Little evidence describes the risks and benefits of progestin-only contraceptives therapy. No good-quality evidence exists to determine the risk of cancer associated with progestin-only contraceptives. Data are insufficient to discern their effect on milk quality and quantity during lactation, though no effect on infant growth or weight was identified (strength of recommendation [SOR]: A, based on systematic Cochrane review)

Blackwell, Jean

Roederer, Mary W.

University of Missouri: MOspace

806 VOL 54, NO 9 / SEPTEMBER 2005  THE JOURNAL OF FAMILY PRACTICECLINICAL INQUIRIESE V I D E N C E - B A S E D A N S W E RWhat are the relative risks and benefits of progestin-only contraceptives?■ Evidence summaryThe risks and benefits associated withprogestin-only contraceptives are not completely studied for all routes of admin-istration. There is insufficient evidenceregarding their risks to point to a definitiveharm with their administration (TABLE). The risk of pregnancy with progestin-only contraceptives ranges from 0.0% to13.2% based on the method that is selected.8 Evidence is lacking to supportuse of progestin-only contraceptives forpremenstrual syndrome or dysfunctionaluterine bleeding.6,7Little evidence describes the risks and benefits of progestin-only contraceptives therapy options. RisksNo good-quality evidence exists to determine therisk of cancer associated with progestin-only contraceptives. Data are insufficient to discern their effect on milk quality and quantity during lactation, though no effect on infant growth orweight was identified (strength of recommendation[SOR]: A, based on systematic Cochrane review).1No increase in blood pressure occurred withoral progestin-only contraceptives or depotmedroxyprogesterone acetate (DMPA) (SOR: B,cohort studies).2 A decrease in bone mineral density was associated with current use of DMPAin studies lasting 2 years or less, yet the cessationof use may attenuate the effect (SOR: B, mostlycase-control).3 Oral and injectable progestin-onlycontraceptives demonstrated no significantincrease in venous thromboembolism, stroke,acute myocardial infarction, or combined cardiovascular disease endpoint (SOR: B, case-control study).4 Termination rates for nonmenstrual effects with progesterone implantswere less than 3% (SOR: B, cohort studies).5BenefitsProgestin-only contraceptives are an effective formof birth control. For the treatment of premenstrualsyndrome or dysfunctional uterine bleeding, inadequate evidence exists to support using progestin-only options (SOR: A, RCTs).6,7Mary W. Roederer, PharmD Department of Family Medicine, University of North Carolina at Chapel HillJean C. Blackwell, MLSHealth Sciences Library, University of North Carolina at Chapel HillC L I N I C A L C O M M E N T A R YPatient-centered, not evidence-based, reasons contribute to shifts in contraception patternsNonlactating women in my practice are choosingprogestin-only contraceptives less often than previously, when DMPA was my second-most-common contraceptive prescription. Patient-centered, not evidence-based, reasons contribute to this shift in prescribing patterns.Many women who chose injectable progestin-only contraceptives because of difficultyremembering to take oral contraceptives havechanged to patch-delivered or intravaginal estrogen-progestins due to concern over potentialweight gain and increased bone loss with progestin-only contraceptives. Intrauterine deviceshave experienced a surge in popularity with theaddition of slow-release progesterone, and condoms remain popular because they reduce disease transmission. When women receive evidence-based risk/benefit contraceptive counseling, they then have the knowledge tochoose the contraceptive that best fits their lifestyle.Paul Crawford, MD, Headquarters AAC Family MedicineResidency, Eglin Air Force Base, Eglin, FlaWhat are the risks and benefits of progestin-only contraceptives? ▲VOL 54, NO 9 / SEPTEMBER 2005 807w w w. j f p o n l i n e . c o mRecommendations from othersThe World Health Organization (WHO)highlights the need to avoid progestin-onlycontraceptives for women younger than 18or older than 45 years, secondary to con-cerns of decreased bone mass. Immediatelypostpartum, women may initiate progestin-only contraceptives if they are not breast-feeding; if breastfeeding, women shouldwait until at least 6 months postpartum. Hypertensive women should avoidprogestin-only contraceptives; women atrisk for hypertension—particularly DMPAusers—are encouraged to measure bloodpressure before and after use. The WHOdocument points out the increased possibil-ity for abnormal uterine bleeding with progestin-only contraceptives use.9American College of Physician’s PIER:Physicians’ Information and EducationResource describes using progestin-onlycontraceptives in hypercoagulable statesand severe hyperlipidemia and avoidinguse in osteoporosis, osteopenia, and chron-ic glucocorticoid use due to a decrease inbone mineral density.10T A B L ERISK TYPE EVIDENCEVTE, stroke, acute MI, Oral injectable No significant association with increased incidence of VTE, or combined CVD endpoint4 stroke, acute MI, or the combined CVD endpointIncreased blood pressure2 Oral DMPA No significant association with increased blood pressure for up to 2–3 years of useNonmenstrual adverse events5 Progesterone • Specific information for each adverse event unavailable• Headache implants • Overall termination rate for nonmenstrual adverse events • Lower abdominal pain less than 3%• Weight gain• AcneEffect on lactation1 All progestin-only • Insufficient evidence to establish an effect on milk quality contraceptives* or quantity• No documented effect on infant growth or weightDecreased BMD3 DMPA • Decreased bone mineral density within 1 standard deviation of mean • Duration of effect inconclusive as cessation of use may attenuate effect• No information on risk of fracturePregnancy8 Oral, DMPA, Based