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ORIGINAL ARTICLES
A double-blind, randomized controlled
trial
on
the
use
of
malunggay
(Moringa
oleifera)
for augmentation of the volume ofbreastmilk among
non-nursing mothers
of
preterm
infants
Ma. Corazon
P.
Estrella, M.D.,
Jacinto
Bias
V.
Man
taring
III,
M.D.,
Grace
Z. David, M.D.,
Michelle
A.
Taup, M.D.*
ABSTRACT
OBJECTIVES:
To
determine
if
there is a significant difference in the
volume
of
breastmilk on postpartum days 3
to
5 among mothers with
,preterm infants
who
take
malunggay
(Moringa oleifera) leaves com-
pared to those
who
were given placebo.
SETTING: Tertiary government hospital
STUDY DESIGN: Double-blind, randomized controlled trial
PATIENTS
AND
METHODS: A total
of
68
postpartum mothers admit-
ted at a tertiary government hospital and whose infants had pediatric
ages
of
less than
37
weeks and admitted
to
the NICU
for
tube feedings
were included in the study. The mothers were randomized to receive
Moringa oleifera(encapsulated in a commercial preparation contain-
ing 250 mg
of
leaves)
or
an identical capsule containing
flour
as pla-
cebo. They were asked
to
pump their breasts using a standardized
breastpump
from
day 1
to
day 5 postpartum. The mothers were given
capsules on postpartum days 3
to
5 . The contents
Of
the capsules
were unknown
to
both Investigator and subjects. T-test was used
to
determine differences in baseline variables. Chi-square was used to
determine difference in baseline
proportions
between groups. One-
way ANOVA was used
to
determine
if
there were significant differences
in the volume
of
breastmilk between treatment and control groups. A
p-value
of
<0.05 was considered significant.
RESULTS:
There was a trend towards increased milk production among
those on Moringa oleifera leaves (Day 3:
114.1
ml ± 62.9 vs. 87.2 ±
49.1;
Day
4:
190 ml ± 103.5 vs. 128.8 ± 84.9; Day 5: 319.7 ml ± 154.10
vs. 120.2 ± 54.7). This was statistically significant on Day 4 (p = 0.007)
and on Day 5 (p = 0.000).
CONCLUSION: Moringa oleifera leaves increase
milk
production on
postpartum days 4
to
5 among mothers
who
delivered preterm in-
fants.
KEYWORDS: breastmilk,
malunggay
Feeding breastmilk to premature in-
fants
is
of
interest because
of
its potential
nutritional and immunologic benefits. The
prevailing consensus is that early milk pro-
* From the Department
of
Pediatrics,
UP-
PGH Medical Center
Vol.
49
No.
1 January-March 2000
duced by women who deliver prematurely
is
more appropriate for VLBW infants than
is donor milk from later stages
of
lactation,
and that is to feed each infant milk pro-
duced by his/her mother minimizes poten-
tial risks from contaminants. To implement
this consensus, mothers
ofVLBW
infants
must produce sufficient milk to meet the
nutritional needs imposed by the acceler-
ated growth rates
of
their infants. More
often than not, however, the biggest ob-
stacle to the initiation
of
feeding breast
milk is collection. Most mothers after initi-
ating expression
of
breastmilk on the first
few days after birth complain
of
insuffi-
cient volume ofbreastmilk. This complaint
has prompted most mothers
to
use milk
formula, shift to bottle feeding, and dis-
continue breastfecding.
Little quantitative data are available
with which to evaluate protocols for the
initiation and maintenance
of
successful
lactation during the long periods
of
infant-
mother separation that commonly follow
premature delivery. De Carvalho, et al
(
19'85)1 reported that the frequency
of
milk
expression was associated positively with
milk production in mothers
of
premature
infants, but the mean volumes
of
milk pro-
duced by women in that study did not meet
the nutrient needs
of
VLBW infants and
declined production are common problems
associated with premature delivery.
