Tags

Type your tag names separated by a space and hit enter

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.
Fertil Steril 2004; 82(2):421-9FS

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.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, University of Rochester School of Medicine and Dentistry, 601 Elmwood Avenue, Rochester, NY 14642, USA. Kathy_Hoeger@urmc.rochester.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

15302293

Citation

Hoeger, Kathleen M., et al. "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." Fertility and Sterility, vol. 82, no. 2, 2004, pp. 421-9.
Hoeger KM, Kochman L, Wixom N, et al. 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. Fertil Steril. 2004;82(2):421-9.
Hoeger, K. M., Kochman, L., Wixom, N., Craig, K., Miller, R. K., & Guzick, D. S. (2004). 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. Fertility and Sterility, 82(2), pp. 421-9.
Hoeger KM, et al. 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. Fertil Steril. 2004;82(2):421-9. PubMed PMID: 15302293.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Hoeger,Kathleen M, AU - Kochman,Lynda, AU - Wixom,Nellie, AU - Craig,Kimberly, AU - Miller,Richard K, AU - Guzick,David S, PY - 2003/09/30/received PY - 2004/02/04/revised PY - 2004/02/04/accepted PY - 2004/8/11/pubmed PY - 2004/9/16/medline PY - 2004/8/11/entrez SP - 421 EP - 9 JF - Fertility and sterility JO - Fertil. Steril. VL - 82 IS - 2 N2 - 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. SN - 0015-0282 UR - https://www.unboundmedicine.com/medline/citation/15302293/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0015028204007319 DB - PRIME DP - Unbound Medicine ER -