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From Hypothesis to Robust Evidence in a Nationwide Multicenter Case–Control Study on 1490 Women: Milk Stasis and Idiopathic Granulomatous Mastitis Publisher Pubmed



Alipour S ; Tabatabaian M ; Aziminezhadan P ; Boloorinejad P ; Orouji A ; Farbod M ; Nafissi N ; Madani F ; Saberi A ; Mazinani A ; Daneshpazhooh M ; Omranipour R ; Hosseinpour R ; Familamir P Show All Authors
Authors
  1. Alipour S
  2. Tabatabaian M
  3. Aziminezhadan P
  4. Boloorinejad P
  5. Orouji A
  6. Farbod M
  7. Nafissi N
  8. Madani F
  9. Saberi A
  10. Mazinani A
  11. Daneshpazhooh M
  12. Omranipour R
  13. Hosseinpour R
  14. Familamir P
  15. Sarkardeh M
  16. Tavakol M
  17. Assarian A
  18. Eslami B

Source: Scientific Reports Published:2025


Abstract

Idiopathic granulomatous mastitis (IGM) is rare globally and infrequent in some middle-east regions. Sex-hormonal factors have been mentioned as predisposing factors for IGM, recent large-sale studies indicate a 7.5-fold increased risk in women who have breastfed. This study investigates BF-related factors that contribute to IGM development. We conducted a multicenter case–control study and recorder BF-related events in 730 IGM patients and healthy 760 controls. The mean age of participants was 36.63 ± 6.49 in the Case and 36.96 ± 6.11 years in the Control Group (p = 0.31). IGM occurred more frequently in the contralateral breast in one-sided BF (p < 0.001), with discordance between the affected side and BF side in 68.3% of cases (p = 0.005). Multivariate analysis revealed significant associations between IGM and one-sided BF (OR = 4.21), post-weaning breast engorgement (OR = 3.06), lactational mastitis (OR = 1.93), and oral medication use for infants (OR = 2.59). The study achieved 100% statistical power for both primary and secondary objectives, with narrow confidence intervals indicating high precision. This study provides robust evidence supporting the milk stasis hypothesis, demonstrating that BF-related issues leading to milk stasis are strongly associated with IGM development. Preventive strategies to minimize milk stasis and encourage bilateral BF may help reduce IGM risk. © 2025 Elsevier B.V., All rights reserved.