  breastfeeding , especially exclusive breast - feeding ( ebf ) , is the ideal method for feeding 
 and growth in the first 6 months of birth . 

breast milk not only reduces the risk of incidence of many acute and chronic diseases such 
 as diarrhea and respiratory infections in breast - fed infants , but also it has numerous 
 benefits to mothers ( for example , the reduced risk of breast cancer , uterus cancer , ovarian 
 cancer , and osteoporosis ) .   among all the possible problems arising during the breastfeeding period , breast conditions 
 and those occurring in the early days of breastfeeding are most important .
nipple problems include the development of 
 macroscopic lesions that occurs on the nipples and areola .
these lesions may appear as 
 eroded skin , wounds , and fissure as well as clinical signs of erythema , edema , white or 
 yellow blisters , dark spots , and ecchymosis .  
the most common 
 consequences of traumatic nipples include infants deprivation of breast milk benefits and 
 it may lead to stress and dissatisfaction in mothers .
studies indicate that problems 
 occurring in the first days following birth may lead to the cessation of breastfeeding . 
 moreover , according to the statement issued by the world health organization ( who ) , less 
 than 40% of infants below 6 months of age are exclusively fed by breast milk .  
the incident of traumatic nipples varies between 29% and 76% , while nipple pain caused 
 from breastfeeding varies between 34% and 96% .
if these pains remain untreated , 26% of nipple pains will develop into nipple 
 fissure and severe pain .  
unfortunately , treatment of traumatic nipple is complicated because of the repeated 
 sucking by the infant , infections caused by the entrance of microorganisms through the 
 nipple fissure , and constant exposure of nipple skin with the infant s oral flora .  
treatment of traumatic nipple dates back to the seventeenth century , but there is no 
 explicit statement on the most suitable topical treatment for traumatic nipples . in this
regard , complementary medicine , 
 especially herbal medicine , plays a major role in improving the quality of postpartum care . 

currently , 40% of common medicines are derived from plants and natural resources .   among the available treatments ,
this composition is capable of absorbing up to 30% of water .   in 2008 , dennis indicated that the application of lanolin is effective for the treatment 
 of sore nipples .
he stated that lanolin along with teaching the correct breastfeeding 
 technique is the best solution to the treatment of nipple fissure .
in contrast , gartner showed that recovery of nipple fissure in 
 the lanolin group took longer .
in 
 another study , dodd & chalmens carried out a comparison between the effects of hydrogen 
 dressing and lanolin on the treatment of traumatic nipples and showed that the hydrogen 
 dressing group experienced a significant decrease in pain as compared to the lanolin 
 group .
however , no significant 
 difference was observed in wound healing between two groups .  
dexpanthenol is one of the skin healers which belongs to the family of b complex vitamins . 

