Original Article

Journal of Evidence-Based
Complementary & Alternative Medicine
The Effect of Hollyhock (Althaea officinalis L) 2017, Vol. 22(1) 25-30
ª The Author(s) 2015

Leaf Compresses Combined With Reprints and permission:

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DOI: 10.1177/2156587215617106
Warm and Cold Compress on Breast journals.sagepub.com/home/cam

Engorgement in Lactating Women:

A Randomized Clinical Trial

Shahla Khosravan, BSN, MSN, PhD1,

Hossein Mohammadzadeh-Moghadam, MD2,
Fatemeh Mohammadzadeh, MSc3,
Samane Ajam Khames Fadafen, BSN4, and Malihe Gholami, PhD5

Abstract
Breast engorgement affects lactation. The present study was conducted to determine the effect of hollyhock combined with warm
and cold compresses on improving breast engorgement in lactating women. Participants included 40 women with breast
engorgement divided into intervention and control groups, with participants in both groups being applied routine interventions
and warm compress before nursing and a cold compress after nursing; however, the intervention group was also applied
hollyhock compress. Both groups received these treatments 6 times during 2 days. The data collected were analyzed in SPSS-16
using a generalized estimating equation. According to the results, a significant difference was observed in the overall breast
engorgement severity in the intervention group (P < .001). The severity of breast engorgement was also found to have a
significant relationship with time (P < .001). According to the findings, hollyhock leaf compress combined with performing
routine interventions for breast engorgement can improve breast engorgement.

Keywords
warm and cold compresses, herbal compress, breast engorgement, hollyhock (Althaea officinalis L)

Received June 18, 2015. Received revised October 13, 2015. Accepted for publication October 15, 2015.

