Evidence map›Paper›PMID 34719004›Full record

Trial reportDaru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences2021

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

Sadaf Alipour, Hadith Rastad, Azin Saberi, Firoozeh Faiz, Arezoo Maleki-Hajiagha, Mahboubeh Abedi

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.3field-weighted citation impact, top 42% 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

0 citing papers in PubMed, 3 citations in OpenAlex.

No citing paper in PubMed yet.

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

6 authors at 3 institutions in 1 country.

Sadaf AlipourBreast Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Hadith RastadCardiovascular Research Center, Alborz University of Medical Sciences, Karaj, Iran.
Azin SaberiDepartment of Surgery, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Firoozeh FaizDepartment of Endocrinology and Metabolism, Arash Women Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Arezoo Maleki-HajiaghaResearch Development Center, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Mahboubeh AbediBreast Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran. abedi.mahboobeh@yahoo.com.ORCID http://orcid.org/0000-0002-3692-2870
Tehran University of Medical Sciences · IRIran University of Medical Sciences · IRJahrom University of Medical Sciences · IR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Administration, OralAdultDouble-Blind MethodDrug Administration ScheduleFemaleFibrocystic Breast DiseaseHumansMetforminMiddle AgedPremenopauseTabletsTreatment OutcomeUltrasonography, MammaryMetforminTablets

Identifiers

PMID34719004
PMCPMC8557102
OpenAlexW3210465789

What OpenQuestion holds

Textmetadata
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Registered trials

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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 OpenQuestion graph.