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A PRACTICAL JOURNAL FOR NURSE PRACTITIONERS

Th e Of f icia l J o u r n a l o f

NPWH

A Peer-Reviewed Journal

Winter 2008 Vol. 7, No. 1

Clinical Supplement

Exploring Options in Premenstrual Dysphoric Disorder Management

Earn CE Credit

Faculty Chair Anne Moore, MSN, RNC, FAANP Faculty Ellen W. Freeman, PhD Mary Jane Minkin, MD

etter L Editor-in-Chief

from the

NO LAUGHING MATTER

Premenstrual disorders have long been the brunt of jokes and fodder for tacky T-shirts. Recognition of these disorders has also been fraught with political controversy over concern that recognition of a distinctly female problem would be used to keep women out of high-level positions where an abundance of testosterone is revered. It is only fairly recently that the most severe manifestations of premenstrual symptoms--known as premenstrual dysphoric disorder or PMDD--have been given a diagnostic code. Even today, the FDA does not consider premenstrual syndrome (PMS) an indication for medications that might alleviate bothersome symptoms. I am disturbed that PMS, an entity that may even have a genetic component, has met with such skepticism, rather than an effective treatment, for so many years. However, treatments are finally available for women whose premenstrual symptoms are no laughing matter. Certain SSRIs can be taken intermittently or on a daily basis. And an oral contraceptive has been approved to treat PMDD in women who also desire contraception. This issue of Women's Health Care, based on a symposium held at the NPWH annual conference in October 2007, reviews the diagnosis of premenstrual disorders and brings you up to date on the latest treatments and their use. We hope that this issue will serve as a reminder that millions of women have suffered for years or even decades with severe premenstrual symptoms. But now we, as NPs, can intervene by taking the time to diagnose and treat PMDD--a very serious matter--properly.

Susan Wysocki, RNC, NP, FAANP, President and CEO, NPWH

NPWH BOARD OF DIRECTORS

EXECUTIVE COMMITTEE

® Anne Moore, MSN, RNC, FAANP

Chair Professor of Nursing Vanderbilt School of Nursing Nashville, Tennessee

NORTH ATLANTIC REGION

® Ivy M. Alexander, PhD, MS, C-ANP

Associate Professor Yale University New Haven, Connecticut

WESTERN REGION

® Sharon Myoji Schnare, RN, FNP, CNM, MSN,

FAANP

® Susan M. Kendig, RNC, MSN, WHCNP

Chair-elect Clinical Assistant Professor Barnes College of Nursing University of Missouri St Louis, Missouri

Clinician and Consultant Women's Health Care Seattle, Washington

SOUTHEAST REGION

® Penelope M. Bosarge, MSN, WHNP

Coordinator, Women's Health Nurse Practitioner Option University of Alabama School of Nursing Birmingham, Alabama Clinical Practice, Planned Parenthood

AT-LARGE MEMBERS OF THE BOARD OF DIRECTORS

® Diane A. Smith, RN, MSN, CRNP

Nurse Practitioner UroHealthcare, LLC Newtown Square, Pennsylvania

® Suzy Reiter, RNC, WHNP, MM, MSN, SANE-A

Treasurer Vice President of Medical Services Planned Parenthood Centers of West MI Grand Rapids, Michigan

SOUTH CENTRAL REGION

® Elizabeth Kostas-Polson, MSN, APN, WHNP-C

Doctoral Nursing Student Niehoff School of Nursing Loyola University Chicago Chicago, Illinois

® Carolyn M. Sutton, MS, RNC, WHNP, FAANP

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® Versie Johnson-Mallard, MSN, ARNP

Assistant Professor Florida A&M University Tallahassee, Florida

® Linda Dominguez, RNC, BSN, WHNP

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GREAT LAKES REGION

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2

Women's Health Care: A Practical Journal for Nurse Practitioners

STAFF

Editor-in-Chief Susan Wysocki, RNC, NP, FAANP Editor Dory Greene Editorial Assistant Dawn Citron Art Director Victoria Baum Publisher Louise K. Young CEO George R. Young

EXPLORING OPTIONS IN PREMENSTRUAL DYSPHORIC DISORDER MANAGEMENT

Winter 2008 Vol. 7, No. 1 Diagnosis of PMDD Treatment Options for PMDD When "Natural" Is Not Enough: Pharmacologic Options for PMDD Case Studies Summary Continuing Education Post-test Answer Sheet and Evaluation Form Daily Record of Severity of Problems 6 7 7 10 15 17 18 19

NPWH STAFF

Susan Wysocki, RNC, NP, FAANP President and CEO Email: [email protected] Gay Johnson Vice President and CFO Email: [email protected] Carol Wiley Office Administrator and Membership Services Email: [email protected] Emily Longvall Continuing Education Coordinator and Administrative Assistant Email: [email protected]h.org Fran Way, RNC, MS Education Consultant Moore Haven, Florida Aimee Gallagher Communications and Health Policy Email: [email protected] Susan Rawlins, RNC, MS Education Consultant Dallas, Texas

W

omen's Health CareTM is published by NP Communications, LLC. It is indexed in CINAHL. Contents of the articles are determined by the authors and do not necessarily reflect the views or opinions of the publisher or advertisers. The authors and publisher disclaim responsibility for any loss, injury, or damage resulting, directly or indirectly, from the use or application of the contents of this journal.

© 2008 NP Communications, LLC. All rights reserved. Women's Health Care: A Practical Journal for Nurse Practitioners is distributed free as a membership benefit to NP members of the National Association of Nurse Practitioners in Women's Health. To become a member of NPWH and receive Women's Health Care: A Practical Journal for Nurse Practitioners free of charge, contact NPWH at (202) 543-9693. Non-nurse practitioners may subscribe at $29 annually.

INFORMATION

We can be reached at: NP Communications, LLC 109 South Main Street Cranbury, NJ 08512 Postmaster: Address Correction Requested Tel: 609-371-5085 Fax: 609-371-5086 Email: [email protected] For change of name or address only: Nurse practitioners must send name, mailing address, and specialty to: Women's Health Care 650 Dresher Road, Horsham, PA 19044 or email information and label code # to [email protected]

This Clinical Supplement is supported by an educational grant provided by Bayer HealthCare Pharmaceuticals.

This Continuing Education activity is sponsored by NPWH. It was developed by Haymarket Medical Education based on a satellite symposium presented at the NPWH 2007 annual conference.