Proper nutrition is essential to children’s overall health and
growth. Particular components of breast milk fully satisfy the
nutritional requirements of lactating infants and ensure their
full development.1 Easy lactation is one of the main factors
contributing to the stimulation of milk secretion that is induced
by the infant’s sucking.2 Breast engorgement is a common
problem occurring in 40% of mothers following childbirth3 and
affects the onset and duration of lactation.4 The excessive dis-
tension of the alveoli leads to the increasing enlargement of the
milk-secreting cells to the extent of creating a rupture. This dis-
tension also reduces blood flow around the alveolar cells and
reduces the activity of the milk-producing cells and exposes the
breast to the risk of mastitis.5 Breast pain and swelling may dis-
courage mothers from breastfeeding their children.6 Breast
engorgement also leads to the swelling of the nipple, which
may impede the infant’s sucking and a successful feeding,
which then creates a vicious cycle that further worsens engor-
gement. Studies conducted on breast engorgement and its
reduction have assessed the effectiveness of treatments such
as warm and cold compresses,7 cold cabbage leaf,8 acupres-
sure, oxytocin spray, lymphatic breast drainage therapy,5
Gua-Sha,4 and acupuncture.9 Analysis of studies reveal contra-
dictory results, and there is a lack of sufficient evidence
1
Social Determinants of Health Research Centre, Gonabad University of
Medical Sciences, Gonabad, Iran
2
Department of Iranian Traditional Medicine, School of Traditional Medicine,
Mashhad University of Medical Sciences, Mashhad, Iran
3
Department of Basic Sciences, Faculty of Paramedicine, Gonabad University
of Medical Sciences, Gonabad, Iran
4
Student Research Committee, Gonabad University of Medical Sciences,
Gonabad, Iran
5
Kashmar Nursing Faculty, Kashmar University of Medical Sciences, Kashmar,
Iran
Corresponding Author:
Samane Ajam Khames Fadafen, BSN, Student Research Committee, Gonabad
University of Medical Sciences, Gonabad, Iran.
Email: samane.ajam@gmail.com
26
supporting the implementation of the examined treatments.10
For instance, alternate warm and cold compresses are reported
to be more effective than acupressure in the treatment of breast
engorgement5; however, since heat increases blood flow, its
application to an engorged breast is often counterproductive.
Yet taking a warm shower may sometimes induce lactation
in the mother, or the mother may be able to manually express
breastmilk and soften the areola for the infant’s easier suck-
ing.11 Although the difference that existed between the control
group and the intervention group at the beginning of the study
makes the interpretation of the results more difficult, studies on
cold compress have shown the cold to cause no harm and to
instead be associated with improved symptoms. The results
of a review study showed that cabbage leaves and gel packs
were equally effective in the treatment of breast engorgement,
as were cabbage extract and placebo cream. Reduced breast
engorgement therefore depends on other factors such as massa-
ging. Ultrasound treatments also produced similar results in the
control group and the case group, and improved symptoms in
this case were probably related to the warmth of radiation or the
effects of massaging. Oxytocin was found to have no therapeu-
tic effects on breast engorgement, while Danzen and combined
Bromelain-Trypsin cause dramatic improvements in the symp-
toms of breast engorgement.12 Anti-inflammatory medications
such as ibuprofen are another category of chemical medications
recommended for the treatment of breast engorgement symp-
toms.13 Medications should be taken with medical advice dur-
ing breastfeeding, as some drugs secrete into milk and should
therefore be taken 30 to 60 minutes after breastfeeding and 3
to 4 hours before the next breastfeeding.14
Herbal medications are recommended as alternative treat-
ments in the majority of health care systems across the world
today.15 Various herbs have been recommended in traditional
medicine for the treatment of breast engorgement, including
peppermint and sage (Salvia officinalis), in either oral form
or oil massage.16 Cabbage has also been recommended and
clinically studied for treating engorged breasts.8 The results
of these studies have shown that the frequent application of
cabbage leaf can reduce breast milk supply and that mothers
who are allergic to cabbage leaf or sulfa drugs should avoid
taking these herbal medications.13 Despite the promising
results of some interventions, there is still a lack of sufficient
trial evidence from the interventions to justify their extensive
use, and further studies are required on this painful and discom-
forting condition threatening sustained breastfeeding.6 Holly-
hock is a plant from the Malvacaea family with the scientific
name of Althaea officinalis L.17 The medicinal forms of this
plant include cold infusion, brew, compress, and extract. The
