Evidence map›Paper›PMID 29237134›Full record

Trial reportJournal of women's health (2002)2018

A Randomized Controlled Multicenter Trial of an Investigational Liquid Nutritional Formula in Women with Cyclic Breast Pain Associated with Fibrocystic Breast Changes.

Robert E Mansel, Tapas Das, Geraldine E Baggs, Michael J Noss, William P Jennings, Jay Cohen, David Portman, Mario Cohen, Anne Coble Voss

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of women's health (2002), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 26% 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

3 citing papers in PubMed, 10 citations in OpenAlex.

  1. Iodine Prescribing Update.Integrative medicine (Encinitas, Calif.) · 2025
    Article
  2. Article
  3. 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

9 authors at 6 institutions in 3 countries.

Robert E Mansel1 Department of Surgery, Cardiff University , Cardiff, Wales, United Kingdom .
Tapas Das2 Research and Development , Abbott Nutrition, Columbus, Ohio.
Geraldine E Baggs2 Research and Development , Abbott Nutrition, Columbus, Ohio.
Michael J Noss3 Synexus (formerly Radiant Research) , Cincinnati, Ohio.
William P Jennings4 Synexus (formerly Radiant Research) , San Antonio, Texas.
Jay Cohen5 Envision Physician Services , Discovery Clinical Research, Plantation, Florida.
David Portman6 Sermonix Pharmaceuticals , LLC, Columbus, Ohio.
Mario Cohen7 Greater Hartford Women's Health Association , West Hartford, Connecticut.
Anne Coble Voss2 Research and Development , Abbott Nutrition, Columbus, Ohio.
Ross Laboratories (United States) · USRadiant Research (United States) · USCardiff University · GBConnecticut Health Foundation · USEpix Pharmaceuticals (United States) · USFlorida Cancer Care · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveA randomized, multicenter, controlled double-blind trial was performed in women with cyclic breast pain (mastalgia) associated with fibrocystic breast changes (FBCs) to determine whether a nutritional formula reduced breast pain and/or nodularity. STUDY

designWomen were randomized to receive a specifically designed liquid formulation (n = 93) (1 g gamma-linolenic acid [GLA], 750 μg iodine, and 70 μg selenium) or control formula (n = 95) (without GLA, iodine, and selenium) daily for three cycles. Women recorded breast pain, medications, and menstrual signs daily using interactive voice-response system. Nodularity was determined by physical breast examination.

resultsBreast pain scores decreased similarly in the experimental (-32.2%) and control (-33.1%) groups (p = 0.64). Nodularity was reduced in the experimental, but not the control group (p = 0.03). Among women who continued pain medication, the amount was reduced in the experimental group relative to controls (p = 0.02).

conclusionWomen with FBC using the formula containing GLA, iodine, and selenium experienced reduced nodularity and in those women who took over-the-counter breast pain medication, a decrease in the quantity of pain medication was observed.

Indexed as

AdolescentAdultBreastBreast DiseasesDouble-Blind MethodFemalegamma-Linolenic AcidHumansIodineMastodyniaMenstrual CycleMiddle AgedPainPain MeasurementProspective StudiesSeleniumgamma-Linolenic AcidIodineSeleniumfibrocystic breast changesgamma-linolenic acidiodinemastalgiaselenium

Identifiers

PMID29237134
PMCPMC5865258
OpenAlexW2772015833

What OpenQuestion 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 OpenQuestion graph.