A pilot study was done by the au-
thors among 10 mothers who delivered
neonates whose pediatric ages were less
than 37 weeks in a tertiary government
hospital. The total amount
of
volume
of
breastmilk expressed for 24 hours was plot-
ted from Day 1 to Day 7. Results showed
that there was a steady increase in milk
volume from days 1 to 3 after which a con-
stant
or
lower volume was recovered from
days 3 to 5. The authors determined that 3
to 5 days postpartum is critical for the suc-
cess
of
implementing a breastfeeding pro-
gram among mothers who deliver preterm
3
golacta.com. Used with permission.
infants.2
OBJECTIVES
This investigation
is
being undertaken
with the following objectives: to determine
the volume
of
breast milk that is expressed
on postpartum days 3 to 5
among
mothers
who delivered prematurely who were given
mulunggay leaves compared to those who
were given placebo
and
to determine
if
there is a significant difference
in
the vol-
ume
of
breast milk on postpartum days 3
to 5 between the two groups.
PATIENTS & METHODS
This
is
a
double-blind
randomized
controlled trial.
All mothers who delivered live infants
Jess than 37
weeks
and admitted to the
NICU
for tube feedings were eligible for
inclusion into the study. Excluded were
mothers with hypertension post-delivery,
diabetes
mellitus,
chorioamnionitis,
chronic illness
or
taking any medication
on
a regular basis, breast anomalies, and
those with infants with congenital anoma-
lies. After informed consent, mothers were
randomized using a table
of
random
num-
bers. Randomization
was
done
by a per-
son
not
involved
in the study.
Assign-
ments were concealed using sealed opaque
envelopes.
Those
assigned
to the treat-
ment group were given Moringa oleifera
leaves in a commercial capsule preparation
250
mg
every
12
hours starting
on
the
3rd
postpartum day.
Those
who were assigned
to the placebo group were given flour con-
tained in identical capsules. Capsules were
prepared by a research assistant
who
was
not directly involved in the study. Treat-
ment assignments
were
unknown
to both
the investigators and study subjects.
After proper orientation, demonstra-
tion and training, mothers were then in-
structed
to
pump
their
breasts
every
4
hours using a standardized breast pump.
Volume was measured using standardized
containers and recorded in standard note-
books provided by the study personnel.
When
available, the
volume
of
milk col-
lected
was
also
measured
by
the
study
personnel. Total
milk
volumes were tabu-
4
lated from post-partum days 3 to 5.
All data were entered using Microsoft
Excel 97. Statistical analysis
was
clone
using
SPSS
version
9.0
software.
T-test was used to determine differ-
ences
in numeric baseline variables. Chi-
square was used to determine difference
in baseline proportions between groups.
One-way
ANOVA was used to deter-
mine
if
there were significant differences
in the
collected
volume
of
breastmilk
among
mothers
on
the study medication
compared
to placebo. A p-value
of
<0.05
was
considered significant.
RESULTS
A total
of
82 mothers were recruited.
There
were
14 subjects who did
not
sub
mit
their notebooks
and
who
were consid
ered drop-outs, 9 from the treatment
grOUJ
and 5 from the control group.
There
wen
11
mothers
whose
data
were
not
complet1
because their infants expired before the
6tl
postpartum
day. Thus, a total
of
68 moth
ers
were
analyzed.
Thirty-one
(31)
moth
ers
were
in
the
Treatment
Group
and
3
~
mothers were in the Control Group.
There
is
no significant difference
ir
the gravidity,
maternal
age, and infants
pediatric ages and infants' birthweights.
The
mean
volume
of
milk collectec
among
the treatment groups from postpar·
tum
days
3 to 5 are presented in Table
~
and Figures
1.
On
day
3, the
Treatment
Group
had
2
Table
1
BASELINE CHARACTERISTICS
OF
TREATMENT
AND
CONTROL GROUP
Baseline Characteristic Treatment Group Control Group
Maternal
Age
(years) 25.8 ±
5.1
30.9 ± 15.7
Pediatric
Age
(weeks) 33.7 ±
1.9
33.1±
2.3
Infant's Weight:(grams) 1,532.7 ± 361.5 1,424.6 ± 359.2
Median gravidity 2 3
Table2
p-
value
0.09
0.30
0.22
0.32
VOLUME OF BREASTMILK (in
m1)
ON PASTPARTUM
DAYS
3 TO 5
OF TREATMENT
AND
CONTROL GROUPS
Day Post-partum Treatment Group Control Group
Day3
Day4
Day 5
114.1+1-62.9 87.2+1-49.1
190.0+-103.5
123.8
+-
84.9
319.7+-154.1
120.2+1-54.7
Figure
1
VOLUME OF BREAST MILK COLLECTED FROM
POST-PARTUM
DAYS
3 TO 5
400
300
~
g200
l3
~
~
{00
I
::r:I
~I
INTERVENTION
I
..
