Metformin in the management of fibrocystic breast disease: a placebo-controlled randomized clinical trial.

Content Provider	Europe PMC
Author	Alipour, Sadaf Rastad, Hadith Saberi, Azin Faiz, Firoozeh Maleki-Hajiagha, Arezoo Abedi, Mahboubeh
Abstract	Background and PurposeFibrocystic disease (FCD) of the breast as a very common health problem in women has estrogen-dependent and proliferative features. No effective management strategy has been validated for this disorder, so far. The anti-hyperglycemic agent metformin has both anti-proliferative and estrogen-suppressing effects. Thus, we investigated metformin as a management strategy for FCD.MethodsThe study was a double-blind placebo-controlled randomized clinical trial. Premenopausal women with FCD according to history, physical exam and ultrasound, who had measurable microcyst clusters on ultrasound (US) were entered the study. Oral placebo and metformin tablets (500 mg) were used twice daily by participants in the intervention and control groups. Size and number of microcyst clusters on US and the subjective pain score were recorded before and after the intervention.Results154 participants were randomly allocated into two groups of 77 interventions and 77 controls. The decrease in size of the largest microcyst cluster in each patient and the mean decrease in number of microcyst clusters were not statistically significant (P = 0.310 and P = 0.637, respectively). However, those microcyst clusters which were ≥ 14 mm became significantly smaller after metformin use (P = 0.006). Additionally, in the subset of participants with pain at baseline, a larger proportion in the intervention group experienced at least 50% reduction in pain score (63.8% (30/47) in the intervention vs. 44.2% (19/43) in the placebo groups, P = 0.031).ConclusionOur study showed that metformin might be effective in the management of FCD. Further studies are proposed for confirmation of this subject.Graphical abstract
Related Links	https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC8557102&blobtype=pdf
ISSN	15608115
Journal	DARU Journal of Pharmaceutical Sciences [Daru]
Volume Number	29
DOI	10.1007/s40199-021-00424-6
PubMed Central reference number	PMC8557102
Issue Number	2
PubMed reference number	34719004
e-ISSN	20082231
Language	English
Publisher	Springer International Publishing
Publisher Date	2021-10-31
Publisher Place	Gewerbestrasse 11, Cham, Ch 6330, Switzerland
Access Restriction	Open
Rights License	© Springer Nature Switzerland AG 2021
Content Type	Text
Resource Type	Article
Subject	Medicine Drug Discovery Pharmacology