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Human Reproduction Update 2011Patients with polycystic ovary syndrome (PCOS) are at risk of arterial disease. We examined the risk of (non)fatal coronary heart disease (CHD) or stroke in patients... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Patients with polycystic ovary syndrome (PCOS) are at risk of arterial disease. We examined the risk of (non)fatal coronary heart disease (CHD) or stroke in patients with PCOS and ovulatory women without PCOS, and assessed whether obesity might explain a higher risk of CHD or stroke.
METHODS
We performed a systematic review and meta-analysis of controlled observational studies. Four definitions of PCOS were considered: World Health Organization type II anovulation, National Institutes of Health criteria, Rotterdam consensus and Androgen-excess criteria. Obesity was defined as BMI > 30 kg/m(2) and/or waist circumference >88 cm. Study quality was assessed using the Newcastle-Ottawa Scale. Primary outcome was fatal/non-fatal CHD or stroke. Definitions of CHD and stroke were based on criteria used by the various authors. The effect measure was the pooled relative risk in a random effects model. Risk ratios and rate ratios were combined here.
RESULTS
After identifying 1340 articles, 5 follow-up studies published between 2000 and 2008 were included. The studies showed heterogeneity in design, definitions and quality. In a random effects model the relative risk for CHD or stroke were 2.02 comparing women with PCOS to women without PCOS (95% confidence interval 1.47, 2.76). Pooling the two studies with risk estimates adjusted for BMI showed a relative risk of 1.55 (1.27, 1.89).
CONCLUSIONS
This meta-analysis showed a 2-fold risk of arterial disease for patients with PCOS relative to women without PCOS. BMI adjustment did not affect this finding, suggesting the increased risk for cardiovascular events in PCOS is not completely related to a higher BMI in patients with PCOS.
Topics: Adult; Aged; Body Mass Index; Coronary Disease; Female; Humans; Middle Aged; Obesity; Polycystic Ovary Syndrome; Risk Factors; Stroke
PubMed: 21335359
DOI: 10.1093/humupd/dmr001 -
The Cochrane Database of Systematic... Feb 2011Polycystic ovary syndrome (PCOS) affects 4% to 18% of reproductive-aged women and is associated with reproductive, metabolic and psychological dysfunction. Obesity... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Polycystic ovary syndrome (PCOS) affects 4% to 18% of reproductive-aged women and is associated with reproductive, metabolic and psychological dysfunction. Obesity worsens the presentation of PCOS and weight management (weight loss, maintenance or prevention of excess weight gain) is proposed as an initial treatment strategy, best achieved through lifestyle changes incorporating diet, exercise and behavioural interventions.
OBJECTIVES
To assess the effectiveness of lifestyle treatment in improving reproductive, anthropometric (weight and body composition), metabolic and quality of life factors in PCOS.
SEARCH STRATEGY
Electronic databases (Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, PsycINFO, CINAHL, AMED), controlled trials register, conference abstracts, relevant journals, reference lists of relevant papers and reviews and grey literature databases, with no language restrictions applied.
SELECTION CRITERIA
Randomised controlled trials comparing lifestyle treatment (diet, exercise, behavioural or combined treatments) to minimal or no treatment in women with PCOS.
DATA COLLECTION AND ANALYSIS
Two authors independently selected trials, assessed methodological quality and risk of bias and extracted data.
MAIN RESULTS
Six studies were included. Three studies compared physical activity to minimal dietary and behavioural advice or no advice. Three studies compared combined dietary, exercise and behavioural interventions to minimal intervention. There were no studies assessing fertility primary outcomes and no data for meta-analysis on ovulation or menstrual regularity. For secondary outcomes, lifestyle intervention provided benefits when compared to minimal treatment for endpoint values for total testosterone (mean difference (MD) -0.27 nmol/L, 95% confidence interval (CI) -0.46 to -0.09, P = 0.004), hirsutism by the Ferriman-Gallwey score (MD -1.19, 95% CI -2.35 to -0.03, P = 0.04), weight (MD -3.47 kg, 95% CI -4.94 to -2.00, P < 0.00001), waist circumference (MD -1.95 cm, 95% CI -3.34 to -0.57, P = 0.006), waist to hip ratio (MD -0.04, 95% CI -0.07 to -0.00, P = 0.02), fasting insulin (MD -2.02 µU/mL, 95% CI -3.28 to -0.77, P = 0.002) and oral glucose tolerance test insulin (standardised mean difference -1.32, 95% CI -1.73 to -0.92, P < 0.00001) and per cent weight change (MD -7.00%, 95% CI -10.1 to -3.90, P < 0.00001). There was no evidence of effect of lifestyle for body mass index, free androgen index, sex hormone binding globulin, glucose or lipids; and no data for quality of life, patient satisfaction or acne.
