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Comparison of Topical, Systemic, and Combined Therapy with Steroids on Idiopathic Granulomatous Mastitis: A Prospective Randomized Study

  • Kenan ÇetinEmail author
  • Hasan E. Sıkar
  • Nuri E. Göret
  • Günay Rona
  • Nagehan Ö. Barışık
  • Hasan F. Küçük
  • Bahadır M. Gulluoglu
Original Scientific Report

Abstract

Background

Idiopathic granulomatous mastitis (IGM) is a benign disorder of the breast, for which the optimal treatment modality remains missing.

Methods

A total of 124 patients with a histopathologically proven diagnosis of IGM were enrolled in a prospective, randomized parallel arm study. Patients were treated with topical steroids in Group T (n: 42), systemic steroids (0.8 mg/kg/day peroral) in Group S (n: 42), and combined steroids (0.4 mg/kg/day peroral + topical) in Group C (n: 40). Compliance with the therapy, response to the therapy, the duration of therapy, side effects and the recurrence rates were compared.

Results

Sixteen patients did not comply with the treatment, and the highest ratio of compliance with therapy was seen in Group T (p < 0.05). Complete clinical regression (CCR) was observed in 90 (83.3%) patients. Response to the treatment (RT) was evaluated radiologically and observed in 89.8% of the patients. There was no statistically significant difference between groups regarding CCR, RT and the recurrence rate. The longest duration of therapy was observed in Group T (22 ± 9.1-week), whereas the shortest was observed in Group S (11.7 ± 5.5-week) (p < 0.001). The systemic side effects were significantly lower in Group T in comparison with Groups S and C (2.4% vs. 38.2% and 30.3%, respectively) (p < 0.001).

Conclusions

The efficiency of the treatment was similar for all groups, both clinically and radiologically. Although the duration of therapy was longer in Group T, the lack of systemic side effects increased the compliance of the patients with the therapy. Therefore, topical steroids would be among first-line treatment options of IGM.

Notes

Acknowledgements

We appreciated our breast care nurse Mrs. Gülşen Akça’s assistance and efforts during the management and surveillance of the patients.

Compliance with ethical standards

Conflict of interest

Author K.Ç. declares that he has no conflict of interest. Author H.E.S. declares that he has no conflict of interest. Author N.E.G. declares that he has no conflict of interest. Author G.R. declares that she has no conflict of interest. Author N.Ö.B. declares that she has no conflict of interest. Author H.F.K. declares that he has no conflict of interest. Author B.M.G. declares that he has no conflict of interest.

Ethical approval

All procedures performed in studies involving human participant were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study protocol was approved by Dr. Lutfi Kirdar Kartal Research and Training Hospital in affiliation with the University of Health Sciences’ ethics committee.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Copyright information

© Société Internationale de Chirurgie 2019

Authors and Affiliations

  1. 1.Department of General SurgeryUniversity of Health Sciences, Kartal Dr. Lutfi Kirdar Training and Research HospitalIstanbulTurkey
  2. 2.Department of RadiologyUniversity of Health Sciences, Kartal Dr. Lutfi Kirdar Training and Research HospitalIstanbulTurkey
  3. 3.Department of PathologyUniversity of Health Sciences, Kartal Dr. Lutfi Kirdar Training and Research HospitalIstanbulTurkey
  4. 4.Breast and Endocrine Surgery Unit, Department of General SurgeryMarmara University School of MedicinePendik, IstanbulTurkey
  5. 5.Department of Breast SurgerySENATURK (Turkish Academy of Breast Sciences)Kadikoy, IstanbulTurkey

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