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TITLE: Management of Cracked in Breastfeeding Women: Clinical Evidence and Guidelines

DATE: 16 December 2010

RESEARCH QUESTIONS

1. What is the clinical effectiveness of the available ointments and for the management of cracked nipples in breastfeeding women?

2. What are the evidence-based guidelines for the management of cracked nipples in breastfeeding women?

KEY MESSAGE

The evidence identified regarding the effectiveness of topical treatments presented mixed conclusions; guidelines suggest the application of expressed for the management of cracked nipples in breastfeeding women.

METHODS

A limited literature search was conducted on key health technology assessment resources, including PubMed, the Cochrane Library (Issue 12, 2010), University of York Centre for Reviews and Dissemination (CRD) databases, ECRI (Health Devices Gold), EuroScan, international health technology agencies, and a focused Internet search. The search was limited to English language articles published between January 1, 2005 and December 7, 2010. For question #1, no filters were applied to limit the retrieval by study type. For question #2, a filter was applied to limit the retrieval by guidelines. Internet links were provided, where available.

The summary of findings was prepared from the abstracts of the relevant information. Please note that data contained in abstracts may not always be an accurate reflection of the data contained within the full article.

Disclaimer: The Health Technology Inquiry Service (HTIS) is an information service for those involved in planning and providing health care in . HTIS responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. HTIS responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report.

Copyright: This report contains CADTH copyright material and may contain material in which a third party owns copyright. This report may be used for the purposes of research or private study only. It may not be copied, posted on a web site, redistributed by email or stored on an electronic system without the prior written permission of CADTH or applicable copyright owner.

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RESULTS

Rapid response reports are organized so that the higher quality evidence is presented first. Therefore, health technology assessment reports, systematic reviews, and meta-analyses are presented first. These are followed by randomized controlled trials, non-randomized studies, and evidence-based guidelines.

OVERALL SUMMARY OF FINDINGS

One systematic review1 and four comparative studies2-5 were identified examining the effectiveness of different topical preparations for the prevention and treatment of painful or cracked nipples in breastfeeding women. The studies presented mixed results and are summarized in Table 1. The included systematic review1 found none of the topical treatments to be superior. Two studies2,3 found peppermint preparations to be helpful in preventing cracked and sore nipples.

Two evidence-based guidelines6,7 were identified. Limited evidence was available to develop recommendations regarding the use of topical preparations for the prevention and treatment of painful or cracked nipples in breastfeeding women. Both guidelines recommend that expressed be applied to the nipples to treat sore or cracked nipples.

Table 1: Topical treatments for pain Study Study type Indications Interventions Results Morland-Schultz SR Prevention EBM, lanolin, vitamin No single topical treatment (2005)1 and A, dexpanthenol, demonstrated superior ability treatment hydrogel therapy, to relieve discomfort. glycerin gel therapy Melli et al. (2007)2 RCT Prevention Peppermint gel, lanolin Fewer nipple cracks were ointment, placebo gel observed in patients using peppermint gel. Sayyah et al. RCT Prevention Peppermint , Fewer nipple cracks and less (2007)3 EBM pain observed in patients using peppermint water. Mohammadzeadeh RCT Treatment EBM, lanolin + Healing time was longer for et al. (2005)4 cleaning, no treatment patients in the lanolin group. The authors suggested EBM be used for treatment of sore nipples Abou-Dakn et al. NRS Treatment EBM, lanolin A statistically significant (2010)5 difference was found in healing rates and nipple pain in favour of lanolin. EBM = expressed breast milk; NRS = non-randomized study; RCT = randomized controlled trial; SR =

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REFERENCES SUMMARIZED

Health technology assessments No literature identified.

