Evidence map›Paper›PMID 18728175›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2008

The impact of metformin, oral contraceptives, and lifestyle modification on polycystic ovary syndrome in obese adolescent women in two randomized, placebo-controlled clinical trials.

Kathleen Hoeger, Kristen Davidson, Lynda Kochman, Tracy Cherry, Laurie Kopin, David S Guzick

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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 88 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
88citing papers in PubMed, 19 pooled it
22.5field-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.

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.

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
3 · Its place in the literature

Who cites it

88 citing papers in PubMed, 19 syntheses or guidelines pooled it, 255 citations in OpenAlex.

  1. Pooled it
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  3. Efficacy of physical activity in polycystic ovary syndrome treatment.Current opinion in endocrinology, diabetes, and obesity · 2024
    Pooled it
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  10. Lifestyle changes in women with polycystic ovary syndrome.The Cochrane database of systematic reviews · 2019
    Pooled it
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  14. Pediatric Obesity-Assessment, Treatment, and Prevention: An Endocrine Society Clinical Practice Guideline.The Journal of clinical endocrinology and metabolism · 2017 · on this map
    Guideline
  15. Pooled it
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  18. Diagnosis and treatment of polycystic ovary syndrome: an Endocrine Society clinical practice guideline.The Journal of clinical endocrinology and metabolism · 2013 · on this map
    Guideline
  19. Pooled it
  20. Trial

28 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Kathleen HoegerDepartment of Obstetrics and Gynecology, University of Rochester Medical Center, 601 Elmwood Avenue, Box 668, Rochester, New York 14642, USA. Kathy_hoeger@urmc.rochester.edu
Kristen Davidson
Lynda Kochman
Tracy Cherry
Laurie Kopin
David S Guzick
University of Rochester Medical Center · US

Funding

UNIVERSITY OF ROCHESTER'S RESEARCH ASSOCIATE ORGANIZATIONUL1RR024160 · NCRR · UNIVERSITY OF ROCHESTER · PI PEARSON, THOMAS ARTHUR · 2006 to 2011
$38.7M
Long-term Treatment of Polycystic Ovary SyndromeK23HD043881 · NICHD · UNIVERSITY OF ROCHESTER · PI HOEGER, KATHLEEN M · 2004 to 2008
$539k
Polycystic Ovarian Syndrome in Overweight AdolescentsR03HD041989 · NICHD · UNIVERSITY OF ROCHESTER · PI HOEGER, KATHLEEN M · 2002 to 2003
$158k
NCRR NIH HHS UL1 RR024160NICHD NIH HHS 5 R03 HD41989-02NICHD NIH HHS K23 HD043881NICHD NIH HHS K23 HD043881-01A1NICHD NIH HHS R03 HD041989
6 · The paper itself

Abstract

contextPolycystic ovary syndrome (PCOS) presents in adolescence, and obesity is a common finding. The benefits and risks of alternate approaches to the management of PCOS in obese adolescent women are not clear.

objectiveWe investigated the effects of metformin, oral contraceptives (OCs), and/or lifestyle modification in obese adolescent women with PCOS.

designTwo small, randomized, placebo-controlled clinical trials were performed. PATIENTS AND

participantsA total of 79 obese adolescent women with PCOS participated.

interventionsIn the single treatment trial, subjects were randomized to metformin, placebo, a lifestyle modification program, or OC. In the combined treatment trial, all subjects received lifestyle modification and OC and were randomized to metformin or placebo.

main outcome measuresSerum concentrations of androgens and lipids were measured.

resultsLifestyle modification alone resulted in a 59% reduction in free androgen index with a 122% increase in SHBG. OC resulted in a significant decrease in total testosterone (44%) and free androgen index (86%) but also resulted in an increase in C-reactive protein (39.7%) and cholesterol (14%). The combination of lifestyle modification, OC, and metformin resulted in a 55% decrease in total testosterone, as compared to 33% with combined treatment and placebo, a 4% reduction in waist circumference, and a significant increase in HDL (46%).

conclusionsIn these preliminary trials, both lifestyle modification and OCs significantly reduce androgens and increase SHBG in obese adolescents with PCOS. Metformin, in combination with lifestyle modification and OC, reduces central adiposity, reduces total testosterone, and increases HDL, but does not enhance overall weight reduction.

Indexed as

Behavior TherapyAdolescentAndrogensChildCholesterolContraceptives, Oral, HormonalC-Reactive ProteinFemaleHumansHypoglycemic AgentsLife StyleLipidsMetforminObesityPlacebosSocial SupportAndrogensCholesterolContraceptives, Oral, HormonalC-Reactive ProteinHypoglycemic AgentsLipidsMetforminPlacebosTestosterone

Identifiers

PMID18728175
PMCPMC2582568
OpenAlexW2054516673

What OpenQuestion 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 OpenQuestion graph.