The Effect of Hollyhock (Althaea officinalis L) Leaf Compresses Combined With Warm and Cold Compress on Breast Engorgement in Lactating Women

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.

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 distension of the alveoli leads to the increasing enlargement of the milk-secreting cells to the extent of creating a rupture. This distension 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 discourage 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 engorgement. 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 acupressure, oxytocin spray, lymphatic breast drainage therapy,⁵ Gua-Sha,⁴ and acupuncture.⁹ Analysis of studies reveal contradictory results, and there is a lack of sufficient evidence 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 sucking.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 massaging. 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 therapeutic effects on breast engorgement, while Danzen and combined Bromelain-Trypsin cause dramatic improvements in the symptoms of breast engorgement.¹² Anti-inflammatory medications such as ibuprofen are another category of chemical medications recommended for the treatment of breast engorgement symptoms.¹³ Medications should be taken with medical advice during 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 treatments 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 discomforting condition threatening sustained breastfeeding.⁶ Hollyhock 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 recommended to relieve pain and treat swelling, such as in the breast.^19,20 The topical application of the roots of marshmallow, which is also from the Malvacaea family and is often known as the equivalent of hollyhock,²¹ has been recommended 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 recommended 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 therapies and they are now more inclined to use them to treat different conditions.²⁴ Regarding nursing is an holistic approach at its essence,²⁵ complementary and alternative medicine therapies have been increasingly integrated into professional nursing practice.²⁶ According to the role of nurses to develop complementary 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 determine the effect of the topical application of the leaves of hollyhock (a plant recommended in traditional medicine) combined with warm and cold compresses in improving breast engorgement 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 mothers who were in the 1st to 15th days after delivery consisted of having breast engorgement with a minimum intensity score of 2 based on the checklist (with a maximum score of 19), a sublingual temperature below 38°C, having had engorgement symptoms during the first 15 days after delivery, no use of medications for stopping breastfeeding, 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 breastfeeding, and demanding to be nursed every 2 to 3 hours.

The study exclusion criteria for the mothers consisted of the incidence 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 unexpected events for either participants interfering with their breastfeeding. The infants were excluded from the study if they lost the study 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 = 2 as the least significant difference. Sample size was ultimately extended to 22 for each group taking into account a 25% potential withdrawal rate.

$$n=\frac{2{\left(z_{1-\frac{\alpha }{2}}+z_{1-\beta }\right)}^2{\sigma }^2\left\{1+\left(m-1\right)\rho \right\}}{m{d}^2}=\frac{2*7.85*{3.7}^2\left\{1+\left(7-1\right)0.15\right\}}{6*2^2}\approx 17$$

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 Kashmar. 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 irradiated 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 breastfeeding. The compress was then removed, and half an hour later, the mother was asked to breastfeed her child and to simultaneously massage 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 control 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 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 engorgement score.^9,29,30 This checklist assessed participants’ erythema (with a score of 0 for “no redness,” 1 for “redness in patches in a limited 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 α values of .79, .82, and .81 for days 3, 4, and 5, respectively, of contacting the breastfeeding clinic.³⁰ This checklist was also used in Iran in a study conducted by Kamali Moradzade,⁵ and its reliability was found as 0.8 using the equivalent forms reliability. The severity of breast engorgement was assessed using the total score obtained for the symptoms of engorgement (Severity Index = Erythema + Breast Tension + 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 χ² 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 control 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.

The mean age of participants was 29.2 ± 3.254 in the control 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 = .073), and the χ² 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 significant differences observed between the groups (P = .663). The mean score of breast engorgement severity before the interventions was 10.05 ± 2.438 in the control group and 9.15 ± 2.412 in the intervention group, with the 2 groups being homogenous in terms of their pre-intervention score (P = .234). The mean score of breast engorgement severity showed a reducing trend in both groups over the 2 days during which the interventions were performed (Table 2); however, a significant 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 intervention 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 negative coefficient indicates a reduced mean score with time (Figure 1).

Table 1.

Comparison of Demographic and Obstetric Variables Between the Intervention and Control Groups.

Group/Variable	Control, n (%)	Intervention, n (%)	P Value (χ2 Test)
Education
Diploma and lesser	13 (65%)	16 (80%)	P = .288
Licenses and higher	7 (35%)	4 (20%)
Parity
Primipara	10 (50%)	7 (35%)	P = .203
Multipara	10 (50%)	13 (65%)
Type of labor
Normal delivery	10 (50%)	13 (65%)	P = .337
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.

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 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

Table 3.

Results of the Generalized Estimating Equations.

Variable	B	Standard Deviation	95% Confidence Interval		Wald Statistic	df	P Value
			Lower	Upper
Intercept	5.535	0.813	3.759	6.947	43.324	1	<.001
Groupa	4.103	1.064	2.017	6.190	14.853	1	<.001
Time	−1.041	0.160	−1.356	−0.727	42.181	1	<.001
Time × Group	−0.320	0.209	−0.731	0.091	2.234	1	.127

^aThe intervention group is considered as the reference.

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 application of warm and cold compresses, not only due to the compresses’ 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 massage. 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 cabbage 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 therapy group managed to better improve nearly all the symptoms 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 engorgement, 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 hollyhock 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 monocytes.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 intervention 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 compresses 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 sample 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 symptoms of this condition.