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  • The international trend to overdiagnosis and overtreatment affects clinical approaches to lactation-related inflammation of the breast stroma
  • The pathogenic microbiota theory of breast inflammation lacks biological plausibility
  • ABM Clinical Protocol #36's distinction between inflammatory vs bacterial mastitis is unhelpful and promotes overuse of antibiotics
  • Diagnoses of subacute or subclinical mastitis and mammary dysbiosis don't help breastfeeding patients in the clinic, but promote antibiotic overuse or inappropriate treatments
  • Critiquing the scientific methods used to collate the Academy of Breastfeeding Medicine's Clinical Protocol #36 'The mastitis spectrum'

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  • S8: Lactation-related breast inflammation
  • CH 9: How to avoid overdiagnoses and unhelpful treatments when managing breast inflammation
  • PT 9.1: Academy of Breastfeeding Medicine Clinical Protocol #36 drives overdiagnoses and overtreatments of breast inflammation

The international trend to overdiagnosis and overtreatment affects clinical approaches to lactation-related inflammation of the breast stroma

Dr Pamela Douglas23rd of Jun 202416th of Jul 2025

breastfeeding; lactation; baby breastfeeds; breast inflammation; cancer; malignancy

There is a worsening international problem of overdiagnosis and overtreatment

Despite the known benefits of breastfeeding for both infant and mother, clinical interventions for problems such as breast inflammation and pain remain a research frontier.1,2

Overuse of medical, surgical and pharmaceutical interventions is an increasingly serious international problem in health care more broadly.3-11 Both patients and clinicians typically overestimate the benefits of medical interventions and underestimate potential harms.12-14

Overdiagnosis and overtreatment is widespread in the treatment of breast inflammation during lactation

Overdiagnosis and overtreatment is already documented in response to problems of unsettled infant behaviour and breastfeeding.15-26 It not surprising, given the relative lack of research into clinical breastfeeding support, that overmedicalisation and overtreatment have stepped into this gap, to become significant problems in the care of breastfeeding women and their babies, including when clinical breast inflammation emerges. Overmedicalisation and overtreatment are inevitable when research or clinical problems are responded to using a reductionist or medicalised lens.

The recommendations made in the Academy of Breastfeeding Medicine's Clinical Protocol #36 The mastitis spectrum in 2022 have resulted in rapid growth in businesses specialising in breastfeeding inflammation treatments, though many of the various treatments offered either lack a robust evidence-base or have been shown to be ineffective.27 You can find out about various of Clinical Protocol's #36's recommendations which have been shown not to work or which lack a physiological rationale here, here and here.28-30

The lack of evaluation studies equally applies to the NDC Clinical Guidelines for Lactation-related Breast Inflammation, which aim to minimise unnecessary diagnoses and interventions. However, the NDC clinical translations are developed from robust theoretical modelling and physiological rationale. You can read more about NDC and implementation science here. See what you think!

Multiple diagnoses are popularly used for the spectrum of benign lactation-related breast inflammation. These diagnoses now include phlegmon, mammary candidiasis, subacute mastitis, subclinical mastitis, infective mastitis, inflammatory mastitis, and white spots. The NDC guidelines don't use the diagnoses listed in the previous sentence, due to lack of physiological rationale or benefit, or because they typically increase the risk of unnecessary antibiotic prescriptions, in the context of what has been described as the slow-motion catastrophe of antimicrobial resistance.23

You can find out more about antibiotic overuse here and about redundant diagnoses which also promote overuse of antibiotics here.

Selected references

Care of breastfeeding mothers and babies is a research frontier

  1. Stuebe AM. We need patient-centred research in breastfeeding medicine. Breastfeeding Medicine. 2021;16(4):349-350.

  2. Rey J. Frontier research: bringing the future closer. Lychnos: Notebooks of the Fundacion Generale CSIC. 2011;5(June):https://fgcsic.es/lychnos/en_en/forum/frontier_research_bringing_the_future_closer.

Calls to address the worsening international problem of overdiagnosis and overtreatment

  1. Brownlee S, Chalkidou K, Doust J, Elshaug AG, Glasziou P, Heath I, et al. Evidence for overuse of medical services around the world. The Lancet. 2017;390:156–168.

  2. Saini V, Brownlee S, Elshaug AG, Glasziou P, Iona Health. Addressing overuse and underuse around the world. The Lancet. 2017;doi:http://dx.doi.org/10.1016/50140-6736(16)32753-9.

  3. Armstrong N. Overdiagnosis and overtreatment: a sociological perspective on tackling a contemporary healthcare issue. Sociology of Health and Illness. 2020;43(1):58-64.

  4. Born KB, Levinson W. Choosing Wisely campaigns globally: a shared approach to tackling the problem of overuse in healthcare. Journal of General Family Medicine. 2019;20(1):9-12.

  5. Brownlee S, Chalkidou K, Doust J, Elshaug AG, Glasziou P, Heath I, et al. Evidence for overuse of medical services around the world. The Lancet. 2017;390:156–168.

  6. Coon ER, Quinonez RA, Moyer VA, Schroeder AR. Overdiagnosis: how our compulsion for diagnosis may be harming children. Pediatrics. 2014;134(5):1-11.

  7. Gupta P, Gupta M, Koul N. Overdiagnosis and overtreatment; how to deal with too much medicine. Journal of Family Medicine and Primary Care. 2020;9:3815-3819.

  8. Stordal K, Wyder C, Trobisch A, Grossman Z. Overtesting and overtreatment - statement from the European Academy of Paediatrics (EAP). European Journal of Pediatrics. 2019;178(12):1923-1927.