this medicine functions as a moisturizer by reducing water loss through the epidermis and 
 maintaining the softness and elasticity of the skin .
peppermint herb which is a native plant to iran , is widely used for the 
 treatment of skin numbness , burns , scars , itching and inflammation . in 2003
, ahluwalia made a comparison between the 
 contributions of peppermint , lanolin , and teabag to the treatment of traumatic nipples and 
 reported a significant decrease in pain and a significant increase in the nipple trauma 
 healing of the peppermint group.they concluded that peppermint increases tissue flexibility 
 and prevents fissure .   in another study ,
sayyah melli showed that the administration of peppermint juice was 
 three times more effective than breast milk in the prevention of nipple fissure .
, akbari indicated that peppermint essence can improve nipple 
 fissure in primiparous women .  
after a vast review of the existing literature , no study was found to have confirmed the 
 effects of dexpanthenol and peppermint on the treatment of traumatic nipple in iran , as all 
 of the studies in this country were conducted on the prevention of trauma .  
considering the high prevalence of traumatic nipple and its complications , the lack of any 
 agreed treatment for traumatic nipples , and the necessity of early treatment of traumatic 
 nipples with the lowest side effects , the present study was carried out to compare the 
 effects of lanolin , peppermint , and dexpanthenol creams on the treatment of traumatic 
 nipples
  this randomized controlled trial conducted to compare the effects of lanolin , peppermint , 
 and dexpanthenol on the treatment of traumatic nipples in breastfeeding mothers .  
the target population included the breastfeeding mothers who visited at the abbas abad and 
 farabi health centers and sanandaj children s hospital in 2014 .
these centers were selected 
 for this study because the number of breastfeeding mothers visiting these centers was 
 high .  
, the sample size was calculated to be 35 for each group by confidence 
 interval of 95% and statistical power of 80% and using the three - group comparison formula . 
 finally , by considering a sample loss of 20% , 42 women were selected in each group .  
the research samples were all of the breastfeeding mothers , who visited at the children s 
 hospital and health centers and who had no drug prohibitions . after obtaining the permission 
 of the ethics committee and the research deputy of tabriz medical sciences university ,
the 
 samples were selected from breastfeeding mothers , who met the inclusion criteria and visited 
 at the abbas abad and farabi health centers and sanandaj children s hospital .   after explaining the research and its method and objectives to the mothers
afterwards , the personal and social information 
 forms were completed and midwifery histories of the subjects were recorded .
the forms and 
 records were completed based on the observation of the breastfeeding methods of the mothers 
 using the store and champion scales .
the samples were finally selected based on the 
 following inclusion criteria : 1 ) primiparous mothers ; 2 ) exclusive feeding with breast milk ; 
 3 ) term infant ; 4 ) infant with below two months of age ; 5 ) obtaining the minimum score of 1 
 from the store and champion scales ; 6 ) mothers free of any medical disorders ; 7 ) lack of 
 sensitivity of mothers to lanolin , peppermint , and dexpanthenol ; 8) infant weight of 2500 to 
 4000 grams ; and 11 ) lack of any nipple disorders ( flat and depressed nipples ) .
the exclusion 
 criteria included the followings : 1 ) infants suffering from tongue and tooth disorders ; 2 ) 
 using pacifiers , bottles , and plastic nipples for infants ; 3 ) history of maternal 
 psychological disorders reported by mothers ; and 4 ) mother or infant suffering from any 
 nipple - irrelevant condition that lead to cessation of breastfeeding .  
the allocation sequence was determined by a 
 computer - generated randomization scheme with the block sizes of 3 and 6 and the allocation 
 ratio 1:1:1 .
then , the tubes were filled with 50 ml of lanolin , lanolin , or dexpanthenol by 
 the laboratory of pharmaceutics of tabriz school of pharmacy .
the peppermint tube contained 
 carbopol , methylparaben , triethanolamine , and glycerin along with 0.2% of peppermint oil , 
 and the dexpanthenol tube contained 5% b complex analogue .
every woman entering the study 
 received sealed , opaque pockets ( of apparently similar sizes ) .
numbers ranging from 1 to 126 
 were printed on the pockets with identical uniform tubes .
the pockets included three types 
 of cream : lanolin cream , peppermint cream , and dexpanthenol cream .
the subjects were 
 randomly assigned into three groups receiving lanolin , peppermint , and dexpanthenol , and 
 neither the researcher nor the subjects were aware of the assignment sequence and the 
 position of each subject . that is to say , this study was a double blind trial .  
the breastfeeding mothers were not allowed to use any other treatment method during the 
 study period and they were asked to report any case of sedatives consumption during the 
 study .
the participants were asked to apply a thin layer of the cream to the traumatic 
 nipple and its areola three times a day immediately after breastfeeding for two weeks .
the 
 participants had recontamination of hand washing with warm water and soap before applying 
 the cream .  
the information was collected through four steps ( prior to intervention and on the third 
 day , seventh day , and fourteenth day ) .  
the participants , who were trained on completion of the store and champion scales in 
 advance , completed the scales on the third , seventh , and fourteenth days and submitted them 
 to the researcher on the fourteenth day ( the appointment day ) .
in addition , a follow - up appointment was set for all of the 
 participants one week after entering the research to record the intake of any sedatives or 
 development of any complication caused by the treatment .
the patients were given a cell 
 phone number to be able to call and ask any questions related to the disease during the 
 daytime until 12 am .
the first part questioned the demographic and social information and the maternal history 
 of subjects .
this questionnaire covered information such as the patient age , marriage age , 
 marital status , education , profession , residence location , midwifery information ( including 
 the number of pregnancies , number of delivery , number of living children ) , history of 
 medical surgeries and history of breastfeeding ( number of infants , duration of breastfeeding 
 period , sedatives received for breastfeeding pains , treatment effect , breastfeeding status , 
 and breast care during pregnancy , following birth and during breastfeeding ) .
the positive 
 response ( yes ) was assigned the 1 score while the negative response ( no ) was assigned the 0 
 score .
score 0 was assigned to no pain and score 5 ( the maximum score ) was 
 assigned to the highest level of pain . 

