Efficacy and Safety of Metformin Compared with Watchful Observation for Breast Fibroadenomas: A Randomized Controlled Assessor-Blinded Study from India
Abstract
Introduction: Breast fibroadenoma (FA) is the most common benign, painless, and solid mass in women of reproductive age and presents as a single or multiple masses located in the same or both breasts. No drug is approved for the treatment of breast FA as yet. Because of the estrogen-dependent and proliferative features of FA and the anti-proliferative and sex hormone-suppressing characteristics of metformin, we aimed to assess metformin for its clinical effectiveness in the treatment of breast FA. The primary objective was to evaluate the efficacy of metformin in comparison with watchful observation in reducing the number and size of breast lumps among patients of breast FA, whereas the secondary objective was to evaluate the safety of metformin used for the treatment of breast FA.
Methods: This was a hospital-based, prospective, two-arm, parallel design, assessor-blinded, randomized controlled trial. Pre-menopausal women aged 18-50 years and diagnosed with breast FA with a lump size < 5 cm were included in the study. Assessment of lump size was done under two categories: smaller mass (<2 cm) and larger mass (≥ 2 cm). One hundred and sixty-eight women were randomized into two groups in a 1:1 ratio to receive either 1000 mg of metformin daily or be put on watchful observation for 12 weeks. The study participants were followed for 24 weeks. Primary outcomes were mean change from baseline in size of the smallest and largest masses and in number of masses at 12 and 24 weeks, as…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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