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The Use of Galactogogues in the Breastfeeding Mother

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To review data regarding the efficacy of galactogogues available in the US to increase breast milk production in postpartum mothers. Literature was sought using PubMed (1966-June 2012) and EMBASE (1973-June 2012). Search terms included breastfeeding, breast milk, lactation, galactogogue, metoclopramide, oxytocin, fenugreek, milk thistle, silymarin, growth hormone, thyroid releasing hormone, medroxyprogesterone, domperidone, goat's rue, beer, Asparagus racemosus, shatavari, Medicago sativa, alfalfa, Onicus benedictus, blessed thistle, Galega officinalis, brewer's yeast, and herbals. All studies including humans and published in English with data assessing the efficacy of galactogogues for increasing breast milk production were evaluated. Breast milk is considered the optimal food source for newborns through 1 year of age. Many factors influence overall maternal production, including maternal pain, illness, balance of time when returning to work, anxiety, or emotional stress. Although a variety of herbal and pharmaceutical options have anecdotal evidence of their ability to improve breast milk production, peer-reviewed studies proving their efficacy are lacking. Metoclopramide, oxytocin, fenugreek, and milk thistle have shown mixed results in improving milk production; however, the trials were small and had a variety of limitations. Nonpharmacologic recommendations should be exhausted before adding therapy. Although anecdotal evidence encourages the use of metoclopramide, fenugreek, asparagus, and milk thistle for their galactogogue properties, efficacy and safety data in the literature are lacking. Oxytocin and domperidone are potentially available for compounding purposes, but safety data are limited. More studies are needed to evaluate the effects of available galactogogues on breast milk production.
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1392 nThe Annals of Pharmacotherapy n2012 October, Volume 46 theannals.com
Breastfeeding is considered the opti-
mal source of nutrition for infants
from birth to 1 year and is supported by
the American Academy of Pediatrics
(AAP) and the World Health Organiza-
tion.1,2 The 2012 AAP Policy on Breast-
feeding recommends exclusive breast-
feeding for 6 months, with continuation
up to 1 year or longer.Breastfeeding has
been associated with both short- and
long-term benefits over formula feeding.
In 2007, the Agency for Healthcare Re-
search and Quality prepared a report
summarizing the literature concerning
the relationship between breastfeeding
and its impact on infant and maternal
outcomes.3Atotal of 9000 abstracts
were reviewed; 43 studies focused on in-
fant health outcomes, 43 studies on ma-
ternal health outcomes, and 29 systemat-
ic reviews or meta-analyses of more than
400 trials. Results of these studies indi-
cated that exclusive breastfeeding for a
minimum of 3 months decreased the risk
of the infant developing acute otitis me-
dia and/or atopic dermatitis and, if the
child were exclusively breastfed for
greater than 4 months, the result was a
decrease in hospitalizations secondary to
lower respiratory tract infection. Addi-
tionally, if breastfeeding continued for greater than 6
months, there was a potential decrease in the occurrence of
acute lymphocytic leukemia and acute myeloid leukemia.
Studies have also shown a potential decrease in death from
sudden infant death syndrome and the development of
asthma, diabetes mellitus, and obesity. The Agency for
Healthcare Research and Quality report also notes the po-
tential benefits to the mother, including reduced risk of
breast and ovarian cancers as well as decreased risk of dia-
betes mellitus type 2 as long as the mother did not have
gestational diabetes.
Despite the AAP recommendations and perceived bene-
fits, breastfeeding rates in the US continue to be low.4At
The Use of Galactogogues in the Breastfeeding Mother
Alicia B Forinash, Abigail M Yancey, Kylie N Barnes, and Thomas D Myles
Obstetrics/Gynecology
Author information provided at end of text.
OBJECTIVE:To review data regarding the efficacy of galactogogues available in
the US to increase breast milk production in postpartum mothers.
DATA SOURCES:Literature was sought using PubMed (1966-June 2012) and
EMBASE (1973-June 2012). Search terms included breastfeeding, breast milk,
lactation, galactogogue, metoclopramide, oxytocin, fenugreek, milk thistle, silymarin,
growth hormone, thyroid releasing hormone, medroxyprogesterone, domperidone,
goat’s rue, beer,
Asparagus racemosus
,shatavari,
Medicago sativa
,alfalfa,
Onicus
benedictus
,blessed thistle,
Galega officinalis
,brewer’s yeast, and herbals.
STUDY SELECTION AND DATA EXTRACTION:All studies including humans and pub-
lished in English with data assessing the efficacy of galactogogues for increasing
breast milk production were evaluated.
DATA SYNTHESIS:Breast milk is considered the optimal food source for newborns
through 1 year of age. Many factors influence overall maternal production, including
maternal pain, illness, balance of time when returning to work, anxiety, or emo-
tional stress. Although a variety of herbal and pharmaceutical options have
anecdotal evidence of their ability to improve breast milk production, peer-
reviewed studies proving their efficacy are lacking. Metoclopramide, oxytocin,
fenugreek, and milk thistle have shown mixed results in improving milk produc-
tion; however,the trials were small and had a variety of limitations.
CONCLUSIONS:Nonpharmacologic recommendations should be exhausted
before adding therapy.Although anecdotal evidence encourages the use of
metoclopramide, fenugreek, asparagus, and milk thistle for their galactogogue
properties, efficacy and safety data in the literature are lacking. Oxytocin and
domperidone are potentially available for compounding purposes, but safety data
are limited. More studies are needed to evaluate the effects of available
galactogogues on breast milk production.
KEY WORDS:breastfeeding, breast milk, fenugreek, galactogogue, herbals,
lactation, metoclopramide, milk thistle, oxytocin, silymarin.
Ann Pharmacother
2012;46:1392-404.
Published Online, 25 Sept 2012,
theannals.com
,doi: 10.1345/aph.1R167
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birth, initiation of breastfeeding occurs for 75% of moth-
ers; however, the rate of breastfeeding decreases to 44.6%
at 6 months and 23.8% at 12 months. Exclusive breast-
feeding rates are even lower at 35% and 14.8% at 3
months and 6 months, respectively. Many factors can con-
tribute to difficulty feeding and may lead to early cessation
of breastfeeding; these include structural abnormalities
such as inverted nipples and oral clefts, infection, pain,
poor latching, and insufficient milk production.5Factors
that have been associated with a reduction in breast milk
production include preterm delivery, maternal illness, anxi-
ety, fatigue, and emotional stress. Because of the many
documented benefits of continued breastfeeding for the in-
fant and mother, different measures are taken to increase
breast milk production. A variety of herbal and pharma-
ceutical products have been recommended as galacto-
gogues, substances that promote lactation. The purpose of
this article is to review data regarding the efficacy of galac-
togogues available in the US for increasing breast milk
production in postpartum mothers.