Winter 2008 Vol. 7, No. 1

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CONTINUING EDUCATION ACTIVITY REQUIREMENTS

1. Intended Audience: This continuing education (CE) activity has been designed to meet the educational needs of nurse practitioners (NPs) involved in the health management of reproductive-aged women. 2. CE Approval Period: January 1, 2008, through December 31, 2009. 3. Estimated Time to Complete This Activity: 1.5 hours 4. Program Description/Identification of Need: Premenstrual dysphoric disorder (PMDD) is a severe premenstrual disorder characterized by distressing symptoms and significant impairments in personal, social, and professional functioning. PMDD probably affects 3% to 8% of US women. PMDD is persistent, expensive, and a significant detriment to a woman's well-being. The disorder can also adversely affect people who interact with women with PMDD, including their partners, family, or co-workers. Surveys of NPWH members have identified PMS/PMDD as an area of need for CE activity. 5. Educational Objectives: Following completion of this Continuing Education program, participants will be able to: a. Differentiate between premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD) b. Discuss the effects of PMS and PMDD on health and quality of life. c. Identify patient-appropriate PMDD treatment strategies that take into consideration a woman's overall needs, including her need for contraception 6. Accreditation Statement: This activity has been approved by the Continuing Education Approval Committee of the National Association of Nurse Practitioners in Women's Health (NPWH) for 1.5 contact hours, including 1.5 contact hours of pharmacology. 7. Faculty Disclosures: NPWH policy requires all faculty members to disclose any affiliation or relationship with a commercial interest that may cause a potential, real, or apparent conflict of interest with the content of a CE program. NPWH does not imply that the affiliation or relationship will affect the content of the CE program. Disclosure provides participants with information that may be important to their evaluation of an activity. Conflicts of interest were resolved prior to development of content. 4 Anne Moore, MSN, RNC, FAANP, serves on an advisory board or panel and on the speakers' bureaus for Bayer HealthCare Pharmaceuticals, Duramed Pharmaceuticals/ Barr Laboratories, Organon USA, and Wyeth Pharmaceuticals. Ellen W. Freeman, PhD, serves on an advisory board or panel for Wyeth, has received grant and research support from Wyeth, Pfizer, and Xanodyne, and is a consultant for Wyeth and Pherin Pharmaceuticals. Mary Jane Minkin, MD, discloses that she serves on an advisory board or panel for Bayer HealthCare Pharmaceuticals and as a consultant for Wyeth-Ayerst and is on the speakers' bureaus for Bayer HealthCare Pharmaceuticals, Novo Nordisk, Organon USA, and Novogyne. 8. Disclosure of Unlabeled Use: NPWH policy requires authors to disclose to participants when they are presenting information about unlabeled use of a commercial product or device or an investigational use of a drug or device not yet approved for any use. 9. Disclaimer: Participating faculty members determine the editorial content of the CE activity; this content does not necessarily represent the views of NPWH, Haymarket Medical Education, or Bayer HealthCare Pharmaceuticals. This content has undergone a blinded peer review process for validation of clinical content. Although every effort has been made to ensure that the information is accurate, clinicians are responsible for evaluating this information in relation to generally accepted standards in their own communities and integrating the information in this activity with those of established recommendations of other authorities, national guidelines, FDA-approved package inserts, and individual patient characteristics. 10. Successful Completion of the Activity: This requires participants to (a) read the educational objectives, disclosures, and disclaimers; (b) study the material in the learning activity; (c) return the activity evaluation and completed post-test with a score of 70% or better during the approval period to the address on the post-test evaluation form. 11. Commercial Support: This program is made possible by an educational grant provided by Bayer HealthCare Pharmaceuticals.

Women's Health Care: A Practical Journal for Nurse Practitioners

EXPLORING OPTIONS IN PREMENSTRUAL DYSPHORIC DISORDER MANAGEMENT

The spectrum of premenstrual disorders affects women of all ages during their reproductive years. The symptoms range from occasional mild discomfort to a debilitating constellation of problems, and few women escape at least some symptoms related to menses. To discuss the topic with greater precision, definitions have been applied to premenstrual symptoms of different severity among females aged 15 to 44 years. The two most prevalent conditions are molimina and premenstrual syndrome (PMS). Molimina is characterized by modest discomfort and no impairment of personal, social, or professional functioning. This is the most common form of menstrual discomfort, affecting 70% to 90% of all American women. The term PMS, as defined by the American College of Obstetricians and Gynecologists (ACOG), refers to moderate to severe discomfort and impairment. PMS affects 20% to 40% of American women.1 In 2000, ACOG published clinical management guidelines for PMS that include diagnostic criteria.2 According to the ACOG criteria, PMS can be diagnosed when a woman has one or more bothersome affective or somatic symptoms consistent with PMS. She must experience identifiable dysfunction in her social or economic performance as a result of those symptoms. The symptoms must occur during the 5 days before menses in each of 3 prior menstrual cycles and must be relieved within 4 days of the onset of menses. These symptoms must not recur until at least cycle day 13. Other disorders must be excluded as the cause of the symptoms, as should use of pharmacologic therapy, exogenous hormone use, and the use of recreational drugs or alcohol, and the diagnosis must be based on prospective diaries that have been kept for a minimum of 2 to 3 consecutive months (Table 1).2 Premenstrual dysphoric disorder (PMDD) is a severe premenstrual disorder characterized by distressing symptoms and significant impairments in personal, social,

TABLE 1.

PMS: ACOG Criteria

Prospective diary for 2­3 consecutive months must demonstrate 1 symptom consistent with PMS resulting in diminished functioning Affective Irritability Depression Angry outbursts Anxiety Confusion Social withdrawal Somatic Breast tenderness Abdominal bloating Headache Swelling of extremities

Key: PMS, premenstrual syndrome; ACOG, American College of Obstetricians and Gynecologists. American College of Obstetricians and Gynecologists. Practice Bulletin. 2000;15:1-9.

Winter 2008 Vol. 7, No. 1

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and professional functioning. PMDD probably affects 3% to 8% of American women.1 Diagnostic criteria for PMDD have been published by the American Psychiatric Association in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSMIV-TR). They include the following: ® At least 5 of 11 symptoms, including at least 1 core symptom ® Symptoms present during last week of luteal phase ® Relief within a few days of menses onset; no recurrence during week after menses ® Symptoms interfere with work, school, usual activities

® Criteria confirmed by prospective daily ratings during 2 or more consecutive, symptomatic cycles.3 Core symptoms of PMDD in this definition include depressed mood; moodiness/emotional lability; anxiety, edginess, or nervousness; and anger/irritability. The full list of symptoms included in this definition of PMDD is shown in Table 2. Failure to conclusively identify the cause or causes of premenstrual disorders has made it challenging to find effective treatments. The question of how menstrual disorders originate is therefore a topic of intense study, and several possible explanations have emerged.

Women with a genetic predisposition may have abnormal responses to normally occurring fluctuations of gonadal hormones; these responses may contribute to symptoms. The pathobiology of premenstrual disorders involves multifaceted interactions among the central nervous system, hormones, and other modulators. Although a number of studies have examined reproductive hormones in association with PMS and PMDD, peripheral levels of these hormones are in the normal range, and no abnormalities associated with PMS and PMDD symptoms have been consistently identified. In neurohormonal systems, serotonin abnormalities such as abnormal 5-HT actions may occur. In this monograph, we will investigate PMDD from a case-study perspective. We will find that PMDD is persistent, expensive, and a significant detriment to a woman's wellbeing. It also can adversely affect people who interact with a woman with PMDD, including her partner, family, or co-workers. The average American woman with PMDD experiences about 8 cumulative years of severe symptoms during her reproductive life.4 PMDD is associated with increased suicidality and substantial comorbidity.5 The economic repercussions of PMDD include increased utilization of healthcare services, missed work, and diminished productivity while at work.5,6 Data indicate that the quality of life in patients with PMDD is similar to that in patients with dysthymic disorder and not much better than that associated with major depressive disorder.7

TABLE 2.

Symptoms of PMDD--DSM-IV-TR Diagnostic Criteria

Core symptoms Depressed mood Moodiness, emotional lability Anxiety, "edginess," nervousness Anger, irritability Other symptoms Fatigue/lethargy Insomnia/hypersomnia Change in appetite, food cravings Decreased interest in usual activities Difficulty concentrating Sense of being overwhelmed Physical symptoms (eg, breast tenderness, bloating) For a diagnosis of PMDD, these criteria must be met: ® At least 5 symptoms, including 1 core symptom, must be present ® Symptoms are present during last week of luteal phase ® Relief occurs within a few days of menses onset; no recurrence during week after menses ® Symptoms interfere with work, school, usual activities ® Criteria are confirmed by prospective daily ratings during 2 or more consecutive, symptomatic cycles

Key: PMDD, premenstrual dysphoric disorder; DSM-IV-TR, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Premenstrual Dysphoric Disorder. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC: American Psychiatric Association; 2000:771-774.

