Original Article Hossein Mohammadzadeh-Moghadam, MD2,

Fatemeh Mohammadzadeh, MSc3,

The Effect of Hollyhock
officinalis L) Leaf Compresses
Combined With Warm and Cold
Compress on Breast
Engorgement in Lactating
Women: A Randomized Clinical
Trial
(Althaea Samane Ajam Khames Fadafen, BSN 4, and
Malihe Gholami, PhD5 Abstract
Journal of Evidence-Based
Complementary & Alternative Medicine 2017, Vol. 22(1) 25-30
ª The Author(s) 2015
Reprints and permission:
sagepub.com/journalsPermissions.nav DOI: 10.1177/2156587215617106
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Shahla Khosravan, BSN, MSN, PhD1,

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.

of the main factors contributing to the stimulation of milk

Proper nutrition is essential to children’s overall health secretion that is induced by the infant’s sucking.2 Breast
and growth. Particular components of breast milk fully engorgement is a common problem occurring in 40% of
satisfy the nutritional requirements of lactating infants mothers following childbirth3 and affects the onset and
and ensure their full development.1 Easy lactation is one 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
26 Journal of Evidence-Based Complementary & Alternative Medicine 22(1)
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
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
3
Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
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
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
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
Khosravan et al 27
inclusion criteria for any reason, including getting a fever during
the course of the intervention.
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
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.

Sampling
The study subjects were selected through convenience
Assessment
sampling and were then randomly divided into an intervention The data collection tools used in this study included a
group and a control group using blocks of 4. The sample size demographic information questionnaire (including items on
was calculated as 17 for each group according to the following age, level of education, and occupation), an obstetric
equation28 and the results of the pilot study, and considering a information form (including items on the number of days since
type I error of 0.05, a test power of 0.8, and d ¼ 2 as the least delivery, the type of delivery, parity, and the number of
significant difference. Sample size was ultimately extended to miscarriages), a lactation status form (including items on
22 for each group taking into account a 25% potential previous breastfeeding history, previous breastfeeding
withdrawal rate. problems, the onset of current lactation, the daily frequency of
2 breastfeeding, and the
s2f1 þ ðm 1Þrg
n¼ md2 and a checklist of breast engor gement
2 z1 a2 þ z1 b score.9,29,30 This checklist assessed
duration of breastfeeding in minutes), participants’ erythema
2 Marand, and confirmed by the Herbarium Department at Jahad
¼ 2 7:85 3:7 f1 þ ð7 1Þ0:15g University of Kash mar. To stabilize their weight, the collected
2 leaf and stem were placed in a dryer at 60 C for 24 hours and
6 2 17
milled to a powder and then irra diated with ultraviolet light for
Based on the sample size measured, a total of 48 women 30 minutes to prevent the development of infections. To
entered the study. 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
Preparation of the Hollyhock Leaf Compress the breast, each participant received her separate tools,
To prepare hollyhock herbal powder, the plant’s leaf and stem including separate warm and cold compresses.
were collected and dried by an herbalist from the herbarium of
 .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
Care Program study con ducted by Kamali Moradzade,5 and its reliability was
Participants received instructions on performing the found as 0.8 using the equivalent forms reliability. The severity
interventions at home by themselves and on evaluating their of breast engorge ment was assessed using the total score
breast engorgement severity based on the groups to which obtained for the symptoms of engorgement (Severity Index ¼
they had randomly been assigned, as the researchers had Erythema þ Breast Tension þ Breast Pain, with scores ranging
limitations on visiting them in their home and performing the from 0 to 19).
interventions for them.
In the control group, a warm compress (43 C to 46 C)5,8 was Statistical Analysis
applied on the engorged breast for 2 minutes13 exactly before
The data extracted from the questionnaires and the checklists
breast feeding. The compress was then removed, and half an
hour later, the mother was asked to breastfeed her child and to were analyzed in SPSS-16 using the w2 and Mann-Whitney
simultaneously mas sage her engorged breast from the top to tests and the generalized estimating equation, which is an
effective method in the analysis of correlated longitudinal data.
the nipple. The cold compress (10 C to 18 C)5,8 was then
The analysis of the data also took into account the
applied for 15 to 20 minutes. To maintain this temperature, the
exchangeable covariance matrix based on the
compress was soaked in water every 2 minutes and then
pseudo-likelihood of the data.
reapplied. The breast engorgement severity was then
assessed and recorded.
In the intervention group, the interventions performed in the Ethical Considerations
con trol group were first repeated, and then, 10 to 15 minutes
The ethical considerations observed in the present study
later, 6 to 8 spoonful (40-50 mL) of hollyhock leaf herbal
included obtaining participants’ written consent for participating
compress were rubbed on their breast and then removed within
in the study, delivering the routine interventions for breast
10 minutes. So both groups had the exact same procedure
engorgement in the con trol group, observing the principles of
except for the application of the Hollyhock.
infection prevention, ensuring the confidentiality of the data,
The procedures were repeated in both groups 3 times per
and reporting the results in generalized form. Hollyhock is also
day for 2 days in a row. In case the mother’s breast
confirmed to be safe for lactating women.
engorgement severity
(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 Results
‘‘shiny redness in a limited area,’’ and 4 for a ‘‘shiny redness
over most of the breast tissue’’), breast tension (with a score of A total of 7 women were excluded from the study,
0 for ‘‘no changes,’’ 1 for ‘‘firm and no tenderness,’’ 2 for ‘‘tense including 4 women from the intervention group and 3
but not uncomfortable,’’ 3 for ‘‘tense and uncomfortable,’’ 4 for from the control group, for reasons such as having
‘‘tense and painful,’’ and 5 for ‘‘very tense and very painful’’),
performed the interventions improperly and, in one of the
and breast pain (a score between 0 and 10). This checklist has
controls, for having mastitis. A total of 40 women
been used in studies conducted by Kvist et al,9,29 and its
reliability has been verified with Cronbach’s a values of .79, completed the interventions, that is, 20 in each group.
28 Journal of Evidence-Based Complementary & Alternative Medicine 22(1)
Table 3. Results of the Generalized Estimating

Table 1. Comparison of Demographic and Obstetric Equations. 95%

Variables Between the Intervention and Control Groups.
Group/Variable Intervention, n P Value (w2 Test) Confidence
(%) Interval
Control, n (%) Standard Wald P
Education Deviation Lower Upper Value Statistic df
Variable B
Diploma and lesser 13 (65%) 16 (80%) P ¼ .288 Licenses 4.103 1.064 2.017 6.190 14.853 1 <.001 Time 1.041 0.160
and higher 7 (35%) 4 (20%) 1.356 0.727 42.181 1 <.001
Parity

Intercept 5.535 0.813 3.759 6.947 43.324 1 <.001 Groupa

Primipara 10 (50%) 7 (35%) P ¼ .203 Type of labor 0.320 0.209 0.731 0.091 2.234 1 .127
Multipara 10 (50%) 13 (65%)
Time Group
Groups During the Different Stages of the Study.
Normal delivery 10 (50%) 13 (65%) P ¼ .337 Cesarean 10
(50%) 7 (35%) Time of Measurement Group 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
Table 2. Comparison of the Severity of Breast Engorgement second intervention 6.90 + 2.954 3.35 + 2.477 After the third
(Mean + Standard Deviation) in the Intervention and Control 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).
a
The intervention group is considered as the reference.
Khosravan et al 29
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,
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
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
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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