  9. Treadwell J. Overdiagnosis and overtreatment: generalists - it's time for a grassroots revolution. Journal of General Practice. 2016;66(644):116-117.

Both patients and clinicians overestimate the benefits of interventions and underestimate side-effects

  1. Hoffman T, Del Mar C. Patients' expectations of the benefits and harms of treatments, screening and tests - a systematic review. JAMA Internal Medicine. 2015;175(2):274-286.

  2. Hoffman T, Del Mar C. Clinicians' expectations of the benefits and harms of treatments, screening, and tests - a systematic review. JAMA Internal Medicine. 2017;177(3):407-419.

  3. Hanoch Y, Rolison J, Freund AM. Reaping the benefits and avoiding the risks: unrealistic optimism in the health domain. Risk Analysis. 2018;39(4):792-804.

The problem of overdiagnosis and overtreatment in the care of parents with babies

  1. Douglas PS, Geddes DB. Practice-based interpretation of ultrasound studies leads the way to less pharmaceutical and surgical intervention for breastfeeding babies and more effective clinical support. Midwifery. 2018;58:145–155.

  2. Douglas P. Diagnosing gastro-oesophageal reflux disease or lactose intolerance in babies who cry alot in the first few months overlooks feeding problems. J Paediatr Child Health. 2013;49(4):e252-e256.

  3. Kapoor V, Douglas PS, Hill PS, Walsh L, Tennant M. Frenotomy for tongue-tie in Australian children (2006-2016): an increasing problem. MJA. 2018:88-89.

  4. Wei E, Tunkel D, Boss E, Walsh J. Ankyloglossia: update on trends in diagnosis and management in the United States, 2012-2016. Otolaryngology - Head and Neck Surgery. 2020:https://doi.org/10.1177%1172F0194599820925415.

  5. Lisonek M, Shiliang L, Dzakpasu S, Moore AM, Joseph KS. Changes in the incidence and surgical treatment of ankyloglossia in Canada. Paedaitrics and Child Health. 2017;22(7):382-386.

  6. Douglas PS. Overdiagnosis and overtreatment of nipple and breast candidiasis: a review of the relationship between the diagnosis of mammary candidiasis and Candida albicans in breastfeeding women. Women's Health. 2021;17:DOI: 10.1177/17455065211031480.

  7. Ellehauge E, Jensen JS, Gonhoj C, Hjuler T. Trends of ankyloglossia and lingual frenotomy in hospital settings among children in Denmark. Danish Medical Journal. 2020;67(5):A01200051.

  8. Douglas PS. Re-thinking lactation-related nipple pain and damage. Women's Health. 2021:DOI: 10.1177/17455057221087865.

  9. Douglas PS. Re-thinking benign inflammation of the lactating breast: classification, prevention, and management. Women's Health. 2022;18:17455057221091349.

  10. Douglas P, Hill P. Managing infants who cry excessively in the first few months of life. BMJ. 2011;343:d7772.

  11. Douglas PS. Excessive crying and gastro-oesophageal reflux disease in infants: misalignment of biology and culture. Med Hypotheses. 2005;64:887-898.

  12. Douglas PS, Hill PS. A neurobiological model for cry-fuss problems in the first three to four months of life. Med Hypotheses. 2013;81:816-822.

The problem of overdiagnosis and overtreatment in lactation-related breast inflammation

  1. Mitchell KB, Johnson HM, Rodriguez JM, Eglash A, Scherzinger C, Cash KW, et al. Academy of Breastfeeding Medicine Clinical Protocol #36: The Mastitis Spectrum, Revised 2022. Breastfeeding Medicine. 2022;17(5):360-375.

  2. Douglas PS. Does the Academy of Breastfeeding Medicine Clinical Protocol #36 'The Mastitis Spectrum' promote overtreatment and risk worsened outcomes for breastfeeding families? Commentary. International Breastfeeding Journal. 2023;18:Article no. 51 https://doi.org/10.1186/s13006-13023-00588-13008.

  3. Douglas PS. Author's response to Comment on: Rethinking lactation-related breast inflammation: classification, prevention and management Women's Health. 2023;19:17455057231166452.

  4. Lesho EP, Laguio-Vila M. The slow-motion catastrophe of antimicrobial resistance and practical interventions for all prescribers. Mayo Clinic Proceedings. 2019;94(6):1040-1047.

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Next up in Academy of Breastfeeding Medicine Clinical Protocol #36 drives overdiagnoses and overtreatments of breast inflammation

The pathogenic microbiota theory of breast inflammation lacks biological plausibility

lactation; breastfeeding; human milk microbiome; breast inflammation; mastitis; baby breastfeeds

The early pathogenic microbiota theory of breast inflammation

By the 1980s a disease-centric view of human milk had taken hold. Because human milk was believed to be sterile, any bacteria cultured from milk was considered to be either infective or contaminant washed back from the infant oral cavity and maternal skin.1, 2 Applying this pathogenic model of breast inflammation, antibiotics were commenced if

  1. Signs and symptoms of mastitis, however defined, persist for more than 12-24 hours;

  2. The woman has concurrent nipple damage; or

  3. The woman feels acutely unwell, for example, with fever.3-5

'Blocked' ducts were believed to be caused by…

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Possums acknowledges the traditional owners of the lands upon which The Possums Programs have been created, the Yuggera and Turrbal Peoples. We acknowledge that First Nations have breastfed, slept with, and lovingly raised their children on Australian lands for at least 65,000 years, to become the oldest continuous living culture on Earth. Possums stands with the Uluru Statement from the Heart.