Physiology of Breastfeeding
Many factors play a role in the development of breast
milk. During early pregnancy, estrogen and progesterone
develop key components of the breast tissue for lactation;
estrogen stimulates milk duct development and proges-
terone forms lobules that are responsible for milk produc-
tion. Prolactin is the predominant hormone that stimulates
mammary glands; however, high progesterone and estro-
gen progesterone levels during pregnancy suppress pro-
lactin’saction on milk production during pregnancy.Addi-
tionally,prolactin and human chorionic somatomam-
motropin stimulate the production of enzymes required for
milk production. After delivery,estrogen and progesterone
levels significantly decrease, allowing prolactin to fully
stimulate the alveoli for milk production. Cortisol, insulin,
vasoactive intestinal peptide, growth hormone, and thy-
roid-releasing hormone stimulate prolactin and influence
the composition of milk, whereas dopamine inhibits pro-
lactin, suppressing its action.6,7 Milk secretion is primarily
controlled by oxytocin, which stimulates the myoepithelial
cells to contract and release stored milk into the ducts (ie,
letdown). Milk must be ejected from the lumen of the alve-
oli into the milk ducts to reach the infant. Infant suckling
stimulates production of prolactin as well as oxytocin.
Milk secretion continues until suckling ends. Interestingly,
even if the alveoli still contain milk, once suckling stops,
no more milk can be released. It is important to allow plen-
ty of time for feeding or breast pumping to empty the
breasts. When all of the milk is released, the breast stimu-
lates additional milk production for the next feeding. This
feedback mechanism leads to an overall increase in supply
over time.6,7
Literature Selection
Asearch of PubMed (1966-June 2012) and EMBASE
(1973-June 2012) was performed with the terms breastfeed-
ing, breast milk, lactation, galactogogue, metoclopramide,
oxytocin, fenugreek, milk thistle, silymarin, growth hormone,
thyroid-releasing hormone, medroxyprogesterone, domperi-
done, goat’s rue, beer, Asparagus racemosus,shatavari, Med-
icago sativa,alfalfa, Onicus benedictus,blessed thistle, Gale-
ga officinalis,brewer’s yeast, and herbals. Limits of English
language and human subjects were applied to the searches.
References of all articles were reviewed to identify additional
relevant articles. All relevant articles were included despite
limitations due to the limited supply of published data evalu-
ating these therapies. These products are commonly recom-
mended in practice by both maternal and pediatric health care
providers. Case reports, case series, and abstracts were ex-
cluded unless they were the only published literature on the
topic. Medications that are not available in the US were ex-
cluded from this review.
Herbal Products
Natural herbal medications, such as fenugreek (Trigo-
nella foenum-graecum), milk thistle (silymarin; Silybum
marianum), A. racemosus (shatavari), alfalfa (M. sativa),
blessed thistle (O. benedictus), goat’s rue (G. officinalis),
fennel (F.vulgare), and brewersyeast, are often recom-
mended to breastfeeding mothers to increase milk produc-
tion. However, data on herbal products are limited and of-
ten based on anecdotal evidence. Fenugreek, milk thistle,
and asparagus are frequently recommended and are the
only herbal galactogogues that have some, although mini-
mal, published clinical data on use in humans.8,9
FENUGREEK
Fenugreek is a member of the pea family and is often
used as artificial maple flavoring.10 The galactogogue prop-
erty of fenugreek was first reported in the 1940s. Although
its exact mechanism of action is unknown, there are 2 pro-
posed mechanisms. The first is that it increases sweat pro-
duction, leading to an increase in milk supply given that
the breast is considered to be a modified sweat gland (Fig-
ure 1).10,11The second thought is that milk flow is increased
by fenugreek phytoestrogens and diosgenin, a steroid sa-
pogenin, components.12 The recommended dose of fenu-
greek is 2-3capsules (580-610 mg per capsule) 3- 4 times
per day, and it may be discontinued once milk supply has
increased to the desired level.10,11Many women have re-
ported results within 24-72 hours.8,10,11
Fenugreek is often prescribed to nursing mothers, based
on anecdotal reports. One physician observed the success-
ful use of fenugreek in more than 1200 patients. Unfortu-
The Annals of Pharmacotherapy n2012 October, Volume 46 n1393
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nately, detailed information was not available in regard to
gestational age, time of initiation, or specific results.10 Two
studies showed that fenugreek appears to stimulate breast
milk production (Table 1).12-14 Limitations of these reports
include lack of reporting maternal and infant adverse ef-
fects, adherence, and doses of fenugreek used. Confound-
ing factors that affect breastfeeding success, including
caloric and fluid intake of mother, other medications used,
frequency and duration of breastfeeding, and stress/pain
level of the mother, were not controlled in these studies.
One study evaluating 10 exclusively pumping women was
presented only in abstract form; full evaluation of the data
is therefore not possible.13 The second study, a randomized
trial, also included a small sample size and focused mainly
on birth weight, loss of birth weight, and time to regain
birth weight.12 Milk volume produced was measured only
on the third day after delivery and the study concluded
when the infant reached birth weight, so the full efficacy of
fenugreek was unable to be determined. The biggest limi-
tation of this study is that the galactogogue tea included
other herbal components thought to have galactogogue
properties, including fennel and goat’s rue; thus, it is diffi-
cult to conclude that benefit is solely from fenugreek.12,15
Although it appears that fenugreek may have some bene-
fit, randomized clinical trials are needed to determine its spe-
cific role as a galactogogue. Safety data are minimal since ad-
verse events and tolerability were not reported. Currently, the
Food and Drug Administration (FDA) lists fenugreek as gen-
erally regarded as safe (GRAS); however, these data are not
specifically aimed at the nursing mother and infant.10,16 Addi-
tionally, no information has been published to describe the
safety or relative infant dose of fenugreek consumption
through breast milk. There are reports of mild gastrointestinal
symptoms in the mother, mainly diarrhea, and there is poten-
tial for hypoglycemic effects.10,11 The fenugreek seed can lead
to a maple-like odor that can be mistaken in infants for
maple-syrup urine disease, which is a metabolism disorder in
which the body is unable to break down certain parts of pro-
teins.9,17 Women who are pregnant should not use fenugreek,
as it has been shown to stimulate uterine contractions.8,16
MILK THISTLE
Another popular herbal galactogogue is milk thistle (sily-
marin, St. Mary’s milk), which has been used for more than
2000 years for a variety of ailments.18 It is theorized that milk
thistle galactogogue effects are secondary to an increase in
prolactin levels, as seen in female rats (Figure 1).19 Clinical
data are limited to 1 placebo-controlled trial14 conducted in
Peru (Table 1).12-14 Limitations of this study include a small
sample size, indirect measurement of milk production by
weighing the infant before and after feeding, as well as not
1394 nThe Annals of Pharmacotherapy n2012 October, Volume 46 theannals.com
AB Forinash et al.
