequently cited in this same literature.
Resources were not exhausted with regard to supporting literature, but stopped searching stopped
when information became repetitive. Canadian sources were used preferentially over American
or international references whenever possible, and the breastfeeding recommendations are from
current Health Canada literature.
Clarification of Terms
To avoid potential misunderstandings, the following terms require a brief explanation of
how they are defined for this particular paper. The terms primary care and primary health care
are often used interchangeably. For the purposes ofthis paper, the definition of primary health
care will be that of the World Health Organization ' s (WHO) Declaration of Alma-Ata:
"Primary health care is essential health care based on practical , scientifically sound and
socially acceptable methods and technology made universally accessible to individuals
and families in the community through their full participation and at a cost that the
community and country can afford to maintain at every stage of their development in the
spirit of self reliance and self-determination. It forms an integral part both of the country's
health system, of which it is the central function and main focus, and of the overall social
and economic development of the community. ft is the first level of contact of
individuals, the family and community with the national health system bringing health
care as close as possible to where people live and work, and constitutes the first element
of a continuing health care process." (WHO, 1978, p. 2)
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The definition of primary care for this paper therefore is that it is an integral part of
primary health care, the main entry point or primary level of contact of individuals and or
families to the national health care system (Thomas-Maclean, Tarlier, Ackroyd-Stolarz, Fortin,
& Stewart, 2008). In other words, primary care settings are where primary health care takes
place, and primary care providers offer primary health care.
The term successful breastfeeding will refer to exclusive breastfeeding of infants to 6
months of age, which means no supplemental feeds with breast milk substitute, but may include
expressed breast milk given by bottle. After 6 months of age, solids are recommended to be
introduced and exclusive breastfeeding is no longer the recommendation (Health Canada, 2004).
Galactagogues are defined as medications, substances, or treatments that are used to initiate,
stimulate, increase, enhance, or maintain maternal milk supply for the purposes ofbreastfeeding
(The Academy Of Breastfeeding Medicine (ABM) Protocol Committee, 2004; Anderson &
Valdes, 2007; Betzold, 2004; Brodribb, 2000; Gabay, 2002; Henderson, 2003; Low Dog, 2009).
Background
Benefits of Breastfeeding
The benefits to newborn s of exclusive breastfeeding have been reported and include, but
are not limited to decreased incidence of gastrointestinal , upper respiratory, and otitis media
infections; decreased incidence of sudden infant death syndrome, prevention of allergies,
improved cognitive development demonstrated by higher scores on IQ tests as well as academic
performance in school, and increased contact between mother and newborn (Public Health
Agency of Canada (PHAC), 2009 ; Health Canada, 2005 ; Health Canada, 2007; Kramer &
Kakuma, 200 I).
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Maternal benefits include decreased incidence of breast and ovarian cancer and
osteoporosis, delayed onset of menses, and increased and more rapid weight loss in the
postpartum period (Health Canada, 2009a; Kramer & Kakuma, 2001 ). Bartick and Reinhold
(2010) performed a pediatric cost analysis and determined that if90% of American families
could exclusively breastfeed their infants for 6 months, the United States (US) would save 13
billion dollars in health care costs and prevent 911 deaths, most of them infant deaths.
Environmental benefits include no processing, no packaging, and no waste, as well as the costbenefits, which are considerable (PHAC, 2009). The Infant Feeding Action Coalition (INF ACT)
Canada (1997) surveyed formula costs across the country based on income assistance for a single
mother, and determined that there was great variation in formula prices, 5%-34% of the monthly
income, depending on the geographical location and demand for formula in that area. The most
expensive locales were remote areas with associated decreased rates of breastfeeding. This led
INFACT to the realization that " [the formula] industry varies its prices according to the degree
of competition presented by breastmilk." (IN FACT Canada, 1997). Breastfeeding for
socioeconomically disadvantaged families, particularly those in rural and remote areas, may
mean the difference between food sec urity or insecurity for the entire family.
Adults who were breastfed as infants, when compared with control groups who were not
breastfed , had lower systolic and diastolic blood pressure (Martin, Gunnell, & Smith, 2005),
lower mean total cholesterol levels, were less likely to be overweight or obese, less likely to be
diagnosed with Type 2 diabetes mellitus, score higher on intelligence tests, and obtain better
grades in school (Hotia, Bahl , Martines, & Victora, 2007). While the direct costs to the health
care system have not been spec ifically meas ured , the decrease in chronic disease cannot help but
to lessen the burden on the system.
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In 2004, Health Canada changed the recommended duration of exclusive breastfeeding
from 4-6 months to 6 months of age, in line with the WHO 2001 recommendation (Health
Canada, 2004). Despite the recommendations and acknowledged benefits to both mother and
baby, while 85% of Canadian women in 2003 initiated breastfeeding, only 17% breastfed
exclusively for at least six months. British Columbia (BC) had the best initiation and duration
rates, with 93% of women initiating breastfeeding, and 28% exclusively breastfeeding for at least
six months (Millar & Maclean, 2005). Interior Health Authority in BC notes an 89% initiation
rate with 53% of women doin g some breastfeeding at six months postpartum (Bryan, 2005),
unfortunately there is no indication of whether or not this is exclusive breastfeeding. For those
women who did not breastfeed exclusivel y for the recommended six months, the most commonly
cited reason for stopping breastfeeding was " not enough milk" (Millar & Maclean, 2005, p. 27),
at 31%. Similar statistics are noted in Australia, the US, and the United Kingdom (UK) with
fewer than 23% of women maintaining any breastfeeding to six months postpartum, and only
50% of women exclusively breastfeeding to six months in developing countries (Blyth et al.,
2002) .
Physiology of Breast Milk Production
Lactogenesis takes place in two stages. Lactogenesis I occurs during the second trimester
of pregnancy, whereby the formation and expansion of ducts and lobules occurs, and epithelial
cells of the alveoli differentiate into secretory cells (Biancuzzo, 2003; Riordan, 2005). Prolactin
is released from the anter ior pituitary gland and stimulates the production of colostrum (Eglash,
Montgomery, & Wood, 2008; Riordan, 2005). The amount of colostrum produced is small , and
it is hypothesized that hi gh leve ls of estrogen and progesterone during pregnancy inhibit the
action of prolactin on milk production prior to delivery of the placenta (Berens, 2004; Gabay,
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2002). Lactogenesis II is the onset of copious milk production, occurs after delivery of the
infant (and perhaps more importantly the placenta), and may take up to eight days postpartum to
be fully achieved (Riordan, 2005).
The delivery of the placenta causes a sharp drop in progesterone levels and thereby
removes that antagonism from the effect of prolactin, which increases milk supply (Berens,
2004; Eglash et al., 2008; Hurst, 2007). This occurs simultaneously with a change in the
composition ofthe breastmilk to one high in lactose and milk lipids, and lower in sodium,
chloride and protein. This is a result of junction complex closure between alveolar cells, which
allows for passage of substances between these alveoli (Riordan, 2005).
Full realization of lactogenesis II and continuation of milk production during the first
three to five days postpartum are dependent on the feedback mechanism of milk removal from
the breast. This occurs with supply and demand infant suckling and feeding, or mechanical
pumping of the breast if infant feeding is not possible (Eglash et al., 2008). When the nipple is
stimulated by infant suckling or mechanical pumping, and milk is removed from the breast, the
hypothalamus inhibits dopamine, which allows for increased release of prolactin from the
anterior pituitary, and therefore increased milk production (Riordan, 2005). Nipple stimulation
also causes release of oxytocin from the posterior pituitary, which helps with milk secretion or
" let down" by causing contraction of myoepithelial cells in the breast (Gabay, 2002). The
culmination of these processes is a switch from the initial process of endocrine-controlled
lactation, which all women experience immediately postpartum whether they breast feed or not,
to the secondary and long-term process of autocrine-controlled lactation, which can only be
maintained through continued breast milk removal (Mohrbacher & Stock, 2003). While this
provides a rather simplified exp lanation of materna l milk production, a more detailed account of
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the process is outside the scope of this project. Rather, this brief explanation can suffice to
demonstrate how NPs might explore possible causes of insufficient milk supply in women and
consider the various causes.
Causes oflnsufficient Nutritional Status in Newborns
There are three possible physiological mechanisms for insufficient nutritional status of a
breastfed newborn. The first is primary failed or delayed lactogenesis II, and while the actual
rates are unknown, it is estimated that between 5% and 15% of women will experience one of
these circumstances (Hurst, 2007). Recall that lactogenesis II is the transition from hormonallyinduced production of colostrum during pregnancy to milk production following delivery. Hurst
differentiates between delayed and failed lactogenesis II, with the implication that delayed
lactogenesis, defined as later than 72 hours after delivery (Riordan, 2005), can still progress to
full and successful lactation, while failed lactogenesis II is further broken down into either a
"primary inability to produce adequate milk volume, or a secondary condition as a result of
improper breastfeeding management and/or infant-related problems"(Hurst, 2007, p. 589).
There are numerous conditions that may impact on the ability to attain lactogenesis II.
The intricate interplay of hormones required to produce breast milk can be interrupted by any
condition that is hormonal in nature such as obesity, thyroid abnormalities, and diabetes (Hurst,
2007). Women with Type I diabetes mellitus have lower levels of prolactin in their breast milk
and this can cause a delay in lactogenesis II. Women with polycystic ovarian syndrome or theca
lutein cysts have higher levels of testosterone, which may interfere with the hormones required
for lactogenesis II and lead to a delay. Postpartum hemorrhage can lead to Sheehan syndrome,
which affects pituitary gland function and therefore prolactin and oxytocin secretion (Hurst,
2007). Retained placental fragments may secrete sufficient progesterone to impair prolactin
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release and thereby interfere with lactogenesis II. Cesarean birth, prolonged second stage of
labour, and maternal stress may increase cortisol levels, which is thought to be associated with
delayed lactogenesis II (Riordan, 2005). Women with anatomical breast abnormalities such as
insufficient mammary glandular tissue, or those who have experienced invasive breast surgery
such as augmentation or reduction, may have physical disruptions in normal lactation. Finally,
cigarette-smoking and administration of hormonal contraceptives during the first week
postpartum also decrease prolactin secretion and therefore breast milk production (Hurst, 2007).
The second cause of insufficient nutritional status of a breastfed newborn is secondary
delayed lactogenesis related to breastfeeding management or breast milk transfer issues. This can
comprise delayed breastfeeding initiation due to maternal-infant separation secondary to any
number of causes, including cesarean section, prolonged second stage of labour, preterm
delivery, maternal or newborn ill health, which can delay onset of lactogenesis II, and feeding
infrequently or supplementing with breast milk substitutes, which leads to decreased prolactin
release and therefore delayed lactogenesis II. Poor infant latch secondary to tongue tie,
congenital malformations such as cleft palate/lip, prematurity, ill health, jaundice, congenital
heart defects, or poor overall breastfeeding technique can lead to decreased milk transfer, or
removal of breast milk from breast, decreasing prolactin secretion and thereby delaying
lactogenesis II (Hurst, 2007).
The third cause of insufficient nutritional status of a breastfed newborn is organic failure
to thrive, which means that there is a pathophysiological reason that the newborn is not gaining
weight. This category encompasses a variety of congenital conditions such as: gastroesophageal
reflux; pyloric stenosis; lactose intolerance; Hirschsprung disease; milk protein intolerance; liver
disease; pancreatic disease; kidney disease; cardiopulmonary disease; thyroid disorders; cerebral
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hemorrhage; mental retardation; bacterial or parasitic infections of the gastrointestinal tract;
inborn errors of metabolism; chromosomal abnormalities; as well as a variety of congenital
syndromes (Evers, 2006; Petersen-Smith & McKenzie, 2009). It is beyond the scope ofthis
paper to discuss the myriad of factors that may affect a newborn's ability to breastfeed and or to
metabolize breastmilk successfully, however it is extremely important that any
pathophysiological cause be ruled out during the initial breastfeeding assessment of a motherbaby dyad.