Systematic reviews and meta-analyses

1. Morland-Schultz K, Hill PD. Prevention of and therapies for nipple pain: a systematic review. J Obstet Gynecol Neonatal Nurs. 2005 Jul;34(4):428-37. PubMed: PM16020410

Randomized controlled trials

2. Melli MS, Rashidi MR, Nokhoodchi A, Tagavi S, Farzadi L, Sadaghat K, et al. A randomized trial of peppermint gel, lanolin ointment, and placebo gel to prevent nipple crack in primiparous breastfeeding women. Med Sci Monit. 2007 Sep;13(9). PubMed: PM17767120

3. Sayyah MM, Rashidi MR, Delazar A, Madarek E, Kargar Maher MH, Ghasemzadeh A, et al. Effect of peppermint water on prevention of nipple cracks in lactating primiparous women: a randomized controlled trial. Int Breastfeed J. 2007;2:7 [cited 2010 Dec 15]. PubMed: PM17442122 Full-text available from: http://www.internationalbreastfeedingjournal.com/content/pdf/1746-4358-2-7.pdf

4. Mohammadzadeh A, Farhat A, Esmaeily H. The effect of breast milk and lanolin on sore nipples. Saudi Med J. 2005 Aug;26(8):1231-4. PubMed: PM16127520

Non-randomized studies

5. Abou-Dakn M, Fluhr JW, Gensch M, Wockel A. Positive Effect of HPA Lanolin versus Expressed Breastmilk on Painful and Damaged Nipples during . Skin Pharmacol Physiol. 2010 Aug 18;24(1):27-35 [cited 2010 Dec 15]. PubMed: PM20720454 Full-text available from: http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowPDF&ArtikelNr=000318 228&Ausgabe=254379&ProduktNr=224194&filename=000318228.pdf

Guidelines and recommendations

6. National Guideline Clearinghouse [Internet]. Rockville (MD): National Guideline Clearinghouse; c2010-. Model breastfeeding policy (revision 2010); 2010 [cited 2010 Dec 15]. Summary available from: http://www.guideline.gov/content.aspx?id=24013 Note: see recommendation #18

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7. Toronto . Breastfeeding protocols for health care providers [Internet]. Toronto (ON): City of Toronto; 2007 [cited 2010 Dec 15]. Available from: http://www.toronto.ca/health/breastfeeding/pdf/protocols.pdf Note: see Nipple creams, gels and ointments, page 33

PREPARED BY: Canadian Agency for Drugs and Technologies in Health Tel: 1-866-898-8439 www.cadth.ca

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APPENDIX – FURTHER INFORMATION:

Guidance documents

8. Maternity guidelines, protocols, policies and pamphlets [Internet]. Victoria, Australia: Grampians Region Health Collaborative. Breastfeeding challenges: nipple problems; 2009 [cited 2010 Dec 15]. Full-text available under ‘Breastfeeding and Feeding’ section: http://www.grampianshealth.org.au/index.php?option=com_content&view=article&id=66&It emid=65 Note: see Treatment for Nipples, page 2

9. Guidelines on the treatment, management and prevention of [Internet]. Belfast, Ireland: Guidelines and Audit Implementation Network (GAIN); 2009 [cited 2010 Dec 15]. Available from: http://www.gain- ni.org/Library/Guidelines/GAIN%20Mastitis%20Guidelines.pdf Note: see Cracked Nipples, page 14

10. Committee on Health Care for Underserved Women, American College of Obstetricians and Gynecologists. ACOG Committee Opinion No. 361: Breastfeeding: maternal and infant aspects. Obstet Gynecol. 2007 Feb;109(2 Pt 1):479-80 [cited 2010 Dec 15]. PubMed: PM17267864 Full-text available from: http://www.acog.org/departments/underserved/clinicalReviewv12i1s.pdf Note: see Nipple Pain, page 10s

Review articles

11. Lochner JE, Livingston CJ, Judkins DZ. Clinical inquiries: Which interventions are best for alleviating nipple pain in nursing ? J Fam Pract. 2009 Nov;58(11):612a-c. PubMed: PM19891933

12. Joanna Briggs Institute. The Management of nipple pain and/or trauma associated with breastfeeding: best practice. [Internet]. South Australia: Joanna Briggs Institute; 2009;13(4) [cited 2010 Dec 15]. Available from: http://www.joannabriggs.edu.au/pdf/BPISEng_13_4.pdf

Additional references

13. Breastfeeding: sore and nipples [Internet]. Children, Youth and Women’s Health Service, Government of South Australia; Adelaide, South Australia; 2010 [cited 2010 Dec 15]. Available from: http://www.cyh.com/HealthTopics/HealthTopicDetails.aspx?p=114&np=302&id=2140

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