***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background A small , non-blinded , RCT ( r and omised controlled trial ) had reported that oral antibiotics reduced the incidence of mastitis in lactating women with Staphylococcus aureus ( S. aureus)- colonized cracked nipples . We aim ed to replicate the study with a more rigorous design and adequate sample size . Methods Our intention was to conduct a double-blind placebo-controlled trial to determine if an antibiotic ( flucloxacillin ) could prevent mastitis in lactating women with S. aureus-colonized cracked nipples . We planned to recruit two groups of 133 women with S. aureus-colonized cracked nipples . Results We spent over twelve months su bmi tting applications to five hospital ethics committees and seven funding bodies , before commencing the trial . Recruitment to the trial was very slow and only ten women were r and omized to the trial after twelve months , and therefore the trial was stopped early . Conclusions In retrospect we should have conducted a feasibility study , which would have revealed the low number of women in these Melbourne hospitals ( maternity wards and breastfeeding clinics ) with damaged nipples . The appropriate use of antibiotics for breastfeeding women with cracked nipples still needs to be tested Trial design A r and omised , parallel group , pragmatic trial . Setting A large UK maternity hospital . Participants Term infants < 2 weeks old with a mild or moderate degree of tongue-tie , and their mothers who were having difficulties breastfeeding . Objectives To determine if immediate frenotomy was better than st and ard breastfeeding support . Interventions Participants were r and omised to an early frenotomy intervention group or a ‘ st and ard care ’ comparison group .  Outcomes Primary outcome was breastfeeding at 5 days , with secondary outcomes of breastfeeding self-efficacy and pain on feeding . Final assessment was at 8 weeks ; 20 also had qualitative interviews . Research ers assessing outcomes , but not participants , were blinded to group assignment . Results 107 infants were r and omised , 55 to the intervention group and 52 to the comparison group . Five-day outcome measures were available for 53 ( 96 % ) of the intervention group and 52 ( 100 % ) of the comparison group , and intention-to-treat analysis showed no difference in the primary outcome —Latch , Audible swallowing , nipple Type , Comfort , Hold score .  Frenotomy did improve the tongue-tie and increased maternal breastfeeding self-efficacy . At 5 days , there was a 15.5 % increase in bottle feeding in the comparison group compared with a 7.5 % increase in the intervention group . After the 5-day clinic , 44 of the comparison group had requested a frenotomy ; by 8 weeks only 6 ( 12 % ) were breastfeeding without a frenotomy . At 8 weeks , there were no differences between groups in the breastfeeding measures or in the infant weight . No adverse events were observed . Conclusions Early frenotomy did not result in an objective improvement in breastfeeding but was associated with improved self-efficacy . The majority in the comparison arm opted for the intervention after 5 days BACKGROUND : Ankyloglossia has been associated with a variety of infant-feeding problems . Frenotomy commonly is performed for relief of ankyloglossia , but there has been a lack of convincing data to support this practice . OBJECTIVES : Our primary objective was to determine whether frenotomy for infants with ankyloglossia improved maternal nipple pain and ability to breastfeed . A secondary objective was to determine whether frenotomy improved the length of breastfeeding . METHODS : Over a 12-month period , neonates who had difficulty breastfeeding and significant ankyloglossia were enrolled in this r and omized , single-blinded , controlled trial and assigned to either a frenotomy ( 30 infants ) or a sham procedure ( 28 infants ) . Breastfeeding was assessed by a preintervention and postintervention nipple-pain scale and the Infant Breastfeeding Assessment Tool . The same tools were used at the 2-week follow-up and regularly scheduled follow-ups over a 1-year period . The infants in the sham group were given a frenotomy before or at the 2-week follow-up if it was desired . RESULTS : Both groups demonstrated statistically significantly decreased pain scores after the intervention . The frenotomy group improved significantly more than the sham group ( P < .001 ) . Breastfeeding scores significantly improved in the frenotomy group ( P = .029 ) without a significant change in the control group . All but 1 parent in the sham group elected to have the procedure performed when their infant reached 2 weeks of age , which prevented additional comparisons between the 2 groups . CONCLUSIONS : We demonstrated immediate improvement in nipple-pain and breastfeeding scores , despite a placebo effect on nipple pain . This should provide convincing evidence for those seeking a frenotomy for infants with signficant ankyloglossia BACKGROUND The negative outcomes associated with painful and damaged nipples have been widely documented in the breastfeeding literature . Numerous studies have been conducted evaluating topical