Perceived Versus Actual Breast Milk Insufficiency
Perceived or actual insufficient milk supply is described in numerous studies as a
common, if not the most common, reason for breastfeeding discontinuation (Dyson, McCormick,
& Renfrew, 2009 ; Flidel-Rimon & Shinwell, 2006; Lewallen et al., 2006; McCarter-Spaulding &
Kearney, 200 l; Sakha & Behbahan, 2008). Perceived breast milk insufficiency is defined as
"the mother's belief that her breast milk is inadequate in amount or nutritional quality to meet
her infant's needs" (McCarter-Spaulding & Kearney, 2001 , p. 517), and is closely linked to
confidence, support, and self-efficacy (Chung, Raman, Trikalinos, Lau, & Jp, 2008; McCarterSpaulding & Kearney, 200 I); while poor latch at the breast, maternal medical conditions, some
medications, and disruptive health care practices are associated with actual breast milk
insufficiency as discussed previously (Berens, 2004; Hurst, 2007; Meier, Furman, & Degenhardt,
2007).
The perception of insufficient maternal milk supply is intertwined with the western
cultural ideals placed on objective measurements for data. Women and families are
uncomfortable with not knowing exactly how much breastmilk the infant is receiving (Lewallen
et al., 2006). When mothers perceive that their milk supply is insufficient, they often respond by
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supplementing unnecessarily with formula, which interferes with the intricate feedback
mechanism that influences maternal milk production as discussed previously, creating a situation
of actual milk insufficiency (McCarter-Spaulding & Kearney, 2001). lfthe baby does not show
any signs of dehydration, is gaining weight, and has adequate output, then there is no problem
with milk insufficiency, no matter what the duration or frequency of feeds are. In this case, logic
would suggest that the mother requires reassurance and education only. For this reason it is
extraordinarily important to educate women regarding variety of feeding patterns among babies,
and the reassuring signs of adequate intake and growth.
Another consideration is the cultural, societal, public health pressure to breastfeed that is
experienced by women. In her summary of the history of breastfeeding in America, Thulier
(2009) observes that research regarding the benefits of breastfeeding to both mother and baby,
the increasing awareness of child health issues, and the need to contain costs to the health care
system have led to the current wave of breastfeeding promotion and awareness campaigns from
all sectors of health care. "Breast is Best" is arguably one of the best known health care slogans
in our society. Perhaps the movement toward more natural , organic foods, and the sense of
distrust and disillusionment with mega-corporations such as Nestle have also contributed to the
increasing trend to breastfeed (Baby Milk Action, n.d.; Breastfeeding.com, n.d. ; International
Baby Food Action Network (IBFAN), n.d.).
Women who are unable to breastfeed for any number of reasons may find themselves
dealing not only with an internal sense of failure, but with a societal burden wherein their sense
of worthiness as a mother is challenged because they are not doing what they may strongly
believe is " best" for their baby. Saisto, Salmela-Aro, Nurmi, and Halmesmaki (2008) found that
women who experienced breastfeeding as pleasant suffered less parental stress when their
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children were toddlers compared to parents who had difficulty breastfeeding, and Health
Canada (2005) has listed "added self-esteem for mother" as a benefit of breastfeeding, and
boldly claim that "mothers often like it more than bottle feeding". This leaves women who are
unable or unwilling to breastfeed at risk for feelings of inadequacy and being abnormal. Women
may find themselves going to extraordinary lengths to succeed at breastfeeding as a way to prove
that they are good mothers (Ryan, Bissell, & Alexander, 2010). The other side ofthis coin is
women who choose to bottle feed against health care provider advice, and are forced to justify
this decision in the face of societal pressure to breastfeed (Ryan et al., 20 I 0) . It could be argued
that this is another reason for perception of breast milk insufficiency, as inadequate breast milk
supply might be viewed as an acceptable reason to not breastfeed, giving women a way out of
the moral dilemma.
Ryan et al. highlight the moral work that women undergo when making decisions around
how to feed their infant with the statement, "They are social and moral actors in both private and
public realms , disciplining their bodies and minds to meet social expectations and preserve their
socia l identity and moral integrity while balancing past, present and future self-concepts ." (Ryan
et al. , 2010, p. 955). Tn other words, the decision to breastfeed is not simply a private, family
matter, but also one made in the public arena and open to public scrutiny and judgement.
Mothers ofpreterm infants and multiples are even more vulnerable to this public and medical
pressure as they begin their role as a mother with no privacy, but instead under the " institutional
authority" and constant observation (Flacking, Ewald, & Starrin, 2007, p. 2405) of health care
providers in the neonatal intensive care unit, where staff are advised to "actively encourage"
mothers of preterm and multiples to breastfeed (British Columbia Perinatal Health Program
(BCPHP), 2007) .
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The pressure to successfully breastfeed, from almost all facets of society and
government on both local and global scales has ensured that medications and herbs that induce or
augment lactation have an excellent marketing niche, as well as buy in from both prescribers and
patients. The prescribing of galactagogues has become commonplace, particularly in situations
known to be challenging for breastfeeding, with much of the literature regarding galactagogue
use discussing its use in mothers ofpreterm infants and multiples (Albright, 2004; Campbell-Yeo
et al., 2010; da Silva, Knoppert, Angelini, and Forret, 2001 ; Henderson, 2003; Leonard, 2002;
Newman, 2003; Wan et al. , 2008) , but also in low risk mother baby dyads that have developed
breast milk insufficiency secondary to poor breastfeeding management, poor breastfeeding
support, or medications.
There are a number of reasons for the increasing use of galactagogues, despite the fact
that they really should only be used as a last resort. We live in a society that is accustomed to
medical treatment in all facets of our health, and so readily accept medications as a solution. A
societal discomfort with not knowing how much breast milk a baby is receiving with each feed ,
and our perception of babi es as chubby and cherubic so that when they are more slender and do
not fit that stereotype, leads to unwarranted concern and a desire to fix a problem that does not
exist. Finally primary care providers may not ascribe the same importance to knowledge of the
normal physiology of breastfeeding as they do to the pathophysiology of disease because of the
perception that this is a natural process. Unfortunately this rather laissez-faire viewpoint, much
the same as that toward herbal and alternative remedies, leads to anecdotal and personal
experience guiding practice rather than evidence, and the subsequently wide variation in practice
with regard to galactagogues that presently exists.
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Herbal Galactagogues
There are numerous herbal remedies and recipes used all over the world to increase milk
supply. For the purposes of this paper, I have chosen to focus on fenugreek and blessed thistle,
the two most commonly recommended herbal galactagogues in Canada (ABM, 2004; Mallory,
2008; Newman, 2003b).
Fenugreek
Fenugreek, or Trigonellafoenum-graecum, is native to southern France, Turkey, northern
Africa, India, and China (D'Itri, 2006). It is eaten as a vegetable in India and Egypt, and is used
extensively in Indian and Chinese medicine for many reasons including induction of labour, help
with digestion, to improve overall health and metabolism , as a poultice to treat skin
inflammations, to treat abdominal pain, impotence, hernias, fever, vomiting, anorexia, weight
loss, coughs, bronchitis, colitis, to decrease serum cholesterol and glucose levels, reduce
vasomotor symptoms in perimenopausal women, treat hair loss in both men and women, and as a
lactation aid (Abascal & Yarnell , 2008; D' ltri, 2006; Low Dog, 2009; Ulbricht et al., 2007).
While the mechani sm of action is not known, it is speculated that the galactagogue effect is
related to the herb's ability to increase sweat production, with the breast being a modified sweat
gland (Curtis, n.d.; Gabay, 2002; Huggins, n.d.; Mallory, 2008)
Fenugreek is usually recommended to be taken two to three times per day when used as a
galactagogue, however there is little agreement on how much should be taken at each dose, with
a range of 400-2400 mg, and acknowledgement that because these are herbal preparations that
are not standardized, it is difficult to know for cetiain what dose the patient is taking at any time
(Abascal & Yarnell, 2008; ABM, 2004; Curtis, n.d.; D'Itri , 2006; Gabay, 2002; Huggins, n.d.;
Low Dog, 2009; Mallory, 2008; Mohrbacher & Stock, 2003; Newman, 2003b). Most sources
20
claim that fenugreek may be discontinued once adequate breast milk supply has been
established, but there is disagreement in the literature regarding whether fenugreek can be
stopped abruptly or should be weaned off over one week (Curtis, n.d.; Gabay, 2002; Huggins,
n.d.; Newman, 2003b).
The side effects of fenugreek are described as a maple syrup odour to urine, sweat, and
breast milk; diarrhea; aggravation of asthma; and hypoglycemia (ABM, 2004; Curtis, n.d.; D'Itri,
2006; Gabay, 2002; Huggins, n.d.; Mallory, 2008; Tiran, 2003; Ulbricht et al., 2007). The babies
of women taking fenugreek can also have urine that smells like maple syrup, and there is some
theoretical risk that these babies could be mistakenly diagnosed with maple syrup urine disease
(Abascal & Yarnell, 2008; Laurence, n.d.; Low Dog, 2009). Other potential concerns with
fenugreek use are allergic reactions, uterine contractions, and an interaction with warfarin that
increases its anticoagulation effect. For these reasons is not recommended in women who are
pregnant, diabetic, asthmatic, who have cardiovascular disease, or previous gastrointestinal
disease (ABM, 2004; D' ltri, 2006; Gabay, 2002; Tiran, 2003; Ulbricht et al., 2007).
There are two citations referred to often in the literature as preliminary reports that
reportedly demonstrate the effectiveness of fenugreek (Co, Hernandez, & Co, 2002; Swafford &
Berens, 2000). Unfortunately it was not possible to locate the report by Co, Hernandez, and Co,
but Dr. Berens was kind enough to e-mail a copy of the unpublished presentation delivered by
herself and Dr. Swafford. Swafford and Berens measured breast milk production in ten women
who were at least 14 days postpartum, with infants born 28-38 weeks gestation. The study took
place over two weeks. The first week the women pumped and measured the volume of breast
milk as a baseline, the second week they took three fenugreek capsules three times daily and
measured their breast milk using the same pumps. The average volume of breast milk pumped
21
daily increased from 207 ml in the first week to 464 ml in the second week. There is no
mention of whether this was exclusive pumping, or following a feed, and it is difficult to know
how much of this increase can be attributed to fenugreek versus a natural increase based on
supply and demand without a control group against which to compare these results.
Another frequently cited study on the use of fenugreek is Huggins (n.d.), who discusses
anecdotally that among approximately 1200 women with whom she has worked and who have
taken fenugreek, "Nearly all of the mothers ... report an increase in milk production, generally
within 24-72 hours" (Huggins, n.d.). It is impossible at this point to know if this increase is
actual or perceived. Newman (2003b) states, "If they [fenugreek and blessed thistle] do work,
you will usually notice a difference within 3 to 4 days ... lfnot, they probably won't work."
(Handout #24). Laurence notes (n.d.), again anecdotally, that her results with fenugreek have
been mixed, with some mothers rep01ting no change in milk supply and others reporting
significant increases.
Fenugreek is listed as Generally Recognized As Safe by the US Food and Drug
Administration (US FDA, 20 l 0), and Health Canada (2009c) also has minimal concerns
regarding its use although they do not have a list of safe herbs per se and they do not require any
safety trials or standardization for fenugreek to be sold in Canada.
Blessed Thistle
Blessed thistle, or Cnicus benedictus, is an herb that has no listed uses other than as a
galactagogue, and it is often recommended to be taken along with fenugreek, with Newman
(2003) claiming that the two herbs work better together. Abascal and Yarnell (2008) include a
recipe for " More Milk Plus" tincture that contains fenugreek, blessed thistle, stinging nettle, and
fennel. The mechanism of action is not listed in the literature so is presumed to be unknown.
22
The recommended dosage is three capsules three times daily or 20 drops of tincture
three times daily. The outcome is suggested to be similar to fenugreek, with increased maternal
milk supply noted, albeit subjectively, within 3-4 days (Mallory, 2008; Newman, 2003b).
Reported side effects include vomiting and diarrhea when taken in amounts greater than 5 grams
per dose. (Mallory, 2008; Newman, 2003b). There were not any studies on blessed thistle found
in the literature.
Health Canada (2008a) has a warning on the product monograph for blessed thistle,
stating: "Consult a health care practitioner prior to use if you are breastfeeding", and that it
should not be used during pregnancy. This monograph does not list lactation as an indication for
use of blessed thistle.