on perfect use and typical use evaluations:progesterone • Oral: 0.0% to 13.2%implants • DMPA: 0.0% to 3.2%• Implants: 0.0% to 2.3%BENEFIT TYPE EVIDENCETreatment of PMS6 Suppositories, No evidence of improvement in PMS symptomspessaries, oralDysfunctional uterine Oral No evidence to support the use of progesterones orbleeding with anovulation7 progestogens in dysfunctional uterine bleeding*Only trials with oral dosages met criteria.DMPA, depot medroxyprogesterone acetate; VTE, venous thromboembolism; MI, myocardial infarction; CVD, cardiovascular disease; PMS, premenstrual syndromeRisks and benefits of progestin-only contraceptivesFAMILYPRACTICETHE JOURNAL OFTHE JOURNAL OF FAMILY PRACTICE uses a simplified rating system called the Strength of Recommendation Taxonomy(SORT). More detailed information can be found in the February 2003 issue,“Simplifying the language of patient care,”pages 111–120.Strength of Recommendation (SOR) ratingsare given for key recommendations for readers.SORs should be based on the highest-quality evidence available.A Recommendation based on consistent and good-quality patient–oriented evidence.B Recommendation based on inconsistent or limited-quality patient-oriented evidence.C Recommendation based on consensus, usual practice,opinion, disease-oriented evidence, or case series for studies of diagnosis, treatment, prevention, or screeningLevels of evidence determine whether a studymeasuring patient-oriented outcomes is ofgood or limited quality, and whether the resultsare consistent or inconsistent between studies.STUDY QUALITY1—Good-quality, patient-oriented evidence (eg, validated clinical decision rules, systematic reviews and meta-analyses of randomized controlled trials[RCTs] with consistent results, high-quality RCTs, ordiagnostic cohort studies)2—Lower-quality patient-oriented evidence (eg, unvalidated clinical decision rules, lower-quality clinical trials, retrospective cohort studies, case controlstudies, case series)3—Other evidence (eg, consensus guidelines, usual practice, opinion, case series for studies of diagnosis,treatment, prevention, or screening)Consistency across studies Consistent—Most studies found similar or at least coherent conclusions (coherence means that differencesare explainable); or If high-quality and up-to-date systematic reviews or meta-analyses exist, they supportthe recommendationInconsistent—Considerable variation among study findingsand lack of coherence; or If high-quality and up-to-date systematic reviews or meta-analyses exist, they do not find consistent evidence in favor of the recommendationEvidence-based medicine ratingsThe American College of Obstetricians andGynecologists (ACOG) specifically endorses the pref-erential use of progestin-only contraceptives by lactat-ing women and women at an increased risk of venousthromboembolism based on good evidence. Forwomen with systemic lupus erythematosus, ACOGrecommends use of progestin-only contraceptives overcombined oral contraceptive, based on fair evidence.By consensus, ACOG recognizes benefits of DMPAfor women with sickle-cell disease and women withcoronary artery disease, congestive heart failure, orcerebrovascular disease. In general, ACOG recom-mends progestin-only contraceptives over combinedoral contraceptives for patients with the followingconditions: migraine headaches, cigarette smoker ofage greater than 35, history of venous thrombo-embolism, coronary artery disease, congestive heartfailure, cerebrovascular disease, postpartum <2 weeks,hypertension with vascular disease or age greater than 35, diabetes with vascular disease or age greater than 35, systemic lupus erythematosus withvascular disease, nephritis, or antiphospholipid anti-bodies, or hypertriglyceridemia.11R E F E R E N C E S1. Truitt ST, Fraser AB, Grimes DA, Gallo MF, Schulz KF. Combined hor-monal versus nonhormonal versus progestin-only contraception inlactation. Cochrane Database Syst Rev 2003; (2):CD003988.2. Hussain SF. Progestogen-only pills and high blood pressure: is therean association? A literature review. Contraception 2004; 69:89–97.3. Banks E, Berrington A, Casabonne D. Overview of the relationshipbetween use of progestogen-only contraceptives and bone mineraldensity. BJOG 2001; 108:1214–1221.4. World Health Organization Collaborative Study of CardiovascularDisease and Steroid Hormone Contraception. Cardiovascular dis-ease and use of oral and injectable progestogen-only contraceptivesand combined injectable contraceptives. Contraception 1998;57:315–324.5. Brache V, Faundes A, Alvarez F, Cochon L. Nonmenstrual adverseevents during use of implantable contraceptives for women: datafrom clinical trials. Contraception 2002; 65:63–74.6. Wyatt K, Dimmock P, Jones P, Obhrai M, O'Brien S. Efficacy of prog-esterone and progestogens in management of premenstrual syn-drome: systematic review. BMJ 2001; 323:776–780.7. Hickey M, Higham J, Fraser IS. Progestogens versus oestrogens andprogestogens for irregular uterine bleeding associated with anovu-lation. Cochrane Database Syst Rev 2000; (2):CD001895.8. Trussell J. Contraceptive efficacy. In: Hatcher RA et al, eds.Contraceptive Technology. 18th rev ed. New York, NY: Ardent Media;2004:773-845.9. World Health Organization. Improving Access to Quality Care inFamily Planning: Medical Eligibility Criteria for Contraceptive Use.3rd ed. Geneva: World Health Organization; 2004.10. American College of Physicians. Contraception recommendationsfor selected conditions or medications. PIER: Physicians' Informationand Education Resource [online]. Philadelphia: American College ofPhysicians, 2005. Available at: online.statref.com. Accessed onAugust 12, 2005. 11. ACOG Practice Bulletin. The use of hormonal contraception inwomen with coexisting medical conditions. Int J Gynaecol Obstet2001; 75:93–106.808 THE JOURNAL OF FAMILY PRACTICECLINICAL INQUIRIES

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