chemical composition of the hollyhock leaf includes mucilage,
polysaccharide, flavonoid, phenolic acid, tannin, and fat.18 In
traditional medicine, a hollyhock leaf and stem compress is rec-
ommended to relieve pain and treat swelling, such as in the
breast.19,20 The topical application of the roots of marshmal-
low, which is also from the Malvacaea family and is often
known as the equivalent of hollyhock,21 has been recom-
mended for the treatment of breast engorgement,22 breast
Journal of Evidence-Based Complementary & Alternative Medicine 22(1)
fissure, and clogged milk ducts,16 and its oral intake also for
increasing lactation.22,23 The clinical effects of hollyhock on
breast engorgement have not yet been studied.
In recent years, Iranians have also become more familiar
with complementary therapies and are now more inclined to
use them to treat different conditions.24 Given the role of nurses
in complementary medicine, further studies are required for
finding new treatments for breast engorgement. The present
study was therefore conducted to determine the effect of the
topical application of the leaves of hollyhock (a plant recom-
mended in traditional medicine) combined with warm and cold
compresses in improving breast engorgement in lactating
women. In recent years, Iranian nurses have also become more
familiar with complementary and alternative medicine thera-
pies and they are now more inclined to use them to treat differ-
ent conditions.24 Regarding nursing is an holistic approach at
its essence,25 complementary and alternative medicine thera-
pies have been increasingly integrated into professional nursing
practice.26 According to the role of nurses to develop comple-
mentary and alternative medicine nursing interventions and
document it in a nursing context (especially herbal therapy for
maternity nursing care), it seems further researches are
required to evaluate the safety and efficacy benefits of these
methods.27 The present study was therefore conducted to deter-
mine the effect of the topical application of the leaves of holly-
hock (a plant recommended in traditional medicine) combined
with warm and cold compresses in improving breast engorge-
ment in lactating women.
Materials and Methods
Study Design
The present randomized, controlled, clinical trial was conducted
in Hazrat Abolfazl Hospital and other health centers in Kashmar,
Iran. On receiving approval from the Ethics Committee of Gonabad
University of Medical Sciences (GMU.REC.1393.6), the study was
registered at the Iranian Registry of Clinical Trials (IRCT ID:
IRCT2014051917754N1). The study inclusion criteria for the moth-
ers who were in the 1st to 15th days after delivery consisted of hav-
ing breast engorgement with a minimum intensity score of 2 based
on the checklist (with a maximum score of 19), a sublingual tempera-
ture below 38 C, having had engorgement symptoms during the first
15 days after delivery, no use of medications for stopping breastfeed-
ing, no use of topical herbal therapies, not having developed breast
abscess or mastitis, no prohibition on lactation, no history of any
allergies to hollyhock or other plants, and nursing every 2 to 3 hours.
For the neonates, the inclusion criteria consisted of being a singleton
and having a full-term birth and normal birth weight (2500-4000 g),
being able to suck on nipples, not being prohibited from breastfeed-
ing, and demanding to be nursed every 2 to 3 hours.
The study exclusion criteria for the mothers consisted of the inci-
dence of allergy to hollyhock, a general temperature exceeding 38 C
after beginning the intervention, the use of or the need to use anti-
inflammatory medications or painkillers interfering with the designed
intervention during the course of the study, and the incidence of unex-
pected events for either participants interfering with their breastfeed-
ing. The infants were excluded from the study if they lost the study
Khosravan et al
inclusion criteria for any reason, including getting a fever during the
course of the intervention.
Sampling
The study subjects were selected through convenience sampling and
were then randomly divided into an intervention group and a control
group using blocks of 4. The sample size was calculated as 17 for each
group according to the following equation28 and the results of the pilot
study, and considering a type I error of 0.05, a test power of 0.8, and
d ¼ 2 as the least significant difference. Sample size was ultimately
extended to 22 for each group taking into account a 25% potential
withdrawal rate.
 2
2 z1a2 þ z1b s2 f1 þ ðm  1Þrg
n¼
md 2
2
2  7:85  3:7 f1 þ ð7  1Þ0:15g
¼  17
6  22
Based on the sample size measured, a total of 48 women entered
the study.
Preparation of the Hollyhock Leaf Compress
To prepare hollyhock herbal powder, the plant’s leaf and stem were
collected and dried by an herbalist from the herbarium of Marand, and
confirmed by the Herbarium Department at Jahad University of Kash-
mar. To stabilize their weight, the collected leaf and stem were placed