Other Herbal Galactagogues
Additional herbs that are mentioned briefly in the literature include: Goat's rue (Galega
officina/is); Fennel seed (Foeniculum vulgare); Chaste tree seed (Vitex agnus-castus); wild
asparagus roots (Aspragus racemosus); aniseed (Pimpinella anisum); fireweed (Epilobium);
stingi ng nettle (Urtica dioica) ; caraway seed ; cinnamon; dill ; raspberry leaf; brewer' s yeast;
alfalfa (Medicago sativa); cotton root (gos.sypium); borage leaves (Borago officina/is); hops
(Humulus lupulus); basil; marshmallow (Abascal & Yarnell , 2008; ABM, 2004; Low Dog, 2009;
Mallory, 2008; Newman, 2003b). These herbs have only anecdotal evidence describing their use
as galactagogues.
There is a small study in Peru that examined the effect on human milk production of
micronized Silymarin, an extract of milk thistle, that has demonstrated success in increasing milk
production in cows. DiPierro, Ca llegari, Carotenuto, and Mollo Tapia (2008) noted an increase
in breast milk production of 85.95% in the women taking si lymarin compared with 32.09% in
23
the placebo group from day of delivery to day 63 postpartum, with no difference in milk
composition. The mechanism of action is unknown, although it is hypothesized that there is an
effect on estrogen that may increase milk production. There are no known side effects (Di Pierro
et al., 2008).
Alternative Non-Pharmaceutical Galactagogues
There are two other complementary or alternative methods of augmenting breast milk
production that were mentioned frequently in the Iiterature, therefore a brief discussion of the use
of alcohol and acupuncture to increase breast milk production is included.
Alcohol
Alcohol is considered a galactagogue in many cultures, including North America, and
many women report that they were told by their primary care provider that alcohol, particularly
barley-based alcohol such as beer, will increase milk production and assist with milk let-down
(Giglia & Binns, 2007; Mennella, 2001; Mennella, Pepino, & Teff, 2005). This is despite the
fact that there is no evidence to support this theory, and in fact , current research suggests just the
opposite.
Mennella (200 I) notes that studies have demonstrated that infants consume, on average,
20% less breastmilk in the 3 to 4 hours after maternal alcohol consumption, compared with
regular feedings. This is not related to the feeding time, or refusal to nurse, but rather to
maternal breast milk production. Alcohol seems to inhibit suckling-induced prolactin
production, oxytocin release, and subsequently milk production and infant intake, although it has
no effect on baseline prolactin levels (Mennella et al., 2005).
24
Acupuncture
It was difficult to find English-language studies examining the effect of acupuncture on
lactation, however there are Chinese-to-English translated abstracts available that claim to
increase milk production using acupuncture (Wang & Li, 2004; Wei, Wang & Han, 2007),
although it is difficult to determine how increased milk supply was measured. As well, there
have been two recorded case studies of inadvertent induction of lactation following acupuncture
treatments in women who were not lactating at the time of treatment (Campbell & Macglashan,
2005; Jenner & Filshie, 2002).
Li's (n.d.) dissertation on the effect of acupuncture on increasing the milk supply of
lactating women claims that traditional Chinese acupuncture increased infant weight gain and
decreased need for supplementation with formula. Her assumption is that this weight gain is
related to maternal milk production. This was a pilot study consisting of27 women in a single
blind controlled trial. It is unfortunate that maternal milk production was not measured in a more
objective manner such as pumping.
Pharmaceutical Galactagogues
The two most frequently discussed pharmaceutical galactagogues in the literature are
metoclopramide and domperidone. In Canada domperidone has become the more widely used of
the two, because it does not cross the blood-brain barrier and so has fewer central nervous
system side effects when compared to metoclopramide.
Metoclopramide
Metoclopramide is a central nervous system dopamine-antagonist that was originally
promoted and sold as an antipsychotic in Europe; however it has been most recently used in
North America as a gastric motility agent for treatment of nausea, vomiting, and
25
gastroesophageal reflux (ABM, 2004; Anderson & Valdes, 2007; Betzold, 2004; Brodribb,
2000; Gabay, 2002). The off-label use of metoclopramide as a galactagogue has been reported
and studied since 1975 (Anderson & Valdes, 2007). It is frequently described as the most
commonly used medication to induce or augment lactation in the US (ABM, 2004; Henderson,
2003). The mechanism of action for metoclopramide with regard to inducing or augmenting
lactation is the antagonism of dopamine- known to inhibit the release of prolactin from the
anterior pituitary. This dopamine antagonism therefore increases prolactin levels, and
subsequently increases breast milk production (Henderson, 2003; da Silva, 2004).
The most commonly prescribed dosage of metoclopramide as a galactagogue is l 0 mg
orally three times daily (ABM, 2004; Anderson & Valdes, 2007; Henderson, 2003; Hsi &
Leeman, n.d.). Possible side effects of metoclopramide include restlessness, anxiety, drowsiness,
insomnia, fatigue, lassitude, dizziness, and Gl effects such as cramping and diarrhea (ABM,
2004; Betzold, 2004; Brodribb, 2000; Henderson, 2003; Hsi & Leeman, n.d .). Metoclopramide
may also increase maternal depression and risk for seizures, and so is not recommended for
women with a known history of depression, psychosis, pheochromocytoma, or seizures (Betzold,
2004; Henderson , 2003). This drug can have extrapyramidal side effects, including dystonic
reactions (ABM, 2004; Gabay, 2002; Betzold, 2004; Hsi & Leeman, N.D.) and the US FDA has
issued a black box warning stating metoclopramide should not be used for longer than 12 weeks
at any dosage due to an increased incidence of extrapyramidal side effects with prolonged
treatment (US FDA, 2009).
Domperidone
Domperidone is approved for use in Canada as a gastrokinetic medication with
indications including treatment of motility disorders, nausea and vomiting, headache disorders
26
associated with nausea and vomiting, gastroparesis, dyspepsia, gastritis, esophageal reflux,
and in anorexia and bulimia to relieve bloating and constipation (ABM, 2004; Albright, 2004;
Brodribb, 2000; Compendium of Pharmaceuticals and Specialties (CPS), 201 0; da Silva et al.,
200 I; Gabay, 2002; Henderson, 2003; Newman, 2003a). The CPS (20 10) does discuss the use
of domperidone as a galactagogue, despite no official approval from Health Canada, stating,
"[ d]omperidone has been used in nursing mothers to improve lactation." (p. 775).
Domperidone is a dopamine antagonist that does not cross the blood/brain barrier. The
mechanism of action with regard to inducing or augmenting lactation is similar to
metoclopramide in that it is the antagonism of dopamine- which inhibits the release of prolactin
from the anterior pituitary. This dopamine antagonism therefore increases prolactin levels, and
subsequently increases breast milk production (Albright, 2004; Betzold, 2004; da Silva, 2004;
Gabay, 2002; Henderson, 2003; Hsi & Leeman, n.d.; Newman, 2003a; Ruddock, 2005; Wan et
al., 2008).
There are discrepancies in the literature regarding the dosage for domperidone when used
as a galactagogue. Recommended dosages range from l 0 mg to 30 mg anywhere from two to
four times daily (ABM, 2004; Albright, 2004; Anderson & Valdes, 2007; Brodribb, 2000.; da
Silva, 2004; Gabay, 2002; Henderson , 2003; Newman , 2003a; Ruddock, 2005; Wan et al., 2008).
Wan et al. (2008) tested both 30mg daily and 60mg daily dosing in their study, and found that
the 60 mg dose only slightly increased prolactin levels compared to the 30 mg dose, while
increasing the incidence and severity of side effects. The CPS (20 I 0) simply notes that "As a
galactagogue, domperidone is usually given at an oral dose of 60 to 80 mg daily though 30 mg
daily has been used". (p. 775).
27
Potential side effects of domperidone include: edema and palpitations (0.5%);
headache (1.2%); insomnia, dizziness, thirst, lethargy, irritability, nervousness(< 1%); acute
dystonic reactions (rare in adults); skin rash, itching, urticaria(< 1%); breast enlargement,
galactorrhea, menstrual irregularities, hot flushes, mastalgia, elevated serum prolactin ( 1.3%);
dry mouth (1.9%); abdominal cramps, diarrhea, regurgitation, appetite changes, nausea,
heartburn, constipation(< 1%); stomatitis, conjunctivitis, urinary frequency, dysuria, leg cramps,
asthenia, drug intolerance, elevation of AST, AL T, cholesterol(< 1%) (CPS, 2010, p. 775).
The effect of domperidone on prolactin levels and breast milk volume has been studied in
two double-blind RCTs with placebo by da Silva et al. (2001), and Campbell-Yeo et al. (2010).
da Silva et al.'s study, while small with only 21 women, demonstrated significantly higher
prolactin levels and breast milk production in women in the domperidone group compared with
women in the placebo group. Campbell-Yeo et al.'s study was slightly larger with 46
participants, and examined mean breast milk volume pumped by mothers of preterm infants
randomly assigned to receive either domperidone I 0 mg three times daily for two weeks or
placebo. " Breast milk volumes increased by 267% in the domperidone-treated group and by
18.5% in the placebo group" (Campbell-Yeo et al., 2010, p. e 107). There was no significant
difference in breast milk composition when energy, fat, carbohydrate, sodium, and phosphate
content were compared in breast milk from the two groups. (Campbell-Yeo et al., 2010). The
patticipants in these studies had all delivered prematurely at 30-31 weeks gestation, and were
entered in the study after demonstrating insufficient milk supply at three to five weeks
postpartum. Both studies observed steady increases in breast milk volume in participants taking
domperidone within 48 hours of initiation of the drug ( da Silva et al., 2001; Campbell-Yeo et al.,
2010).
28
Wan et. a! (2008) performed a double-blind, randomized crossover trial to examine the
effect of dosage of domperidone on milk supply in six women. Breast milk volumes were
measured on day 0 and day 7 of the study and were found to be statistically similar between the
two groups, however the authors concede that this is likely due to the low power of their study
with so few participants. It is interesting to note the authors' observation of a higher prevalence
of side effects such as dry mouth, headache, and abdominal cramping in the group receiving 20
mg three times daily compared with the group receiving 10 mg three times daily.
Finally, Brown et al. (2000) examined the effect of parity on the response often nonpregnant women to a single dose of one of the following: metoclopramide 5 mg, or 10 mg, or
domperidone 10 mg. The authors found that among nulliparous women metoclopramide 10 mg
had a more rapid onset of action and overall higher peak prolactin levels compared with the 5 mg
dose or the domperidone. However, among multiparous women there was no difference in onset
of action timing or peak prolactin levels between either the two doses of metoclopramide or the
domperidone. The authors suggest that parity should be considered when determining which
drug/dose to prescribe as a galactagogue. This information may be useful if prescribing
galactagogues for nulliparous women who are adopting and wish to breastfeed, however this
topic is outside the scope of this paper. The pertinent point for the purposes of this paper is that
all l 0 women responded with increased prolactin levels to both of these drugs.
In the past decade, domperidone has become widely used in practice in Canada for its
off-label use as a galactagogue. While there are no statistics on actual number of prescriptions
written for domperidone as a galactagogue, interviews were done with numerous practitioners
regarding their own practice. Each of these practitioners, who were either NPs or physicians,
had prescribed domperidone as a galactagogue, and had found it to increase milk supply,
29
however there was acknowledgement that simply increasing milk supply did not always solve
the problem of insufficient nutrition in the newborn. It was recognized that other factors often
contributed to breast milk insufficiency such as poor breastfeeding technique, and previous
maternal breast surgery. Clinicians prescribed domperidone most frequently using the CPS as a
resource for determining dosage, with no consensus as to the length of time women should be
taking it, and all used infant weight gain as an indicator of efficacy. Domperidone is anecdotally
considered a safe drug with an excellent side effect profile and therefore is more likely to be
prescribed by practitioners, although most admitted to not having examined any research
regarding domperidone as a galactagogue (A. Carter, personal communication, July 20, 2010; C.
Lapadat, personal communication, March 12, 201 0; C. Evanson, personal communication, June
3, 201 0; R. Klepsch, personal communication, March 10, 201 0; I. Scrooby, personal
communication, July 14, 2010; V. Stafford, personal communication, March 22, 2010).