Figure 1. Physiology of lactation and potential medication mechanisms of action. PIH = prolactin inhibiting hormone; PRH = prolactin releasing hormone.
aExact mechanism of action unknown but known to increase prolactin.
including detailed information on both the mother and in-
fants, infant weight gain, adverse event data, and adherence.
Randomized controlled trials evaluating the benefit of milk
thistle are needed to show its benefit, safety, and potential role
as a galactogogue. As with many herbal agents, safety data
are minimal and, unlike fenugreek, milk thistle is not listed as
GRAS by the FDA. No data are available describing the rela-
tive infant dose of milk thistle after breast milk consump-
tion.18
SHATAVARI
Shatavari is a popular galactogogue used in India. The
exact mechanism of action is unknown but could possibly
be secondary to the presence of steroidal saponins, which
potentially increase prolactin levels.20 Two studies have
been conducted to determine whether prolactin increased
with shatavari; unfortunately, the results were conflict-
ing.20,21 Both studies looked at milk production as a sec-
ondary outcome; however, this was determined indirectly
by weighing the infant before and after treatment. Once
again, study results were conflicting. Other limitations of
the trials included small sample size, omission of detailed
information on adherence, reasons for drop-outs, and in-
formation about adverse events for both mother and infant.
As with milk thistle, shatavari is not listed as GRAS by the
FDA.22 There is also recent evidence showing teratogenicity
in animal studies, thus shatavari should be avoided in preg-
nant females.23 No data are available describing relative in-
fant dose of shatavari after breast milk consumption.22,23
Randomized controlled trials are needed to determine the
benefit, safety, and potential role as a galactogogue.
Potentially Available from Compounding
Pharmacies
OXYTOCIN
Before oxytocin nasal spray was voluntarily removed
from the US market in 1995 and worldwide in 1999, it was
commonly used to promote milk letdown in women with
decreased milk production. Supplemental oxytocin in-
creased breast milk production because it causes contraction
of the myoepithelial cells that surround areola tissue in the
breast (Figure 1).24 Three randomized, double-blind studies
have been conducted evaluating the impact of oxytocin nasal
spray immediately prior to each breastfeeding session to in-
crease breast milk production (Table 2).25-31 Oxytocin nasal
spray 3 IU per spray prior to each feeding from birth to 5
days postpartum showed significant differences in overall
breast milk production. Production increased 3- to 5-fold
with oxytocin nasal spray compared with placebo in primi-
parous mothers and 2-fold in multiparous mothers.
Oxytocin appears to be generally well tolerated, but minor
epistaxis was reported by 1 woman in 1 study.25 No infant ad-
verse events were reported; however,safety cannot be as-
sumed since only a small number of exposures occurred.
Limitations of these studies include small sample size, short
duration, minimal to no information on infant weight gain re-
ported, evaluated only the effects in preterm delivery, and
overall medication adherence was not verified.24-27 The first
trial also used an indirect method for measuring production
by breast engorgement instead of actual milk production.25
Overall, oxytocin improved milk production when used in
late preterm deliveries compared with historical controls but
The Use of Galactogogues in the Breastfeeding Mother
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Table 1. Comparison of Herbal Galactogogue Clinical Trialsa
Infant
Age Milk Effect on Infant
Reference Regimen Patients (FT/PT) Attainment Milk Production Weight
Turkyilmaz Fenugreek tea, Fenugreek tea (n = 22) 1 day Nursing, except day 3 Day 3 postdelivery: fenugreek Lactation
201112 3cups daily Control (n = 22) (FT) postdelivery by 73.2 ± 53.5 mL; control consultant for all
Placebo (n = 22) mechanical breast pump 38.8 ± 16.3 mL; placebo groups
31.1 ± 12.9 mL (p = 0.004)
7.3 ± 2.7 mL; placebo
9.9 ± 3.5 mL
Swafford Fenugreek 10 Breast pump Daily average increase from
200013 3capsules 207 to 464 mL (p = 0.004)
daily16
Di Pierro Micronized Milk thistle (n = 25) Nursing, then pumping to Milk thistle 601.92 mL (day 0),
200814 milk thistle Control (n = 25) void the gland 989.76 mL (day 30), and
420 mg/day 1119.24 mL (day 60); an
for 63 days 85.95% increase
Placebo 530.36 mL (day 0),
649.76 mL (day 30),
700.56 mL (day 60); a
32.09% increase
FT = full-term delivery; PT = preterm delivery.
aNo data have been reported on maternal or infant adverse events.
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AB Forinash et al.