AUTHORS' CONCLUSIONS
Lifestyle intervention improves body composition, hyperandrogenism (high male hormones and clinical effects) and insulin resistance in women with PCOS. There was no evidence of effect for lifestyle intervention on improving glucose tolerance or lipid profiles and no literature assessing clinical reproductive outcomes, quality of life and treatment satisfaction.
Topics: Abdominal Fat; Female; Humans; Insulin Resistance; Life Style; Obesity; Polycystic Ovary Syndrome; Randomized Controlled Trials as Topic; Virilism; Weight Loss
PubMed: 21328294
DOI: 10.1002/14651858.CD007506.pub2 -
European Journal of Dermatology : EJD 2009Our objective was to develop clinical practice guidance for the evaluation of hirsutism in premenopausal women. The Skin Academy is led by an international...
Our objective was to develop clinical practice guidance for the evaluation of hirsutism in premenopausal women. The Skin Academy is led by an international interdisciplinary team of experts, and aims to use the latest scientific and clinical data in selected dermatological diseases, to promote awareness, education and best clinical practice, thus improving patient care. The Skin Academy is an international platform designed to drive and develop education and awareness programmes, and to transfer scientific knowledge in dermatology across Europe and wider geographical areas. Consensus was guided by systematic review and discussion of current clinical practice across Europe during several group meetings of The Skin Academy, supported by conference calls, and e-mail communications. The outcome of the discussions was an evaluation form to be used by the clinician to help evaluate a patient presenting with excessive hair growth. This round-table expert opinion consensus paper, and the Diagnostic Evaluation Form it contains, is presented for discussion by the wider dermatology community.
Topics: European Union; Evidence-Based Medicine; Female; Hirsutism; Humans; International Cooperation; Medical Records; Premenopause; Risk Factors; Societies, Medical
PubMed: 19726276
DOI: 10.1684/ejd.2009.0786 -
The Cochrane Database of Systematic... Apr 2009Hirsutism is the presence of excessive hair growth in women and is an important cosmetic condition often resulting in severe distress. The most common cause is by... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Hirsutism is the presence of excessive hair growth in women and is an important cosmetic condition often resulting in severe distress. The most common cause is by increased production of male sex hormones (androgens). It is also affected by increased sensitivity to androgens in the hair follicles, and secretory glands around hair follicles (sebaceous glands). Spironolactone is an antiandrogen and aldosterone antagonist used to treat hirsutism.
OBJECTIVES
The objective was to investigate the effectiveness of spironolactone and/or in combination with steroids (oral contraceptive pill included) in reducing excess hair growth and/or acne in women.
SEARCH STRATEGY
The Cochrane Menstrual Disorders and Subfertility Group (MDSG) trials register was searched (April 2008). The Cochrane MDSG register is based on regular searches of MEDLINE, EMBASE, CINAHL, PsycINFO and CENTRAL, handsearching of 20 relevant journals and conference proceedings, and searches of several key grey literature sources. In addition, all reference lists of relevant trials were searched and drug companies contacted for details of unpublished trials.
SELECTION CRITERIA
All randomised controlled comparisons of spironolactone versus: placebo, steroids (oral contraceptive pill included), spironolactone of varying dosages, or spironolactone and steroids versus steroids alone when used to reduce hair growth and acne in women.
DATA COLLECTION AND ANALYSIS
Nine trials were included in the review, eight trials were excluded. Two other trials are awaiting assessment. Only one trial studied acne as an outcome, the remainder were concerned with hirsutism. Major outcome measures include the following: subjective observations, Ferriman and Gallwey hair scores, hormonal and biochemical parameters, side effects, sebum production measurement.