Domperidone is not approved by the US FDA for any use at all; however women are able
to obtain domperidone from other countries such as Canada, or through compounding
pharmacies (Wlock, 2006) . This prompted the US FDA to issue a warning to women who are
using or are considering using domperidone to augment or induce lactation. The warning is
based on reported deaths following the administration of domperidone intravenously in patients
who were receiving chemotherapy (US FDA, 2004). There have been no reported incidents with
the oral route. The drug plasma levels in oral administration are approximately 80 to 150-fold
lower than similar doses administered via the intravenous route. Domperidone's bioavailability
is only 13% to 18% when administered orally, which is reported to be a marked difference from
intravenous administration (Betzold , 2004; Ruddock, 2005). Campbell-Yeo et al. had begun
enrollment in their study on domperidone in Canada when the US FDA warning was issued.
30
While the study was placed on hold briefly, a No Objection Letter was issued by Health
Canada October I, 2004, and ethics approval was reinstated for the study October 5, 2004
(Campbell-Yeo et al., 2007).
Less Commonly-Used Medications
Growth hormone, thyrotropin-releasing hormone, sulpiride, chlorpromazine, recombinant
human prolactin, and oxytocin nasal-spray are also briefly mentioned in the literature
(ABM,2004; Gabay, 2002; Sauberan & Wight, 2006), however these are not commonly used as
galactagogues, and research is limited, therefore they will not be discussed in this paper.
Summary of Present Research
There is a considerable scarcity of evidence regarding the use of herbal preparations such
as fenugreek, however there is a lot of unreferenced, personal anecdotal-based discussion of their
use available from a large variety of sources. There have not been any RCTs done with any
herbal preparations and the Iiterature review for the use of fenugreek as a galactagogue is a
conflicting one with many gaps. Many of the sources did not provide references, evidence, or
sometimes even expla in the claims that were made. There was not a single study to support the
safety or efficacy of blessed thistle as a galactagogue. This may be a res ult of the mentality that
natural products are by their very nature safe and therefore do not require the same rigorous
examination that pharmaceuticals are subjected to, which may lead to anecdotal evidence being
viewed as satisfactory.
To date the most compelling evidence for an herbal galactagogue comes from the RCT
with placebo trial of silymarin, or milk thistle, in Peru (Di Pierro et al. , 2008), that enrolled 50
women (higher than many of the pharmaceutical galactagogue studies) and demonstrated
increase in milk supply through test-weighing of the infants as well as measured volumes of
31
breastmilk pumped following feeds. It would be compelling to see these results repeated in
further trials.
Current research would suggest that alcohol should not be touted as a galactagogue, that
it actually decreases maternal milk production and breast milk intake by infants rather than
improving it as is commonly suggested. In fact, more research needs to be done to determine
possible effects on the breastfeeding infant who is exposed to alcohol through breast milk, as this
may prove to actually be a harmful intervention.
From the limited information currently available, acupuncture may improve maternal
breastmilk production and therefore may be a potentially useful galactagogue. The safety profile
of acupuncture is also reasonable, provided single-use disposable needles are used (Li, n.d.), with
the only identified concern being that it simply may not work. More research with more
objective means of determining milk production needs to be done. However, there does not
appear to be any reason to actively discourage women from attempting this approach at this time
with the proviso that there is limited evidence for the effectiveness of acupuncture in increasing
milk supply.
Metoclopramide remains prominent in the US literature, with the abundance of studies
done in the 1970's and 1980 ' s cited as confirmation of its effectiveness as a galactagogue.
However, there have been few recent studies performed and it is not widely used in Canada due
to its higher incidence of side effects when compared to domperidone.
The four most recent studies on domperidone use as a galactagogue all demonstrated that
domperidone is effective in increasing prolactin levels and breast milk production compared with
placebo or with no intervention (Brown et al. , 2000; Campbell-Yeo et al. , 20 I 0; DaSilva et al. ,
2001; Wan et al., 2008). These studies were all randomized, which places them in the "good"
32
level in the hierarchy of evidence (Evans, 2003), and means that the studies focused clearly on
the effectiveness of domperidone in increasing maternal milk production, rather than examining
its use in clinical practice, or using anecdotal evidence. RCTs are currently considered to be the
least biased type of study and to yield the strongest evidence of effectiveness of an intervention
(Johnston, 2005). All four studies were single centre studies, and all were relatively small, with
participant numbers ranging from six to 46 women. This places them at a level 3 out of 5 on the
hierarchy of evidence scale (Ciliska, Thomas, & Buffet, 2008), and suggests that further research
with larger numbers of participants with a multi-centre approach would be valuable in
confirming efficacy as well as determining risks and side effects.
There has not been any research done regarding the use of domperidone with mothers of
older infants. Perhaps this is not a common use of domperidone: certainly the practitioners that
were interviewed for this paper only spoke of use during the newborn period. This is not to say
that this use does not occur, simply that I was not able to find any information, anecdotal or
otherwise, regarding the use of domperidone with older infants.
Analysis of Clinical Practice Guidelines
The guideline from the Academy of Breastfeeding Medicine (ABM) is " Protocol #9: Use
of galactogogues initiating or augmenting maternal milk supply", and is the only clinical practice
guideline currently available for clinicians regarding prescribing of galactagogues. Until
recently, this guideline was available for viewing on the both the National Guideline
Clearinghouse (NGC) and ABM websites, however the NGC has recently removed the guideline
from their website. The NGC states that:
Guideline summaries are removed from the NGC Web site because they no longer meet
the NGC Jnclusion Criteria with respect to date, or because the guideline developer has
33
indicated that the clinical practice guideline upon which the summary is based is
obsolete, should no longer be used, or has not yet been replaced with a new/revised
guideline.
(NGC, 2010)
A critical analysis of this guideline using the Appraisal of Guidelines for Research & Evaluation
(AGREE) Instrument (The AGREE Collaboration, 200 I), reveals many flaws and gaps, which I
will outline below.
The first issue that I uncovered with this critique of the guideline was the lack of
multidisciplinary input, despite the wide range of health care providers who would be accessing
these guidelines. There is no input from health care professions such as pharmacists, nurses, or
lactation consultants despite their obvious role in breastfeeding success. In fact, there were only
four people on the committee for these guidelines, and all are fellows with the ABM.
A second concern is the lack of any type of decision-making tool for clinicians, and no
patient information handouts. Essentially the guideline consi sts of a brief summary of research,
or expert consensus when no research is available, with no clarification as to how this
information should be used in practice. There is a lack of information regarding appropriate
follow up for treatment recommendations, expected outcomes, or possible barriers to treatment
such as cost and availability.
Finally, several herbal preparations are discussed in the guideline, despite the lack of
evidence of their safety or efficacy. The references for the herbal recommendations are the
anecdotal references discussed earlier in this paper (Co, Hernandez, and Co, 2002; Huggins; n.d.;
Low Dog, 2001; Swafford & Berens, 2000), and the Huggins reference is the only one easily
accessible online. The presentation by Low Dog is no longer available (T. Low Dog, personal
communication, June 7, 201 0), and there is no contact information for Co et al.: however, I was
able to obtain the Swafford and Berens paper via personal communication. The inability to
34
actually find the references used does not seem appropriate for a clinical practice guideline,
and the use of these references could lead the undiscerning practitioner to assume that there is
evidence to support the use of these herbal preparations, when in fact this is not the case.
Despite these flaws, the ABM guideline is cited in the Fraser Health Breastfeeding
Guidelines (Fraser Health Authority, 2008), and in much of the literature (Hsi & Leeman, N.D.;
Mallory, 2008; Marasco, 2007; Shealy, Li, Benton-Davis, and Grummer-Strawn, 2005). There
are no Canadian CPGs, but much of the recent research on galactagogues has come from Canada
(Brown, et al., 2000; Campbell-Yeo et al., 20 10; DaSilva et al., 2001 ).
Implications for Practice
Galactagogues should not be a first line treatment for possible breast milk insufficiency.
The practitioner must first determine whether the insufficient maternal milk supply is a perceived
problem or an actual problem. If it is an actual problem then it must be determined which of the
three categories of causes is the basis of the problem: primary failed or delayed lactogenesis II;
secondary delayed lactogenesis related to breastfeeding management or breast milk transfer
issues; or organic failure to thrive, with newborn pathology. There are no guidelines currently
available to aid with this determination, nor with what assessments and interventions should take
place prior to prescribing galactagogues.
The recommendations that follow reflect the available evidence, and focus on the first
several weeks following delivery rather than older infants. There is perhaps an assumption that
breast milk insufficiency is more urgent in the initial weeks following birth, when all of the
infant's nutritional needs are expected to be met by breast milk, rather than in older infants who
may be consuming solid foods in addition to breast milk. However, it is reasonable to assume
that an NP faced with the possibility of decreased breast milk supply in the mother of an older
35
infant could perform the same assessments and interventions recommended below, with the
understanding that congenital newborn conditions are unlikely to appear at this point. Rather,
issues of maternal hormonal conditions, the introduction of new maternal medications, or
changes in feeding patterns are much more likely.
Assessment of Maternal Milk Supply
So what assessments should be performed by the NP when a woman presents with the
chief complaint of "I don't have enough milk to feed my baby"? The initial issue is whether or
not the milk insufficiency is a perceived or actual problem. This is quite easily determined with
the following assessments. The infant's weight should be assessed and weight should be plotted
serially on a growth chart to track patterns ofweight change. A weight loss of5-10% can be
normal in the first three to four days after birth, however breastfeeding should be assessed when
infant has lost more than 7% (BCPHP, 1997; Health Canada, 2007; Mohrbacher & Stock, 2003).
The baby should regain birth weight by two to three weeks after birth (BCPHP, 1997; Health
Canada, 2007; HealthLink BC, 2009; Mohrbacher & Stock, 2003). Weight gain thereafter
should be approximately 120 to 180 grams per week, or 17 to 26 grams per day for the first three
to four months of life (BCPHP, 1997; Health Canada, 2007; La Leche League International
(LLLI), 2007; Mohrbacher & Stock, 2003).
Second, the output of the baby should be assessed. By day 5, baby should be having at
least six wet diapers every day and the urine should be clear or light yellow in colour, not dark or
odorous. There should also be two to five quarter-sized bowel movements daily. The baby must
also be assessed for signs of dehydration such as lethargy, poor skin turgor, sunken fontanelles,
jaundice, dry mucous membranes and eyes, or fever (BCPHP, 1997; Health Canada, 2007;
Health Link BC, 2009; LLLl, 2007; Mohrbacher & Stock, 2003).
36
Should it be determined that the baby is not gaining weight adequately, does not have
sufficient output, and or shows signs of dehydration, it must be determined whether this is an
issue of insufficient milk supply or poor milk transfer. The LATCH breastfeeding assessment
tool has been found to be a valid tool for assessing breastfeeding latch both in the hospital and
community settings, and is recommended to flag women and baby dyads who are at increased
risk for early weaning due to nipple discomfort (Riordan, Bibb, Miller, & Rawlins, 2001).
Improper latch can lead to inadequate emptying of the breast, in turn leading to decreased milk
production as well as inadequate infant intake (Hurst, 2007). Therefore, a tool to assess latch is
an important aspect of primary care breastfeeding management, and should be used to determine
adequacy of breastfeeding sessions.
The LATCH tool is a relatively quick measurement of latch that primary health care
providers may find helpful in assessing latch and determining if this is the cause of poor infant
breast milk intake. Should the nurse practitioner find that the latch score identifies concerns with
the latch such as poor infant suck, a tongue-tie, or flat to inverted nipples then this can be further
assessed and dealt with by the practitioner. If he or she is not competent or comfortable in this
area, then referral to another resource such as a lactation consultant, breastfeeding counselor, or a
La Leche League representative should be considered , subject to availability. Discussion of how
to correct problems with latch is beyond the scope of this project.
