Trial reportFertility and sterility2011
The effects of metformin with lifestyle therapy in polycystic ovary syndrome: a randomized double-blind study.
Trial report in Fertility and sterility, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 57 papers, 15 of them syntheses that pooled 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
57 citing papers in PubMed, 15 syntheses or guidelines pooled it, 137 citations in OpenAlex.
- Effects of metformin on bone mineral density and bone turnover markers: a systematic review and meta-analysis.BMJ open · 2023Pooled it
- Comparison of dietary and physical activity behaviors in women with and without polycystic ovary syndrome: a systematic review and meta-analysis of 39 471 women.Human reproduction update · 2022Pooled it
- Effectiveness of exercise interventions on mental health and health-related quality of life in women with polycystic ovary syndrome: a systematic review.BMC public health · 2021Pooled it
- Effects of Dietary Glycemic Index and Glycemic Load on Cardiometabolic and Reproductive Profiles in Women with Polycystic Ovary Syndrome: A Systematic Review and Meta-analysis of Randomized Controlled Trials.Advances in nutrition (Bethesda, Md.) · 2021Pooled it
- Effects of metformin on blood lipid profiles in nondiabetic adults: a meta-analysis of randomized controlled trials.Endocrine · 2020Pooled it
- Exercise Interventions in Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis.Frontiers in physiology · 2020Pooled it
- Pooled it
- Metformin use and risk of fracture: a systematic review and meta-analysis of observational studies.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019Pooled it
- Exercise, or exercise and diet for the management of polycystic ovary syndrome: a systematic review and meta-analysis.Systematic reviews · 2019Pooled it
- Insulin-sensitising drugs (metformin, rosiglitazone, pioglitazone, D-chiro-inositol) for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility.The Cochrane database of systematic reviews · 2017 · on this mapPooled it
- A systematic review of reviews: exploring the relationship between obesity, weight loss and health-related quality of life.Clinical obesity · 2017Pooled it
- Interventions for hirsutism (excluding laser and photoepilation therapy alone).The Cochrane database of systematic reviews · 2015Pooled it
- Adverse effects of the common treatments for polycystic ovary syndrome: a systematic review and meta-analysis.The Journal of clinical endocrinology and metabolism · 2013Pooled it
- Diagnosis and treatment of polycystic ovary syndrome: an Endocrine Society clinical practice guideline.The Journal of clinical endocrinology and metabolism · 2013 · on this mapGuideline
- Dietary interventions and quality of life: a systematic review of the literature.Journal of nutrition education and behaviorPooled it
- Changes in antral follicle dynamics following weight loss in women with polycystic ovary syndrome.Human reproduction (Oxford, England) · 2025Trial
- Metformin Treatment in PCOS Pregnancies Reduces Maternal Infections and Increases the Risk of Allergies and Eczema in the Offspring: Post Hoc Analyses of Two Randomised Controlled Trials and One Follow-Up Study.BJOG : an international journal of obstetrics and gynaecology · 2025Trial
- Efficacy of high-intensity interval training for improving mental health and health-related quality of life in women with polycystic ovary syndrome.Scientific reports · 2023Trial
- Hyperandrogenism and menstrual imbalance are the best predictors of metformin response in PCOS patients.Reproductive biology and endocrinology : RB&E · 2022Trial
- Weight Reduction Through a Cognitive Behavioral Therapy Lifestyle Intervention in PCOS: The Primary Outcome of a Randomized Controlled Trial.Obesity (Silver Spring, Md.) · 2020Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 2 countries.
Funding
Abstract
objectiveTo 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.
designDouble-blind randomized 6-month trial of MET versus PBO.
settingTwo 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.
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What OpenQuestion holds
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.