MAIN RESULTS
In the two trials that compared 100 mg of spironolactone with placebo significant differences were reported for subjective improvements in hair growth (OR 7.18, 95% CI 1.96 to 26.28), although not the Ferriman-Galwey score (WMD 7.20, 95% CI -10.98 to -3.42)). Data could not be otherwise pooled as only one trial reported an outcome.
AUTHORS' CONCLUSIONS
From the studies included in this review, there is some evidence to show that spironolactone is an effective treatment to decrease the degree of hirsutism but there was no evidence for effectiveness for the treatment of acne vulgaris. Studies in this area are scarce and small. Individual study data indicates some superiority of spironolactone over other drugs but results cannot be generalised.
Topics: Acne Vulgaris; Androgen Antagonists; Drug Therapy, Combination; Female; Hirsutism; Humans; Randomized Controlled Trials as Topic; Spironolactone
PubMed: 19370553
DOI: 10.1002/14651858.CD000194.pub2 -
Fertility and Sterility Feb 2009To review all available data and recommend a definition for polycystic ovary syndrome (PCOS) based on published peer-reviewed data, whether already in use or not, to... (Review)
Review
OBJECTIVE
To review all available data and recommend a definition for polycystic ovary syndrome (PCOS) based on published peer-reviewed data, whether already in use or not, to guide clinical diagnosis and future research.
DESIGN
Literature review and expert consensus.
SETTING
Professional society.
PATIENTS
None.
INTERVENTION(S)
None.
MAIN OUTCOME MEASURE(S)
A systematic review of the published peer-reviewed medical literature, by querying MEDLINE databases, to identify studies evaluating the epidemiology or phenotypic aspects of PCOS.
RESULT(S)
The Task Force drafted the initial report, following a consensus process via electronic communication, which was then reviewed and critiqued by the Androgen Excess and PCOS (AE-PCOS) Society AE-PCOS Board of Directors. No section was finalized until all members were satisfied with the contents, and minority opinions noted. Statements were not included that were not supported by peer-reviewed evidence.
CONCLUSION(S)
Based on the available data, it is the view of the AE-PCOS Society Task Force that PCOS should be defined by the presence of hyperandrogenism (clinical and/or biochemical), ovarian dysfunction (oligo-anovulation and/or polycystic ovaries), and the exclusion of related disorders. However, a minority considered the possibility that there may be forms of PCOS without overt evidence of hyperandrogenism, but recognized that more data are required before validating this supposition. Finally, the Task Force recognized and fully expects that the definition of this syndrome will evolve over time to incorporate new research findings.
Topics: Biomarkers; Diagnosis, Differential; Evidence-Based Medicine; Female; Health Status Indicators; Humans; Hyperandrogenism; Menstruation Disturbances; Ovarian Function Tests; Ovary; Ovulation; Phenotype; Polycystic Ovary Syndrome; Predictive Value of Tests; Terminology as Topic
PubMed: 18950759
DOI: 10.1016/j.fertnstert.2008.06.035 -
The Journal of Clinical Endocrinology... Dec 2007Women with polycystic ovarian syndrome (PCOS) are at increased risk for developing glucose intolerance and type 2 diabetes mellitus (DM). Recommendations for the timing... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
Women with polycystic ovarian syndrome (PCOS) are at increased risk for developing glucose intolerance and type 2 diabetes mellitus (DM). Recommendations for the timing and method of screening have varied. The purpose of this statement is to determine the optimal screening method, timing of screening, and treatment modalities for impaired glucose tolerance (IGT) among women with PCOS.
PARTICIPANTS
The expert panel was appointed by the Androgen Excess Society (AES) to review the literature and make recommendations based on the available evidence. Meetings were open, and there was no funding for the panel.
EVIDENCE
A systematic review was conducted of the published, peer-reviewed medical literature using MEDLINE to identify studies that addressed the prevalence, risk factors, testing, and treatment for IGT in both adults and adolescents with PCOS. Unpublished data were not considered.