Table 2. Comparison of Clinical Trials with Prescription Products
Infant
Age Milk Infant Maternal Infant
Reference Regimen Patients (FT/PT) Attainment Effect on Milk Production Weight ADRs ADRs Notes
Oxytocin Nasal Spray (within 5 minutes prior to each pump)
Huntingford Oxytocin Oxytocin Day 1 Milk production day 7: oxytocin, mean Day 4: Minor epistaxis Oxytocin 4-5 IU (no spray amount provided)
196125 before (n = 24) (unknown 3.4 oz; placebo, mean 2.3 oz Oxytocin, (n = 1) Randomized, double-blind
feeding Placebo whether (p < 0.001) –147 g Average length of use: oxytocin 70 hours
for up to (n = 24) FT/PT) Placebo, (before 14 feedings); placebo 78 hours
10 days –207 g (before 16 feedings)
(p = 0.01) No significant difference in primary outcome
of level of breast engorgement (clinical
observation)
Ruis Oxytocin Oxytocin Day 1 Pump Primiparous: 3- to 5-fold increase Oxytocin 3 IU 1 spray, pump 10 minutes,
198126 before (n = 8) (PT) Multiparous: 2-fold increase instill 2 sprays, pump 10 minutes, repeat
pumping for Placebo Oxytocin: 1964 ±308 mL for other breast
5 days (n = 4) Placebo: 510 ±142 mL Randomized, double-blind
(p = 0.0002) Gestation age <38 weeks
Fewtrell Oxytocin prior Oxytocin (PT) Pump every Day 5: None None Oxytocin 100 µL (~4 IU/dose)
200627 to pumping (n = 27) 3 hours Oxytocin median 667 g Randomized, double-blind, intention-to-
for 5 days Placebo Placebo median 530 g treat, maintained 80% power
(n = 24) (p = 0.9) Mean gestational age 29 weeks
Received education on lactation
Domperidone
Campbell- Domperidone Domperidone 3-4 weeks Pump Baseline to 14-day milk volume: Domperidone: none None Gestational age <31 weeks
Yeo 201028 10 mg 3 (n = 22) (PT) Domperidone 184.4-380.2 mL Milk volume increased within 48 hours
times/day Placebo (266.8%)
or placebo (n = 24) Placebo 217.7-250.8 mL (18.5%)
for 2 weeks p < 0.005
Wan Domperidone: Domperidone 16-117 Pump Baseline: mean 8.7 g/h–1 Abdominal cramps Conducted in Australia
200829 10 mg 3 (n = 6) days 30 mg: mean 23.6 g/h–1 (p = 0.0217) (30 mg: 1; 60 mg: 2) Randomized, double-blind
times/day or (mean 53) 60 mg: mean 29.4 g/h–1 (p = 0.0047) Constipation (60 mg: 1) Gestational age, mean 26.5 weeks
20 mg 3 (PT) Dry mouth (30 mg: 3; (24-29.4)
times/day 60 mg: 5) 2 nonresponders
for 2 weeks Depressed mood
Crossover (60 mg: 1)
Headache (30 mg: 1;
60 mg: 3)
da Silva Domperidone Domperidone Mean 31- Pump Domperidone: 112.8 mL to 162.2 mL None None Conducted in Canada
200130 10 mg 3 (n = 11) 33 days (44.5%; p < 0.05) Randomized, double-blind
times/day Placebo (PT) Placebo: 48.2 mL to 56.1 mL (16.6%) Gestational age mean, 29.1 weeks
for 1 week (n = 9)
no improvement in early preterm deliveries compared with
placebo.
Currently, oxytocin is available in intramuscular and intra-
venous injection forms in the US; however, it lacks the indi-
cation for lactation purposes. Oxytocin powder is still avail-
able for compounding pharmacies and could potentially be
used as a galactogogue. Available data do not describe the
relative infant dose and theoretical infant dose in breast
milk.32
DOMPERIDONE
In addition to oxytocin, domperidone is a potential galac-
togogue available in powder formulation for potential com-
pounding. Domperidone is a dopamine antagonist and can
increase prolactin levels (Figure 1). Domperidone 10 mg
orally every 8 hours for 2 weeks has been shown to increase
milk supply in 48 hours, and it has a low relative infant dose
of 0.04% and a subtherapeutic theoretical infant dose of 0.18
µg/kg/day.28-31,33 Domperidone significantly increased milk
production in women with preterm deliveries (Table 2).25-31 It
appears to be generally well tolerated, but abdominal cramps,
headaches, constipation, and depression have been reported,
although rates were higher when the dose was increased to
20 mg every 8 hours. No infant adverse events were reported;
however, safety cannot be assumed since only a small num-
ber of exposures occurred. Limitations of these domperidone
studies include small sample size; location, having been con-
ducted in other countries; and potential confounders that may
have affected milk supply, such as fluid and calorie intake,
frequency of pumping, medical history, and concomitant
medications, were not provided.
Despite effectiveness, this formerly commercially avail-
able product was removed from the market in 2004. The
FDA released a statement expressing concerns for dom-
peridone safety in lactating women due to potential for car-
diac arrhythmias and sudden cardiac death in 2004 and
again in 2009.34,35 This risk was discovered in oncology pa-
tients with hypokalemia receiving intravenous domperi-
done; however, the FDA issued warnings specific to lactat-
ing mothers to avoid the use of domperidone.
Prescription Products
METOCLOPRAMIDE
Metoclopramide is a commonly prescribed galactogogue
that acts through dopamine antagonism to increase pro-
lactin levels and stimulate increased milk production (Fig-
ure 1).36-41 In one study, milk supply increased 52% after 2
days of treatment.38 Metoclopramide has been studied as 10
mg given orally 3 times a day for 5 days to 4 weeks, but
most commonly 7-14 days, initiated with onset of lactation
or later for partial or complete lactation failure in both
preterm and full-term infants (Table 3).36-48 Metoclopramide
The Use of Galactogogues in the Breastfeeding Mother
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Petraglia Domperidone Group A: Group A: Nursing Domperidone: day 2, 347 ±36 mL None None Group A: history of lactation problems
198531 10 mg 3 Domperidone 2 days Placebo: day 2, 335 ±30 mL Group B: Primiparous with insufficient
times/day (n = 8) lactation after 2 weeks
for 3-10 Placebo Feedings 6-7 times/day
days (n = 7) Infants weighed pre- and postfeedings
Group B: Group B: Domperidone: day 10, 673 ±44 mL to determine milk amount
Domperidone 2 weeks Placebo: day 10, 398 ±45 mL (p < 0.01) Milk supply significantly higher with
(n = 9) Group A: domperidone vs placebo at days 4, 6, 8,
Placebo Domperidone: day 2, 105 ±35 mL and 10
(n = 8) Domperidone: day 5, 475 ±51 mL
(p < 0.05)
Group B:
Domperidone: day 2, 371-417 mL; day
5, 631-708 mL
ADRs = adverse drug reactions; FT = full-term delivery; PT = preterm delivery.
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AB Forinash et al.