preparations to treat nipple pain and damage with equivocal findings . No studies have evaluated the effectiveness of the increasingly popular all- purpose nipple ointment ( APNO ) . The purpose of this trial is to evaluate the effect of the APNO versus lanolin on nipple pain among breastfeeding women with damaged nipples . SUBJECTS AND METHODS A double-blind , r and omized controlled trial was conducted in a large single-site , tertiary-care hospital in Toronto , ON , Canada . Breastfeeding women ( n=151 ) identified as having damage to one or both nipples were r and omized to apply either APNO ( intervention group ) or lanolin ( control group ) to their nipples according to the trial protocol . The primary outcome was nipple pain at 1 week after r and omization measured using the Short Form McGill Pain Question naire . Additional outcomes at 1 week after r and omization and 12 weeks postpartum included nipple yeast symptoms and /or mastitis , rates of breastfeeding duration and exclusivity , and maternal satisfaction with infant feeding method and treatment ointment . RESULTS There were no significant group differences in mean pain scores at 1 week after r and omization . Women in the lanolin group reported significantly greater satisfaction with their infant feeding method and had nonsignificantly higher breastfeeding duration and exclusivity rates at 12 weeks postpartum . CONCLUSION Results suggest that APNO is not superior to lanolin in treating painful , damaged nipples Painful and /or damaged nipples associated with breastfeeding are common and represent a challenge for both the persons experiencing nipple pain and /or trauma and for those providing treatment . However , evidence -based data has been insufficient to demonstrably minimize these common reasons for failure to initiate or continue successful breastfeeding . The aim of this study was to evaluate the efficacy of specific- grade highly purified anhydrous ( HPA ) lanolin versus expressed breastmilk ( EBM ) for the treatment of painful and damaged nipples associated with breastfeeding in a prospect i ve controlled clinical trial evaluating 84 lactating mothers .  Nipple trauma and healing rates were rated by the Nipple Trauma Score . Nipple pain intensity was assessed on a visual analog scale . Outcome parameters were in favor of the HPA lanolin group , reaching statistical significance for healing rates , nipple trauma and nipple pain . In our study , we found HPA lanolin more effective than EBM , inducing faster healing of nipple trauma ( absolute risk reduction of 0.43 ) and reducing nipple pain ( absolute risk reduction of 0.61 on day 3 ) . We concluded that HPA lanolin , combined with breastfeeding education , was more effective than EBM , combined with breastfeeding education , in reducing nipple pain and promoting healing of nipple trauma Pre- and perinatal variables commonly found to predict breast-feeding duration were examined to see whether they also predicted breast-feeding problems in the first week postpartum . One hundred and twenty-eight families who prenatally committed to breast-feeding for at least 6 weeks comprised the sample . The families were r and omly assigned to one of two groups : a group in which bottle feedings would be avoided in Weeks 2–6 postpartum and a group in which approximately one bottle per day would be given during the same period .  Breastfeeding events most commonly experienced as problems in previous studies were also reported by mothers in this sample . Multiple regression analyses revealed that bottle use in the hospital , lower satisfaction with first breastfeeding , and group assignment were weakly predictive of the Breast-feeding Problem Score at 1 week , R2 = .154 , p = .0004 . The negative effect of hospital bottle use was greater for women in the bottle-restricted group than for women in the planned-bottle group The research undertaken in this study utilized a case-control group nested within a prospect i ve cohort which was followed for the first 3 months postpartum . Mothers with mastitis and their controls were requested to complete a self-report question naire design ed to investigate the association between the potential risk factors , identified from the literature , and lactation mastitis . Logistic regression analyses of the possible risk factors were performed separately for mothers who had not breastfed Obviously and those mothers who had breastfed at least one infant prior to this lactation/nalysis showed blocked duct(s ) and increased levels of stress were the significant pre icors for mastitis in mothers who had breastfed a previous infant and blocked duct(s ) , restriction from a tight bra , attachment difficulties , and nipple pain during a feed were the significant predictors for mastitis in first time breastfeeding mothers AIM This study investigated if a maternally reported , immediate improvement in breastfeeding following division of tongue-tie is due to a placebo effect . METHODS This r and omized controlled trial was conducted at Southampton General Hospital , Southampton , UK , in 2003 - 2004 . Sixty breastfed babies 5 - 115 days old ( mean , 32 days ; median , 23 days ) were r and omized to division ( Group