CONSENSUS PROCESS
The panel held meetings to review the literature and draft the statement as a committee. The AES board members reviewed and critiqued the manuscript, and changes were made based on their comments.
CONCLUSIONS
The panel recommends that all patients with PCOS be screened for IGT with a 2-h oral glucose tolerance test. A few members of the AES board recommend alternatively screening women with PCOS for IGT and type 2 DM using an oral glucose tolerance test only in patients with a body mass index of 30 kg/m2 or greater or in lean patients with additional risk factors. Patients with normal glucose tolerance should be rescreened at least once every 2 yr, or more frequently if additional risk factors are identified. Those with IGT should be screened annually for development of type 2 DM. PCOS patients with IGT should be treated with intensive lifestyle modification and weight loss and considered for treatment with insulin-sensitizing agents.
Topics: Adolescent; Diabetes Mellitus, Type 2; Female; Glucose Intolerance; Humans; Hyperandrogenism; Polycystic Ovary Syndrome
PubMed: 18056778
DOI: 10.1210/jc.2007-1549 -
The Cochrane Database of Systematic... Oct 2007Endometriosis is defined as the presence of endometrial tissue (stromal and glandular) outside the normal uterine cavity. Conventional medical and surgical treatments... (Review)
Review
BACKGROUND
Endometriosis is defined as the presence of endometrial tissue (stromal and glandular) outside the normal uterine cavity. Conventional medical and surgical treatments for endometriosis aim to remove or decrease the deposits of ectopic endometrium. The observation that hyper androgenic states (an excess of male hormone) induce atrophy of the endometrium has led to the use of androgens in the treatment of endometriosis. Danazol is one of these treatments. The efficacy of danazol is based on its ability to produce a high androgen and low oestrogen environment (a pseudo menopause) which results in atrophy of the endometriotic implants and thus an improvement in painful symptoms.
OBJECTIVES
To determine the effectiveness of danazol compared to placebo or no treatment in the treatment of the symptoms and signs, other than infertility, of endometriosis in women of reproductive age.
SEARCH STRATEGY
We searched the Cochrane Menstrual Disorders and Subfertility Group Specialised Register of trials (searched April 2007), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2007), and MEDLINE (1966 to April 2007). In addition, all reference lists of included trials were searched, and relevant drug companies were contacted for details of unpublished trials.
SELECTION CRITERIA
Randomised controlled trials in which danazol (alone or as adjunctive therapy) was compared to placebo or no therapy. Trials which only reported infertility outcomes were excluded.
DATA COLLECTION AND ANALYSIS
Only five trials met the inclusion criteria and two authors independently extracted data from these trials. All trials compared danazol to placebo. Three trials used danazol as sole therapy and three trials used danazol as an adjunct to surgery. Although the main outcome was pain improvement other data relating to laparoscopic scores and hormonal parameters were also collected.
MAIN RESULTS
Treatment with danazol (including adjunctive to surgical therapy) was effective in relieving painful symptoms related to endometriosis when compared to placebo. Laparoscopic scores were improved with danazol treatment (including as adjunctive therapy) when compared with either placebo or no treatment. Side effects were more commonly reported in those patients receiving danazol than for placebo.
AUTHORS' CONCLUSIONS
Danazol is effective in treating the symptoms and signs of endometriosis. However, its use is limited by the occurrence of androgenic side effects.
Topics: Danazol; Endometriosis; Estrogen Antagonists; Female; Humans; Pelvic Pain; Randomized Controlled Trials as Topic
PubMed: 17943735
DOI: 10.1002/14651858.CD000068.pub2 -
The Journal of Clinical Endocrinology... Apr 2007At present, women with type 1 diabetes (DM1) are being treated with supraphysiological doses of exogenous insulin with the aim of providing a strict metabolic control,... (Review)
Review
CONTEXT
At present, women with type 1 diabetes (DM1) are being treated with supraphysiological doses of exogenous insulin with the aim of providing a strict metabolic control, thereby avoiding the long-term complications of this disease. We hypothesized that PCOS would be especially prevalent in DM1, as might happen in any condition in which the ovary and the adrenals are exposed to excessive insulin concentrations. As will be seen in the present review, androgen excess and PCOS are very frequent complaints in women with DM1, yet nowadays hyperandrogenism is seldom diagnosed in these patients.