Table 3. Comparison of Metoclopramide Clinical Trials
Infant
Metoclopramide Age Milk Effect on Maternal Infant
Reference Regimen Patients (FT/PT) Attainment Milk Production Infant Weight ADRs ADRs Notes
Guzman 10 mg 2 times/ Metoclopramide 2 days (FT) Data not collected; considered All had history of decreased
197936 day for 4 weeks (n = 11) good for all groups; lactation
Placebo (n = 10) supplemental formula not Metoclopramide group started
who could start needed medications before starting
metoclopramide lactation
during week 2
Control (n = 30)
Ertl 199137 10 mg 3 times/day Metoclopramide 1 day (FT) Not noted; milk No baseline values Pumping or weighing of babies
for 5 days (n = 11) samples by Day 5: metoclopramide,
Placebo (n = 11) expression 276.4 ±36.6 mL; placebo,
150.0 ±25.3 mL (p < 0.01)
Ehrenkranz 10 mg 3 times/day Metoclopramide 32 ±3.7 Electrical or Metoclopramide 93.3 ±18 mL Diarrhea (1), None All babies premature; mean
198638 for 7 days, then (n = 17) days (PT) hand breast (day 1) to 197.4 ±23 mL nervousness (1), gestational age 30.4 ±0.7 weeks
tapered over 2 pump (day 7) (p < 0.001) tiredness (1)
days
Kauppila 5, 10, or 15 mg 5 mg (n = 10) 8-62 days Nursing 5 mg: 12.1 mL (92.4 vs 104.5) 5 mg: 380 ±153 g Tiredness (1), Crossover vs placebo for each
198139 3 times/day for 10 mg (n = 13) (FT) Placebo: 4.4 mL (96.8 vs 92.4) Placebo: 331 ±144 g headache (1), strength of metoclopramide
2 weeks 15 mg (n = 14) 10 mg: 42.5 mL (96.3 vs 138.8) 10 mg: 439 ±143 g anxiety (1), Lactational response measured
(p < 0.001) Placebo: 385 ±132 g hair loss (2), by weighing infant
Placebo: 10.5 mL (96.3 vs 15 mg: 480 ±138 g intestinal –8 dropouts
106.8) Placebo: 449 ±162 g disorders (2)
15 mg: 50 mL (80.3 vs 130.3)
(p < 0.05)
Placebo: –0.3 mL (80.3 vs 80)
Kauppila 10 mg 3 times/day (n = 17) 18-141 Nursing Baseline vs end of treatment Baseline, mean 4653 g Tired (5), nausea Gas (1)
198140 for 3 weeks, offdays First treatment: 194 mL Gain, mean 5%/week (2), headache
1 week, repeat (mean (433 ±55 mL vs 626 ±76 mL; (1), vertigo (1),
for 2 weeks 40.8) p < 0.001) gas (1)
(unknown Second treatment: 214 mL
whether (390 ±73 mL vs 606 ±56 mL;
FT/PT) p < 0.01)
Kauppila 10 mg 3 times/day (n = 11) 4-20 weeks Nursing 285 ±75 mL to 530 ± Tired (4), tired plus None Randomized controlled
198541 for 3 weeks Placebo (n = 14) (unknown 162 mL/day (p < 0.01) headache (1), Conducted in Finland
whether Placebo: no change tired plus nausea
FT/PT) (1)
Lewis 10 mg 3 times/day (n = 10) 7-10 days Not noted Similar rates of breastfeeding None None Published as letter to the editor
198042 for 7 days Placebo (n = 10) (14 FT, 3 at 10 days, 6 weeks, and 3 Randomized controlled
PT per months postpartum All delivered via caesarean
group) section
De Gezelle 10 mg 3 times/day (n = 7) vs control 1 day Nursing every 50.7 ±14.6 g (day 3) to 84.3 None None Production estimated by weighing
198343 for 8 days (n = 6) (FT) 3 hours ±28.8 g (day 8) vs control: baby before and after second
41.7 ±24 g (day 3) to 41.7 ±daily feeding
25.6 g (day 8)
Day 3, NS
Day 8, p < 0.05
The Use of Galactogogues in the Breastfeeding Mother
The Annals of Pharmacotherapy n2012 October, Volume 46 n1399
theannals.com
Gupta 10 mg 3 times/day (n = 32) Unknown Nursing Complete lactation failure: 4 no None None Conducted in India
198544 for 10 days Complete lactation (FT/PT) response; 8 had response All infants managed in specialized
failure (12) (supplemental feedings de- care center for prematurity (6),
Partial lactation creased from 505.83 ±60.20 birth weight <2500 g (9), low
failure (20) mL to 223.75 ±64.75 mL at birth weight for gestational age
8 weeks) (3), neonatal infection (5),
Partial lactation failure: 13 hyperbilirubinemia (3), maternal
required supplementary feedings, pre-eclampsia (7) 4 nonrespond-
but decreased from 270.5 ±ers in complete lactation failure
36.87 mL to 153.07 ±38.85 group had complete failure of
mL at 8-week follow-up; 7 lactation for 30 days prior to
eliminated supplementary study entry
feedings within 5-11 days of
initiating metoclopramide
Hansen 10 mg 3 times/day (n = 28) vs placebo 3 days Electric breast Metoclopramide not associ- Facial rash and 1 death Randomized controlled
200545 for 10 days (n = 29) (PT) pump ated with significant increase itching (1) at day All received education from
in milk volume compared with 10, lactation nurse
placebo on each of 17 study not Women recorded length of time
days related pumping each time (results not
to provided)
study Preterm infants with gestational
drug age 23-34 weeks at delivery
Milk volume exact data not
presented (only represented in
graph)
Seema 10 mg 3 times/day (n = 25) vs control <4 months Nursing Not noted No significant difference Conducted in India
199746 for 10 days (n = 25) (unknown Relactation successful in 49 for 12-14 weeks of All received vitamin supplemen-
whether (98%) mothers follow-up tation and lactation education
FT/PT) 76% of mothers did not start
breastfeeding “soon after delivery”
86% baseline had complete
lactation failure; 14% were
partial failure
Infant weight exact data not
presented (only represented in
graph)
Birth weight estimated to nearest
5 g
Sakha 10 mg 3 times/day (n = 10) vs control Unknown Nursing Data not provided No difference between Randomized controlled
200847 for 15 days (n = 10) (FT) groups over 15 days Conducted in Iran
Metoclopramide 351.1 g All received training for breast-
vs control 328.5 g feeding
Fife 201148 10 mg 3 times/day (n = 13) vs placebo Within 6 Pumping every All increased significantly from Moderate to very None Randomized controlled
for 8 days (n = 13) hours (PT) 3 hours baseline severe reports 3 metoclopramide and 4 placebo
No differences between groups Fatigue (10), dropouts
nervous (3), Did not maintain power (10 pts.
