Metformin as a new option in the medical management of breast fibroadenoma; a randomized clinical trial.
Breast Ultrasonography
Fibroadenoma
Fibrocystic Breast Disease
Metformin
Therapy
Journal
BMC endocrine disorders
ISSN: 1472-6823
Titre abrégé: BMC Endocr Disord
Pays: England
ID NLM: 101088676
Informations de publication
Date de publication:
20 Aug 2021
20 Aug 2021
Historique:
received:
16
01
2021
accepted:
15
07
2021
entrez:
21
8
2021
pubmed:
22
8
2021
medline:
11
1
2022
Statut:
epublish
Résumé
Fibroadenoma (FA) is the most common benign solid breast mass in women, with no definite method of management. Because fibroadenoma is dependent on female sex hormones and comprises hypertrophic changes at cellular levels, we investigated the effects of metformin (MF), a safe hypoglycemic agent with anti-estrogenic and anti-proliferative properties, in the management of fibroadenoma. In this randomized clinical trial study, eligible women with fibroadenomas were assigned randomly to the metformin (1000 mg daily for six months) or the placebo group. Breast physical and ultrasound exam was performed before and after the intervention, and the changes in the size of fibroadenomas were compared in the two groups. Overall, 83 patients in the treatment, and 92 in the placebo group completed the study. A statistically significant difference in changing size between the two groups was observed only in the smallest mass. In the largest FAs, the rate of size reduction was higher in the treatment group (60.2 % vs. 43.5 %); while a higher rate of enlargement was observed in the placebo group (38 % vs. 20.5 %). In the smallest FAs, the rate of the masses that got smaller or remained stable was about 90 % in the treatment group and 50 % in the placebo group. We categorized size changes of FAs into < 20 % enlargement and ≥ 20 % enlargement. The odds ratio (OR) for an elargemnt less than 20% was 1.48 (95 % CI = 1.10-1.99) in the treatment group in comparison with the placebo group; the odds for an enlargement less than 20% was higher in women with multiples fibroadenomas (OR = 4.67, 95 % CI: 1.34-16.28). In our study, no serious adverse effect was recorded, and the medicine was well-tolerated by all users. This is the first study that evaluates the effect of MF on the management of fibroadenoma, and the results suggest a favorable effect. Larger studies using higher doses of MF and including a separate design for patients with single or multiple FAs are suggested in order to confirm this effect. This trial (IRCT20100706004329N7) was retrospectively registered on 2018-10-07.
Sections du résumé
BACKGROUND
BACKGROUND
Fibroadenoma (FA) is the most common benign solid breast mass in women, with no definite method of management. Because fibroadenoma is dependent on female sex hormones and comprises hypertrophic changes at cellular levels, we investigated the effects of metformin (MF), a safe hypoglycemic agent with anti-estrogenic and anti-proliferative properties, in the management of fibroadenoma.
METHODS
METHODS
In this randomized clinical trial study, eligible women with fibroadenomas were assigned randomly to the metformin (1000 mg daily for six months) or the placebo group. Breast physical and ultrasound exam was performed before and after the intervention, and the changes in the size of fibroadenomas were compared in the two groups.
RESULTS
RESULTS
Overall, 83 patients in the treatment, and 92 in the placebo group completed the study. A statistically significant difference in changing size between the two groups was observed only in the smallest mass. In the largest FAs, the rate of size reduction was higher in the treatment group (60.2 % vs. 43.5 %); while a higher rate of enlargement was observed in the placebo group (38 % vs. 20.5 %). In the smallest FAs, the rate of the masses that got smaller or remained stable was about 90 % in the treatment group and 50 % in the placebo group. We categorized size changes of FAs into < 20 % enlargement and ≥ 20 % enlargement. The odds ratio (OR) for an elargemnt less than 20% was 1.48 (95 % CI = 1.10-1.99) in the treatment group in comparison with the placebo group; the odds for an enlargement less than 20% was higher in women with multiples fibroadenomas (OR = 4.67, 95 % CI: 1.34-16.28). In our study, no serious adverse effect was recorded, and the medicine was well-tolerated by all users.
