{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Chen X"],"funding":["Guangzhou Science, Technology and Innovation Commission (Bureau of Science and Information Technology of Guangzhou Municipality)","Sun Yat-sen University (SYSU)","Natural Science Foundation of Guangdong Province (Guangdong Natural Science Foundation)","National Natural Science Foundation of China (National Science Foundation of China)"],"pagination":["9144"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11500097"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["15(1)"],"pubmed_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; P<sub>non-inferiority</sub> = .01) in intention-to-treat population, and 92.6% vs 98.2% ("],"journal":["Nature communications"],"pubmed_title":["Ductal lavage followed by observation versus oral corticosteroids in idiopathic granulomatous mastitis: A randomized trial."],"pmcid":["PMC11500097"],"funding_grant_id":["#2019A1515011467, #2019A1515110075 and #2021A1515012361","#202102010221","#82271650","#SYS-Q-202002, #20180233"],"pubmed_authors":["Hu T","Zhang J","Huang H","Yu F","Su L","Liu Q","Liu S","Gui X","Ding L","Jiang Y","Chen X","Wu W","Wang Y","Zhao J","Rao N","Tan L","Chen Q","Chen K","Tan C","Zeng Y","Xiao Q","Ye L","Li Y","Yang Y","Li S","Yong J","Zhu L","Cai X","Xu Y"],"additional_accession":[]},"is_claimable":false,"name":"Ductal lavage followed by observation versus oral corticosteroids in idiopathic granulomatous mastitis: A randomized trial.","description":"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; P<sub>non-inferiority</sub> = .01) in intention-to-treat population, and 92.6% vs 98.2% (","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Oct","modification":"2026-07-15T08:05:29.682Z","creation":"2025-04-04T02:57:23.917Z"},"accession":"S-EPMC11500097","cross_references":{"pubmed":["39443446"],"doi":["10.1038/s41467-024-53143-2"]}}