constipation (2), per group)
depression (2), Preterm infants delivered 34
headache (1), weeks gestation
diarrhea (1) All pts. received lactation
No difference education
compared with Milk volume exact data not present-
placebo ed (only represented in graph)
ADRs = adverse drug reactions; FT = full-term delivery; PT = preterm delivery.
has been studied in 13 trials with mixed results; however,
the most recent, a randomized controlled trial with strong
trial design, failed to maintain power, which may have con-
tributed to the lack of significant differences found between
groups.48 Metoclopramide crosses into breast milk, but this
would result in subtherapeutic infant exposure because of a
low relative infant dose of 4.4%; the theoretical infant dose
is 18.75 µg/kg/day.49 One study estimated that the maxi-
mum exposure of the infant to metoclopramide would be
45 µg/kg/day, whereas typical pediatric dosing is 100-500
mg/kg/day for reflux.42,49 The only adverse event reported in
infants has been intestinal gas. Limitations of these studies
include small sample sizes, short duration, and indirect
measurement of milk production by weighing the infant be-
fore and after feeding, as well as not reporting maternal and
infant adverse events, infant weight gain, and adherence.
Additionally, no data were provided about several factors
known to influence milk supply, including length or fre-
quency of breastfeeding, caloric and fluid intake, and
stress/pain evaluation of the mother,nor was information
regarding adherence reported. Several studies were con-
ducted in different countries, making it difficult to evaluate
the influence of culture, diet, and other differences that
might exist. Overall, metoclopramide has been evaluated as
agalactogogue in 213 mothers, with mixed results. When
comparing various patient characteristics (preterm vs full-
term), time of initiation (within 14 days postpartum vs lat-
er), or trial characteristics (milk production measured by
weighing the infant vs pumping; randomized controlled tri-
als vs other designs), no subgroup strongly demonstrated
efficacy or overall efficacy.
Metoclopramide should not be used for all patients. The
labeling has a boxed warning for risk of tardive dyskinesia
when the drug is used for more than 3 months.50 Women
with a history of tardive dyskinesia or seizures or who are
at risk for developing tardive dyskinesia should avoid us-
ing this product. Metoclopramide may also increase the
risk for serotonin syndrome when used with other medica-
tions that act on serotonin. A few examples include selec-
tive serotonin receptor inhibitors, serotonin-norepinephrine
receptor inhibitors, monoamine oxidase agonist inhibitors,
and tramadol. Metoclopramide is renally eliminated and
requires dose reductions to 50% the normal dose when cre-
atinine clearance is less than 40 mL/min. Patients with
pheochromocytoma should also avoid metoclopramide be-
cause of the potential for hypertensive crisis. Despite the
AAP listing of metoclopramide as a drug with effects that
are unknown but that may be of concern, it received a lac-
tation category of L2 (safer: been studied in a limited num-
ber of breastfeeding women without an increase in adverse
events in the infant, and/or evidence of demonstrated risk
in infant is remote) in Medications in Mother’s Milk and is
considered medication with small risk in Drug Use in
Pregnancy and Lactation.49-51
Other Medications
Several other medications have been suggested as galacto-
gogues and/or have properties that may improve lactation.
First-generation antipsychotics and risperidone produce in-
creased prolactin levels and may increase milk supply. How-
ever, without a diagnostic indication for their use, we do not
recommend initiating therapy for breast milk production
alone because of potential maternal and infant adverse
events.32
Beer has been recommended for nursing mothers since
the 1800s. Beer is thought to increase milk production by in-
creasing prolactin levels.52,53 However, studies have shown
that breastfeeding infants consume 20% less milk 3- 4 hours
after the ingestion of beer by the mother, which was unrelated
to the number or duration of feedings but was likely sec-
ondary to decreased quantity produced.54,55 Additionally,
some of the alcohol consumed by the mother is transferred to
her milk and consumed by the infant. Alcohol consumption
has detrimental effects on the infant, including disruption in
sleep patterns and effects on gross motor development.55
Therefore, beer is no longer recommended as a galacto-
gogue.2
Although not touted as a galactogogue, depot-medrox-
yprogesterone (DMPA) has been shown to have favorable
effects on milk supply in women using the drug for contra-
ceptive purposes.56-58 It is speculated that galactogogue
properties may be secondary to an increase in prolactin
levels.58 Todate, no studies looking at DMPAgalacto-
gogue effects as a primary outcome have been completed.
Human growth hormone (GH) in doses ranging from 0.1
to 0.2 IU/kg/day (maximum of 16 IU/day) for 7 days has also
been used as a galactogogue because of its proposed ability to
increase prolactin levels.59,60 GH lacks FDA indication for use
as a galactagogue and has several limitations for use. First, it
is injected subcutaneously, which would require mothers to
prepare and inject it multiple times per day.Second, GH is
expensive. Also, the FDA is conducting an investigation on
the safety of GH use during childhood, with specific con-
cerns for increased mortality due to bone tumors and cardio-
vascular events in children exposed to GH.61 Considering
these factors, GH is not recommended for use as a galacto-
gogue.
Thyroid-releasing hormone (TRH) has also been used
as a galactogogue. TRH is secreted in breast milk and, to
date, 3 of 4 studies have reported no benefit to using TRH
as a galactogogue. TRH dosing in these studies ranged
from 1 mg as a nasal spray 4 times daily for 10 days, 5 mg
twice daily for 5 days, 20 mg twice daily for 2 weeks, to 20
mg twice daily for 3 weeks. Each study reported an in-
crease in triiodothyronine and thyroxine; however,the
studies have not reported incidences of hyperthyroidism in
the mothers or infants.62-65 Unfortunately, the study periods
have not been long enough for the effects of elevations in
1400 nThe Annals of Pharmacotherapy n2012 October, Volume 46 theannals.com
AB Forinash et al.
triiodothyronine and thyroxine to be fully evaluated, and
there is a potential for mothers and infants to develop hy-
perthyroidism. Because of this risk and lack of evidence
overall of increased breast milk production, TRH is not
recommended for use as a galactogogue at this time.