Diagnosis of PMDD

Recall that the DSM-IV-TR criteria for PMDD stipulate that patients

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Women's Health Care: A Practical Journal for Nurse Practitioners

must have at least 5 PMDD symptoms, of which at least 1 must be a core symptom, which include depressed mood; moodiness; anxiety, edginess, or nervousness; and anger/irritability. In addition, symptoms must recede during menses and not return for at least 1 week. Symptoms must also cause serious personal, social, or professional impairment. The clinician also needs to determine whether a patient's symptoms are attributable to another disorder such as depression or a personality disorder. That distinction may be complicated by the fact that some disorders are subject to premenstrual exacerbation, although PMDD symptoms abate completely in the follicular phase of the menstrual cycle. Several validated instruments are available for tracking premenstrual symptoms. These include ® DRSP, or Daily Record of Severity of Problems8,9 ® COPE, or Calendar of Premenstrual Experiences10,11 ® PSST, or Premenstrual Symptoms Screening Tool12 ® VAS, or Visual Analogue Scale13 ® DSR, or Daily Symptom Report14 The DRSP is reproduced on page 19 and can be photocopied for use with your patients. It is available at www.pmdd.factsforhealth.org

St John's wort may reduce the efficacy of oral contraceptives (OCs).15,16 Use of St John's wort has also been associated with altered menstrual flow and bleeding in women taking OCs concurrently.17 St John's wort is associated with several other problems. The evidence in favor of its efficacy in depression is inconsistent.15,18 In addition, as is the case with most herbal products, the composition and potency of commercially available St John's wort preparations is not standardized, a fact that may surprise patients who assume that the US Food and Drug Administration (FDA) has oversight of herbal products as it does over OTC medications. It is important to explain to patients that questions about safety, composition, and potency are also a problem with other herbals sometimes used for PMS and PMDD, including kava kava, black cohosh, chasteberry extract, and evening primrose oil. Evidence for the efficacy of these compounds is also inconsistent. Nonpharmacologic treatments that are effective in alleviating symptoms in some women include aerobic exercise, boosting calcium intake, and cognitive-behavioral therapy (CBT). In addition to its other numerous benefits, aerobic exercise, maintained for at least 20 to 30 minutes per day on at least 3 days of the week, may alleviate PMDD symptoms. It has been postulated that aerobic exercise boosts endorphin levels, which are often low during the late luteal phase of the menstrual cycle.19 Increasing calcium intake to 1200 mg daily, either through diet or by the use of supplements, may offer modest benefits to women with

PMDD.20 In a case­control study within the Nurses' Health Study II, high levels of calcium plus vitamin D intake were inversely associated with PMS.21 CBT is short-term, structured therapy using behavioral techniques that test, challenge, and change maladaptive and inaccurate cognition. In two studies, CBT was more effective than no treatment among women with PMS.22,23 In another study, CBT was as effective as the selective serotonin reuptake inhibitor (SSRI) antidepressant fluoxetine, although this therapy was associated with a slower response.24

When "Natural" Is Not Enough: Pharmacologic Options for PMDD

Many, if not most, women with PMDD find that measures such as aerobic exercise and increased calcium intake are helpful but not sufficient for the management of their symptoms. Among the pharmacologic options that have been studied to treat premenstrual symptoms are SSRI antidepressants, spironolactone, anxiolytics, gonadotropinreleasing hormone (GnRH) agonists, and OCs. We will discuss each class of agents in turn. The SSRIs fluoxetine, paroxetine CR, and sertraline are FDA approved for the treatment of PMDD. Multiple randomized, controlled trials have demonstrated improvements in the mood, behavioral, and physical symptoms of PMDD with use of these SSRIs.25,26 Of interest, the onset of effect of these SSRIs is much more rapid in PMDD treatment than in the treatment of depression and anxiety 7

Treatment Options for PMDD

It is possible that patients who recognize that they have symptoms of depression will attempt to treat those symptoms with the herbal St John's wort. It must be noted that some evidence suggests that

Winter 2008 Vol. 7, No. 1

disorders. Clinically significant improvements in PMDD symptoms may be seen as early as the first cycle of use.27 These medications can be given daily or intermittently--for example, just during the luteal phase. Luteal-phaseonly administration reduces overall exposure to the medication, the cost of treatment, and risk of side effects. Many women find luteal-phase administration more acceptable in the sense that they can treat episodic symptoms with episodic treatment. In addition, any perceived stigma attached to taking a psychiatric medication may be minimized by taking an SSRI intermittently.

FIGURE 1.

Classification of Progestins

Progesterone 19-nortestosterone 17-spirolactone

Pregnanes

Estranes

Gonanes

· Medroxyprogesterone acetate · Cyproterone acetate · Chlormadinone acetate

· Norethindrone · Norethindrone acetate · Ethynodiol diacetate

· Norgestrel* · Levonorgestrel · Norgestimate · Desogestrel · Gestodene

· Drospirenone

*Active metabolite is norelgestromin, used in transdermal contraceptive patch. Active metabolite is etonogestrel, used in contraceptive vaginal ring.

The progestin drospirenone (drsp) is the only progestin derived from spironolactone that is currently used in an oral contraceptive. Most progestins in OCs are derived from 19-nortestosterone.

The side effects of SSRIs are a burden to some women, however. The most prominent side effects include diminished libido and weight gain, and these problems may limit the use of these medications for PMDD.28 Anxiolytics are sometimes recommended by healthcare professionals to help manage PMS and PMDD symptoms, but known side effects include drowsiness, sedation, and impaired task performance. Dependence is an important concern; patients must be carefully evaluated for risks of dependence. Dosing should be strictly limited to the luteal phase. No anxiolytics have specific FDA approval for the treatment of PMDD. 8

Spironolactone, a potassium-sparing diuretic, has been used to treat premenstrual symptoms, notably water retention, although it has shown some benefit in relieving other symptoms. Spironolactone is not approved by the FDA for PMS/PMDD indications. GnRH agonists relieve PMDD symptoms by suppressing ovulation, thereby inducing a chemical menopause. Accordingly, GnRH therapy may be accompanied by such menopausal symptoms as hot flashes and night sweats. Also, bone density may be diminished with continued GnRH use. A young woman would require addback of estrogen and progestin or other bone-protective therapy. These factors plus the relatively

high cost of therapy mean that GnRH agonists are generally used only when other treatments have failed, and, even then, the duration of therapy must be limited. GnRH agonists are not FDA approved for the treatment of PMDD. Traditional OCs have no effect on premenstrual mood in most women.29 However, one OC does have an indication for PMDD in women who elect to use an OC for contraception. This formulation contains ethinyl estradiol (EE) 20 µg and drospirenone (drsp) 3 mg and is administered in a 24/4 regimen--24 days of active hormone pills followed by 4 days of placebo pills. The progestin drsp is derived from 17-spirolactone, an analog of spironolactone with

Women's Health Care: A Practical Journal for Nurse Practitioners

antimineralocorticoid and antiandrogenic activity. All other progestins used in OCs in the United States are derived from 19-nortestosterone (Figure 1). By blocking aldosterone at its receptor, drsp increases sodium and water excretion and potassium retention.30

the intervention group and 29.99 in the placebo group, demonstrating that the drsp/EE OC used in a 24/4 regimen was statistically superior to placebo (P <.001).32 Scores were broken down into mood, physical, and behavioral symptoms of PMDD (Figure 2).