in a dryer at 60 C for 24 hours and milled to a powder and then irra-
diated with ultraviolet light for 30 minutes to prevent the development
of infections. To prepare the herbal compress, 10 g of the powder were
mixed with cooled boiled water and the solution was ready for use
within 30 minutes. To prevent the development of infections in the
breast, each participant received her separate tools, including separate
warm and cold compresses.
Care Program
Participants received instructions on performing the interventions at
home by themselves and on evaluating their breast engorgement
severity based on the groups to which they had randomly been
assigned, as the researchers had limitations on visiting them in their
home and performing the interventions for them.
In the control group, a warm compress (43 C to 46 C)5,8 was
applied on the engorged breast for 2 minutes13 exactly before breast-
feeding. The compress was then removed, and half an hour later, the
mother was asked to breastfeed her child and to simultaneously mas-
sage her engorged breast from the top to the nipple. The cold compress
(10 C to 18 C)5,8 was then applied for 15 to 20 minutes. To maintain
this temperature, the compress was soaked in water every 2 minutes
and then reapplied. The breast engorgement severity was then
assessed and recorded.
In the intervention group, the interventions performed in the con-
trol group were first repeated, and then, 10 to 15 minutes later, 6 to
8 spoonful (40-50 mL) of hollyhock leaf herbal compress were rubbed
on their breast and then removed within 10 minutes. So both groups
had the exact same procedure except for the application of the
Hollyhock.
The procedures were repeated in both groups 3 times per day for 2
days in a row. In case the mother’s breast engorgement severity
27
reached zero prior to the sixth repeat of the procedures, the researchers
stopped the intervention for her.
During these 2 days, the mothers were advised in both groups to
nurse their infant from both breasts every 2 to 3 hours and for 10 to
15 minutes.
Assessment
The data collection tools used in this study included a demographic
information questionnaire (including items on age, level of education,
and occupation), an obstetric information form (including items on the
number of days since delivery, the type of delivery, parity, and the
number of miscarriages), a lactation status form (including items on
previous breastfeeding history, previous breastfeeding problems, the
onset of current lactation, the daily frequency of breastfeeding, and the
duration of breastfeeding in minutes), and a checklist of breast engor-
gement score.9,29,30 This checklist assessed participants’ erythema
(with a score of 0 for ‘‘no redness,’’ 1 for ‘‘redness in patches in a lim-
ited area,’’ 2 for ‘‘full redness in a limited area,’’ 3 for a ‘‘shiny redness
in a limited area,’’ and 4 for a ‘‘shiny redness over most of the breast
tissue’’), breast tension (with a score of 0 for ‘‘no changes,’’ 1 for
‘‘firm and no tenderness,’’ 2 for ‘‘tense but not uncomfortable,’’ 3 for
‘‘tense and uncomfortable,’’ 4 for ‘‘tense and painful,’’ and 5 for ‘‘very
tense and very painful’’), and breast pain (a score between 0 and 10).
This checklist has been used in studies conducted by Kvist et al,9,29
and its reliability has been verified with Cronbach’s a values of .79,
.82, and .81 for days 3, 4, and 5, respectively, of contacting the breast-
feeding clinic.30 This checklist was also used in Iran in a study con-
ducted by Kamali Moradzade,5 and its reliability was found as 0.8
using the equivalent forms reliability. The severity of breast engorge-
ment was assessed using the total score obtained for the symptoms of
engorgement (Severity Index ¼ Erythema þ Breast Tension þ Breast
Pain, with scores ranging from 0 to 19).
Statistical Analysis
The data extracted from the questionnaires and the checklists were
analyzed in SPSS-16 using the w2 and Mann-Whitney tests and the
generalized estimating equation, which is an effective method in the
analysis of correlated longitudinal data. The analysis of the data also
took into account the exchangeable covariance matrix based on the
pseudo-likelihood of the data.
Ethical Considerations
The ethical considerations observed in the present study included
obtaining participants’ written consent for participating in the study,
delivering the routine interventions for breast engorgement in the con-
trol group, observing the principles of infection prevention, ensuring
the confidentiality of the data, and reporting the results in generalized
form. Hollyhock is also confirmed to be safe for lactating women.
Results
A total of 7 women were excluded from the study, including 4
women from the intervention group and 3 from the control
group, for reasons such as having performed the interventions
improperly and, in one of the controls, for having mastitis. A
total of 40 women completed the interventions, that is, 20 in
each group.
28 Journal of Evidence-Based Complementary & Alternative Medicine 22(1)