If breast milk transfer is found to be adequate using a latch assessment tool, but the infant
is not gaining weight appropriately, or is losing weight, then the issue is more likely to be related
to breast milk production, which is estimated to affect 5-15% of breastfeeding women (Hurst,
2007). Hurst notes that primary lactation failure can be related to conditions such as " anatomic
breast abnormalities or hormonal aberrations. Insuffici ent mam mary glandular tissue,
37
postpartum hemorrhage with Sheehan syndrome, theca-lutein cyst, polycystic ovarian
syndrome, and some breast surgeries" (Hurst, 2007, p. 590). The process of diagnosing any of
these conditions requires a thorough history and physical examination, which should include the
details of the pregnancy, labour and delivery. Laboratory tests should be ordered to check for
any hormonal irregularities, and the specific tests and assessments will vary depending on what
diagnoses are being ruled in or out.
Secondary lactation failure in the first six weeks postpartum can be related to poor latch
as mentioned above, as well as the over-use of pacifiers, restrictive feeding schedules rather than
baby-led feeding, supplementary feeds, and some maternal medications such as oral
contraceptives (Hurst, 2007). Once again, a thorough history that includes a review of all
medications and herbs is required to assess for this, along with detailed recall of feeds and use of
pacifiers and supplements. Secondary lactation failure can and should be managed with
education regarding the use of pacifiers, supplementary feeds, and restrictive feeding schedules
and how these can interfere with breast milk production. Maternal medications that are found to
be interfering with milk supply should be discontinued if possible, and alternative treatments
found.
Primary lactation failure requires treatment of the underlying cause. Treatment of both
primary and secondary lactation failure should be accompanied by increased breast stimulation,
i.e. infant suckling at the breast and or pumping the breasts, and increased breast emptying to
stimulate milk production (Hurst, 2007). Only after these measures have been implemented
should the use of pharmaceutical galactagogues be considered, and only with close follow up and
re-assessment within two to three days.
38
NP Scope of Practice
The prescribing of domperidone is within the scope of practice for NPs in BC (The
College ofRegistered Nurses of British Columbia (CRNBC), 2010), however the assumption in
the scope of practice document is that the domperidone is being prescribed for its approved use
as a gastrokinetic medication. So what does the legislation say regarding NP prescribing of
medications for off-label purposes, which is to say, prescribing a medication for its side effects
rather than its approved purpose?
The CRNBC does not directly address the subject ofNPs prescribing medications for offlabel uses, however there are examples in grey literature (Keith, 2007) as well as in family NP
practice in BC (C. Evanson, personal communication, June 3, 2010; C. Lapadat, personal
communication, March 12, 2010; V. Stafford, personal communication, March 23, 2010).
Consulting with the CRNBC N P practice consultant regarding this issue revealed that as long as
the standards of practice are met, in this case the standards under section B of the scope of
practice document "Prescribing and Dispensing Drugs", then off-label prescribing is an
acceptable practice (CRNBC, 20 I 0; A. Komaryk, personal communication, May 11 , 20 l 0). In
the UK, NPs may prescribe medications for off-label uses where this is common practice (Drug
and Therapeutics Bulletin, 2006). There is no official Health Canada or Canadian Medical
Association policy on off-label medication prescribing (Silversides, 2006): however, it is
acknowledged that this is common practice. This is mainly due to the logistics of obtaining
approval to market a drug for a second purpose, which can take years (Canadian Broadcasting
Corporation News, 2008). The US FDA also acknowledges this as common practice among
prescribers and recommends that the prescriber must have excellent knowledge of the
medication, and that the off-label use of any medication should be evidence-based (2009).
39
Despite the absence of any actual policies regarding off-label prescribing, there does
not appear to be any official reason for nurse practitioners not to prescribe medications for offlabel use. This is provided that there are no known contraindications in the patient's history, that
they are practicing within their scope of practice, have an excellent understanding of the
pharmacodynamics, pharmacokinetics, expected therapeutic effect, and possible adverse effects
of that drug, as well as compelling evidence of the drug 's safety and efficacy when used for this
purpose.
Recommendations
There is an abundance of evidence that suggests that well-informed primary care
providers with education and training regarding lactation is one of the most important and
influential factors in increasing breastfeeding initiation, success, and duration rates (ABM, 2006;
Chung et al., 2008; Couto De Oliveira, Bastos Camacho, & Tedstone, 2001; Dennis, 2002;
Dyson et al., 2009; Eglash et al., 2008; Gill, Reifsnider, & Lucke, 2007; Hurst, 2007; Porteous,
Kaufman, & Rush , 2000; Shealy et al., 2005; Sikorski, Renfrew, Pindoria, & Wade, 2003).
All primary health care providers, including nurse practitioners, should ensure that they
have an adequate knowledge base to discuss benefits to mother and baby of breastfeeding, the
risks associated with formula feeding, and the current cost of formula in their community. They
should have sufficient knowledge to assess breastfeeding technique, in other words, latch and
milk transfer, and they should be confident with methods to intervene when there are problems
with latch or milk transfer (PHAC, 2002).
I believe that this should be incorporated into the curriculum of all primary health care
providers, including nurse practitioners. WHO/Unicef has developed a 20 hour breastfeeding
course that teaches health care providers lactation management and The Infant Feeding Action
40
Coalition (INF ACT) Canada offers this course frequently (INF ACT Canada, 201 0; Unicef,
2009). This course should be included as part of the basic curriculum for nurse practitioners,
particularly those in the family and pediatric streams of practice. The importance of
breastfeeding as primary health care promotion cannot be overemphasized, and it should be
given more time in health care provider education than it currently receives. In my nurse
practitioner program, management of breastfeeding problems was simply one of twenty learning
objectives in one week of class. This cannot be considered adequate in light of the frequency
with which breastfeeding issues such as perceived or actual insufficient milk supply lead to
discontinuation of breastfeeding (Millar & Maclean, 2005). There was no information available
regarding number of hours spent learning about breastfeeding in other primary care provider
courses.
Research should be actively pursued with regard to the most commonly-prescribed
galactagogues, domperidone and fenugreek. For the women who demonstrate actual insufficient
milk supply, with infants showing nutritional insufficiency when all other causative factors have
been ruled out, domperidone may mean the difference between being successful at breastfeeding,
or having to supplement with formula. This is of huge impot1ance to these women and families
on a personal level, and to Canadians overall as a public health issue. As discussed earlier, the
short and long term benefits to mother and baby are significant, and for this reason the use of a
safe and effective galactagogue is relevant and important.
What is missing from the recommendations regarding herbal treatments as galactagogues
is evidence. There are a number of reasons for this. The first is that companies that market
herbal over-the-counter remedies are not required to follow the same rigorous process as
manufactured pharmaceutical s. It does not make much sense to spend money on expensive trials
41
if it is not required in order to sell your product. The second is the perpetual myth that
somehow herbal remedies are safer and less toxic than pharmaceuticals. Those who market
herbal preparations point out that these herbs have been used for generations, with plenty of
anecdotal evidence to back them up. A third is the current organic and natural trend discussed
earlier, which favours herbs and supplements, vilifying mega-corporations such as
pharmaceutical companies, and encouraging a more natural approach to all aspects of life. What
is not considered is the stringent guidelines and safety testing that is required for pharmaceuticals
and is not required for herbal remedies. I would suggest that requiring the same standardization
and testing for safety and efficacy with herbal products would help NPs to make informed
decisions regarding their use, and to offer education and guidance to their patients. NPs, as
holistic health care providers, may have a special interest in pushing for these types of
regulations at a policy level in Canada.
The lack of research regarding safety of herbal preparations simply means that there is no
record of adverse events, not that those event do not occur. People are living longer, and with a
better quality of life thanks to pharmaceuticals and the research that they inspire, and this is what
many proponents of the natural /organic movement forget. The medications produced must be
efficacious, tolerable, and safe, or the pharmaceutical companies do not make any money from
them, because health care providers do not continue to prescribe questionable or poorly tolerated
medications to their patients.
The promotion of herbs by high profile figures such as Jack Newman help to perpetuate
the myth that somehow herbal remedies are safer and less toxic than pharmaceuticals. Jack
Newman is a well-respected physician and crusader for breastfeeding, which is admirable, but
the complete lack of references or research on his websites and handouts, which are easily
42
accessible by the public, cannot be overlooked (Newman, 2003a; Newman, 2003b). Herbal
preparations such as fenugreek and blessed thistle have not been subjected to the same rigorous
testing as pharmaceutical galactagogues and therefore their efficacy, safety, and even
recommended dosage have not been agreed upon in the literature (Abascal & Yarnell, 2008;
Curtis, n.d.; Health Canada, 2009; Huggins, n.d.; Lagrave, n.d. ; Laurence, n.d.; Low Dog, 2009 ;
Marasco, 2007; Mills, Duguoa, Perri, & Koren , 2006; Newman, 2003a; Tiran, 2003; Ulbricht et
al. , 2007)
Alcohol has not shown any efficacy as a galactagogue, and due to potential for side
effects for the infant as well as the potential for abuse, using alcohol as a galactagogue should be
actively discouraged. Patients should be educated regarding the demonstrated decrease in breast
milk consumption by infants whose mothers drink even moderate amounts of alcohol prior to
breastfeeding, which suggests alcohol is actually counter-productive as a galactagogue
(Mennella et al. , 2005).
There is limited evidence regarding acupuncture, but what is available is compelling, and
the safety profile is excellent. Further research should be done with regard to efficacy, but as a
complementary alternative therapy there is no reason to actively discourage its use.
Metoclopramide does seem to demonstrate effectiveness with increasing prolactin levels,
but the increased incidence of side effects, and in particular the ability of metoclopramide to
cross the blood-brain barrier and cause extrapyramidal side effects makes it a less-attractive
choice. The continued use of metoclopramide as a galactagogue in the US likely has more to do
with the difficulty obtaining domperidone and with the FDA warning, than with any practitioner
preference for this drug.
43
The research on domperidone is ongoing, and the drug also appears to have efficacy
with regard to increasing prolactin levels and thereby milk supply, however, prolactin levels are
only one factor in breast milk production, which is why an adequate knowledge base in
lactogenesis and management of common breastfeeding problems as well as how to intervene
with them must accompany any pharmaceutical intervention. Larger scale studies would be
beneficial, particularly with regard to the safety profile of domperidone in light of the US FDA
warning against its use in any capacity. In the meantime, domperidone is commonly used in
Canada as a galactagogue, with no reported safety concerns. There is no apparent reason to not
use domperidone as the research currently available is compelling, provided that other possible
causes of insufficient nutritional status of the newborn have been ruled out or identified and
addressed. Cost is not prohibitive at less than two dollars per day for a dosage of 10 mg four
times daily (Maclean, 2007). The cost of formula is approximately $2.50 to $3.50 per day
depending on the brand (Skelton, 2009), so when one considers the health benefits of
breastfeeding compared with formula feeding, using domperidone to increase breastfeeding
success is a very feasible intervention , and in fact is a better and less-expensive option than
supplementing with formula.
If domperidone is appropriate, then the research to date suggests that a dosage of I 0 mg
orally three times daily for two weeks is likely to be effective, while minimizing possible side
effects (Campbell-Yeo et al., 2010; DaSilva et al., 2001; Wan et al., 2008). Follow up with the
mother and baby should involve infant weights, serial plotting on a growth chart, and 24 hour
surveillance of the newborn 's output. The frequency of follow up is at the discretion of the NP
with consideration to the specific circumstances of each case. The mother must be educated
44
regarding the feedback mechanism involved in autocrine control of breast milk production,
and ensure that her breasts are adequately emptied on a frequent basis to facilitate this.
Conclusion
The benefits of breastfeeding in newborns include decreased incidence of infections,
allergies, SIDS, and potential improvement in cognitive development (PHAC, 2009; Health
Canada, 2005; Health Canada, 2007; Kramer & Kakuma, 200 I). Long term benefits for adults
breastfed as infants include lower blood pressure, lower cholesterol, lower incidence of obesity
and type 2 diabetes mellitus (Horta et al., 2007 ; Martinet al., 2005). Maternal benefits include
decreased incidence of some cancers and osteoporosis, increased weight loss in the postpartum
period , and decreased cost. Environmental benefits include no packaging, waste or processing.
These benefits are well-known, and the societal pressure to breastfeed is enormous. This
has led to an increase in the request for galactagogues by breastfeeding women and their
families, and the NP as primary health care provider should be prepared to prescribe
galactagogues appropriately and safely. This requires adequate knowledge of the physiology of
breastfeeding, of the causes of lactation failure, and adequate assessment of breastfeeding latch
and milk transfer using validated tools. It also requires vigilance with regard to current
literature, and critical analysis of all recommendations to ensure that they are up to date, and that
the evidence presented is based on adequate and well-done research.
