Evidence map›Paper›PMID 34416879›Full record

Trial reportBMC endocrine disorders2021

Metformin as a new option in the medical management of breast fibroadenoma; a randomized clinical trial.

Sadaf Alipour, Mahboubeh Abedi, Azin Saberi, Arezoo Maleki-Hajiagha, Firoozeh Faiz, Saeed Shahsavari, Bita Eslami

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC endocrine disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.9field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 15 citations in OpenAlex.

  1. Metformin in the management of fibrocystic breast disease: a placebo-controlled randomized clinical trial.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2021
    Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. Metformin and Cancer, an Ambiguanidous Relationship.Pharmaceuticals (Basel, Switzerland) · 2022
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Sadaf AlipourBreast Disease Research Center, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.
Mahboubeh AbediDepartment of Radiology, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Azin SaberiDepartment of Surgery, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Arezoo Maleki-HajiaghaResearch Development Center, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Firoozeh FaizDepartment of Endocrinology and Metabolism, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Saeed ShahsavariDepartment of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
Bita EslamiBreast Disease Research Center, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran. dr.bes.96@gmail.com.ORCID http://orcid.org/0000-0002-3011-9905
Tehran University of Medical Sciences · IRMotamed Cancer Institute · IRQazvin University of Medical Sciences · IR

Funding

Deputy of Research of Tehran University of Medical Sciences 97-01-218-37716
6 · The paper itself

Abstract

backgroundFibroadenoma (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.

methodsIn 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.

resultsOverall, 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.

conclusionsThis 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 registrationThis trial (IRCT20100706004329N7) was retrospectively registered on 2018-10-07.

Indexed as

AdolescentAdultBreast NeoplasmsCase-Control StudiesFemaleFibroadenomaFollow-Up StudiesHumansHypoglycemic AgentsMetforminMiddle AgedPrognosisRetrospective StudiesYoung AdultHypoglycemic AgentsMetforminBreast UltrasonographyFibroadenomaFibrocystic Breast DiseaseMetforminTherapy

Identifiers

PMID34416879
PMCPMC8377455
OpenAlexW3193603770

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.