CONCLUSIONS
CONCLUSIONS
This is the first study that evaluates the effect of MF on the management of fibroadenoma, and the results suggest a favorable effect. Larger studies using higher doses of MF and including a separate design for patients with single or multiple FAs are suggested in order to confirm this effect.
TRIAL REGISTRATION
BACKGROUND
This trial (IRCT20100706004329N7) was retrospectively registered on 2018-10-07.
Identifiants
pubmed: 34416879
doi: 10.1186/s12902-021-00824-4
pii: 10.1186/s12902-021-00824-4
pmc: PMC8377455
doi:
Substances chimiques
Hypoglycemic Agents
0
Metformin
9100L32L2N
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
169Subventions
Organisme : Deputy of Research of Tehran University of Medical Sciences
ID : 97-01-218-37716
Informations de copyright
© 2021. The Author(s).
Références
Am J Clin Pathol. 2001 May;115(5):736-42
pubmed: 11345838
Hum Reprod. 2002 Nov;17(11):2858-64
pubmed: 12407039
Int J Cancer. 1994 Jun 1;57(5):681-3
pubmed: 8194875
Semin Oncol. 2016 Feb;43(1):123-133
pubmed: 26970131
Breast J. 2008 May-Jun;14(3):275-8
pubmed: 18397185
Breast. 2000 Feb;9(1):35-6
pubmed: 14731582
Photomed Laser Surg. 2015 Aug;33(8):404-8
pubmed: 26226170
Br J Surg. 1996 Feb;83(2):264-5
pubmed: 8689184
Breast. 2016 Oct;29:62-7
pubmed: 27428472
Breast Dis. 2017;37(2):49-53
pubmed: 28598826
Cell Metab. 2018 Nov 6;28(5):679-688.e4
pubmed: 30244975
J Natl Cancer Inst. 2003 Feb 19;95(4):302-7
pubmed: 12591986
Cell Cycle. 2009 Mar 15;8(6):909-15
pubmed: 19221498
Expert Opin Drug Saf. 2015 Jun;14(6):921-34
pubmed: 25936229
World J Surg. 2007 Jun;31(6):1178-84
pubmed: 17431715
Radiology. 2003 Oct;229(1):233-8
pubmed: 14519878
Minerva Ginecol. 2002 Dec;54(6):531-5
pubmed: 12432338
Pathology. 2020 Oct;52(6):627-634
pubmed: 32771211
Int J Mol Med. 2015 Apr;35(4):1088-94
pubmed: 25716282
Drugs. 1989 Apr;37(4):451-90
pubmed: 2661195
J Cancer Res Ther. 2016 Dec;12(Supplement):C138-C142
pubmed: 28230006
Clin Transl Oncol. 2014 Aug;16(8):746-52
pubmed: 24338509
Am Fam Physician. 2009 Dec 15;80(12):1405-8
pubmed: 20000302
Clin Imaging. 2019 Sep - Oct;57:35-39
pubmed: 31103907
Br J Cancer. 2011 May 10;104(10):1558-63
pubmed: 21522148
Indian J Surg. 2015 Dec;77(Suppl 2):484-9
pubmed: 26730050
Br J Surg. 1989 Apr;76(4):390-1
pubmed: 2720350
Am J Epidemiol. 2003 Feb 15;157(4):364-75
pubmed: 12578807
Oncotarget. 2016 Jun 28;7(26):40767-40780
pubmed: 27004404
SAGE Open Med. 2019 Jul 16;7:2050312119865114
pubmed: 31360518
Am J Epidemiol. 2002 Oct 1;156(7):599-605
pubmed: 12244028
Clin Radiol. 2008 May;63(5):511-5; discussion 516-7
pubmed: 18374713
Lancet Diabetes Endocrinol. 2019 Apr;7(4):256-266
pubmed: 30792154
Breast J. 2010 Jan-Feb;16(1):73-6
pubmed: 19825000