There are no herbal remedies that have been studied adequately enough to recommend
their use in primary health care. The two drugs that have been studied and thus far demonstrate
efficacy in increasing maternal milk supply are domperidone and metoclopramide.
Domperidone is the more commonly used in Canada, due to its decreased incidence of side
effects when compared to metoclopramide. The prescribing of domperidone must be
45
accompanied by counseling regarding breastfeeding technique and the need for baby-led
feeding versus scheduled feeding, and avoidance of the use of supplementary feeds or pacifiers.
As well , women who are prescribed domperidone should be followed closely, within two to three
days, and infants must be watched closely for signs of improving intake, with closely supervised
supplementation as required.
[nsufficient milk supply is a complicated, multifactorial issue that women should not be
expected to cope with alone. This requires intensive follow up with a health care provider that is
well-educated and confident regarding breastfeeding assessment and intervention. The
perception that breastfeeding is a natural process is possibly one that has led to the
extraordinarily poor numbers of women who are able to meet the Health Canada (2004)
recommendations for exclusive breastfeeding duration (Millar & McLean, 2005). Domperidone
is currently the only galactagogue that demonstrates efficacy along with an acceptable side effect
profile, but this drug should not be prescribed haphazardly or without close supervision.
Domperidone should be used when deemed appropriate, with excellent assessment and
follow up by an experienced, educated clinician. The best armament the primary health care NP
has with regard to perceived or actual breast milk insufficiency is knowledge to ensure that this
drug is used appropriately and only when absolutely required. The NP must be able to provide
reassurance when no intervention is required , to provide excellent counseling regarding
breastfeeding technique, and to confidently prescribe domperidone once the need is determined
through thorough assessment. It must also be noted that NPs must support mothers who choose
to bottle feed their infants, particularly in the face of societal , cultural, and government pressure
to breastfeed.
46
There is plenty of evidence that support and education from primary health care
providers is often all that is required to help women succeed with breastfeeding. Systematic
assessment and therapeutic intervention using the algorithm in appendix A when the NP is faced
with perceived or actual breast milk insufficiency will help to decrease the unnecessary use of
galactagogues in practice, ensure that when they are used the dosage and monitoring of
effectiveness is methodical and safe, and help to increase the rate of successful breastfeeding as
per the Health Canada recommendations.
47
References
Abascal, K., & Yarnell, E. (2008). Botanical galactagogues. Alternative and Complementary
Therapies, 14(6), 288-294. doi : 10.1 089/act.2008.14602
The Academy Of Breastfeeding Medicine (ABM). (2004). Protocol #9: Use of galactogogues in
initiating or augmenting maternal milk supply.
The AGREE Collaboration (2001). The appraisal of guidelines for research & evaluation
(AGREE) instrument. London, England: The AGREE Research Trust.
Albright, L. M. (2004). Domperidone in lactation: Use as a galactagogue. International Journal
of Pharmaceutical Compounding, 8(5), 329-335.
Anderson, P. 0., & Valdes, V. (2007). A critical review of pharmaceutical galactagogues.
Breastfeeding Medicine, 2(4 ), 229-242. doi: 10.1 089/bfm.2007 .0013
Baby Milk Action. (n.d.). The Nestle boycott. Retrieved July 3, 20 I 0 from
http://www. babym i1kaction.org/pages/boycott.htm !#top
Bat-tick, M., & Re inhold, A. (20 10). The burden of suboptimal breastfeeding in the United
States: A pediatric cost ana lys is [Abstract]. Pediatrics, 125(5), e 1048-e I 056.
doi: 10.1542/peds.2009-1616
Berens, P. D. (2004). Applied physiology in the peripartum management of lactation. Clinical
Obstetrics and Gynecology, 47(3), 643-655.
Betzold, C. M. (2004). Resources for Clinicians: Galactagogues. Journal of Midwifery &
Women 's Health, 49(2), 151-154. doi: I 0.10 16/j.j mwh.2003.12.007
Biancuzzo, M. (2003). Breastfeeding the newborn: Clinical strategies for nurses (2nd ed.). St.
Louis, Missouri: Mosby.
48
Blyth, R. , Creedy, D. K. , Dennis, C. L., Moyle, W., Pratt, J. , & De Vries, S.M. (2002). Effect
of maternal confidence on breastfeeding duration: An application of breastfeeding selfefficacy theory. Birth, 29(4), 278-284.
Breastfeeding.com. (n.d.). The Nestle boycott. Retrieved July 3, 20 I 0 from
http://www.breastfeeding.com/advocacy/advocacy boycott.html
British Columbia Perinatal Health Program (BCPHP) (1997). General guideline 3: Nutrition part
1: Breastfeeding the healthy term infant. Retrieved June 17, 2010, from
http://www.bcphp.ca//sites/bcrcp/files/Guidelines/General/MasterGeneral3NutritionPatti
Breastfeeding.pdf
British Columbia Perinatal Health Program (BCPHP) (2007). Nutrition part III: Breastfeeding
multiples. Retrieved July 19, 2010, from
http://www. perinatalserv icesbc.ca/I si tes/bcrcp/fi les/G u idelines/Genera l/Gen3 CB reastfeed
ingMultiplesNovem ber2006.pdf
Brodribb, W. (2000). Galactagogues (substances that are claimed to increase milk supply) .
Retrieved October 9, 2009 from http ://www. breastfeeding.asn .au/bfinfo/galact.html
Brown, T. E. , Fernandes, A., Grant, L. J. , Hutsul , J. , & McCoshen, J. A. (2000). Effect of parity
on pituitary prolactin response to metoclopramide and domperidone : Implications for the
enhancement of lactation. Journal of Human Lactation, 7(1), 65-69.
doi:l0.1177/ l 07155760000700110
49
Bryan, H. (2005). Pop. Health: A population of healthy people: A picture of health in the
Interior Health region: Population health profile June 2005. Retrieved June 16, 2010,
from Interior Health Authority website: Interior Health Authority website:
http://www.interiorhealth.ca/ uploadedFiles/Choose Health/Pop Health/PopHealthReport
2005.pdf
Campbell , A., & Macglashan, J. (2005). Acupuncture-induced galactorrhoea- A case report.
Acupuncture in Medicine, 23(3), 146.
Campbell-Yeo, M. L., Allen, A. C., Joseph, K. S. , Ledwidge, J. M., Caddell, K., Allen, V. M.,
Dooley, K. C. (20 10). Effect of domperidone on the composition of preterm human
breast milk. Pediatrics, 125(1), e 107-e 114. doi: 10.1542/peds.2008-3441
Canadian Broadcasting Corporation News. (2008, January 23). Off-label drugs. Retrieved March
17, 20 I 0, from http://www.cbc.ca/news/background/health/off-label-drugs .html
Canadian Institute For Health Information (2006). The regulation and supply of nurse
practitioners in Canada: 2006 Update (ISBN l-55392-855-5). Retrieved from
www. cihi .ca
Chung, M., Raman, G., Trikalinos, T. , Lau , J. , & lp, S. (2008). Interventions in primary care to
promote breastfeeding: An evidence review for the U.S. Preventative Services Task
Force. Annals of Internal Medicine, 2008(149), 565-582.
Ciliska, D., Thomas, H., & Buffet, C. (2008). An introduction to evidence-informed public health
and a compendium of critical appraisal tools for public health practice. Retrieved March
12, 20 l 0, from National Collaborating Centre for Methods and Tools website:
http://www.nccmt.ca/pubs/ei ph backgrounder.pdf
50
Co, M. M., Hernandez, E. A., & Co, B. G. (21). A comparative study on the efficacy of the
different galactogogues among mothers with lactational insufficiency. Abstract. Paper
presented at the AAP Section on Breastfeeding, 2002 NCE.
College OfRegistered Nurses Of British Columbia (CRNBC) (2010). Scope ofpractice for nurse
practitioners (family): Standards, limits, and conditions (Pub. No. 424). Vancouver, BC :
CRNBC.
Compendium ofpharmaceuticals and specialties (CPS) : the Canadian drug reference for health
professionals (50th ed.). (20 10). Toronto, ON: Canadian Pharmacists Association.
Couto De Oliveira, M . 1., Bastos Camacho, L.A., & Tedstone, A. E. (2001) . Extending
breastfeeding duration through primary care: A systematic review of prenatal and
postnatal interventions. Journal of Human Lactation, 17(4), 326-343.
doi:10.1l77/08903344010 1700407
Curtis, C. (n.d.). Fenugreek FAQ. Retrieved from
http://www. breastfeed ingon Iine .com/fenugreek.shtm I
D' ltri , N. (2006). More milk? Fenugreek as a galactogogue. Virginia Nurses Today, May, June,
July 2006, 9-l 0. Retrieved from http ://www.v irginianurses.com
da Silva, 0. P. (2004). Domperidone for lactating women. Canadian Medical Association
Journal, 171(7), 725-726.
da Silva, 0. P. , Knoppert, D. C., Angelini, M. M., & Forret, P. A. (200 l). Effect of domperidone
on milk production in mothers of premature newborns: a randomized, double-blind,
placebo-controlled trial. Canadian Medical Association Journal, 164( I). Retrieved from
http://www.cmaj.ca/cgi/co ntent/full/164/ l/17
51
Dennis, C. (1999). Theoretical underpinnings ofbreastfeeding confidence: A self-efficacy
framework. Journal of Human Lactation, 15, 195-20 I.
doi: 10.1177/089033449901500303
Dennis, C. L. (2002). Breastfeeding initiation and duration: A 1990-2000 literature review.
Journal of Obstetric, Gynecologic, and Neonatal Nurses, 31(1), 12-32.
DiPierro, F., Callegari , A., Carotenuto, D. , & Mollo Tapia, M. (2008). Clinical efficacy, safety
and tolerability ofBIO-C (micronized silymarin) as a galactagogue. Acta Biomed,
79, 205-210.
Drug & Therapeutics Bulletin (2006). Non-medical prescribing. Drug & Therapeutics Bulletin,
44(5), 33-36.
Dyson, L., McCormick, F. M. , & Renfrew, M. J. (2009). Interventions for promoting the
initiation of breastfeeding (Review). The Cochrane Collaboration, 2009(2), . Retrieved
from http://www.thecochranelibrary.com
Eglash , A., Montgomery, A., & Wood, J. (2008). Breastfeeding. Dis Mon, 54, 343-411.
doi: 10.10 16/j .disamonth .2008.03.00 L
Evans, D. (2003). Hierarchy of evidence: A framework for ranking evidence evaluating
healthcare interventions. Journal of Clinical N ursing, 12, 77-84.
Evers, D. B. (2006). Alterations of digestive function in children. In K.L. McCance & S.E.
Huether (Eds .), Pathophysiology: the biologic basis for disease in adults and children
(5th ed., pp. 1447-1470). St. Louis, Missouri: Elsevier Mosby.
52
Flacking, R., Ewald, U., & Starrin, B. (2007). "I wanted to do a good job": Experiences of
'becoming a mother' and breastfeeding in mothers of very preterm infants after discharge
from a neonatal unit. Social Science & Medicine, 64, 2405-2416.
doi: 10.1 016/j .socscimed.2007 .03 .008
Flidel-Rimon, 0., & Shinwell, E. S. (2006). Breast feeding twins and high multiples. Archives of
Disease in Childhood- Fetal and Neonatal Edition, 91, F377-F380.
doi: I 0. 1136/adc.2005 .082305
Fraser Health Authority (2008). Breastfeeding guidelines 1000 (BFG 1000). : Fraser Health
Breastfeeding Practice Counci I.
Gabay, M.P. (2002). Galactagogues: Medications that induce lactation . Journal of Human
Lactation, 18(3), 274-279. doi : 10.1177/089033440201800311
Giglia, R. C., & Binns, C. W. (2007). Alcohol and breastfeeding: What do Australian mothers
know? Asia Pacific Journal ofClinical Nutrition, 16(suppl1), 473-477.