Change from Baseline

The shortened hormone-free Similar results were demonstrated interval (HFI) used with this OC in a double-blind, randomized, reduces the severity of hormonecrossover controlled trial in which withdrawal symptoms, including 64 women with PMDD were ranpelvic pain, headaches, breast domized to receive either placebo tenderness, and bloating, that are associated with standard OC regimens (21 days of FIGURE 2. active hormone pills, then 7 days of placebo pills).31 A number of newer OCs that have received FDA approval in recent years also use 0 a shortened--or no-- HFI to improve both -5 tolerability and contraceptive efficacy. The efficacy of the EE/drsp OC for PMDD symptom management was demonstrated in a randomized, double-blind, placebo-controlled parallel-group study that enrolled 450 women with PMDD.32 Two run-in cycles were followed by 3 treatment cycles, with daily symptom charting using the validated DRSP. Women in the intervention group took an OC containing 3 mg drsp and 20 µg EE in a 24/4 regimen. Overall scores on the 24-question DRSP decreased by 37.49 in

-10 b -15 -20 -25 Mood Symptoms a

or the study OC.33 Each group completed 3 treatment cycles followed by a washout cycle before crossing over to the alternate treatment. PMDD symptoms improved on two rating scales, the DRSP and the Premenstrual Tension Scale (PMTS), and measures of quality of life, enjoyment, and satisfaction (on the Q-LES-Q scale) also improved. Changes on the DRSP were statistically significant (Figure 3).33 An examination of data from four separate studies indicates that the

drsp 3 mg/EE 20 µg Versus Placebo: Change from Baseline

b

drsp/EE

N = 450 women with PMDD

aP

bP

Placebo

= .003 vs placebo <.001 vs placebo

Physical Symptoms

Behavioral Symptoms

Daily Record of Severity of Problems scores were reduced more in the intervention group than in placebo users in this randomized, double-blind, parallel trial.

Yonkers KA, et al. Obstet Gynecol. 2005;106:492-501.

These are data from a randomized, double-blind, placebo-controlled, parallel-group study in 450 women with PMDD. Two run-in cycles were followed by 3 treatment cycles, with daily symptom charting using the validated Daily Record of Severity of Problems (DRSP). Women in the intervention group took an OC containing 3 mg drsp and 20 µg EE in a 24/4 regimen. Overall scores on the 24-question DRSP decreased by 37.49 in the intervention group and 29.99 in the placebo group, showing that drsp/EE in a 24/4 regimen was significantly superior to placebo (P <.001). Scores broken down into mood, physical, and behavioral symptoms of PMDD are presented in this figure.

Winter 2008 Vol. 7, No. 1

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FIGURE 3.

Crossover RCT: Differences in Change-From-Baseline Scores: drsp/EE Versus Placebo

Differences between change from baseline scores for drospirenone/EE and placebo

10

7.4

5

P = .04

Benefit Benefit

0

-5

P <.0001

P = .01

­7.4

-10

­12.5

-15

DRSP

PMTS-S

Q-LES-Q

DRSP = Daily Record of Severity of Problems PMTS-S = Rating Scale for Premenstrual Tension, self-rated Q-LES-Q = Endicott Quality of Life Enjoyment and Satisfaction Questionnaire

Pearlstein TB, et al. Contraception. 2005;72:414-421.

erratic nature of her class performance. They report that although she is usually an excellent, approachable, and supportive instructor, at times she is shorttempered, impatient, and sarcastic, often for several days. During her last cycle, her boyfriend vacated the apartment they share for two nights because of her extreme moodiness. Ann Marie feels much better for 2 to 3 weeks after her period, functions better at work and in her studies, and others find it easier to be around her, until her symptoms begin again. Ann Marie feels that depression is likely. Having heard that St John's wort would be a "natural" way to treat her depressive symptoms, she now selfmedicates with St John's wort daily.

In a randomized, double-blind, controlled, crossover trial, women with PMDD were randomized to receive an OC or placebo. Each group completed 3 treatment cycles followed by a washout cycle before crossing over to the alternate treatment. As shown here, PMDD symptoms improved on two rating scales, the DRSP and the PMTS-S, and measures of quality of life, enjoyment, and satisfaction (on the Q-LES-Q scale) also improved. Changes on the DRSP were statistically significant.

OC containing drsp 3 mg/EE 20 µg in a 24/4 regimen and the antidepressant sertraline are similarly effective to each other and significantly superior to placebo in the treatment of PMDD symptoms (Figure 4).32-35 As assessed by scores on the Clinical Global Impression Improvement scale, the percentage of women whose symptoms were "improved" or "very much improved" was similar among women taking drsp 3 mg/EE 20 µg in parallel- and crossover-design studies and women taking sertraline continuously or intermittently. 10

Case Study: Ann Marie

Ann Marie is a 24-year-old graduate student who also works as a teaching assistant in her department. She seeks help from her healthcare practitioner because she is depressed, angry, sleepless, tired, and distracted in the 7 to 10 days before the onset of her period. The situation has reached a crisis point because her academic work is clearly impaired. Further, students have complained to the chair of her department about the way she deals with them and the

Women's Health Care: A Practical Journal for Nurse Practitioners

Benefit

Response Rates (%)

Ann Marie is overweight, with a body mass index (BMI) of 28. Her family history is significant for several conditions. Her mother has hypertension, her sister has experienced depression, and her maternal grandmother died of complications of diabetes. Multiple family members are obese. Ann Marie and her boyfriend use condoms for contraception. She had a pregnancy scare 3 months ago when a condom broke.

FIGURE 4.

4 Different Studies in Women With PMDD: Response Rates* Similar Using drsp/EE (24/4 regimen) and Sertraline

80 70 60 50 40 30 20 10 0

65 a 50

62 b

62 c

Medication Placebo

58 d 45

32

34

Medication vs Placebo aP = .002 b P = .009 cP < .001 d P = .036

Parallel 1

Crossover 2

Continuous 3

Intermittent 4

drsp 3 mg/EE 20 µg

Sertraline

Discussion

*Response = very much/much improved on Clinical Global Impression Improvement scale.

Ann Marie may have 1. Yonkers KA, et al. Obstet Gynecol. 2005;106:492-501. 2. Pearlstein TB, et al. Contraception. 2005;72:414-421. arrived in the office 3. Yonkers KA, et al. JAMA.1997;278:983-988. with the problems 4. Halbreich U, et al. Obstet Gynecol. 2002;100:1219-1229. caused by her preAn examination of data from four separate studies indicates that the OC containing drsp 3 mg/EE menstrual symptoms 20 µg in a 24/4 regimen and the antidepressant sertraline are similarly effective to each other foremost on her and significantly superior to placebo in the treatment of PMDD symptoms. As assessed by scores mind, but she clearly on the Clinical Global Impression Improvement scale, the percentage of women who were has several important improved or very much improved was similar among women taking drsp/EE in parallel- and health issues. Her crossover-design studies and women taking sertraline continuously or intermittently. most pressing issue is her need for effective report, the reactions of people drawback: None provides effective contraception, as underscored by contraception. Sertraline or anotharound her, notably her boyfriend her recent pregnancy scare. Her er SSRI might provide effective and students, and a lack of sympuse of St John's wort also deserves treatment for her PMDD, but it scrutiny. Ann Marie and the people toms and signs of other disorders around her are suffering from turning up in her history and physi- provides no contraceptive action. symptoms that appear in the days cal examination. She could keep a After a review of the contraceptive before her period, and some diagsymptom diary for 2 to 3 months to options, she expresses an interest in nostic work is required in order to confirm this diagnosis, but, given taking an OC. The OC discussed tailor the most appropriate treatthe severity of her personal and earlier (containing drsp 3 mg/EE ment for her. Her treatment professional situation, she may ben20 µg and administered in a 24/4 options will also be guided by her efit from initiating treatment soonregimen) is FDA approved for treatweight and the strong family history er. She also needs a more effective ing PMDD in women who choose of obesity, depression, hypertension, means of contraception. In Ann an OC for birth control, so it could and diabetes. Marie's case, spironolactone, anxioffer Ann Marie both effective olytics, and GnRH agonists to treat In Ann Marie's case, a PMDD diagcontraception and treatment of nosis seems likely based on her selfPMDD symptoms. the PMDD have a single important 11