EVIDENCE ACQUISITION
We conducted a systematic review of all the published studies addressing hyperandrogenic symptoms in women with DM1, identified through the Entrez-PubMed search engine, followed by a comprehensive review of the pathophysiology and clinical and laboratory features of PCOS in women with DM1.
EVIDENCE SYNTHESIS
The prevalence of PCOS in adult women with DM1 is 12-18, 40, and 31% using National Institute for Child Health and Human Development, Rotterdam, and Androgen Excess Society criteria, respectively. Mild hirsutism and biochemical hyperandrogenism are present in 30 and 20% of the patients, respectively. In addition, menstrual abnormalities are observed in 20% of adult women with DM1, and a prevalence of 50% of polycystic ovarian morphology is reported.
CONCLUSIONS
Physicians treating women with DM1 should be aware of the risk of hyperandrogenism in them and should include evaluation of hirsutism, menstrual abnormalities, and biochemical hyperandrogenism in their routine examinations. Future studies are needed to determine the best preventive and therapeutic options for the hyperandrogenism of these patients.
Topics: Diabetes Mellitus, Type 1; Female; Humans; Hyperandrogenism; Insulin Resistance; Polycystic Ovary Syndrome; Prevalence
PubMed: 17284617
DOI: 10.1210/jc.2006-2641 -
The Cochrane Database of Systematic... 2003Hirsutism is the presence of excessive hair growth in women and is an important cosmetic condition often resulting in severe distress. Hirsutism is most often caused by... (Review)
Review
BACKGROUND
Hirsutism is the presence of excessive hair growth in women and is an important cosmetic condition often resulting in severe distress. Hirsutism is most often caused by increased production of male sex hormones also known as androgens. It is also affected by increased sensitivity to androgens in the hair follicles, and the secretory glands around the hair follicles, called sebaceous glands. Spironolactone is an antiandrogen and aldosterone antagonist used to treat hirsutism.
OBJECTIVES
The objective of this review was to investigate the effectiveness of spironolactone and/or in combination with steroids (oral contraceptive pill included) in reducing excess hair growth and/or acne in women.
SEARCH STRATEGY
We searched the Cochrane Menstrual Disorders and Subfertility Group trials register (searched 12 June 2003). The Cochrane Menstrual Disorders and Subfertility Group register is based on regular searches of MEDLINE, EMBASE, CINAHL, PsycINFO and CENTRAL, the handsearching of 20 relevant journals and conference proceedings, and searches of several key grey literature sources. In addition, all reference lists of relevant trials were searched and drug companies contacted for details of unpublished trials.
SELECTION CRITERIA
All randomised controlled comparisons of spironolactone versus: placebo, steroids (oral contraceptive pill included), spironolactone of varying dosages, or spironolactone and steroids versus steroids alone when used to reduce hair growth and acne in women.
DATA COLLECTION AND ANALYSIS
Seven trials were included in the review, eight trials were excluded. Two other trials are awaiting assessment. All included trials were small (no more than 41 participants) randomised and controlled. Only one trial studied acne as an outcome, the remainder were concerned with hirsutism. Two trials investigated spironolactone versus placebo; one trial was a dosage studies of spironolactone; one trial compared spironolactone with spironolactone in combination with dexamethasone; one trial used topical spironolactone for the treatment of acne, one trial compared three treatments; spironolactone, finasteride, cyproterone acetate. Major outcome measures include the following: subjective observations, Ferriman and Gallwey hair scores, hormonal and biochemical parameters, side effects, sebum production measurement.
MAIN RESULTS
All sample populations were small and confidence intervals were wide. In the two trials that compared 100 mg of spironolactone with placebo significant differences were reported for subjective improvements in hair growth (OR 7.18, 95% CI 1.96 to 26.28), Ferriman-Galwey score (WMD 7.20, 95% CI -10.98 to -3.42)). The remaining comparisons were not statistically significant. There were statistically significant improvements in Ferriman-Galwey scores 12 months after the end of treatment in those women who received 100mg/day spironolactone compared to 12.5 mg/day cyproterone acetate (first 10 days of cycle) (WMD -1.18, 95% CI -2.1 to -0.26) and 5mg/day finasteride (WMD -2.34, 95% CI -3.23 to -1.45).