A ) or non-division ( Group B ) . The mother and a trained observer were blinded and assessed breastfeeding before the intervention . Fifty-seven babies were analyzed because blinding failed in three of the babies in Group A. Following the intervention , the mother 's and observer 's views were noted , and then those infants allocated to non-division had their tongue-tie divided . RESULTS Seventy-eight percent ( 21 of 27 ) of mothers in Group A reported an immediate improvement in feeding following the intervention , compared with 47 % ( 14 of 30 ) in Group B ( two-tailed χ(2 ) p<0.02 ; 95 % confidence interval , 6 - 51 % ) . At 1-day follow-up , 90 % ( 54 of 60 ) reported improved feeding following division . At 3-month follow-up , 92 % ( 54 of 59 ) still reported improved feeding , with 51 % ( 30 of 59 ) continuing to breastfeed . CONCLUSIONS There is a real , immediate improvement in breastfeeding , detectable by the mother , which is sustained and does not appear to be due to a placebo effect BACKGROUND Sore nipples are common during lactation and remain the major reason for failing to establish successful breastfeeding . To formulate a peppermint gel and to evaluate its effect on the prevention of nipple crack associated with breast-feeding , a r and omized double-blinded clinical trial comparing the above formulation with modified lanolin and a neutral ointment was carried out . MATERIAL / METHODS Two hundred and sixteen primiparous participants were assigned r and omly to three groups . Each group applied only one of the above three preparations on both breasts for 14 days . Each group consisted of 72 primiparous mothers and was seen for a maximum of four follow-up visits within 14 days and a final visit at week 6 . The rate of nipple and areola crack and pain was evaluated . RESULTS The study groups were comparable in mean age and route of delivery . Nipple crack were less in mothers who received peppermint gel than in those who received lanolin ointment or placebo ( chi(2)=16.8 , df=6 , P=0.01 ) . Relative risk of nipple crack in the lanolin group ( RR : 2.41 , 95%CI : 1.20 - 3.01 ) was higher than in the peppermint group ( RR : 1.85 , 95%CI : 1.64 - 3.10 ) . CONCLUSIONS Prophylactic peppermint gel in breastfeeding lactating women is associated with fewer nipple cracks and is more effective than lanolin and placebo . It could be recommended for preventing of nipple crack along with teaching better breastfeeding technique at the initiation of breastfeeding PURPOSE Ankyloglossia ( " tongue-tie " ) occurs in nearly 5 % of neonates , but its clinical significance relating to breast-feeding difficulties is controversial . We tested the hypothesis that in infants with ankyloglossia referred because of breast-feeding difficulties , frenotomy alleviates the symptoms . METHODS Twenty-five mothers of healthy infants with ankyloglossia were recruited because of sore nipples . Infants were r and omized to either of 2 sequences : ( 1 ) frenotomy , breast-feeding , sham , breast-feeding ( n = 14 ) or ( 2 ) sham , breast-feeding , frenotomy , breast-feeding ( n = 11 ) . The mothers as well as all personnel taking care of the child after each sham or frenotomy procedure were masked as to the study sequence . In every sequence , and after each sham or frenotomy procedure , a st and ardized latch score and pain score were obtained from the mother 
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We did not pool data for other outcomes due to either heterogeneity in outcome measures or differing interventions .There was no evidence that glycerine gel dressings or breast shells with lanolin significantly improved nipple pain .
However , this beneficial effect was not maintained after six to seven days of treatment .
There were no group differences in nipple pain perceptions at any assessment between women who applied expressed breast milk and women who applied nothing .
Women who applied an " all- purpose nipple ointment " , in comparison to women who applied lanolin , had no improvement in nipple pain after seven days of treatment .
There was insufficient evidence that glycerine gel dressings , lanolin with breast shells , lanolin alone , expressed breast milk , or all- purpose nipple ointment improved maternal perceptions of nipple pain .
Overall , there was insufficient evidence to recommend any intervention for the treatment of nipple pain .
However , one important finding was that regardless of the treatment used , for most women nipple pain reduced to mild levels after approximately seven to 10 days ' postpartum .
The provision of anticipatory guidance regarding usual time to pain reduction may be a useful strategy in assisting women to continue to breastfeed and to do so exclusively .
There was insufficient evidence that glycerine gel dressings , breast shells with lanolin , lanolin alone , or the all- purpose nipple ointment significantly improved maternal perceptions of nipple pain .
The results from these four trials of good method ological quality suggested that applying nothing or just expressed breast milk may be equally or more beneficial in the short-term experience of nipple pain than the application of an ointment such as lanolin .