CoChat
Sign Up
Cited by 278Ovarian function and disordersDiabetes, Cardiovascular Risks, and LipoproteinsEndometriosis Research and Treatment

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

Open access
Hoeger, Kathleen M, Kochman, Lynda, Wixom, Nellie, Craig, Kimberly, Miller, Richard K, Guzick, David S·2004·Fertility and Sterility
DOI 10.1016/j.fertnstert.2004.02.104
Open this paper in CoChat — free accountOpen PDF

Abstract

Objective To 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).Design Prospective, randomized, placebo-controlled pilot trial.Setting Academic 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.

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.2004.02.104

Cites

44 of 44 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?

  • At study end (48 weeks), no subjects had IFG or IGT in Hoeger et al. (2004).

    “At study end (48 weeks), no subjects had IFG or IGT (Hoeger et al. , 2004).”

    From Metformin and lifestyle modification in polycystic ovary syndrome: systematic review and meta-analysis (2015) · cites this paper as Hoeger et al. , 2004

    The Clinical and Metabolic Parameters passage (page unavailable) reports that two placebo subjects had elevated fasting or two-hour glucose at 48 weeks, contrary to the claim that no subjects did. It reports no such elevations in the three treatment groups, but does not separately classify subjects as having IFG or IGT. (LLM, conf=0.82)

    Checked by a reasoning model — may be wrong.

    Experimental — accuracy not yet measured

  • The number of menstrual cycles from 6 to 12 months was greater in the lifestyle plus metformin group than in the lifestyle plus placebo group (mean difference 1.38, 95% CI 0.47 to 2.29, P=0.003).

    “The number of menstrual cycles from 6 to 12 months was greater in the lifestyle + metformin compared with lifestyle + placebo groups (MD 1.38, 95% CI 0.47-2.29, P ¼ 0.003).”

    From Metformin and lifestyle modification in polycystic ovary syndrome: systematic review and meta-analysis (2015) · cites this paper as Hoeger et al., 2004

    The Ovulation section (page not available) reports slightly more menstrual events over the 48-week study in the lifestyle-plus-metformin group than in the lifestyle-plus-placebo group (6.6 versus 6.2). It does not report menstrual-cycle counts specifically from 6 to 12 months or the claimed mean difference, confidence interval, and P value; its finding of no significant difference concerns ovulatory events, not menstrual cycles. (LLM, conf=0.82)

    Experimental — accuracy not yet measured

  • Except for two studies (Hoeger et al., 2004; Gambineri et al., 2006), follow-up duration was 6 months or shorter.

    “Duration of follow-up, except for two studies (Hoeger et al. , 2004; Gambineri et al. , 2006), was 6 months or shorter.”

    From Metformin and lifestyle modification in polycystic ovary syndrome: systematic review and meta-analysis (2015) · cites this paper as Hoeger et al. , 2004

  • In Hoeger et al., abnormal fasting or 2-hour post-OGTT glucose levels were reported in two subjects on metformin, three on lifestyle, and none on lifestyle plus metformin at baseline.

    “In Hoeger et al. , abnormal fasting or 2 h post OGTT glucose levels were reported in two subjects on metformin, three on lifestyle and none on lifestyle + metforminat baseline.”

    From Metformin and lifestyle modification in polycystic ovary syndrome: systematic review and meta-analysis (2015) · cites this paper as Hoeger et al. , 2004

  • Two studies lasting 12 months and 48 weeks provided data on BMI, testosterone, SHBG, FAI, menstruation, fasting glucose, glucose AUC, and insulin AUC.

    “Data on BMI, testosterone, SHBG, FAI, menstruation, fasting glucose, glucose AUC and insulin AUC were also available from two studies with durations of 12 months and 48 weeks (Hoeger et al. , 2004; Gambineri et al. , 2006).”

    From Metformin and lifestyle modification in polycystic ovary syndrome: systematic review and meta-analysis (2015) · cites this paper as Hoeger et al., 2004

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

Cited by

Sorted by citations

Related

Authors
Hoeger, K. M., Kochman, L., Wixom, N., Craig, K., Miller, R. K., & Guzick, D. S.
Affiliations
  • University of Rochester Medicine (US)
  • University of Rochester (US)
Corresponding author
Hoeger, Kathleen M
ORCID
Venue
Fertility and Sterility
Publisher
Elsevier BV
Published
2004-08
Volume
82
Issue
2
Pages
421-429
ISSN
0015-0282 (ISSN-L)
DOI
10.1016/j.fertnstert.2004.02.104
OpenAlex
W2001380683
Cited by
278
References
44
Citations by year
2026: 4 · 2025: 9 · 2024: 6 · 2023: 8 · 2022: 7 · 2021: 9 · 2020: 16 · 2019: 13 · 2018: 5 · 2017: 13 · 2016: 8 · 2015: 18 · 2014: 12 · 2013: 14 · 2012: 7
FWCI
17.54
Type
journal article
Language
en
Open access
Licence
Locations
  • Fertility and Sterility (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • University of Rochester
  • Strong
  • National Institutes of Health
  • National Center for Research Resources (RR-00044, 5-M01-RR-00044, M01 RR-00044, M01RR000044)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (K12HD001332, K12 HD 01332-03)
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 modification, weight loss, ovulation, androgen reduction, free androgen index, overweight women, obesity, trial dropout, body mass index
MeSH terms
Adipose Tissue, Adult, Blood Glucose, Body Composition, Double-Blind Method, Female, Humans, Hypoglycemic Agents, Life Style, Metformin, Obesity, Patient Dropouts, Pilot Projects, Polycystic Ovary Syndrome, Weight Loss, Body Mass Index, Electric Impedance, Patient Selection

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