REVIEWER'S CONCLUSIONS
Six months treatment with 100 mg/day spironolactone compared with placebo was associated with a statistically significant subjective improvement in hair growth and a decrease in Ferriman-Galwey scores. Spironolactone 100mg/day is superior to finasteride 5 mg/day and low dose cyproterone acetate 12.5 mg/day (first 10 days of cycle) up to 12 months after the end of treatment. The effectiveness of treatment for acne vulgaris cannot be determined due to the small sample populations involved in the trials. Its value in clinical practice is difficult to assess from currently available research.
Topics: Acne Vulgaris; Drug Therapy, Combination; Female; Glucocorticoids; Hirsutism; Humans; Male; Mineralocorticoid Receptor Antagonists; Randomized Controlled Trials as Topic; Spironolactone
PubMed: 14583916
DOI: 10.1002/14651858.CD000194 -
The Cochrane Database of Systematic... 2001Hirsutism is the presence of excessive hair growth in women and is an important cosmetic condition often resulting in severe distress. Hirsutism is most often caused by... (Review)
Review
BACKGROUND
Hirsutism is the presence of excessive hair growth in women and is an important cosmetic condition often resulting in severe distress. Hirsutism is most often caused by increased production of male sex hormones also known as androgens. It is also affected by increased sensitivity to androgens in the hair follicles, and the secretory glands around the hair follicles, called sebaceous glands. Spironolactone is an antiandrogen and aldosterone antagonist used to treat hirsutism. Since 1978, many studies have been conducted to determine its effectiveness.
OBJECTIVES
The objective of this review was to investigate the effectiveness of spironolactone and/or in combination with steroids (oral contraceptive pill included) in reducing excess hair growth and/or acne in women.
SEARCH STRATEGY
All publications of randomised controlled trials of spironolactone versus placebo and/or in combination with steroids (oral contraceptive pill included) were identified. Search strategy was developed by the Menstrual Disorder Group. All accessible electronic databases were searched. In addition, all reference lists of relevant trials were searched and drug companies contacted for details of unpublished trials.
SELECTION CRITERIA
All randomised controlled comparisons of spironolactone versus: placebo, steroids (oral contraceptive pill included), spironolactone of varying dosages, or spironolactone and steroids versus steroids alone when used to reduce hair growth and acne in women.
DATA COLLECTION AND ANALYSIS
Six trials were included in the review, seven trials were excluded. Two other trials are awaiting assessment. All included trials were small (no more than 40 participants) randomised and controlled. Only one trial studied acne as an outcome, the remainder were concerned with hirsutism. Two trials investigated spironolactone versus placebo; one trial was a dosage studies of spironolactone; one trial compared spironolactone with spironolactone in combination with dexamethasone; the remaining trial used topical spironolactone for the treatment of acne. Major outcome measures include the following: - subjective observations - Ferriman and Gallwey hair scores - hormonal and biochemical parameters - side effects - sebum production measurement
MAIN RESULTS
All sample populations were small and confidence intervals were wide. In the two trials that compared 100 mg of spironolactone with placebo significant differences were reported for subjective improvements in hair growth (OR 7.18, 95%CI 1.96, 26.28), Ferriman-Galwey score (WMD 7.20, 95%CI -10.98, -3.42)). The remaining comparisons were not statistically significant.
REVIEWER'S CONCLUSIONS
Six months treatment with 100 mg spironolactone compared with placebo was associated with a statistically significant subjective improvement in hair growth and a decrease in Ferriman-Galwey scores. The effectiveness of treatment for acne vulgaris cannot be determined due to the small sample populations involved in the trials. Its value in clinical practice is difficult to assess from currently available research.
Topics: Acne Vulgaris; Drug Therapy, Combination; Female; Glucocorticoids; Hirsutism; Humans; Male; Mineralocorticoid Receptor Antagonists; Randomized Controlled Trials as Topic; Spironolactone
PubMed: 11687072
DOI: 10.1002/14651858.CD000194