Cited by 138Ovarian function and disordersDiabetes, Cardiovascular Risks, and LipoproteinsEndometriosis Research and Treatment

The effects of metformin with lifestyle therapy in polycystic ovary syndrome: a randomized double-blind study

Open access
Ladson, Gwinnett, Dodson, William C., Sweet, Stephanie D., Archibong, Anthony E., Kunselman, Allen R., Demers, Laurence M., Williams, Nancy I., Coney, Ponjola +1 more·2011·Fertility and Sterility

Abstract

Objective To determine if the combination of lifestyle (caloric restriction and exercise) and metformin (MET) would be superior to lifestyle and placebo (PBO) in improving the polycystic ovary syndrome (PCOS) phenotype.Design Double-blind randomized 6-month trial of MET versus PBO.Setting Two academic medical centers.Patient(s) One hundred fourteen subjects with PCOS were randomized to MET (N = 55) or PBO (N = 59).Intervention(s) Subjects collected urine daily for ovulation monitoring, had monthly monitoring of hormones and weight and determination of body composition by dual-energy x-ray absorptiometry, glucose tolerance, and were evaluated for quality of life at baseline and completion.Main outcome measure(s) Ovulation rates and testosterone levels.Result(s) Dropout rates were high. There was no significant difference in ovulation rates. Testosterone levels were significantly lower compared with baseline in the MET group at 3 mos but not at 6 mos. There were no differences in weight loss between groups, but MET showed a significant decline at 6 months compared with baseline (-3.4 kg, 95% confidence interval -5.3 to -1.5 kg). We noted divergent effects of MET versus PBO on oral glucose tolerance test indices of insulin sensitivity (increased) and secretion (worsened). Total bone mineral density increased significantly in MET. There were no differences in quality of life measures between the groups. The MET group had increased diarrhea and headache, but fewer bladder infections and musculoskeletal complaints.Conclusion(s) The addition of metformin to lifestyle therapy produced little reproductive or glycemic benefit in women with PCOS, although our study had limited power owing to a high dropout rate. It is not possible at baseline to identify women likely to drop out.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1016/j.fertnstert.2010.12.002

Cites

43 of 43 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

2 of the 45 references couldn’t be matched to a known paper.

Cited by

Sorted by citations

Authors
Ladson, G., Dodson, W. C., Sweet, S. D., Archibong, A. E., Kunselman, A. R., Demers, L. M., Williams, N. I., Coney, P., & Legro, R. S.
Affiliations
  • Meharry Medical College (US)
  • Pennsylvania State University (US)
  • Virginia Commonwealth University (US)
Corresponding author
Legro, Richard S.
Venue
Fertility and Sterility
Publisher
Elsevier BV
Published
2011-03
Volume
95
Issue
3
Pages
1059-1066.e7
ISSN
0015-0282 (ISSN-L)
OpenAlex
W2146522847
Cited by
138
References
45
Citations by year
2026: 3 · 2025: 7 · 2024: 6 · 2023: 9 · 2022: 9 · 2021: 11 · 2020: 13 · 2019: 5 · 2018: 5 · 2017: 11 · 2016: 8 · 2015: 10 · 2014: 14 · 2013: 11 · 2012: 8
FWCI
10.25
Type
journal article
Language
en
Open access
Locations
  • Fertility and Sterility (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • University of Pennsylvania
  • Pennsylvania State University
  • Penn State College of Medicine
  • National Center for Research Resources (MO1 RR10732, C06RR016499, U54RR026140, M01RR010732)
  • National Institute on Minority Health and Health Disparities (U54MD007593)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (U54HD044315)
Topics
  • Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
  • Health Sciences › Medicine › Reproductive Medicine › Endometriosis Research and Treatment
Keywords
polycystic ovary syndrome, metformin, lifestyle therapy, caloric restriction, physical activity, ovulation rate, testosterone, insulin sensitivity, insulin secretion, glucose tolerance, weight loss, bone mineral density, quality of life, adverse drug reactions
MeSH terms
Adult, Diet, Reducing, Double-Blind Method, Female, Humans, Hypoglycemic Agents, Life Style, Metformin, Ovulation, Patient Dropouts, Polycystic Ovary Syndrome, Testosterone, Exercise, Placebo Effect, Treatment Outcome, Caloric Restriction, Glycemic Index

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review