Winter 2008 Vol. 7, No. 1

Case Study: Eileen

Eileen is 30 years of age, married, and the mother of a 5-year-old girl and 3-year-old twin boys. She has been treated for depression intermittently since high school. During the past several years, media coverage of bipolar disorder has increased, as has direct-to-consumer advertising for medications used to treat bipolar disorder. Eileen has read much of this information, as well as many pages of Web-based material, and she now suspects that she has bipolar disorder rather than major depression. She bases her conclusion on the fact that her moods fluctuate.

Eileen also reports that she is irritable when dealing with her husband and young children. Her problems have also created a financial hardship for her family. Until recently, she had a part-time job, which she quit because her fatigue and poor mood had diminished the quality of her work and made the job completely overwhelming. As a result of her having quit her job, Eileen's husband has had to take on more overtime at his place of employment to compensate for the lost income. He is now home less often to help with their energetic preschoolers. All of these factors have combined to add further stress to their lives. Eileen has sought medical help for symptom relief, both for her own sake and that of her family. There is an additional complication: Eileen and her husband would like to have another child during the next few years. Her mood problems make this scenario seem extraordinarily difficult, so she wants professional help to review her options.

Compared with the way she felt a week ago, just before her period, she says she feels less depressed and anxious. She is also sleeping a bit better than she was then. She is happy to report that she has not been irritable with her children or husband in the past few days. Two facets of her illness have not changed: She is still feeling overwhelmed and down. Her symptoms have improved but are still present. A nuanced diagnosis In consideration of the findings during this visit, Eileen's healthcare practitioner rules out PMDD because the symptoms do not abate after menses. Eileen still seems apathetic and "blue," and she acknowledges that this is the case. Her responses to the questions on the Hamilton Depression Rating Scale suggest moderate depression.36 Eileen reports having no episodes of excessive energy or talkativeness, excessive spending, or racing thoughts. Her healthcare practitioner also notes no evidence of mania. Eileen receives a diagnosis of mild to moderate unipolar depression that is exacerbated during the premenstrual phase of her cycle. (This is the diagnosis she was given in high school.) Some conditions are exacerbated by menstrual phases; others simply coexist with PMS or PMDD (Table 3). Treatment for distinct conditions The diagnostic work-up has clarified Eileen's treatment requirements. She needs effective treatment for depression. She also needs effective contraception. In Eileen's case, these are two separate issues. Eileen states that she has been treated in the past with tricyclic antidepressants. She says that they have been effective, but she has been unhappy with the side effects, especially lethargy. She has

Discussion

During the initial assessment, her healthcare practitioner rules out several conditions in the differential diagnosis that may be exacerbated premenstrually, including migraine, irritable bowel syndrome, and thyroid disorders. Although patients are advised to keep a symptom diary for at least 2 months to confirm the diagnosis of premenstrual disorders, this may not be practical for Eileen. She is in considerable distress, as is her husband. In light of how difficult this situation is for Eileen and her entire family, her practitioner asks her to return for a symptom assessment shortly after the end of her next period. What a difference a week makes Eileen returns for an evaluation 3 days after her period ends.

Eileen has many serious complaints. Taken in the context of her role as the mother of three very young children, these problems seem overwhelming at times. Her sleep is nonrestorative and she suffers from serious daytime fatigue. Her appetite is usually poor, but then it surges just before her period, when she is prone to bingeing on sweets. She also reports difficulty concentrating, great anxiety, and feeling down, blue, and depressed. 12

Women's Health Care: A Practical Journal for Nurse Practitioners

used these medications intermittently; she has frequently discontinued them when she begins to feel better. Eileen learns that three of the newer SSRI antidepressants--fluoxetine, sertraline, and paroxetine CR--are approved by the FDA for the treatment of both depression and PMDD. She could take one of these antidepressants and use either an OC or another contraceptive. She is willing to try an SSRI. Eileen needs some education about antidepressant use. Her practitioner explains that it is counterproductive to stop taking an antidepressant when she begins to feel better because the condition may recur. She should follow carefully the directions of her practitioner about appropriate medication use, especially about altering the dosage or discontinuing antidepressant therapy. Eileen may benefit from taking an anti-

depressant for many months after she feels fully recovered from depression. Depression--and possibly antidepressants--can be hazardous to both mother and fetus. She should make sure her depression is well controlled before becoming pregnant again. Because she is coping with three young children and depression, she needs contraception that requires little ongoing attention. With that in mind, intrauterine contraception or a contraceptive implant may be a good choice for Eileen.

Case Study: Joan

Joan is a 41-year-old woman who was divorced 18 months ago. She has a history of disruptive premenstrual symptoms, menorrhagia, and dysmenorrhea. In recent months, her menstrual cycle has become increasingly irregular. In addition, she is bleeding more heavily than

usual and passing clots. Joan sleeps poorly and is irritable and fatigued, especially in the week before her period. She experiences hot flashes occasionally. Joan is seeking help now because her premenstrual symptoms have become more bothersome than ever. When Joan was in her early 20s, she starting taking OCs in the hope of achieving some improvement in her premenstrual symptoms. She quit taking OCs because they did not offer her much symptom relief, and she experienced side effects that she found intolerable. She has not tried new OCs or any other method of contraception in the interim because her ex-husband had had a vasectomy. She now has a new boyfriend, and this is the first intimate relationship for Joan since her divorce. The couple is using condoms but do not consider this a long-term solution for contraception. When asked about her family history, Joan discloses that her mother died of ovarian cancer at age 50.

TABLE 3.

Differential Diagnosis of PMS/PMDD

Some physical and psychiatric disorders can be exacerbated during the premenstrual phase and should be considered whenever a woman presents with possible PMS or PMDD. Examples include: ® ® ® ® ® ® ® ® ® ® ® ® ® Adrenal disorders Allergies Asthma Chronic fatigue syndrome Dysthymic disorder Generalized anxiety disorder Irritable bowel syndrome Major depressive disorder Migraine Panic disorder Perimenopausal symptoms such as mood disturbances, fatigue, and hot flashes Seizure disorders Thyroid disorders

Discussion

Joan has several important and related problems that require resolution. She has severe and worsening premenstrual symptoms. Her 13

Sources: ACOG Practice Bulletin. Premenstrual syndrome. Obstet Gynecol. 2000;95. Premenstrual Dysphoric Disorder. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC: American Psychiatric Association; 2000:771-774.

