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Guideline Summary
Guideline Title
Polycystic ovary syndrome.
Bibliographic Source(s)
American College of Obstetricians and Gynecologists (ACOG). Polycystic ovary syndrome. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2009 Oct. 14 p. (ACOG practice bulletin; no. 108).  [85 references]
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Polycystic ovary syndrome (PCOS)

Guideline Category
Assessment of Therapeutic Effectiveness
Diagnosis
Evaluation
Management
Prevention
Treatment
Clinical Specialty
Dermatology
Endocrinology
Family Practice
Internal Medicine
Obstetrics and Gynecology
Intended Users
Physicians
Guideline Objective(s)

  • To examine the best available evidence on the diagnosis and clinical management of polycystic ovary syndrome (PCOS)
  • To aid practitioners in making decisions about appropriate obstetric and gynecologic care

Target Population

Women with polycystic ovary syndrome

Interventions and Practices Considered

Diagnosis

  1. Patient and family history
  2. Physical examination, including blood pressure, body mass index, waist circumference, and presence of stigmata of hyperandrogenism and insulin resistance
  3. Laboratory tests, including documentation of biochemical hyperandrogenemia, exclusion of other causes of hyperandrogenism, evaluation for metabolic abnormalities, and fasting lipid and lipoprotein levels
  4. Ultrasound examination
  5. Optional tests
    • Gonadotropin determinations
    • Fasting insulin levels
    • 24-hour urinary free-cortisol excretion test or low dose dexamethasone suppression test

Management/Treatment

Anovulation and Amenorrhea

  1. Combination oral contraceptives
  2. Progestin, including medroxyprogesterone acetate
  3. Insulin-sensitizing agents, including metformin and thiazolidinediones*

Note: None of the antidiabetic agents noted are currently approved by the U.S. Food and Drug Administration (FDA) for treatment of PCOS-related menstrual dysfunction, although metformin appears to have the safest risk–benefit ratio.

*Considered but not recommended.

Ovulation Induction

  1. Clomiphene citrate
  2. Clomiphene citrate and dexamethasone
  3. Low-dose gonadotropins
  4. Ovarian drilling with laser or diathermy (recommended as second-line therapy)
  5. Aromatase inhibitors such as letrozole and anastrozole (not FDA-approved for ovulation induction)
  6. Metformin as adjunct to clomiphene

Hirsutism

  1. Combined oral contraceptives
  2. Antiandrogens, including spironolactone, flutamide, and finasteride
  3. Insulin-sensitizing agents
  4. Eflornithine
  5. Mechanical hair removal, such as shaving, plucking, waxing, depilatory creams, electrolysis, and laser vaporization

Prevention of Cardiovascular Disease and Diabetes

  1. Lifestyle modification
  2. Insulin-sensitizing agents such as metformin
  3. Statins
Major Outcomes Considered

  • Sensitivity and specificity of diagnostic tests
  • Risk of developing type 2 diabetes and cardiovascular disease
  • Ovulatory function
  • Pregnancy rate after ovulation induction, including multiple pregnancy rate
  • Incidence of hirsutism

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

The MEDLINE database, the Cochrane Library, and the American College of Obstetricians and Gynecologists' (ACOG's) own internal resources and documents were used to conduct a literature search to locate relevant articles published between January 1985 and February 2009. The search was restricted to articles published in the English language. Priority was given to articles reporting results of original research, although review articles and commentaries also were consulted. Abstracts of research presented at symposia and scientific conferences were not considered adequate for inclusion in this document. Guidelines published by organizations or institutions such as the National Institutes of Health and the American College of Obstetricians and Gynecologists were reviewed, and additional studies were located by reviewing bibliographies of identified articles.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Studies were reviewed and evaluated for quality according to the method outlined by the U.S. Preventive Services Task Force.

I Evidence obtained from at least one properly designed randomized controlled trial.

II-1 Evidence obtained from well-designed controlled trials without randomization.

II-2 Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group.

II-3 Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments also could be regarded as this type of evidence.

III Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review
Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

Analysis of available evidence was given priority in formulating recommendations. When reliable research was not available, expert opinions from obstetrician-gynecologists were used. See also the "Rating Scheme for the Strength of Recommendations" field regarding Grade C recommendations.

Rating Scheme for the Strength of the Recommendations

Based on the highest level of evidence found in the data, recommendations are provided and graded according to the following categories:

Level A - Recommendations are based on good and consistent scientific evidence.

Level B - Recommendations are based on limited or inconsistent scientific evidence.

Level C - Recommendations are based primarily on consensus and expert opinion.

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation

Practice Bulletins are validated by two internal clinical review panels composed of practicing obstetrician-gynecologists generalists and sub-specialists. The final guidelines are also reviewed and approved by the American College of Obstetricians and Gynecologists (ACOG) Executive Board.

Recommendations

Major Recommendations

The grades of evidence (I-III) and levels of recommendations (A-C) are defined at the end of the "Major Recommendations" field.

The following recommendations and conclusions are based on good and consistent scientific evidence (Level A):

  • An increase in exercise combined with dietary change has consistently been shown to reduce diabetes risk comparable to or better than medication.
  • Improving insulin sensitivity with insulin-sensitizing agents is associated with a decrease in circulating androgen levels, improved ovulation rate, and improved glucose tolerance.
  • The recommended first-line treatment for ovulation induction remains the antiestrogen clomiphene citrate.
  • The addition of eflornithine to laser treatment is superior in the treatment of hirsutism than laser alone.

