Abstract | OBJECTIVE: DESIGN: Prospective, randomized, placebo-controlled pilot trial. SETTING: Academic medical center. PATIENT(S): 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.
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Authors | Kathleen M Hoeger, Lynda Kochman, Nellie Wixom, Kimberly Craig, Richard K Miller, David S Guzick |
Journal | Fertility and sterility
(Fertil Steril)
Vol. 82
Issue 2
Pg. 421-9
(Aug 2004)
ISSN: 0015-0282 [Print] United States |
PMID | 15302293
(Publication Type: 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.)
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Chemical References |
- Blood Glucose
- Hypoglycemic Agents
- Metformin
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Topics |
- Adipose Tissue
(anatomy & histology)
- Adult
- Blood Glucose
(drug effects, metabolism)
- Body Composition
- Body Mass Index
- Double-Blind Method
- Electric Impedance
- Female
- Humans
- Hypoglycemic Agents
(therapeutic use)
- Life Style
- Metformin
(therapeutic use)
- Obesity
(drug therapy, physiopathology, rehabilitation)
- Patient Dropouts
- Patient Selection
- Pilot Projects
- Polycystic Ovary Syndrome
(complications, physiopathology)
- Weight Loss
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