Gill, S. L., Reifsnider, E., & Lucke, J. F. (2007). Effects of support on the initiation and duration
ofbreastfeeding. Western Journal of Nursing Research, 29(6), 708-723 .
doi:l0.1177/0 193945906297376
Health Canada (2004). Exclusive breastfeeding duration - 2004 Health Canada recommendation
(HC Pub. No. 4824). Retrieved from Health Canada website: http://www.hc-sc.gc.ca/fnan/nutritionlchild-enfant/infant-nourisson/excl bf dur-dur am excl-eng.php
Health Canada. (2005). Pediatric clinical practice guidelines for nurses in primary care.
Retrieved June 17, 2010, from http: //www.hc-sc.gc .ca/fniah spnia/pubs/services/ nursing-infirm/200 I ped gu ide/chap 07-eng.php# 7-5
53
Health Canada. (2007). Breastfeeding. Retrieved February 12, 20 l 0, from http://www.hcsc.gc.ca/fn-an/pubs/infant-noun·isson/nut infant nourrisson term 3-eng.php#tphp
Health Canada. (2008). Blessed thistle. Retrieved June 17, 2010, from http://www.hcsc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/mono blessedthistlechardon ben i-eng.php
Health Canada. (2009a). 10 great reasons to breastfeed your baby. Retrieved February 12, 2010,
from http://www.phac-aspc .gc.ca/dca-dea/prenatal/reasons-raisons-eng.php
Health Canada (2009b). Fenugreek. Retrieved February 19,2010, from http://www.hcsc.gc.ca/dhp-mps/alt formats/hpfb-dgpsa/pdf/prodnatur/monograph fenugreek revisedeng.pdf
HealthLink BC. (2009). Breastfeeding. Retrieved June 6, 2010, from
http://www.healthlinkbc.ca/healthfiles/hfile70 .stm#E3
Henderson, A. (2003). Domperidone: Discovering new choices for lactating mothers.
Association of Women 's Health Obstetrical and Neonatal Nurses: Lifelines, 7( L) , 54-60.
doi: I 0.117711 091592303251726
Horta, B. L., Bahl , R., Martines, J. C. , & Victora, C. G. (2007). Evidence on the long-term effects
of breastfeeding: Systematic reviews and meta-analyses. Geneva, Switzerland: World
Health Organization (WHO). Retrieved February 12, 2010, from
http://whqlibdoc. who.int/publications/2007 /9789241595230 eng. pdf
Hsi, A., & Leeman, L. (N.D.). Management of common breastfeeding problems: Breastfeeding
residency curriculum [PowerPoint slides].
Huggins, K. E. (n.d.). Fenugreek: one remedy for low milk production. Retrieved February 11,
2010, from http: //www.breastfeedin gon Iine.com/fenuhugg. shtm I
54
Hurst, N. M. (2007). Recognizing and treating delayed or failed lactogenesis II. Journal of
Midwifery & Women's Health, 52(6) , 588-594. doi:10.1016/j.jmwh.2007.05.005
The Infant Feeding Action Coalition (INFACT) Canada. (1997). The cost offormula and infant
feeding security. Retrieved June 15, 2010, from http://www.infactcanada.ca/security.htm
The Infant Feeding Action Coalition (INF ACT) Canada. (20 I 0). Upcoming courses presented by
INFACT Canada/JBFAN North America. Retrieved July 3, 20 I 0, from
http://www. infactcanada.ca/Lactation Mgmt Course.htm
International Baby Food Action Network (IBFAN). (n.d.). Defending breastfeeding. Retrieved
July 3, 2010, from http://www.ibfan.org/index-ibfan.html
Jenner, C., & Filshie, J. (2002). Galactorrhoea following acupuncture. Acupuncture in Medicine,
20(2-3), 107-108.
Jensen, D., Wallace, S., & Kelsay, P. (1994). LATCH: A breastfeeding charting system and
documentation tool. Journal of Obstetrical, Gynecological, and Neonatal Nurses, 23(1),
27-32.
Johnston, L. (2005). Critically appraising quantitative evidence. ln S .M. Melnyk & E. FineoutOverholt (Eds.), Evidence-based practice in nursing & healthcare (pp. 79-125).
Philadelphia, PA: Lippincott Williams & Wilkins.
Keith , S. (2007). Gabapentin as an alternate sleep medication . Advanced Registered Nurse
Practitioner Care: Official Newsletter of ARNPs United of Washington State, 18(1 0), .
Retrieved from http://www.nurse.org/wa/arnpcare/071 Ocare.pdf
55
Kramer, M.S. , & Kakuma, R. (2001). The optimal duration of exclusive breastfeeding: A
systematic review. Geneva, Switzerland: Department of Nutrition for Health and
Development. Department of Child and Adolescent Health and Development. World
Health Organization (WHO). Retrieved February 12, 2010, from
http://whglibdoc.who.int/hg/200 1/WHO NHD 01.08.pdf
Lagrave, W. (n.d.). Herbs for breastjeeding. Retrieved February 11 , 2010, from
http://www .child b irthso Iuti ons.com/ arti c les/postpartu m/herbsbrst/i ndex. php
La Leche League International (LLLI). (2007). How can I tell
if my baby is getting enough milk?
Retrieved June 6, 2010, from http://www.llli .org/FAQ/enough.html
Laurence, R . A . (n.d.). Herbs and breastjeeding. Retrieved February 11 , 2010, from
http://www .breastfeeding.com
Leonard, L. G. (2002). Breastfeeding higher order multiples : Enhancing support during the
postpartum hospitalization period. Journal of Human Lactation, 18(4), 386-392.
doi:l 0. J 177/08903340223 7914
Lewallen , L. P. , Dick, M . J. , Flowers, J. , Powell, W. , Zickefoose, K . T. , Wall , Y . G., Price, Z. M .
(2006). Breastfeeding support and early cessation. Journal of Obstetric, Gynecologic, and
Neonatal Nursing, 35(2), 166-172. doi:l0.111l /J.1552-6909.2006.0003l.x.
Li, K. (N.D.). A pilot study to evaluate the effect of acupuncture on increasing milk supply of
Lactating mothers. (Master's Thesis, Victoria University of Technology, Melbourne,
Australia).
Low Dog, T. (200 l ). Lactogogues. Paper presented at the International Lactation Consultants
Association (lLCA) Annual Meeting ..
56
Low Dog, T. (2009). The use of botanicals during pregnancy and lactation. Alternative
Therapies, 15(1), 54-58.
Maclean, C. (2007). Nausea in adults. In J. Gray (Ed.), Therapeutic choices (5 1h ed., pp. 14811489). Ottawa, ON: Canadian Pharmacists Association.
Mallory, J. (2008). Supplement sampler: Natural galactogogues. Retrieved February 11, 2010,
from http://www.fammed.wisc.edu/integrative
Marasco, L. (2007). Commonly used herbal galactagogues. Retrieved June 6, 2010, from
http://www.ilca.org
Martin, R. M., Gunnell, D., & Smith, G. D. (2005). Breastfeeding in infancy and blood pressure
in later life: Systematic review and meta-analysis. American Journal of Epidemiology,
161(1), 15-26. doi:10.1093/aje/kwh338
McCarter-Spaulding, D. E. , & Kearney, M. H. (200 1). Parenting self-efficacy and perception of
insufficient milk supply. Journal of Obstetric, Gynecologic, and Neonatal Nursing,
30(5), 515-522.
Meier, P. P., Furman, L. M ., & Degenhardt, M. (2007) . Increased lactation risk for late preterm
infants and mothers: Evidence and management strategies to protect breastfeeding.
Journal of Midwifery & Women 's Health, 52(6), 579-587.
doi:lO.l 016/j.jmwh.2007.08.003
Mennella, J. (2001). Alcohol's effect on lactation. Alcohol Research & Health, 25(3), 230-234.
Mennella, J. A. , Pepino, M . Y., & Teff, K. L. (2005). Acute alcohol consumption disrupts the
hormonal m iIieu of lactating women. The Journal of Clinical Endocrinology &
Metabolism, 90(4), 1979-1985. doi:IO.l210/jc.2004-1593
57
Millar, W. 1., & Maclean, H. (2005). Breastfeeding practices. Health Reports: Statistics
Canada, Catalogue 82-003, 16(2), 23-31.
Mills, E., Duguoa, J., Perri , D., & Koren, G. (2006). Herbal medicines in pregnancy and
lactation: An evidence-based approach. London, UK: Taylor & Francis.
Mohrbacher, N., & Stock, J. (2003). La Leche League International: the breastfeeding answer
book (3rd ed., Rev.). Schum burg, IL: La Leche League International.
National Guideline Clearinghouse (NGC). (2010, March 8). Withdrawn NGC summaries.
Retrieved March 14, 20 l 0, from
http://www.guideline.gov/browse/gawithdrawn.aspx?st=A
Newman, J. (2003a). Handout 19: Domperidone. from http://www.breastfeedingonline.com
Newman, J. (2003b). Handout # 24: Miscellaneous treatments. from
http://www.breastfeedingonline.com
Petersen-Smith, A. M., & McKenzie, S. B. (2009). Gastrointestinal disorders. In C.E. Burns,
A.M. Dunn, M.A. Brady, N.B. Starr, & C.G. Blosser (Eds .), Pediatric primary care (4th
ed., pp. 795-844) . St. Louis, Missouri: Saunders Elsevier.
Porteous, R. , Kaufman, K. , & Rush, J. (2000). The effect of individualized professional support
on duration ofbreastfeeding: A randomized controlled trial. Journal of Human Lactation,
16(4 ), 303-308.
Public Health Agency Of Canada (PHAC) (2002). Family-centred maternity and newborn care:
National guidelines: Chapter 7: Breastfeeding. Retrieved March 17, 2010, from
http://www. phac-as pc. gc.ca/ dca-dea/pu b Iications/fcmc07 -eng. php#tph p
Public Health Agency of Canada (PHAC). (2009) . 10 Great reasons to breastfeed your baby
[Brochure]. Ottawa, ON: Author.
58
Riordan, J. (2005). Breastfeeding and Human Lactation (3ed ed.). Toronto, ON: Jones and
Bartlett Publishers.
Riordan, J. , Bibb, D. , Miller, M., & Rawlins, T. (200 1). Predicting breastfeeding duration using
the LATCH breastfeeding assessment tool. Journal of Human Lactation, 17(1 ), 21-23.
Ruddock, B. (2005). Domperidone and lactation. Canadian Pharmacists Journal, 138(2), 28-29.
Ryan, K., Bissell, P., & Alexander, J. (2010). Moral work in women's narratives of
breastfeeding. Social Science & Medicine, 70, 951-958.
doi: 10.10 16/j.socscimed.2009.11.023
Saisto, T. , Salmela-Aro, K. , Nurmi, J. E., & Halmesmaki , E. (2008). Longitudinal study on the
predictors of parental stress in mothers and fathers of toddlers. Journal of Psychosomatic
Obstetrics & Gynecology, 29(3), 213-222. doi: 10.1080/01674820802000467
Sakha, K., & Behbahan, A. G. (2008). Training for perfect breastfeeding or metoclopramide:
Which one can promote lactation in nursing mothers? [Abstract]. Breastfeeding
Medicine, 3(2) , 120-123 .
Sauberan, J., & Wight, N. E. (2006). Galactagogue update. Breastfeeding Update, 6(1), 5-6.
Shealy, K. R. , Li, R., Benton-Davis, S., & Grummer-Strawn , L. M. (2005). The CDC guide to
breastfeeding interventions. Retrieved from Centers for Disease Control and Prevention
website: http://www.cdc.gov/breastfeeding
Sikorski, J., Renfrew, M. J. , Pindoria, S., & Wade, A. (2003). Support for breastfeeding mothers:
A systematic review. Pediatric and Perinatal Epidemiology, 17, 407-417 .
Silversides, A. (2006). Former director general: Health Canada needs broader drug safety
powers. Canadian Medical Association Journal, 174( I 0), 1395-1396.
doi : 10.1503/cmaj.060422
59
Skelton, C. (2009, February 20). Store-brand formula vs. Similac, Enfami l, Nestle. The
Vancouver Sun. Retrieved from http://www.vancouversun.com/index.html
Swafford, S., & Berens, P. (2000). Effect offenugreek on breast milk production. Paper
presented at the 5th International meeting of the academy of breastfeeding medicine.
Tucson, AZ.