Winter 2008 Vol. 7, No. 1

menstrual bleeding is heavy. Her vasomotor symptoms and increasingly irregular periods suggest that she may have entered perimenopause. With her new relationship (after her divorce from a man who had had a vasectomy), Joan has a renewed need for contraceptives. She had a bad experience with OCs about 20 years ago. A maternal history of ovarian cancer is also a significant aspect of her health history. Diagnostic fine points Careful consideration of her symptoms and other findings is necessary before making a diagnosis. Joan demonstrates no evidence of depression, migraine, seizure disorder, thyroid disorders, or other health problems. In the week immediately before menses she experiences hopelessness, anxiety, heightened personal conflicts, and emotional lability. All of her symptoms resolve within 4 days of the onset of menses, and she remains symptom-free for at least two and a half weeks. Joan is one symptom short of the five required to meet a DSM-IV-TR diagnosis of PMDD, although the four symptoms she does exhibit are core PMDD symptoms. PMS, however, seems like the most accurate diagnosis in light of ACOG criteria. Joan needs treatment for these distressing and worsening premenstrual symptoms, as well as her heavy bleeding. Joan's other complaints merit further clarification; she needs a complete physical examination and laboratory and diagnostic studies to rule out the presence of fibroids and to evaluate for other possible causes of heavy bleeding. A complete blood count and measurement of her thyroid-stimulating hormone (TSH) level are essential. 14

A hemoglobin determination will show if her heavy bleeding has resulted in anemia. Ascertaining her TSH level will help rule out hypothyroidism, which can be associated with heavy bleeding and mood problems. Note that determination of her luteinizing hormone and follicle-stimulating hormone levels is not recommended because levels of these hormones fluctuate widely during the perimenopause and are difficult to interpret. Further, the test results are unlikely to change the clinical approach to Joan's problems. To rule out endometrial cancer and hyperplasia, it may be prudent to perform an endometrial biopsy. The likelihood of finding a significant pathology is low, however, because Joan does not have risk factors associated with endometrial cancer (>50 years, obesity, hypertension, diabetes). Alternatively, an ultrasound performed right after her period could help rule out fibroids and assess the endometrial stripe. Updating perceptions of OCs Joan needs to understand that perimenopause is a natural stage of life, not a disease state. She also needs to know that hormone therapy given to perimenopausal women is not known to be helpful in treating premenstrual symptoms. Based on the physical findings and symptom report, it is likely that Joan is in perimenopause but does not have PMDD, per the DSM-IV-TR criteria. Her most immediate problems are her heavy bleeding and need for effective contraception. A reasonable strategy would involve addressing those two problems first and then reassessing her other symptoms. Joan's healthcare practitioner explains that any of the contempo-

rary OCs will, in addition to providing contraception, likely reduce her heavy bleeding, diminish her perimenopausal symptoms, and regulate her erratic periods, and that one of the new OCs has been studied for PMDD and may help with all of her symptoms, including her irritability.32,33 In addition, her risk of ovarian cancer may be reduced through the use of an OC, an important consideration for Joan given her family health history. The relationship between OC use and a reduced risk of ovarian cancer has been clear for some years.37 Among the mechanisms that may be responsible is inhibition of ovulation or direct biologic effects of the hormones. Joan remains concerned about side effects that made her discontinue OC use 20 years earlier, however. Her practitioner explains that OCs have changed considerably since then and are not associated with the severe side effects she remembers. Contemporary OCs contain less estrogen and progestin than did those available in the 1980s, and they may be less likely to lead to symptoms that are associated with these hormones. In addition, newer OC regimens often include a modified HFI that is shorter or less frequent than that used in the traditional 21/7 regimen. These modifications have been documented to lessen hormone withdrawal symptoms.31,38 A shorter HFI, such as with a 24/4 OC regimen, also reduces the chance of follicular escape. Patients typically experience less pelvic pain, headaches, breast tenderness, bloating, and need for pain medication with the shortened HFI.31 Two OCs currently are available

Women's Health Care: A Practical Journal for Nurse Practitioners

in the 24/4 regimen; one contains the progestin drsp and the other contains norethindrone. Another treatment option Joan also has other contraceptive options that may be suitable for her, including the levonorgestrelreleasing intrauterine system (LNGIUS). Like the copper-containing intrauterine device, the LNG-IUS has contraceptive efficacy similar to that associated with sterilization.39,40 Its contraceptive actions may include inducing a spermicidal foreign-body reaction, producing thickened mucus that blocks sperm penetration, and suppressing endometrial proliferation.41 Its noncontraceptive benefits include reductions in dysmenorrhea and menorrhagia, an advantage for women who, like Joan, are troubled by excessive bleeding. It can provide the progestin component of menopausal hormone therapy. Most of the side effects are experienced shortly after the device is placed and then begin to diminish. There is a low risk of serious adverse events. Like the coppercontaining IUD and the contraceptive implant, it is convenient for patients, and its success is not hampered by poor patient adherence or improper or inconsistent use. The LNG-IUS can be left in place for up to 5 years. The first-year failure rate is 0.1%.42 The LNG-IUS is not, however, known to alleviate premenstrual symptoms, nor is it associated with a lower risk of ovarian cancer.

Marie's academic career as well as her relationship with her boyfriend. Women who wish to optimize nonpharmacologic treatment of premenstrual disorders can be advised to engage in some form of aerobic exercise for at least 20 to 30 minutes per day on at least 3 days of each week. Exercise may boost endorphin levels, which tend to be low late in the luteal phase of the menstrual cycle. Increasing calcium intake may also help, at least with PMS symptoms, as suggested by the Nurses' Health Study II and clinical trials. Three SSRIs, fluoxetine, sertraline, and paroxetine CR, have an indication for the treatment of PMDD. These agents play an important role in the management of PMDD symptoms in many women. Although OCs have a reputation for improving menstrual symptoms, OCs in general do not provide effective PMDD treatment. An exception is the OC with drsp 3 mg/EE 20 µg given in a 24/4-day regimen, which has received an FDA indication for the treatment of PMDD symptoms in women who choose an OC for contraception. Many patients are unaware of the refinements that have been made in OC dosing and regimens in recent years. Eileen's case demonstrates the importance of realizing that more than one condition may be responsible for a patient's clinical picture. Eileen has mild to moderate unipolar depression that is exacerbated premenstrually. Careful assessment of her symptoms was required to make this nuanced diagnosis. Although tricyclic antidepressants had worked for her depression in the past, the side effects were troublesome, and Eileen agreed to try an SSRI. Understanding that she must avoid pregnancy until her

depression is well controlled, she also agreed to choose a form of contraception that requires little ongoing attention, such as intrauterine contraception or a contraceptive implant. Eileen's case also demonstrates the importance of supplementing patient self-education via the Internet and mass media with professional opinion. Eileen had selfdiagnosed bipolar disorder, based on what she had read and heard about the disorder, coupled with the fluctuations she noticed when her depression was exacerbated premenstrually. It quickly became apparent, however, that she did not have this disorder. Although PMDD affects a relatively small percentage of American women--prevalence is understood to be between 3% and 8% of menstruating women--its impact can be profoundly distressing to them and, by extension, to those around them. As such, PMDD merits the clinical attention required to make an accurate diagnosis. This process may take some time, as women are asked to track their symptoms for a minimum of 2 to 3 menstrual cycles to confirm the diagnosis. It also calls for insight, such as that required to rule out other disorders that are subject to premenstrual exacerbation or to recognize when PMDD may be comorbid with other conditions. These efforts lead to the rewarding ability to manage the life-disrupting symptoms of PMDD by identifying appropriate therapy that suits a woman's needs and personal preferences. I Anne Moore, MSN, RNC, FAANP, is Professor of Nursing at Vanderbilt University and maintains a clinical women's health practice in Nashville, Tennessee. She is certified both as a 15

Summary

Premenstrual symptoms range from minor molimina to PMS to PMDD. A severe disorder, PMDD can disrupt personal, social, and professional life. In this case series, we saw how PMDD threatened to derail Ann