Table 1. Comparison of Demographic and Obstetric Variables Table 3. Results of the Generalized Estimating Equations.
Between the Intervention and Control Groups.
95%
Control, Intervention, P Value Confidence
Group/Variable n (%) n (%) (w2 Test) Interval
Standard Wald P
Education Variable B Deviation Lower Upper Statistic df Value
Diploma and lesser 13 (65%) 16 (80%) P ¼ .288
Licenses and higher 7 (35%) 4 (20%) Intercept 5.535 0.813 3.759 6.947 43.324 1 <.001
Parity Groupa 4.103 1.064 2.017 6.190 14.853 1 <.001
Primipara 10 (50%) 7 (35%) P ¼ .203 Time 1.041 0.160 1.356 0.727 42.181 1 <.001
Multipara 10 (50%) 13 (65%) Time  0.320 0.209 0.731 0.091 2.234 1 .127
Type of labor Group
Normal delivery 10 (50%) 13 (65%) P ¼ .337 a
The intervention group is considered as the reference.
Cesarean 10 (50%) 7 (35%)

Table 2. Comparison of the Severity of Breast Engorgement (Mean

+ Standard Deviation) in the Intervention and Control Groups
During the Different Stages of the Study.

Group
Time of Measurement
Control Intervention

Before beginning intervention 10.05 + 2.438 9.15 + 2.412

After the first intervention 8.4 + 2.891 5.45 + 3.748
After the second intervention 6.90 + 2.954 3.35 + 2.477
After the third intervention 4.85 + 3.313 0.80 + 1.281
After the forth intervention 3.48 + 3.871 0.30 + 1.129
After the fifth intervention 3.02 + 3.995 0.20 + 0.696
After the sixth intervention 3.02 + 3.995 0.20 + 0.696