Discussion
Breast milk is considered to be the optimal food source for
newborns through 1 year of age. Although it is a natural food
source, women often encounter difficulties when attempting
to breastfeed and turn to supplemental sources of nutrition,
such as formula, for their infant prior to the infant’s first birth-
day. Although there are a variety of herbal and pharmaceuti-
cal options that have anecdotal evidence supporting their
ability to improve breast milk production, peer-reviewed
studies proving their efficacy and safety are lacking.
When approaching lactation difficulties, health care
providers should provide recommendations in a stepwise
fashion. Nonpharmacologic measures should first be used to
increase breast milk production. All mothers should receive
extensive education about proper breastfeeding techniques,
including latching, positioning, and length of feeding, since
these factors can significantly affect breastfeeding. Stress
contributes to decreased milk production by decreasing oxy-
tocin release.6,7,14 Because of this, relaxation techniques, deep
breathing, gentle massages, eating or drinking enjoyable
foods and beverages, and listening to music while breastfeed-
ing have been shown to initiate the milk ejection reflex as has
looking at things that remind her of the baby, such as a pic-
ture or blanket, while pumping.66 Other methods that encour-
age complete emptying of the breasts include massaging and
warming the breasts while pumping.67-69 Techniques to in-
crease milk supply include increasing feeding/pumping time,
decreasing intervals between feedings, increasing duration of
pumping, and increasing caloric and fluid intake. Some stud-
ies have shown that pumping both breasts simultaneously
may increase breast milk production as well as save the
mother time.66,70
If nonpharmacologic interventions fail to improve sup-
ply,the health care provider could consider recommending
metoclopramide or fenugreek; however, both medications
lack strong evidence to support efficacy. Metoclopramide and
fenugreek have some clinical evidence of their usefulness in
increasing breast milk production in lactating women and
they appear to be safe for the breastfeeding infant. Although
fenugreek is rated as GRAS, it is important for the health care
provider to remember that it has minimal safety data when
used as a galactogogue. As for safety, metoclopramide is con-
sidered by AAP to be a medication with unknown effects,
but its use may be of concern; however,other breastfeeding
sources have granted it category L2 status, medication with
small risk.49,51
Studies focused on breastfeeding are limited and often
lack the rigor and design that are expected in medical re-
search. Limitations of lactation studies often include small
sample sizes, short duration, and indirect measurement of
milk production by weighing the infant before and after
feeding. Additionally, trials commonly lack control for fac-
tors known to influence milk supply, including length or
frequency of breastfeeding, caloric and fluid intake, warm-
ing and massaging of breasts, and evaluation of maternal
levels of stress/pain. Currently, there are no available data
evaluating repeat courses or effects on lactation after medi-
cation discontinuation for any medication.
Summary
Although anecdotal evidence encourages the use of meto-
clopramide, fenugreek, asparagus, and milk thistle for their
galactogogue properties, efficacy and safety data in the litera-
ture are lacking. When examining the limited reported data
on potentially subtherapeutic exposure to the infant, it is like-
ly that metoclopramide and fenugreek can be used; however,
exposed infants should be monitored for any adverse events.
Oxytocin and domperidone are potentially available for com-
pounding purposes, but safety data are limited. Unfortunately,
at this time there is not enough efficacy and/or safety evi-
dence to support using other proposed galactogogues such as
milk thistle, goat’srue, beer,brewersyeast, alfalfa, aspara-
gus, domperidone, oxytocin, GH, TRH, or DMPA. Addition-
ally,potential risk for maternal and/or infant harm has not
been fully elucidated. More studies are needed to evaluate the
effects of available galactogogues on breast milk production.
Alicia B Forinash PharmD BCPS BCACP, Associate Professor of
Pharmacy Practice, Department of Pharmacy Practice, St. Louis
College of Pharmacy, St. Louis, MO
Abigail M Yancey PharmD BCPS, Associate Professor of Phar-
macy Practice, St. Louis College of Pharmacy
Kylie N Barnes PharmD BCPS, PGY-2 Ambulatory Care Phar-
macy Resident, St. Louis College of Pharmacy
Thomas D Myles MD, Professor, Obstetrics/Gynecology, Depart-
ment of Obstetrics, Gynecology,and Women’sHealth, School of
Medicine, St. Louis University
Correspondence: Dr. Forinash, aforinash@stlcop.edu
Reprints/Online Access: www.theannals.com/cgi/reprint/aph.1R167
Conflict of interest: Authors reported none
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67. Feher SD, Berger LR, Johnson JD, Wilde JB. Increasing breast milk pro-
duction for premature infants with a relaxation/imagery audiotape. Pedi-
atrics 1989;83:57-60.
68. Jones E, Dimmock PW, Spencer SA. A randomized controlled trial to
compare methods of milk expression after preterm delivery. Arch Dis
Child Fetal Neonatal Ed 2001;85:F91-5. doi: 10.1136/fn.85.2.F91
69. Morton J, Hall JY, Wong RJ, Thairu L, Benitz WE, Rhine WD. Combin-
ing hand techniques with electric pumping increases milk production in
mothers of preterm infants. J Perinatol 2009;29:757-64.
doi: 10.1038/jp.2009.87
70. Kent JC, Geddes DT,Hempworth AR, Hartmann PE. Effect of warm
breastshields on breast milk pumping. J Hum Lact 2011;27:331-8.
doi: 10.1177/0890334411418628.
EXTRACTO
Uso de Estimulantes de Producción de Leche Materna en Madres
que Amamantan
AB Forinash, AM Yancey, KN Barnes, y TD Myles
Ann Pharmacother 2012;46:1392- 404.
OBJETIVO: Revisar los datos existentes sobre la eficacia de productos
disponibles en los Estados Unidos y utilizados para estimular la
producción de leche materna.
FUENTE DE DATOS: Se realizó una búsqueda en PubMed (1966–junio
2012) y EMBASE (1973–junio 2012) utilizando los términos
amamantar, leche materna, lactancia, metoclopramida, oxitocina,
hormona de crecimiento, hormona estimulante de la tiroides,
medroxiprogesterona, domperidona, hierbas, galactogogue, fenugreek,
milk thistle, silymarin, goat’s rue, beer, asparagus racemosus, shatavari,
medicago sativa, alfalfa, onicus benedictus, blessed thistle, galega
officinalis, y brewer’s yeast.
SELECCIÓN DE ESTUDIOS Y EXTRACCIÓN DE DATOS: Se evaluaron todos los
estudios que incluyeran humanos, publicados en el idioma inglés y que
evaluaran la eficacia de productos utilizados para estimular la
producción de leche materna.