Winter 2008 Vol. 7, No. 1

women's health nurse practitioner and as a nurse colposcopist. Ms Moore is chair of the board of directors of the National Association of Nurse Practitioners in Women's Health. Ellen W. Freeman, PhD, is Research Professor in the departments of Obstetrics and Gynecology and Psychiatry at the University of Pennsylvania School of Medicine in Philadelphia. She is also co-director of the Human Behavior and Reproduction Unit in the Department of Obstetrics and Gynecology and directs a premenstrual syndrome research program. She is the principal investigator on studies involving menopause and ovarian aging as well as premenstrual disorders. Mary Jane Minkin, MD, is Clinical Professor of Obstetrics and Gynecology at Yale University School of Medicine, New Haven, Connecticut, where she teaches students in the medical school and physician assistant program about infectious disease in women's health; she also instructs residents in obstetrics and gynecology about premenstrual disorders and menopause. In addition, Dr Minkin practices obstetrics and gynecology in New Haven and in Guilford, Connecticut, and is the author of several patient-directed books on women's health. References

1. Ginsburg KA, Dinsay R. Premenstrual syndrome. In: Ransom SB, ed. Practical Strategies in Obstetrics and Gynecology. Philadelphia: W.B. Saunders Company; 2000:684-694. 2. American College of Obstetricians and Gynecologists. Practice Bulletin. Premenstrual syndrome. Obstet Gynecol. 2000;95. 3. Premenstrual Dysphoric Disorder. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC: American Psychiatric Association; 2000:771-774. 4. Hylan TR, Sundell K, Judge R. The impact of premenstrual symptomatology on functioning and treatment-seeking behavior: experience from the United States, United Kingdom, and France. J Womens Health Gend Based Med. 1999;8:1043-1052. 5. Wittchen HU, Becker E, Lieb R, et al. Prevalence, incidence and stability of premenstrual dysphoric disorder in the community. Psychol Med. 2002;32:119-132.

6. Dean BB, Borenstein JE. A prospective assessment investigating the relationship between work productivity and impairment with premenstrual syndrome. J Occup Environ Med. 2004;46:649-656. 7. Halbreich U, Borenstein J, Pearlstein T, et al. The prevalence, impairment, impact, and burden of premenstrual dysphoric disorder (PMS/PMDD). Psychoneuroendocrinology. 2003;28(Suppl 3):1-23. 8. Endicott J, Nee J, Harrison W. Daily Record of Severity of Problems (DRSP): reliability and validity. Arch Womens Ment Health. 2006;9(1):41-49. 9. Borenstein JE, Dean BB, Yonkers KA, Endicott J. Using the daily record of severity of problems as a screening instrument for premenstrual syndrome. Obstet Gynecol. 2007; 109(5):1068-1075. 10. Feuerstein M, Shaw WS. Measurement properties of the calendar of premenstrual experience in patients with premenstrual syndrome. J Reprod Med. 2002;47:279-289. 11. Mortola JF, Girton L, Beck L, Yen SS. Diagnosis of premenstrual syndrome by a simple, prospective, and reliable instrument: the calendar of premenstrual experiences. Obstet Gynecol. 1990;76:302-307. 12. Steiner M, Macdougall M, Brown E. The premenstrual symptoms screening tool (PSST) for clinicians. Arch Women Ment Health. 2003;6:203-209. 13. Steiner M, Streiner DL, Steinberg S, et al. The measurement of premenstrual mood symptoms. J Affect Disord. 1999;53:269-273. 14. Freeman EW, DeRubeis, RJ, Rickels K. Reliability and validity of a daily diary for premenstrual syndrome. Psychiatry Res. 1996;65:97-106. 15. National Center for Complementary and Alternative Medicine. St John's Wort. http://nccam.nih.gov/health/ stjohnswort/ 16. Hammerness P, Basch E, Ulbricht C, et al. St John's wort: a systematic review of adverse effects and drug interactions for the consultation psychiatrist. Natural Standard Research Collaboration. Psychosomatics. 2003;44:271-282. 17. MedlinePlus. St John's wort (Hypericum perforatum L.) Available at: http://www.nlm.nih.gov/medlineplus/druginfo/ natural/patient-stjohnswort.html 18. Linde K, Berner M, Egger M, Mulrow C. St John's wort for depression: meta-analysis of randomised controlled trials. Br J Psych. 2005;186:99-107. 19. Steege JF, Blumenthal JA. The effects of aerobic exercise on premenstrual symptoms in middle-aged women: a preliminary study. J Psychosom Res. 1993;37:127-133. 20. Thys-Jacobs S, Starkey P, Bernstein D, Tian J. Calcium carbonate and the premenstrual syndrome: effects on premenstrual and menstrual symptoms. Premenstrual Syndrome Study Group. Am J Obstet Gynecol. 1998;179:444-452. 21. Bertone-Johnson ER, Hankinson SE, Bendich A, et al. Calcium and vitamin D intake and risk of incident premenstrual syndrome. Arch Intern Med. 2005;165:1246-1252. 22. Taylor D. Effectiveness of professional--peer group treatment: symptom management for women with PMS. Res Nurs Health. 1999;22:496-511. 23. Blake F, Salkovskis P, Gath D, et al. Cognitive therapy for premenstrual syndrome: a controlled trial. J Psychosom Res. 1998;45:307-318. 24. Hunter MS, Ussher JM, Cariss M, et al. Medical (fluoxetine) and psychological (cognitive-behavioural therapy) treatment for premenstrual dysphoric disorder: a study of treat-

ment processes. J Psychosom Res. 2002;53:811-817. 25. Steiner M, Pearlstein T, Cohen LS, et al. Expert guidelines for the treatment of severe PMS, PMDD, and comorbidities: the role of SSRIs. J Womens Health (Larchmt). 2006;15(1): 57-69. 26. Sundstrom-Poromaa I, Bixo M, Bjorn I, Nordh O. Compliance to antidepressant drug therapy for treatment of premenstrual syndrome. J Psychosom Obstet Gynecol. 2000;21:205-211. 27. Pearlstein T. Premenstrual dysphoric disorder. In: Tasman A, Kay J, Lieberman J, eds. Psychiatry. 2nd ed. London, UK: Wiley & Sons Ltd.; 2003:1271. 28. Freeman EW. Luteal phase administration of agents for the treatment of premenstrual dysphoric disorder. CNS Drugs. 2004;18(7):453-68. Review. 29. Joffe H, Cohen LS, Harlow BL. Impact of oral contraceptive pill use on premenstrual mood: Predictors of improvement and deterioration. Am J Obstet Gynecol. 2003;189: 1523-1530. 30. Krattenmacher R. Drospirenone: Pharmacology and pharmacokinetics of a unique progesterone. Contraception. 2000;62:29-38. 31. Sulak P, Scow RD, Preece C, et al. Hormone withdrawal symptoms in oral contraceptive users. Obstet Gynecol. 2000;95:261-266. 32. Yonkers KA, Brown C, Pearlstein TB, et al. Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder. Obstet Gynecol. 2005;106(3): 492-501. 33. Pearlstein TB, Bachmann GA, Zacur HA, Yonkers KA. Treatment of premenstrual dysphoric disorder with a new drospirenone-containing oral contraceptive formulation. Contraception. 2005;72:414-421. 34. Yonkers KA, Halbreich U, Freeman E, et al. Symptomatic improvement of premenstrual dysphoric disorder with sertraline treatment. A randomized controlled trial. Sertraline Premenstrual Dysphoric Collaborative Study Group. JAMA. 1997;278:983-988. 35. Halbreich U, Bergeron R, Yonkers KA, et al. Efficacy of intermittent, luteal phase sertraline treatment of premenstrual dysphoric disorder. Obstet Gynecol. 2002;100:1219-1229. 36. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960;23:56-62. 37. Schildkraut JM, Calingaert B, Marchbanks PA, et al. Impact of progestin and estrogen potency in oral contraceptives on ovarian cancer risk. J Natl Cancer Inst. 2002; 94(1):32-38. 38. Mishell DR, Jr. Rationale for decreasing the number of days of the hormone-free interval with use of low-dose oral contraceptive formulations. Contraception. 2005;71:304-305. 39. Varma R, Sinha D, Gupta JK. Non-contraceptive uses of levonorgestrel-releasing hormone system (LNG-IUS)--a systematic enquiry and overview. Eur J Obstet Gynecol Reprod Biol. 2006;125:9-28. 40. Grimes DA, Lopez LM, Manion C, Schulz KF. Cochrane systematic reviews of IUD trials: lessons learned. Contraception. 2007;75(6 suppl):S55-S59. 41. Hatcher RA, et al. Contraceptive Technology. 18th rev. ed. New York, NY: Ardent Media; 2004. 42. Peterson HB, Curtis KM. Clinical practice. Long-acting methods of contraception. N Engl J Med. 2005;353:2169-2175.