Plaoollo
I
o.J-.
--,..,---:---:-:----::---::,.-::-
..
___.
o
r-
OAY
p-
value
0.052
0.007
0.000
The Philippine Journal
of
Pediatrics
golacta.com. Used with permission.
mean breastmilkvolumeof 114.1 ± 62.9
m1
compared to the Control Group with a
mean
of
87.2 ± 49.1 mi. This showed a
mean difference
of20-30
ml
or
a 28-32%
increase in breast milk volume in favor
of
treatment.
On day 4, the Treatment Group had a
higher mean breast milk volume
of
190 ±
103.5 ml compared to the Control Group
with only 123.8 ± 84.9 ml. This showed a
mean difference
of
54-77 ml or a
51.:.58
%
increase in favor
of
treatment.
On day 5, the difference was even big-
ger with the Treatment Group haviiig a
breast
milk
volume of319.7 ±
154.1
m1
com-
pared to the Control Group who had 120.2
± 54
.7
mi. This had a mean difference
of
154-245
ml or a
152-176%
increase in
breast milk volume
in
favor
of
treatment.
There were no reported adverse ef-
fects in both groups. ·
DISCUSSION
Lactogenes.
is
is initiated in the post-
partum period by a fall in plasma proges-
terone in the presence
of
maintained prol-
actin
concentrations. Initiation
of
the proc-
ess does not depend on suckling
of
the
infant although the rate
of
milk secretion
after the third or fourth day postpartum
declines
if
milk removal is not practiced at
regular intervals.3 A foreign study4 on milk
volume produced by women aged 20 to 38
years who delivered at 28 to 30 weeks ges-
tation showed that optimal milk produc-
tion
was associated with five or more milk
expressions
per
day
and
pumping
durations that exceeded 100 minutes per
day.
After deli very, the basal levels
of
pro-
lactin
fall
and,
even
in
women
who
breastfeed, they
approach
the
normal
range by 2 to 3 weeks postpartum.5 When
suckling occurs prolactin is promptly re-
leased, the levels rising 5 to 10 fold for
about 30 minutes. Tactile sensitivity
of
the
nipple, markedly reduced during preg-
nancy, increases within a few hours
of
de-
livery and
is
clearly geared to efficient suck-
ling.
~
Vol.
49
No.
1 January-March 2000
In the early puerperium, the amount
of
milk
produced
correlates
with
the
amount
of
prolactin released during suck-
ling, significantly larger amounts
of
prol-
actin being released by
"good"
feeders
(over 700 ml
of
milk a day) than by "poor"
feeders, both the yield
of
milk and the
amount
of
prolactin released increases.6
Many physiologic factors influence
milk composition and volume. These in-
clude
premature
delivery,
age
of
the
mother, within-feed regulation
of
milk re-
lease, and the baby's demand for milk.'
There
is
little infonnation on milk volume
produced by mothers giving birth prema-
turely.1 Anecdotally, premature deliveries
have been associated with a decrease in
volume
of
breastmilk compared to term
deliveries because
of
the relative absence
of
sucking stimulation among mothers
of
preterm infants who cannot nurse because
of
the long infant-mother separation and
because their infants may be too small to
suckle directly.
Honnonal stimulation
of
the mammary
gland, such as occurs during nursing,
is
an
important regulator
of
amount
of
milk
produced. In the
non-nursing
mother,
breast stimulation by pump can also in-
duce prolactin release comparable with that
induced by suckling.6
As
long as sucking
stimulation continues,
in
this study, the
pumping action
of
a breast pump/reliever,
there
is
pr.oduction
of
large volumes
of
milk. Conversely,
if
there is a decrease in
blood flow, as occurs in response
to
stress,
milk secretion declines because the mam-
mary supply
of
oxygen, glucose, fatty adds,
and amino adds
is
reduced.R Maternal
stress was not evaluated during the study,
although each family was experiencing
strain due to their infants' hospitalization.
Lactagogues
or
galactogues are spe-
cial foods, drinks, or herbs which people
believe can increase a mother's milk sup-
ply.
