1. health and fitness
2. disorders

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
Letter 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
NORTH ATLANTIC REGION
WESTERN REGION
➤ Anne Moore, MSN, RNC, FAANP
➤ Ivy M. Alexander, PhD, MS, C-ANP
➤ Sharon Myoji Schnare, RN, FNP, CNM, MSN,
Chair
Professor of Nursing
Vanderbilt School of Nursing
Nashville, Tennessee
➤ Susan M. Kendig, RNC, MSN, WHCNP
Chair-elect
Clinical Assistant Professor
Barnes College of Nursing
University of Missouri
St Louis, Missouri
➤ Suzy Reiter, RNC, WHNP, MM, MSN, SANE-A
Treasurer
Vice President of Medical Services
Planned Parenthood Centers of West MI
Grand Rapids, Michigan
➤ Carolyn M. Sutton, MS, RNC, WHNP, FAANP
Secretary
Associate Director, Clinical Services
University of Texas
Southwestern Medical Center
Dallas, Texas
➤ Linda Dominguez, RNC, BSN, WHNP
Immediate Past Chair
Assistant Medical Director
Planned Parenthood of New Mexico
Albuquerque, New Mexico
2
Associate Professor
Yale University
New Haven, Connecticut
FAANP
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
SOUTH CENTRAL REGION
➤ Elizabeth Kostas-Polson, MSN, APN, WHNP-C
Doctoral Nursing Student
Niehoff School of Nursing
Loyola University Chicago
Chicago, Illinois
GREAT LAKES REGION
➤ Gail Miller, CRNP
Ohio Department of Health
Columbus, Ohio
AT-LARGE MEMBERS OF THE
BOARD OF DIRECTORS
➤ Diane A. Smith, RN, MSN, CRNP
Nurse Practitioner
UroHealthcare, LLC
Newtown Square, Pennsylvania
➤ Versie Johnson-Mallard, MSN, ARNP
Assistant Professor
Florida A&M University
Tallahassee, Florida
➤ Mary Ann Nihart, MA, APRN, CS, BC
Clinical Faculty
University of California, Davis
Private Practice and Consultant
Pacifica, California
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
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]
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
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Winter 2008 Vol. 7, No. 1
EXPLORING OPTIONS IN PREMENSTRUAL
DYSPHORIC DISORDER MANAGEMENT
Winter 2008 Vol. 7, No. 1
Diagnosis of PMDD
6
Treatment Options for PMDD
7
When “Natural” Is Not Enough: Pharmacologic Options for PMDD
7
Case Studies
10
Summary
15
Continuing Education Post-test
17
Answer Sheet and Evaluation Form
18
Daily Record of Severity of Problems
19
W
omen’s Health Care™ is published by NP Communications,
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© 2008 NP Communications, LLC. All rights reserved.
Women’s Health Care: A Practical Journal for Nurse Practitioners is distributed free as a
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Practitioners in Women’s Health. To become a member of NPWH and receive
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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.
3
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
Winter 2008 Vol. 7, No. 1
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
TABLE 1.
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,
PMS: ACOG Criteria
Prospective diary for 2–3 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.
5
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
TABLE 2.
➤ 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.
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.
6
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
Diagnosis of PMDD
Recall that the DSM-IV-TR criteria
for PMDD stipulate that patients
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
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
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 case–control 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
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
Pregnanes
• Medroxyprogesterone
acetate
• Cyproterone acetate
• Chlormadinone acetate
19-nortestosterone
Estranes
• Norethindrone
• Norethindrone
acetate
• Ethynodiol
diacetate
17α-spirolactone
Gonanes
• 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
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.
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.
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.
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
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 17α-spirolactone, an
analog of spironolactone with
8
Women’s Health Care: A Practical Journal for Nurse Practitioners
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).
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 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.
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
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
Winter 2008 Vol. 7, No. 1
Change from Baseline
drsp 3 mg/EE 20 µg Versus Placebo:
Change from Baseline
-10
b
b
-15
-20
drsp/EE
a
N = 450 women with PMDD
aP
bP
-25
Mood
Symptoms
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.
9
FIGURE 3.
10
5
P = .04
Benefit
7.4
0
P <.0001
P = .01
Benefit
-5
Benefit
Differences between change from
baseline scores for drospirenone/EE and placebo
Crossover RCT: Differences in
Change-From-Baseline Scores:
drsp/EE Versus Placebo
–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.
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
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.
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
Ann Marie and her
boyfriend use condoms for contraception. She had a pregnancy scare 3 months
ago when a condom
broke.
Discussion
FIGURE 4.
4 Different Studies in Women With PMDD:
Response Rates* Similar Using
drsp/EE (24/4 regimen) and Sertraline
80
70
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.
60
65 a
Medication
Placebo
62 c
62 b
58 d
50
45
50
40
32
34
30
20
Medication
vs Placebo
aP = .002
b P = .009
cP < .001
d P = .036
10
0
Parallel 1
Crossover 2
drsp 3 mg/EE 20 µg
Continuous 3
Intermittent 4
Sertraline
*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
Winter 2008 Vol. 7, No. 1
11
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.
Discussion
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
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.
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
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-
TABLE 3.
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
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
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
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.
Discussion
Joan has several important and
related problems that require resolution. She has severe and worsening premenstrual symptoms. Her
13
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.
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
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. ■
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
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.
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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
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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.
a
b
c
d
6.
a
b
c
d
2.
a
b
c
d
7.
a
b
c
d
3.
a
b
c
d
8.
a
b
c
d
4.
a
b
c
d
9.
a
b
c
d
5.
a
b
c
d
10.
a
b
c
d
EVALUATION FORM
NPWH would appreciate your comments regarding the quality of the information presented in this issue. Please help us by
answering the following questions. Please circle one answer.
1. The program objectives were fully met.
6. What new information did you learn from this program?
Strongly agree Agree Disagree Strongly disagree
__________________________________________________
2. The quality of the educational process (method of presentation and information provided) was satisfactory and
appropriate.
Strongly agree Agree Disagree Strongly disagree
3. The information provided evidence-based science without commercial bias.
Strongly agree Agree Disagree Strongly disagree
4. The educational activity has enhanced my professional
effectiveness in treating patients.
Strongly agree Agree Disagree Strongly disagree
__________________________________________________
__________________________________________________
7. Please provide us with suggestions for improving this
activity.
__________________________________________________
__________________________________________________
__________________________________________________
8. Recommendations for topics for future presentations?
__________________________________________________
5. The educational activity will result in a change in my
practice behavior.
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City, State, Zip_________________________________________________________________________________________
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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
1
2
3
Felt depressed, sad, “down,” or “blue” or
felt hopeless; or felt worthless or guilty
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
4
Felt angry, or irritable
5
Had less interest in usual activities (work,
school, friends, hobbies)
6
Had difficulty concentrating
7
8
9
10
11
Felt lethargic, tired, or fatigued; or had
lack of energy
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
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
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.
Winter 2008 Vol. 7, No. 1
19
SAVE the DATE
11th ANNUAL
WOMEN’S HEALTH CARE
in the NEW MILLENNIUM
OCTOBER 15 – 18 , 2008
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