it is also used to assess the recovery of wound depth and 
 the extent of damage caused to the tissue .
the breastfeeding mothers used this scale and its 
 numerical scale to assess the extent of nipple trauma and its recovery .  
lack of trauma was assigned the 0 score and larger numbers were recorded for deeper 
 traumas . the scale ended with the maximum score ( being 5 ) .
this tool has been used in various studies inside and outside the country , and its validity 
 have been confirmed by champion .
this tool has been used in various 
 studies inside and outside the country , and its validity have been confirmed by 
 storr . the reliability of the store 
 and champion scales was measured using the test - retest method ( r>0.7 ) .
the data was analyzed using spss software 
 ver.13 and the following test methods : test - retest method , kruskal 
wallis method , chi - square 
 test , anova , and repeated measures anova .
  in this clinical trial , 150 breastfeeding mothers were assessed were assessed for 
 eligibility and finally 126 mothers were included in the research ( figure 1 ) .  
consort flow diagram    results of this study revealed that the three study groups were similar in demographic , 
 social , and fertility properties .
the mean ( sd ) age of study samples in the lanolin , 
 peppermint , and dexpanthenol groups was 27.7 years ( 8.6 ) , 27 years ( 6.1 ) , and 27.2 years 
 ( 5.9 ) , respectively .
the mean ( sd ) marriage age was 19.8 years ( 4.4 ) , 20.4 years ( 3.5 ) , and 
 21.6 years ( 4.2 ) for the lanolin , peppermint , and dexpanthenol groups , respectively .
more than half of mothers in the three groups had delivered once , and only in the 
 dexpanthenol group 3 mothers ( 7.8% ) had a history of four deliveries or more .
most mothers 
 in the three groups had just delivered their first infants and most of the mothers had an 
 experience of natural childbirth . only 8 ( 20% ) , 4 ( 9.5% ) , and 7 ( 16.7% ) patients in the 
 lanolin , peppermint , the mean ( sd ) score of nipple pain in the lanolin , peppermint , and 
 dexpanthenol groups prior to intervention was 3.12 ( 0.93 ) , 3.07 ( 1.02 ) , and 3.07 ( 1.02 ) , 
 respectively .
the mean ( sd ) score of nipple pain on the third day of intervention was 1.29 
 ( 0.60 ) , 1.26 ( 0.54 ) , and 1.33 ( 0.65 ) for the lanolin , peppermint , and dexpanthenol groups , 
 respectively .
the mean ( sd ) nipple pain on the seventh day of intervention was 0.24 ( 0.49 ) , 
 0.21 ( 0.47 ) , and 0.14 ( 0.42 ) for the lanolin , peppermint , and dexpanthenol and dexpanthenol 
 groups had a history of cesarean section .
most mothers in the three groups had no history of 
 previous surgeries and only one participant in the dexpanthenol group ( 2.6% ) had surgery 
 history ( table 1 ) .  
all of the figures , except for the specified figures , are expressed as frequency 
 ( % ) .chi - square test ; one - way analysis of variance ( anova ) , 
  two - tailed chi square test   groups , respectively .
more than 80% of mothers entered the painless phase on the seventh 
 day of intervention .
the number of mothers who entered the aforementioned stage was 32 
 ( 78% ) , 33 ( 80.5% ) , and 37 ( 88.1% ) in the lanolin , peppermint , and dexpanthenol groups , 
 respectively .
on the fourteenth day of intervention 100% of mothers in three groups entered 
 the painless phase .  
the result showed that the mean score of nipple pain at the prior to intervention stage , 
 third , seventh , and fourteenth days of intervention was not significantly different between 
 three group ( p>0.05 ) .
but , repeated measures anova showed a significant difference in 
 comparison of the three time periods of intervention in each group ( p<0.001 ) ( table 2 ) . 