In most parts
of
the Philippines, women
take malunggay (Moring a oleifera) leaves
mixed
in
chicken
or
shellfish soups to en-
hance breast milk production. The mecha-
nism
of
action has not been explained but
it was effective as a galactogogue and has
been used by generations
of
nursing
llJOth-
ers especially those with inadequate lac-
tation. 9
A
local
study
done
in
1996
by
Almirante and Lim demonstrated the lac-
tation-enhancing
effect
of
malunggay
leaves as evidenced by a greater increase
in
maternal serum prolactin levels and per-
centages
of
gains in the infants' weights
among the lactating mothers who took the
malunggay leaves.
10
This ca.n probably
explain its mechanism
of
actiQQ.
A follow-
up study done by the same authors among
hypertensive mothers showed similar re-
sults, with significant increases
of
tin val-
ues in the
treatment
group
(Moring a
oleifera group) compared to the placebo.
11
The authors in the same study recorded
the breastmilk volume
of
a subgroup
of
mothers (eight out
of
31
mothers) whom
they did direct measurements
of
expressed
milk on the first, second, and fourth month
postpartum. They recommenced adding
more subjects to this subgroup
of
moth-
ers to increase the level
of
significance.
11
So far, no study has demonstrated the
clinical effect
of
malunggay leaves on a
more clinically relevant outcome, that
of
breast milk volume, particularly on moth-
ers
of
pretem1 infants.
Our current study demonstrated the
lactation-enhancing effect
of
malunggay
(Natalac capsules) leaves
as
evidenced by
the significantly greater increase in the
volume
of
milk expressed by mothers on
the 3rd to the 5th postpartum day given
Moringa oleifera capsules compared to
those given placebo. The increase in vol-
ume
of
breastmilk on the third day post-
partum only had a tendency
to
be signifi-
cant at p < 0.052. This may be due to the
fact that we only started giving the treat-
ment drug (Moringa oleifera capsules) on
this day. We recommend either giving the
treatment drug earlier, probably on post-
partum day 2 or increasing the sample size
to
increase the level
of
significance for sta-
tistical analysis on day 3 postpartum.
CONCLUSION ·
We, conclude that Moringa oleifera
leaves increase the volume
of
breastmilk
produced by mothers
of
preterm infants
on post-partum days 3 to 5.
We
therefore
5
golacta.com. Used with permission.
recommend its routine use among moth-
ers of preterm infants
to
augment lacta-
tion, thereby ensuring
an
adequate sup-
ply
of
breastmilk in the population that
needs it the most.
REFERENCES
1.
De Carvalho M & Anderson
DM.
Fre-
quency of Milk Expression and Milk
Production
by
Mothers of Non-Nurs-
ing Premature Neonates. AJDC.
1985:139:483-85.
2.
Estrella MCP & Man taring
JB
III.
Vol-
ume ofBreastmilk Expressed
by
Non-
Nursing Mothers of Preterm infants
on
the First Post-partum
Week:
A Pi-
lot Study. March 1999. (Unpublished)
3.
Woolridge
MW
& Greasely
V.
The
Initiation of Lactation: The Effect
of
Early versus Delayed Contact for
7.
Suckling
on
Milk Intake in the First
Week
Postpartum. Early Human De-
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1985:
12:269-278.
Metabolism,44,
1101.
Anderson GH. Human Milk Feeding.
Pediatric Clinics of North America.
1985:
32
(2):
335-53.
4.
Hopkinson JM & Schanier
RJ.
Milk
Production
by
Mothers
of
Premature
Infants. Pediatrics. 1988:81:815-20.
5.
Neville
MC.
Regulation of Mammary
Development
and
lactation. Lactation,
Physiology,
Nutrition,
and
Breastfeeding. New York: Plenum
Press,
1983:
103-40.
6.
Aono
T,
Sihoji
T,
Shoda
T,
& Kurach
K.
The Initiation of Human Lactation
and Prolactin Response
to
Suckling.
Journal of Clinical Endocrinology
and
8.
Tucker HA. Endocrinology
of
Lacta-
tion. Seminars in Perinatology. 1979:
33:
199-223.
9.
Department
of
Health, Philippines.
Helping Mothers
to
Breastfeed. Pub-
lished
by
UNICEF,
1991.
10.
Alrnirante
CY
& Lim
CHTN.
Effective-
ness of natalac
as
a Galactogogue.
Journal
of
Philippine Medical Asso-
ciation.
1996:
71:
265-272.
11.
Almirante
CY
&
Lim
CHTN.
Enhance-
ment ofBreastfeeding Among Hyper-
tensive Mothers. Increasingly Safe
and Successful Pregnancies. 1996:
279-286.
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