Thomas-Maclean, R., Tarlier, D., Ackroyd-Stolarz, S., Fortin, M., & Stewart, M. (2008). Tutor
P HC 2003/2004 research trainees "no cookie-cutter response" conceptualizing primary
health care. Retrieved June 16,2010, from http://www.uwo .ca/fammed/csfm/tutorphc/pdf/TUTO R %20 Deft ni tion%20ot%20pri mary%20hea lth %2 Ocare. pdf
Thulier, D. (2009). Breastfeeding in America: A history of influencing factors. Journal of
Human Lactation, 25( 1), 85-94. doi: 10.1177/0890334408324452
Tiran, D. (2003). The use of fenugreek for breast feeding women. Complementary Therapies in
Nursing and Midwifery, 9(3), 155-156.
Ulbricht, C., Basch, E. , Burke, D., Cheung, L. , Ernst, E. , Giese, N., ... Weissner, W. (2007).
Fenugreek (Trigonella foenum-graecum L. Leguminosae): An evidence-based systematic
review by the Natural Standard Research Co llaboration. Journal of Herbal
Pharmacotherapy, 7(3-4), 143-177. doi: 10.1080/ 15228940802142852
Unicef. (2009). Baby-friendly hospital initiative training materials (updated 2009). Retrieved
July 3, 2010, from http://www.unicef.org/nutrition/index 24850.html
U.S. Food And Drug Administration (FDA) (2004). FDA talk paper: FDA warns against women
using unapproved drug, Domperidone, to increase milk production. Washington, D.C:
U.S. Department of Health & Human Services.
60
U.S. Food and Drug Administration (FDA). (2009a). Department of health and human
services black box warning: Metoclopramide. Retrieved July 19,2010, from
http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyinformationforP
atientsandProviders/ UCMlll378.pdf
U.S. Food And Drug Administration (FDA). (2009b). "Off-label " and investigational use of
marketed drugs, biologics, and medical devices. Retrieved March 17, 20 I 0, from
http://www.fda.gov/ScienceResearch/SpeciaiTopics/RunningCiinicaiTrials/Guidanceslnf
ormationSheetsandNotices/ucm ll6355.htm
U.S. Food And Drug Administration (FDA) (201 0). Title 21: Food and drugs: Part 182-
Substances generally recognized as safe (182.1). Washington, D.C: Electronic Code of
Federal Regulations.
Wan, E. W-X, Davey, K., Page-Sharp, M., Hartmann, P. E. , Simmer, K., & flett, K. F. (2008).
Dose-effect study of domperidone as a galactagogue in preterm mothers with insufficient
milk supply, and its transfer into milk. British Journal of Clinical Pharmacology, 66(2),
283-289. doi: I 0.1lll /j .l365-2125 .2008.03207 .x
Wang, Y. , & Li , X. (2004). Treatment of 54 cases of lactation insufficiency with acupuncture
[Abstract]. Journal of Acupuncture and Tuina Science, 2(2).
Wlock, K. (2006). Domperidone? Keeping abreast of the controversies. British Columbia Drug
and Poison Information Centre. Retrieved from http: //www.dpic.org
World Health Organization (WHO). ( 1978). Declaration ofAlma-Ala: International conference
on primary health care. Alma-Ata, USSR: WHO.
61
World Health Organization (WHO). (200 1). Global strategy for infant and young child
feeding, the optimal duration of exclusive breastfeeding. Retrieved from
http://www.who.int/gb/ebwha/pdf files/ WHA54/ea54id4.pdf
World Health Organization (WHO). (2009). Breastfeeding. Retrieved from
http://www.who.int/topics/breastfeeding/en/
Wei, L., Wang, H., Han, Y., et. al. (2007). Clinical observation on the effect of electroacupuncture at Shaoze (SI 1) for insufficient lactation after delivery. Journal of
Traditional Chinese Medicine, II. Abstract retrieved from
http://en.cnki .eom.cn/ Article en/CJFDTOTAL-ZZYZ200711 0 16.htm
62
Appendix A: Algorithm for Assessment of Breast Milk Insufficiency in Newborn Period
Clinical Presentation:
Breast Milk Insufficiency
I
infant Wt gain appropriate?
Number of voids and stools
adequate?
No supplementation with
breast milk substitutes?
I
Yes
Reassure mother and
follow as per usual
I
[
No
Determine Cause
J
I
~Maternal Milk Production
Issue
1
I
r
...
4
I
Maternal Endocrine
Disorder:
Obesity
Thyroid
Diabetes Mellitus
PCOS
PPH
./
'
T re•t ""dodyiog diwroe<
Consider Domperidone
l
Breast Milk Metaboli.sm
Issue
Congenital disorders
Inborn Errors of
Metabolism
Milk Transfer Issue
I
Poor Latch:
Correct poor technique
Treat underlying cause such as
tongue-tie, cleft palate
Dompcridone not appropriate
r
-
Rule out and treat prn
May require breast milk
substitute
ill frequent Feeds or \
Delayed Breastfeeding
initiation:
Ensure frequency of feeds
adequate
Consider Domperidone
supplementation:
Ensure at least 8 feeds per
24 hrs and gradually
remove any supplemental
feeds, replace with BF
Consider Dornperidone
'-...
Anatomical Breast
Abnormalities
Maternal Stressors:
CIS, Prolonged 2"d stage
of labour
Personal stress
Smoking
OCP I" week postpartum
\..
/
Reassurance
Counseling as indicated
Smoking Cessation
Switch to progesteroneonly OCP
\.. Consider Domperidone
-
...
/Consider Dornpcridone \
If not able to provide
adequate amount of breast
milk, consider comfort
feeding and
supplementing with
formula
63
Name
Fenugreek
(Trigo nella
foenumgraecum)
Blessed
Thistle
(Cnicus
benedictus)
Goat's Rue
(Galega
officina/is)
A"ppen d"IX B : H er b a I G a I ac t agogues
Recommended
Evidence to
Support Use
Dosage
Other Uses
-No RCTs
-Labour induction
-Daily dosage
recommendations
-One large
-improvement of
anecdotal report
range from 400digestion, overall
re: use with
2400mg,
divided
health and
into two or three
over 1200
metabolism
doses daily
women
- Treatment of
-2 "preliminary
inflammation,
-No consensus,
reports" given
abdominal pain,
and no
standardization of at conferences
impotence, hernias,
fever, vomiting,
dosage in
that are not
anorexia, weight loss, packaging
obtainable
coughs, bronchitis,
colitis
-None, other than as
-3 capsules 3
-Anecdotal
only, no studies
galactagogue
times daily OR
-20 drops of
tincture 3 times
daily
- platelet aggregation
-taken in tea form: -reports of
increased milk
inhibition,
1tsp dried leaves
in 8 ounces water
supply when
antibacterial
properties, and weight steeped for 10 min used in cows
2-3 times daily
-no human
loss
OR
studies
-1-2m Is of tincture
3 times daily
-None, other than as a
galactagogue
Milk Thistle
(Silybum
marianum)
Fennel Seed
(Foeniculum
vulgare)
Chaste Tree
Seed
(Vitex agnuscastw)
-treatment of: colic
in infants, acute and
chronic glaucoma,
dementia, and
dysmenorrhea
- treatment of
premenstrual
syndrome (PMS) and
premenstrual
-taken in tea form:
I teaspoon
crushed seeds in 8
ounces water
steeped for 10
minutes 1-3 times
daily.
-In tea form: 57gms of seeds
daily
-Small RCT in
Peru
demonstrated
significant
.
.
111crease 1n
breastmilk
production
-No studies on
galactagogue
effects
-as a tea, 1
teaspoon of chaste
berries in one cup
of water 3 times
-No studies that
demonstrate
effectiveness
Side Effects
-Maple syrup
odour to urine,
sweat, and
breastmilk
-Diarrhea
-Asthma
aggravation
-Hypoglycemia
-Uterine
contractions
-Increases effect
of warfarin
-vomiting and
diarrhea
-hypoglycemia
-decreased
calcium,
albumin,
hematocrit,
white blood
cells, and
platelets
-No known side
effects
-No known side
effects
- GI upset,
dizziness,
headache,
fatigue, and dry
dysphoric disorder
(PMDD)
-treatment for
menstrual cycle
irregularities, and
cyclical breast
discomfort
64
mouth
-contraindicated
during
pregnancy
daily OR
- 2.5 milliliters of
tincture three
times daily OR
-20 to 40 mg per
day
Appendix C: Alternative Galactagogues
Name of Treatment
Alcohol
Acupuncture
Drug
Metoclopramide
Common Recommendation
Barley-based alcohol such as
beer will increase milk supply
and aid milk let-down reflex
Acupuncture administered 3
times per week for 2 weeks
performed by qualified
acupuncture therapist using
disposable needles
Appendix D: Pharmaceutical
Recommended
Usual
Galactagogue
Indications
Dosage
-Treatment of
10 mg orally 3
times daily
delayed gastric
emptying
-Treatment of
nausea and
vomiting
postoperatively
Evidence to Support Use
None. Studies show that
alcohol decreases sucklinginduced prolactin production
(not baseline prolactin) and
oxytocin release, thereby
inhibiting both milk
production and milk let-down
A single blind RCT showed
increased infant weight gain
and decreased need for
supplementation with formula
when acupuncture used to
increase maternal milk supply
Galactagogues
Adverse Effects
- restlessness,
anxiety,
drowsiness,
insomnia, fatigue,
lassitude, dizziness,
and GI effects such
as cramping and
diarrhea
-may also increase
maternal depression
and risk for seizures
-Rarely can have
extrapyramidal side
effects, including
dystonic reactions
Evidence to
Support Use
-Conflicting
evidence, with
much of the cited
research being
done before 2000
-2 recent studies
did not show
.
.
mcrease m
breastmilk
production or
infant weight
gain with
metoclopramide
use
-wide disparities
in dosage,
literature notes
range of3090mg per day in
2-4 divided
doses
-Latest evidence
suggests
30mg/day
adequate, with
larger doses
increasing side
effects but not
therapeutic
effect
-Common local
practice is I 020mg 2-4 times
daily
-Test subjects
were injected
subcutaneously
once daily for 7
days
-dry mouth,
abdominal
cramping,
headache, and
diarrhea
-does not cross the
blood/brain barrier
so no CNS effects
-Antipsychotic
-Not available in
Canada
-50 mg orally 23 times daily
-Antipsychotic
-25 mg orally 3
times daily for I
week
- sedation, weight
gain, depression,
restlessness,
impaired
concentration, and
extrapyramidal
effects
-see sulpiride
- treatment of
nausea and
vomiting, gastro
paresis,
dyspepsia, and
esophageal
reflux
Domperidone
-None, other
than as potential
galactagogue
(experimental)
recombinant
human prolactin
(r-hPRL)
Sulpiride
Chlorpromazine
-No significant
adverse effects
observed
65
-2 double-blind
RCTs since 2000
demonstrate
significantly
increased
prolactin levels
and breastmilk
volume
(measured by
pumping) in
women given
domperidone
-Double-blind,
placebocontrolled RCT
done in 2007 on
non-lactating
women
demonstrated
expressible
galactorrhea in
test subjects
given r-hPRL
-No studies since
2000, and studies
done prior to this
found to have
methodologyIssues
-No studies
available for use
as a galactagogue
66
A,ppen d"IX E : Th e LATCH B reas Ueed"mg Assessment T 00
L: Latch
A: Audible
swallowing
T: Type of nipple
C: Comfort
(breast/nipple)
H: Hold (positioning)
0
Too sleepy or reluctant
No latch achieved
1
Repeated attempts
Hold nipple in mouth
Stimulate suck
None
A few with
stimulation
Inverted
Flat
Engorged
Cracked/bleeding/large
blisters or bruises
Severe discomfort
Filling
Reddened/small
blisters or bruises
Mild/moderate
discomfort
Minimal assist
Teach one side,
mother does other
Staff holds and then
mother takes over
Full assist (staff holds
infant at breast)
(Jensen et al. , 1994)
2
Grasps breast
Tongue down
Lips flanged
Rhythmic sucking
Spontaneous and
intermittent at <24
hours
Spontaneous and
frequent at >24 hours
Everted (after
stimulation)
Soft
Non-tender
No assist from staff
Mother able to
position/hold infant