Comparison of the effect of surgical and medical therapy for the treatment of idiopathic granulomatous mastitis

BACKGROUND: Idiopathic granulomatous mastitis (IGM) is defined as a rare, inflammatory, chronic and benign disease mimicking malignant hyperplasia of mammary glands. There is no definitive therapeutic strategy for IGM; nevertheless, some approaches can be exploited as beneficial strategies. In this study, the surgery strategy was compared with coincident treatment with azithromycin and corticosteroid in IGM patients. MATERIALS AND METHODS: This study was implemented as clinical trial during 2011-2013 in Isfahan, Iran. The target population comprised women whose IGM was substantiated. The medical group consisted of 20 patients, which were compared with a historical control group treated through surgical approach. Surgical group comprised 39 patients. Partial mastectomy was implemented in the surgical group whereas treatment protocol comprising azithromycin and prednisolone administered in medical group. Recurrence of mass was followed for 12 months. Fischer exact test, Chi-square test, Mann-Whitney and regression tests were applied for statistical analysis. This study was registered in Iranian Registry of clinical trial (IRCT number: IRCT 2013123015999N1). RESULTS: No significant differences were recognized in side of lesions, lymphadenopathy, fever and pain; however, number of abscesses, number of lesions and size of lesions were significantly higher in the surgical group (P < 0.0001). Furthermore, probability of relapse correlated with the number of lesions, (odds ratio = 24.67 confidence interval [CI] = 2.2-269.3), whereas methods of IGM treatment did not contribute to the likelihood of relapse (odds ratio = 12.5 CI = 0.52-299). CONCLUSION: This clinical trial demonstrated that pharmaceutical treatment has appropriate efficacy, in treatment and prevention of IGM relapse. Moreover, this study presented hazf gardad number of the lesions as the most appropriate criteria for IGM prognosis, thus the probability of relapse decreases whether earlier IGM recognizing could be implemented.