Nature Communications (Oct 2024)

Ductal lavage followed by observation versus oral corticosteroids in idiopathic granulomatous mastitis: A randomized trial

  • Xiaolin Chen,
  • Heng Huang,
  • Hui Huang,
  • Juanjuan Yong,
  • Liling Zhu,
  • Qianru Chen,
  • Luyuan Tan,
  • Yinduo Zeng,
  • Yaping Yang,
  • Jianli Zhao,
  • Nanyan Rao,
  • Linxiaoxiao Ding,
  • Wenjing Wu,
  • Yudong Li,
  • Xiujuan Gui,
  • Liming Ye,
  • Yanlian Xu,
  • Yumei Jiang,
  • Linhong Su,
  • Qiaozhen Xiao,
  • Xueying Cai,
  • Tingting Hu,
  • Cui Tan,
  • Qiongmei Liu,
  • Shuyi Liu,
  • Jinghua Zhao,
  • Ying Wang,
  • Fengyan Yu,
  • Jian Zhang,
  • Shunrong Li,
  • Kai Chen

DOI
https://doi.org/10.1038/s41467-024-53143-2
Journal volume & issue
Vol. 15, no. 1
pp. 1 – 10

Abstract

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Abstract Oral corticosteroids represents the most prevalent treatment for idiopathic granulomatous mastitis. Ductal lavage with triamcinolone acetonide and antibiotics followed by observation (DL-OBS) has emerged as a novel strategy, but a comparison of them remains lacking. Here in this multicenter, open-label, non-inferiority, randomized trial (ClinicalTrials.gov identifier: NCT03724903), we assigned 140 patients to oral corticosteroids (N = 71) and DL-OBS (N = 69), stratified by baseline M-score. The primary outcome is complete Clinical Response rate at 1 year. The non-inferiority margin is −15%. The primary outcome is 85.5% in DL-OBS and 87.3% in oral corticosteroids (difference: −1.8%; 95%CI, 13.2 to 9.5; Pnon-inferiority = .01) in intention-to-treat population, and 92.6% vs 98.2% (difference −5.6%; 95%CI −13.4 to 2.2; Pnon-inferiority = .01) in per-protocol population, respectively. The most common (>15%) adverse events were Cushingoid, epigastric pain and arthralgia in oral corticosteroids, and irregular menstruation in DL-OBS, respectively. Here, we report that DL-OBS shows similar efficacy to oral corticosteroids but with better safety profile.