The following recommendations and conclusions are based on limited and inconsistent scientific evidence (Level B):

  • Women with a diagnosis of polycystic ovary syndrome (PCOS) should be screened for type 2 diabetes and impaired glucose tolerance with a fasting glucose level followed by a 2-hour glucose level after a 75-g glucose load.
  • Women with PCOS should be screened for cardiovascular risk by determination of body mass index (BMI), fasting lipid and lipoprotein levels, and metabolic syndrome risk factors.
  • Reduction in body weight has been associated with improved pregnancy rates and decreased hirsutism, as well as improvements in glucose tolerance and lipid levels.
  • There may be an increase in pregnancy rates by adding clomiphene to metformin, particularly in obese women with PCOS.
  • If clomiphene citrate use fails to result in pregnancy, the recommended second-line intervention is either exogenous gonadotropins or laparoscopic ovarian surgery.

The following recommendations and conclusions are based primarily on consensus and expert opinion (Level C):

  • Combination low-dose hormonal contraceptives are most frequently used for long-term management and are recommended as the primary treatment of menstrual disorders.
  • Women in groups at higher risk for nonclassical congenital adrenal hyperplasia and a suspected diagnosis of PCOS should be screened to assess the 17- hydroxyprogesterone value.
  • A low-dose regimen is recommended when using gonadotropins in women with PCOS.
  • There is no clear primary treatment for hirsutism in PCOS.

Definitions:

Grades of Evidence

I Evidence obtained from at least one properly designed randomized controlled trial.

II-1 Evidence obtained from well-designed controlled trials without randomization.

II-2 Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group.

II-3 Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments also could be regarded as this type of evidence.

III Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees

Levels of Recommendations

Level A - Recommendations are based on good and consistent scientific evidence.

Level B - Recommendations are based on limited or inconsistent scientific evidence.

Level C - Recommendations are based primarily on consensus and expert opinion.

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate diagnosis, treatment and management of polycystic ovary syndrome

Potential Harms

Side Effects of Medication

  • Progestins. Progestin-only oral contraceptives are associated with high incidence of breakthrough bleeding.
  • Oral contraceptives. May be associated with a significant elevation in circulating triglycerides as well as in high-density lipoprotein (HDL) levels.
  • Clomiphene citrate. Use of clomiphene citrate can result in ovarian hyperstimulation syndrome. There is a 10% increased risk of twin gestations with the use of clomiphene citrate and a significantly greater risk with the use of exogenous gonadotropins.
  • Insulin-sensitizing agents. The most common adverse reactions of metformin are gastrointestinal symptoms (diarrhea, nausea, vomiting, abdominal bloating, flatulence, and anorexia). Metformin is also associated with a small risk of lactic acidosis. 
  • Antiandrogens. All antiandrogens are teratogenic and pose a risk of feminization of the external genitalia in a male fetus if the patient conceives. Spironolactone can cause and exacerbate hyperkalemia; therefore, it should be used cautiously in women with renal impairment. The most common side effect of flutamide is dry skin, but its use has been associated with hepatitis in rare cases. Only minimal hepatic and renal toxicity is associated with finasteride.
  • Eflornithine. A variety of adverse skin conditions have been reported in a small percentage of patients. Side effects were primarily local with stinging, burning, erythema, and rarely a rash.
  • Cosmetic management of hirsutism. Plucking can cause folliculitis, pigmentation, and scarring.

Qualifying Statements

Qualifying Statements

These guidelines should not be construed as dictating an exclusive course of treatment or procedure. Variations in practice may be warranted based on the needs of the individual patient, resources, and limitations unique to the institution or type of practice.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Foreign Language Translations
Patient Resources
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Living with Illness
IOM Domain
Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)
American College of Obstetricians and Gynecologists (ACOG). Polycystic ovary syndrome. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2009 Oct. 14 p. (ACOG practice bulletin; no. 108).  [85 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2009 Oct
Guideline Developer(s)
American College of Obstetricians and Gynecologists - Medical Specialty Society
Source(s) of Funding

American College of Obstetricians and Gynecologists (ACOG)

Guideline Committee

American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins-Gynecology

Composition of Group That Authored the Guideline

Not stated

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Not available at this time.

Print copies: Available for purchase from the American College of Obstetricians and Gynecologists (ACOG) Distribution Center, PO Box 4500, Kearneysville, WV 25430-4500; telephone, 800-762-2264, ext. 192; e-mail: sales@acog.org. The ACOG Bookstore is available online at the ACOG Web site External Web Site Policy.

Availability of Companion Documents

None available

Patient Resources

The following is available:

  • Polycystic ovary syndrome. American College of Obstetricians and Gynecologists (ACOG); 2009.

Available from the American College of Obstetricians and Gynecologists (ACOG) Web site External Web Site Policy. Copies are also available in Spanish External Web Site Policy.

Print copies: Available for purchase from the American College of Obstetricians and Gynecologists (ACOG) Distribution Center, PO Box 4500, Kearneysville, WV 25430-4500; telephone, 800-762-2264, ext. 192; e-mail: sales@acog.org. The ACOG Bookstore is available online at the ACOG Web site External Web Site Policy.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This summary was completed by ECRI on February 4, 2004. The information was verified by the guideline developer on July 26, 2004. This summary was updated by ECRI Institute on December 16, 2009. This summary was updated by ECRI Institute on November 8, 2010 following the U.S. Food and Drug Administration advisory on Avandia (rosiglitazone). This summary was updated by ECRI Institute on June 27, 2011 following the U.S. Food and Drug Administration advisory on Zocor (simvastatin). This summary was updated by ECRI Institute on April 13, 2012 following the U.S. Food and Drug Administration advisories on Statin Drugs and Statins and HIV or Hepatitis C drugs.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

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