anova with repeated measure , anova   the mean ( sd ) nipple trauma score prior to invention was 3.41 ( 0.89 ) , 3.38 ( 0.89 ) , and 
 3.36 ( 1.10 ) for the lanolin , peppermint , and dexpanthenol groups , respectively .
one patient 
 ( 2.4% ) in the peppermint group and 4 patients in the lanolin and dexpanthenol groups ( 9.5% ) 
 experienced the worst nipple trauma conditions .
the mean ( sd ) nipple trauma score on the 
 third day of intervention was 2.00 ( 0.67 ) , 2.09 ( 0.73 ) , and 1.88 ( 0.77 ) for the lanolin , 
 peppermint and dexpanthenol groups , respectively .
one patient in the lanolin group ( 2.4% ) 
 and 2 patients in the dexpanthenol group ( 4.8% ) entered the phase with no skin changes .
the 
 mean ( sd ) nipple trauma score on the seventh day of intervention was 0.22 ( 0.52 ) , 0.19 
 ( 0.46 ) , and 0.19 ( 0.50 ) for the lanolin , peppermint , and dexpanthenol groups , respectively . 

more than 80% of mothers entered the phase with no skin changes on the seventh day of 
 intervention .
the number of mothers entering the aforementioned stage was 34 ( 82.9 ) , 34 
 ( 82.9% ) , and 36 ( 85.7% ) in the lanolin , peppermint and dexpanthenol groups , respectively .
on 
 the fourteenth day of intervention 100% of mothers in the three groups showed no skin 
 changes .
no significantly statistical difference was found between nipple pain score in the 
 three groups on the third , seventh , and fourteenth days of observation and on the start day 
 ( p>0.05 ) ( table 3 ) . 

anova with repeated measure , anova   however , the results of repeated measures anova indicated a significant decrease in each 
 group the comparison of the three phases ( p<0.001 ) ( table 
 3 ) .   in the research procedure all of the three groups were asked to first apply the cream to 
 their forearms and administer the drug
no infant 
 reaction was also observed in the three groups to nipples coated with the aforementioned 
 creams . that is to say , the infants easily started and continued drinking breast milk . 

therefore , no difference was made to the breastfeeding procedure and no complication was 
 observed .
there was also no statistically significant difference between the groups in terms 
 of side effects when taking creams .
  research results revealed the equivalent effects of the 0.2% peppermint , lanolin , and 
 dexpanthenol creams on the treatment of nipple pain and trauma .
a thin layer of these creams 
 was administered every 8 hours for two weeks . in the present study , according to the store 
 scale , the pain of participants in the lanolin group declined by 0% , 78% , and 100% on the 
 third , seventh , and fourteenth days of intervention , respectively . moreover ,
2.4% , 80.5% , 
 and 100% of reduction were observed in the peppermint group in the aforementioned days and 
 2.4% , 88.1% , and 100% of decline were observed in the dexpanthenol group , respectively .
, were in line with the results of our study 
 regarding the effectiveness of lanolin . in 
 the study by abou - dakn
et al . , 80% decline was observed on the seventh day and full recovery 
 was obtained on the fourteenth day . 