The mean age of participants was 29.2 + 3.254 in the con-
trol group and 27.15 + 5.102 in the intervention group. The
Mann-Whitney test showed no significant differences between
the 2 groups in terms of their mean age (P ¼ .073), and the w2
test showed the 2 groups to be matched for education, parity,
and type of delivery (Table 1). The mean duration of time from
the date of delivery until the incidence of postpartum breast
engorgement was 4.7 + 1.949 days in the control group and
5.05 + 2.665 days in the intervention group, with no signifi-
cant differences observed between the groups (P ¼ .663). The
mean score of breast engorgement severity before the interven-
tions was 10.05 + 2.438 in the control group and 9.15 + 2.412
in the intervention group, with the 2 groups being homoge-
nous in terms of their pre-intervention score (P ¼ .234). The
mean score of breast engorgement severity showed a reduc-
ing trend in both groups over the 2 days during which the
interventions were performed (Table 2); however, a signifi-
cant difference was observed between the 2 groups, and
according to the generalized estimating equation, the mean
overall score of breast engorgement was lower in the inter-
vention group by the significant amount of 4.103 (P < .001),
compared to that in the control group (Table 3). In addition,
there was a significant relationship between the score of
breast engorgement severity and time (P < .001), as the neg-
ative coefficient indicates a reduced mean score with time
(Figure 1).
Figure 1. The mean severity breast engorgement depending on time.
Discussion
The results obtained in the present study showed a decreasing
trend in the mean severity of breast engorgement in both
groups; however, this trend was steeper in the intervention
group compared to that in the control group.
Symptoms of breast engorgement improved with the appli-
cation of warm and cold compresses, not only due to the com-
presses’ own effectiveness in reducing engorgement but also
due to the effects of the other routine interventions performed
for the participants, including frequent nursing and breast mas-
sage. In a study by Kamali Moradzade et al,5 alternate warm
and cold compresses were also found to improve symptoms
of breast engorgement more than acupressure. In a study by
Arora et al8 on the effects of cabbage leaf and warm and cold
compresses, both treatments were found to reduce the severity
of breast engorgement; however, warm and cold compresses
were more effective in relieving the pain of engorgement.
Results of a study by Mathew7 comparing the effects of cab-
bage leaf and warm compress showed the 2 methods to be
equally effective in reducing breast engorgement. In a study
conducted by Chiu et al,4 warm compress and breast massage
were shown to improve the symptoms of engorgement in the
control group; however, the Gua-sha treatment used in the
Khosravan et al
therapy group managed to better improve nearly all the symp-
toms of breast engorgement, except for body temperature.
The results of the present study showed that symptoms of
breast engorgement improve faster with the combined use of
warm and cold compresses, hollyhock leaf compress, and the
performing of routine interventions. Given that no studies have
yet been conducted on the effect of hollyhock on breast engor-
gement, the results obtained from this study could not be
compared to any similar studies; however, these results may
support sources of traditional medicine in claiming that holly-
hock has a softening quality, since traditional medicine
recommends hollyhock leaf and stem compresses for healing
and relieving the pain of swelling, such as swelling of the
breast.19,20 In vitro studies on hollyhock also confirm the anti-
inflammatory and immune system stimulating effects of this
flowering plant; these studies have also shown that the root
extract of this plant stimulates phagocytosis and the release
of oxygen radicals and leukotrienes from human neutrophils,
and that its aqueous extract induces the release of cytokines,
interleukin-6, and tumor necrosis factor from human mono-
cytes.21 Roohi Boroujeni et al31 examined the effect of the oral
intake of 40 mg of hollyhock extract with 300 mL of ginger in
the treatment of cough and showed anti-inflammatory effects for
the plant. Hollyhock is also suggested to be an antispasmodic
plant. Sadighara et al32 also examined hollyhock and found it
to have a much greater anti-inflammatory effect compared to the
other plants studied. Nouraldini et al17 studied and confirmed the
antispasmodic effect of the aqueous root extract of hollyhock on
the tracheal smooth muscles in rats, which is consistent with the
softening effect found for hollyhock in the present study.
Limitations
The limitations of this study included having to delegate the
performing of some of the interventions to the participants
(after providing training and ensuring that both groups had
learnt to properly perform the interventions) in order to avoid
interfering with their personal lives by visiting them in their
homes at inappropriate hours. Furthermore, the researcher
could not assess the severity of engorgement after each session
of the intervention or blind the subjects to the type of interven-
tion they were receiving given the time and place limitations of
the study and the frequency of the interventions. Moreover, to
observe the codes of research ethics, the intervention group
received the routine interventions used for breast engorgement,
breast massages, nursing consultation, and warm and cold com-
presses in addition to hollyhock compress. Further studies are
therefore recommended to be conducted on the effectiveness
of the sole use of hollyhock in treating breast engorgement
compared to the other methods available and with larger sam-
ple sizes and by blinding the subjects.
Conclusion
According to the findings of the present study, a hollyhock
leaf compress combined with the performing of routine
29
interventions for breast engorgement can improve the symp-
toms of this condition.
Authors’ Note
The present study was part of a master’s thesis in nursing by Samane
Ajam Khames Fadafen, Gonabad University of Medical Sciences,
Gonabad, Iran. This research was approved by the Research Review
Committee of Gonabad University of Medical Sciences (Research
Code P/4/28).
Acknowledgements
The authors would like to express their gratitude to all the individuals
who helped conduct this study, especially the deputy of education,
research and technology and the vice chancellor of the university; the
authorities and employees of the hospital and health centers of Kash-
mar; and all the mothers without whose participation this study would
not have been possible.
Author Contributions
All the authors have made contributions to (a) the proposal and design
of the study, the acquisition of the data, and the analysis and interpre-
tation of the data; (b) the drafting of the article and revising it critically
for important intellectual content; and (c) the final approval of the ver-
sion to be submitted.
Declaration of Conflicting Interests
The authors declare to have no conflicts of interest with respect to the
research, authorship, and/or publication of the article.
Funding
The authors disclosed receipt of the following financial support for the
research, authorship, and/or publication of this article: This study was
funded by the Research Administration of Gonabad University of
Medical Sciences, Gonabad, Iran.
Ethical Approval
The present study protocol was approved by the Ethics Committee of
Gonabad University of Medical Sciences, Gonabad, Iran (Code No.
GMU.REC.1393.6).
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