16

Women's Health Care: A Practical Journal for Nurse Practitioners

EXPLORING OPTIONS IN PREMENSTRUAL DYSPHORIC DISORDER MANAGEMENT

Continuing Education Post-test

Record your answer by circling the letter of the correct answer to each question in the Answer Box on page 18.

1. What proportion of American women are affected by premenstrual dysphoric disorder (PMDD)? a. 1% b. 2% to 4% c. 3% to 8% d. 11% 2. According to the American College of Obstetricians and Gynecologists, a diagnosis of premenstrual syndrome (PMS) may be made on the basis of how many symptoms? a. 1 b. 2 c. 3 d. 4 3. Diagnostic criteria for PMDD published by the American Psychiatric Association (APA) require that a. A woman exhibit at least 6 symptoms, of which at least 3 are core symptoms. b. A woman exhibit at least 5 symptoms, of which at least 1 is a core symptom. c. A woman exhibit at least 3 symptoms, of which at least 1 is a core symptom. d. A woman exhibit at least 5 symptoms, of which at least 2 are core symptoms. 4. APA diagnostic criteria specify that PMDD symptoms adhere to which of the following patterns? a. At least 2 symptoms persist throughout the menstrual cycle. b. Symptoms manifest no earlier than 48 hours before the onset of menses. c. Symptoms are most bothersome during the follicular phase of the menstrual cycle. d. Symptoms appear in the last week of the luteal phase of the menstrual cycle. 5. Which of the following nonpharmacologic treatments has demonstrated efficacy similar to pharmacologic therapy in managing PMDD symptoms? a. St John's wort b. Cognitive-behavioral therapy c. Kava kava d. Chasteberry

Winter 2008 Vol. 7, No. 1

6. For women with premenstrual disorders, aerobic exercise a. Should be limited to the follicular phase of the cycle because an elevated heart rate can exacerbate premenstrual symptoms. b. May offer some symptom improvement by contributing to elevated endorphin levels. c. Must take place on a daily basis to offer any benefits. d. Must be conducted for at least a 45-minute duration to offer any benefits. 7. Which of the following has been approved by the US Food and Drug Administration (FDA) for the management of the symptoms of PMDD? a. The antidepressants fluoxetine, venlafaxine, and bupropion b. All oral contraceptives (OCs) marketed in the United States c. Gonadotropin-releasing hormone agonists d. The SSRI antidepressants fluoxetine, paroxetine CR, and sertraline 8. Which describes the OC that has been approved by the FDA for the management of the symptoms of PMDD? a. 3 mg drospirenone/20 µg ethinyl estradiol in a 24/4 regimen b. 3 mg drospirenone/30 µg ethinyl estradiol in a 21/7 regimen c. 0.15 mg levonorgestrel and 30 µg ethinyl estradiol in a 24/4 regimen d. 90 µg levonorgestrel/20 µg ethinyl estradiol in a continuous daily regimen 9. In women using OCs, reducing the formerly standard 7-day hormone-free interval to 4 days has been demonstrated to have what effect? a. Reduces the severity of hormone-withdrawal symptoms associated with standard OC regimens. b. Exacerbates PMDD symptoms c. Diminishes libido d. Diminishes OC efficacy and tolerability 10. Depression and PMDD a. Are mutually exclusive diagnoses. b. Nearly always occur in tandem in the same patients. c. Both demonstrate a consistently cyclic pattern of symptoms. d. May occur in the same patient but are distinct disorders.

17

ANSWER SHEET AND EVALUATION FORM

PROCEDURE

To receive credit and your exam score: ® Read the article. ® Complete and return the post-test by December 31, 2009. ® Provide the information requested below. ® Mail or fax this completed form to: NPWH Continuing Education 505 C Street, NE Washington, DC 20002 Fax: 202-543-9858

ANSWER BOX

1. 2. 3. 4. 5. a a a a a b b b b b c c c c c d d d d d 6. 7. 8. 9. 10. a a a a a b b b b b c c c c c d d d d d

EVALUATION FORM

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ACCREDITATION INFORMATION

This activity has been approved by the Continuing Education Approval Program of the National Association of Nurse Practitioners in Women's Health (NPWH) for 1.5 contact hours, including 1.5 contact hours of pharmacology. The actual time I spent completing this CE activity is ____________hours___________minutes. Signature:___________________________________________________Date__________________

18

Women's Health Care: A Practical Journal for Nurse Practitioners

Daily Record of Severity of Problems Please print and use as many sheets as you need for at least two FULL months of ratings.

Name or Initials _______________________________________ Month/Year __________________________________________

Each evening note the degree to which you experienced each of the problems listed below. Put an "x" in the box which corresponds to the severity: 1 - not at all, 2 - minimal, 3 - mild, 4 - moderate, 5 - severe, 6 - extreme.

Enter day (Monday="M," Thursday="R," etc) Note spotting by entering "S" Note menses by entering "M" Begin rating on correct calendar day > > > > 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

6 5 4 3 2 1 6 5 4 3 2 1 6 5 4 3 2 1 6 5 4 3 2 1 6 5 4 3 2 1 6 5 4 3 2 1 6 5 4 3 2 1 6 5 4 3 2 1 6 5 4 3 2 1 6 5 4 3 2 1 6 5 4 3 2 1 6 5 4 3 2 1 6 5 4 3 2 1 6 5 4 3 2 1 © Jean Endicott, PhD, and Wilma Harrison, MD. Reprinted with permission.

1

Felt depressed, sad, "down," or "blue" or felt hopeless; or felt worthless or guilty

2

Felt anxious, tense, "keyed up" or "on edge" Had mood swings (ie, suddenly feeling sad or tearful) or was sensitive to rejection or feelings were easily hurt

3

4

Felt angry, or irritable

5

Had less interest in usual activities (work, school, friends, hobbies)

6

Had difficulty concentrating

7

Felt lethargic, tired, or fatigued; or had lack of energy

8

Had increased appetite or overate; or had cravings for specific foods Slept more, took naps, found it hard to get up when intended; or had trouble getting to sleep or staying asleep Felt overwhelmed or unable to cope; or felt out of control Had breast tenderness, breast swelling, bloated sensation, weight gain, headache, joint or muscle pain, or other physical symptoms

9

10

11

At work, school, home, or in daily routine, at least one of the problems noted above caused reduction of productivity or inefficiency At least one of the problems noted above caused avoidance of or less participation in hobbies or social activities

At least one of the problems noted above interfered with relationships with others

Winter 2008 Vol. 7, No. 1

19

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