Protocol for a randomized controlled trial of steroid versus methotrexate as first-line monotherapy in the management of idiopathic granulomatous mastitis.

ABSTRACT:

Background

Idiopathic granulomatous mastitis (IGM) is a rare inflammatory breast disease affecting mainly young to middle aged women. Its aetiology is idiopathic and poorly understood, but recent evidence supports its autoimmunity pathogenesis. This pathogenesis supports the current first line treatment involving steroid monotherapy or steroid combination therapy with methotrexate, however, there is no single well-established treatment protocol that has been shown to most effectively cure the disease. Thus, this prospective, open, two arm randomised controlled trial comparing the effectiveness of steroid versus methotrexate therapy in the treatment of IGM patients was developed, with the hypothesis that methotrexate has a higher 6-months clinical complete response and radiologicall

SUBMITTER: Goh SSN 

PROVIDER: S-EPMC12558474 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature