Evidence map›Metformin × body weight & composition›PMID 15302293›Full record

Trial reportFertility and sterility2004

A randomized, 48-week, placebo-controlled trial of intensive lifestyle modification and/or metformin therapy in overweight women with polycystic ovary syndrome: a pilot study.

Kathleen M Hoeger, Lynda Kochman, Nellie Wixom, Kimberly Craig, Richard K Miller, David S Guzick

Registry-linked trialAbstract readClinical TrialComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Fertility and sterility, 2004. The graph read 1 number from its abstract, feeding 1 cell of the map: it supports the treatment in 1. It is linked to trial NCT02303470 (Vigorous Exercise Versus Moderate Exercise to Improve Glucose Metabolism and Metabolic Parameters in Women With Polycystic Ovary Syndrome and Insulin Resistance), which is not on this map. Cited by 61 papers, 14 of them syntheses that pooled it.

1number the graph read from it
1cell of the map it votes in
61citing papers in PubMed, 14 pooled it
18.8field-weighted citation impact, top 1% 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.

← favours the treatmentfavours the comparator →
-60.20 · no effect
Body weight & compositionfavours the treatment · against placebo · obesity, gdmfeeds one cell of the map
weight loss -16.2-60.2 to -4.40
If weight loss occurred during metformin therapy, the odds ratio for regular ovulation was 16.2 (95% confidence interval 4.4-60.2).
FeedsMetformin×body weight & composition

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Metformin×body weight & composition

SupportsOpen on the map →What to test next →

19 readable studies in this cell: 7 favour the treatment, 6 find no difference, 6 favour the comparator.

Belief with this paper
0.50contested · 8 families support, 4 contradict · against placebo
Without it
0.50This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2004
weight loss -16.2-60.2 to -4.40
NCT018093271,186 enrolled · 2013
Δ -0.90-1.60 to -0.20
NCT008598981,093 enrolled · 2009
Δ -1.37-2.03 to -0.71
NCT00643851994 enrolled · 2008
Δ -0.05-0.72 to 0.61
NCT02932475831 enrolled · 2017
Δ 0.04
NCT00676338820 enrolled · 2008
Δ -0.04-0.61 to 0.53
NCT02980276535 enrolled · 2017
Δ -0.70-1.30 to -0.20
Effect of Metformin Added to Insulin on Glycemic Control Among Overwei…PMID 26624824 · 164 enrolled · 2013
Δ 17.05.00 to 29.0
Weight and Glucose Reduction Observed with a Combination of Nutritiona…PMID 27093610 · 53 enrolled · 2013
increase 1.26-0.24 to 2.75
Efficacy and safety of ipragliflozin as an add-on therapy to sitaglipt…PMID 29862619 · 2018
Δ -1.72
Outcomes in children of women with type 2 diabetes exposed to metformi…PMID 36746160 · 2023
Δ 0.07-0.31 to 0.45
Effects of metformin on the body composition in subjects with risk fac…PMID 15715892 · 2005
increase 16.5
Metformin for the prevention of diabetes among people with HIV and eit…PMID 37460828 · 2023
Δ -1.47-2.58 to -0.35
4 · 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.

NCT02303470 naunknown statusnot on this mapstarted 2015, after this paper: background citation

Vigorous Exercise Versus Moderate Exercise to Improve Glucose Metabolism and Metabolic Parameters in Women With Polycystic Ovary Syndrome and Insulin Resistance: A Prospective Randomized Pilot Study

TypeinterventionalSponsorUniversity of California, San FranciscoRan2015 to 2025Enrolled47ConditionsPolycystic Ovary Syndrome, Insulin ResistanceArmsVigorous Exercise, Moderate Exercise
5 · Its place in the literature

Who cites it

61 citing papers in PubMed, 14 syntheses or guidelines pooled it, 277 citations in OpenAlex.

  1. Pooled it
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  4. The Impact of Bariatric Surgery Compared to Metformin Therapy on Pregnancy Outcomes in Patients with Polycystic Ovarian Syndrome: a Systematic Review and Meta-analysis.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2021
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Lifestyle changes in women with polycystic ovary syndrome.The Cochrane database of systematic reviews · 2019
    Pooled it
  10. Pooled it
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  12. Pooled it
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  15. Trial
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1 more citing papers are in PubMed but not listed here.

6 · The record

Corrections and comments

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

7 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Kathleen M HoegerDepartment of Obstetrics and Gynecology, University of Rochester School of Medicine and Dentistry, 601 Elmwood Avenue, Rochester, NY 14642, USA. Kathy_Hoeger@urmc.rochester.edu
Lynda Kochman
Nellie Wixom
Kimberly Craig
Richard K Miller
David S Guzick
University of Rochester · US

Funding

YOHIMBINE CHALLENGE IN PARKINSONIAN PATIENTS WITH PANIC DISORDERM01RR000044 · UNIVERSITY OF ROCHESTER · 1985 to 2005
$13.3M
WOMENS REPRODUCTIVE HEALTH RESEARCH CAREER CENTERK12HD001332 · UNIVERSITY OF ROCHESTER · 1999 to 2005
$1.6M
NCRR NIH HHS 5 M01 RR 00044NICHD NIH HHS K12 HD 01332-03
8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

objectiveTo obtain data from a pilot randomized trial on the effect of metformin therapy and lifestyle modification on ovulation and androgen concentrations in women with polycystic ovary syndrome (PCOS).

designProspective, randomized, placebo-controlled pilot trial.

settingAcademic medical center. PATIENT(S): Thirty-eight overweight or obese women with PCOS. INTERVENTION(S): All subjects were randomized to one of four 48-week interventions: metformin 850 mg two times per day, lifestyle modification plus metformin 850 mg two times per day, lifestyle modification plus placebo, or placebo alone. MAIN OUTCOME MEASURE(S): Recruitment, dropout, and compliance with a long-term lifestyle intervention in PCOS; preliminary estimates of treatment effect on ovulation, as measured by weekly urinary pregnanediol glucuronide, and on total T and free androgen index. RESULT(S): It was necessary to screen seven women to have one subject randomized. The dropout rate was 39%, with the majority of dropouts occurring within the first 24 weeks. Mean body mass index was >39 mg/kg(2). Modest weight reduction was found in all treatment groups, with the most significant reduction occurring with the combination of metformin and lifestyle intervention. Significant androgen reduction occurred in the combination group only. Ovulation rates did not differ significantly between groups. However, when data were analyzed by presence or absence of weight reduction in subjects, independent of treatment group, the estimated odds ratio for weight loss was 9.0 (95% confidence interval 1.2-64.7) with respect to regular ovulation. If weight loss occurred during metformin therapy, the odds ratio for regular ovulation was 16.2 (95% confidence interval 4.4-60.2). CONCLUSION(S): Key methodologic issues for a large-scale, randomized trial of lifestyle intervention in PCOS include minimizing early dropout from the lifestyle intervention and including a range of body mass index that is not skewed toward severe obesity. Weight reduction might play the most significant role in restoration of ovulation in obese women with PCOS.

Indexed as

Life StyleWeight LossAdipose TissueAdultBlood GlucoseBody CompositionBody Mass IndexDouble-Blind MethodElectric ImpedanceFemaleHumansHypoglycemic AgentsMetforminObesityPatient DropoutsPatient SelectionBlood GlucoseHypoglycemic AgentsMetformin

Identifiers

PMID15302293
OpenAlexW2001380683

What Socratic holds

Texttitle and abstract
Read underepoch 390

Registered trials

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.