SÍNTESIS DE DATOS: Apesar que existe evidencia anecdótica que indica
que varias opciones farmacéuticas y productos herbarios causan un
aumento en la producción de leche materna, no existe suficiente
evidencia en la literatura que apoye su eficacia. Estudios con
metoclopramida, oxitocina, fenugreek, y milk thistle han tenido
resultados inconsistentes relacionados con la producción de leche
materna. Las muestras estudiadas son pequeñas y sus diseños tienen
varias limitaciones.
CONCLUSIONES: La leche materna es considerada la mejor fuente de
alimento para niños desde su infancia hasta el primer año de edad.
Varios factores influyen la producción de leche materna, incluyendo
presencia de dolor, enfermedades, tiempo disponible, ansiedad, y estrés
emocional. Se deben agotar las recomendaciones no farmacológicas
antes de añadir algún otro tratamiento. A pesar que existe evidencia
anecdótica que fomenta el uso de metoclopramida, fenugreek,
asparagus, y milk thistle para aumentar la producción de leche materna,
es necesaria evidencia científica que apoye su eficacia y seguridad. La
oxitocina y domperidona pudieran estar disponibles para la preparación
de mezclas extemporáneas potencialmente útiles, pero los datos sobre la
seguridad de su uso son limitados. Son necesarios estudios que evalúen
el efecto de los productos disponibles en la producción de leche materna.
Traducido por Astrid J García-Ortiz
RÉSUMÉ
L’Usage des Galactogogues chez la Mère qui Allaite
AB Forinash, AM Yancey, KN Barnes, et TD Myles
Ann Pharmacother 2012;46:1392- 404.
OBJECTIF: Revoir les données concernant l’efficacité des galactogogues
disponibles aux États-Unis et utilisés pour favoriser une production
accrue de lait maternel après l’accouchement.
SOURCES DE DONNÉES: Une revue de la documentation scientifique a été
effectuée par le biais de PubMed (1966 à Juin 2012) et EMBASE (1973
àJuin 2012). Les termes de recherche de langue anglaise incluaient:
breastfeeding, breast milk, lactation, galactogogue, metoclopramide,
oxytocin, fenugreek, milk thistle, silymarin, growth hormone, thyroid
releasing hormone, medroxyprogesterone, domperidone, goat’s rue,
beer, asparagus racemosus, shatavari, medicago sativa, alfalfa, onicus
benedictus, blessed thistle, galega officinalis, brewer’s yeast, et herbals.
SÉLECTION DES ÉTUDES ET EXTRACTION DES DONNÉES: Toutes les études de
langue anglaise incluant des sujets humains et des données évaluant
l’efficacité des galactogogues pour augmenter la production de lait
maternel ont été évaluées.
SYNTHÈSE DES DONNÉES: De l’information anecdotique est disponible
pour une variété d’options pharmaceutiques et botaniques concernant
leur utilité pour améliorer la production de lait maternel. Cependant la
documentation scientifique démontrant leur efficacité est insuffisante.
Les options tels que le métoclopramide, l’oxytocine, le fenugreek, et le
milk thistle ont démontré des résultats conflictuels en ce qui a trait à leur
capacité d’augmenter la production de lait maternel. Cependant, les
essais cliniques sont de faible envergure et présentent plusieurs limites.
CONCLUSIONS: Le lait maternel est considéré comme l’option nutritive
optimale pour les nouveaux nés jusqu’à l’âge de 1 an. Plusieurs facteurs
influencent la production de lait maternel incluant les douleurs
postpartum et subséquentes, la maladie, le temps disponible lors d’un
retour au travail, l’anxiété, et le stress émotionnel. Les options non
pharmacologiques doivent être épuisées avant d’ajouter une thérapie
médicamenteuse. Bien que des données anecdotiques encouragent
The Use of Galactogogues in the Breastfeeding Mother
The Annals of Pharmacotherapy n2012 October, Volume 46 n1403
theannals.com
l’utilisation de métoclopramide, de fenugreek, d’asparagus racemosus, et
de milk thistle pour leurs propriétés galactogogues, les données
concernant leur efficacité et leur innocuité sont insuffisantes dans la
documentation scientifique. L’oxytocine et le dompéridone sont des
traitements potentiellement disponibles pour des fins de préparations
magistrales mais les données d’innocuité sont limitées. Des études
additionnelles sont nécessaires afin d’évaluer les effets des
galactogogues présentement disponibles sur la production de lait
maternel.
Traduit par Chantal Guévremont
1404 nThe Annals of Pharmacotherapy n2012 October, Volume 46 theannals.com
AB Forinash et al.
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Breastfeeding rates in many developed countries remain low, and maternal perception of insufficient milk production is a major contributing factor. Mothers with a perception of insufficient milk should be advised that normal breastfeeding frequencies, suckling times, and amounts are very variable. If objective assessment confirms insufficient milk production, mothers should ensure optimal milk removal frequency and thorough breast drainage. In addition, galactogogues can be prescribed. Understanding physiological principles underlying milk production will help clinicians reassure and assist mothers.
Article
The objective of this study was to investigate the efficacy of metoclopramide on augmentation of milk production in mothers of premature newborns. This was a randomized, double-blind, placebo-controlled trial. Women who delivered at ≤34 weeks of gestation, with no prior breastfeeding experience, singleton pregnancy, and no contraindications to using metoclopramide were eligible for entry. Twenty-five women were randomly assigned to receive 10 mg of metoclopramide or placebo three times daily for 8 days starting within 36 h of birth. Certified lactation nurses provided breastfeeding education. Breast milk expressed at each pumping session over the 8 days of treatment was recorded. Data from 18 patients were available for analysis. Milk production in both groups increased rapidly during the first 4 days and then more gradually to an average for the last 4 days of 633 ± 168 (9) ml/day [mean ± SEM (n)] for the placebo group and 459 ± 91 (10) ml/day for the metoclopramide group. Analysis with a repeated-measures ANOVA indicated a significant increase in milk production during the 8-day measurement period [within subjects p < 0.001]; however, there was no significant difference in milk production between the two groups [between subjects p = 0.427]. Side effects were similar between groups. In mothers with preterm babies, metoclopramide treatment does not augment (sample size had 80% power for detection of 50% difference) the breast milk production. Maternal interest, education, and support are recognized as mainstay in accomplishing successful lactation.