these findings are also consistent with our findings , but in their research the effect of 
 peppermint water on the treatment of nipple pain was reported to be more than lanolin cream
. 
 therefore , their study does not comply with our study in general and the difference in the 
 results was resulted from the fully uniform intervention in our study . moreover , in their 
 research the groups were not equally exposed to intervention , because 100 patients in the 
 lanolin group , 50 patients in the teabag group , and 50 patients in the peppermint group were 
 undergone the intervention .   in the present study , according to the champion scale , similar levels of improvement in 
 term of nipple trauma resulted from administration of the peppermint , lanolin and 
 dexpanthenol creams . in a study conducted by kuscu et al . , the results of using dexpanthenol 
 for the treatment and recovery of trauma were similar to our results .
that is to say , 
 dexpanthenol contributes to the healing of skin wounds through epithelialization and 
 granulation .
it also leads to wound improvement by storing water through the 
 epidermis . in the research by dennis 
 et al .
, the patients were mainly complaining about pain and 78% and 71% of pain declines 
 were observed in the multipurpose ointment and lanolin groups on the seventh day of 
 treatment , respectively .  
the results of their study are consistent with our study regarding the decreased pain 
 symptoms .
vieira et al . , conducted a systematic review and concluded that administration of 
 lanolin with or without breast milk was the most effective intervention for the treatment of 
 traumatic nipples as compared with other the treatments such as breast milk , hydrogel , 
 adhesive polyethylene film dressings , a spray containing chlorhexidine with alcohol , and 
 distilled water . in the other study by 
 mohammadzadeh et al .
, the duration of trauma recovery in the lanolin group was higher than 
 the breast milk and control groups .
the 
 reason for the difference between our results and the above research was the limitations 
 that were found on this research .  
for example , no scale was used to determine the scores for nipple trauma andthe ranking 
 was carried out under the supervision of a researcher , who was aware of the study groups . 

one of the advantages of this study was the innovation in using 0.2% peppermint essence in 
 the form of cream for the treatment of traumatic nipples .
moreover , the recovery of patients 
 on the 3 , 7 , and 14 days of treatment was also 
 followed .  
since no pre - term and abnormal infants were included in the study , the research findings 
 can not be generalized to these infants .
moreover , this research was not carried out in 
 medical centers of villages , and other cities .
therefore , the trainings , the program 
 resulted from the native specifications of sanandaj city , and its results may not be 
 applicable to other areas and cities of iran .  
few studies have been conducted in iran and the world on traumatic nipple 
 treatment , it is recommended to carry out further studies on this topic .
it is recommended to conduct studies on the possible maternal and neonatal side effects 
 of substances used for traumatic nipple treatment .
  the contribution of peppermint to the treatment of traumatic nipples is similar to that of 
 lanolin and dexpanthenol .
therefore , peppermint could be considered as an effective 
 alternative to the treatment of traumatic nipples in patients willing to use herbal 
 medicines .
  hereby we express our gratitude to the personnel of bessat hospital , abbas abad and farabi 
 clinics in sanandaj , and the laboratory of pharmaceutics of tabriz school of pharmacy who 
 assisted us in preparing the medicines .
we also would like to thank the authorities of the 
 school of nursing and midwifery and research deputy of tabriz university of medical sciences 
 for their financial support and also other colleagues who aided us in the course of this 
 research .
 
 introduction : traumatic nipple is among the most common 
 problems of the breastfeeding period which leads to early cessation of breastfeeding . the 
 study aimed to compare the effects of the lanolin , peppermint , and dexpanthenol creams on 
 the treatment of traumatic nipples . 
 
 methods : this double - blind randomized controlled trial was 
 carried out on 126 breastfeeding mothers . 
 the mothers had visited at the health centers 
 and children s hospitals in sanandaj city . 
 the selected participants were randomly divided 
 into the following three groups of lanolin , peppermint , and dexpanthenol cream groups . 
 
 nipple pain was measured using the store scale while trauma was measured with the champion 
 scale . 
 analyses were carried out through the kruskal  
 wallis test , chi - square , anova , and 
 repeated measures anova by using spss software ver . 13 . 
 results : the result showed that the mean score of nipple 
 pain and nipple trauma at the prior to intervention stage , third , seventh , and fourteenth 
 days of intervention was not significantly different between three groups . 
 but , repeated 
 measures anova showed a significant difference in comparison of the four time periods of 
 intervention in each group . 
 conclusion : results of this study 
 revealed that the lanolin , 
 peppermint , and dexpanthenol medicines had similar therapeutic effects on traumatic 
 nipple . 
Introduction
Materials and methods
Results
Discussion
Conclusion
Acknowledgments
Ethical issues
Conflict of interest