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New drug therapies help women overcome challenges
Forget all the jokes about premenstrual syndrome (PMS). For women with severe forms of the condition, the symptoms are no laughing matter. Depression, feelings of hopelessness, or self-deprecating thoughts; marked anxiety or tension; feeling "keyed up" or "on edge" wide mood swings; and physical symptoms such as breast tenderness, headache, joint or muscle pain, bloating, or weight gain are just some of the indications that a diagnosis of PMS or premenstrual dysphoric disorder (PMDD) may be in order.
But how do you distinguish between PMS and PMDD? First, determine the patient’s symptoms, then understand how those symptoms are impacting her life, advises Steven Sondheimer, MD, professor of obstetrics and gynecology at the University of Pennsylvania Medical Center in Philadel-phia, and co-director of its premenstrual syndrome treatment program.
PMS is common, and its symptoms can range in severity from barely noticeable to severe, explains Jean Endicott, PhD, professor of clinical psychology in the department of psychiatry in the college of physicians and surgeons at New York City-based Columbia University. Endicott also serves as chief of the department of research assessment and training in the department of psychiatry, and director of the premenstrual evaluation unit at Columbia Presbyterian Medical Center, also in New York City. PMDD is the name given to severe PMS that is characterized by marked premenstrual problems with dysphoric mood and other clinical characteristics and clinically significant impairment in psychosocial functioning, states Endicott. Approximately 3% to 7% of women have PMDD, she notes.
Chart the symptoms
While there is no universally accepted definition or set of diagnostic criteria for PMS, most experts agree that temporality and severity are key to an on-target diagnosis.1
To qualify as PMS, symptoms must appear during the woman’s luteal phase, which begins with ovulation, and decrease greatly or disappear with the onset of menstruation or shortly thereafter. Symptoms that persist throughout the cycle, even if they increase or diminish, do not fit into a diagnosis for PMS.
Common PMS symptoms include, among others, abdominal bloating, irritability, mood swings, headache, weight gain, fatigue, food cravings, tension, and breast swelling. Although as many as 85% of menstruating women report one or more symptoms of PMS, only 5% to 10% of women experience symptoms severe enough to be debilitating.2
Listen to your patient to understand what kind of relief she is seeking, suggests Sondheimer. A patient who presents with premenstrual breast tenderness might simply fear she has breast cancer. Once it is determined her breast exam is normal, she might not have any desire for any treatment for her symptoms, he explains.
Symptoms of PMS must be severe enough to cause trouble. To understand the impact of symptoms and devise an effective treatment plan, have women keep a daily symptom chart where they note what symptoms occur, when they occur, and how disruptive each one is. A diary kept for two or more cycles might indicate another medical condition, such as depression, anxiety, endometriosis, or diabetes, which may be the real cause of a woman’s symptoms.
When is it PMDD?
While PMS usually is not particularly troublesome for a woman, by definition, PMDD impairs her functioning and has an impact not only on her life, but also can negatively impact the lives of others with whom she interacts, states Endicott. Unlike PMS, PMDD is characterized as a psychiatric disorder, with its criteria defined by the Washington, DC-based American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV).
"The distinction between severe premenstrual problems with mood and the more common forms of PMS was always important, but now that we have widely accepted diagnostic criteria for PMDD, and effective treatments for PMDD have been identified, the distinction has taken on additional significance because women with PMDD can now obtain the help they need," Endicott explains.
For a PMDD diagnosis, the patient must have:
• five or more of the following symptoms during most menstrual cycles in the past year: irritability, tension, depressed mood, mood swings, decreased interest in usual activities, difficulty concentrating, lethargy, marked change in appetite, insomnia or hypersomnia, sense of being overwhelmed, and physical symptoms such as breast tenderness and bloating. One or more of those symptoms must be depressed mood, tension, mood swings, or irritability.
• a disturbance that significantly interferes with social or occupational functioning.
• symptoms that are not an exacerbation of another disorder, such as major depressive disorder.3
Make sure the symptom diaries you provide patients with contain the items needed to make the diagnosis of PMDD, says Endicott. Women should be told to consider each item and rate the severity with which it was experienced during the past 24 hours, she suggests.
The daily ratings will help determine the pattern of premenstrual problems (which occur first and can be used as "early warning signs"), the timing of onset and offset of specific problems (which can be of importance in planning the timing of medication), as well as the relative severity of the problems during different phases of the menstrual cycle, says Endicott. In addition, sometimes just charting the symptoms and being cognizant of when they occur gives patients a sense of power over what is going on, states Sondheimer.
Look at new therapies
For women with mild to moderate PMS, getting adequate sleep, eating a healthy diet, exercising regularly, and eliminating nicotine and alcohol may help in easing troublesome symptoms, says Sondheimer. While there have been no studies to ascertain their effectiveness against the affective symptoms of PMS, combined oral contraceptives do offer some women relief while providing effective birth control, he notes.
For women with PMDD, recent clinical research has led to increased use of selective serotonin reuptake inhibitors. In July 2000, the Food and Drug Administration approved Sarafem (fluoxetine hydrochloride, Eli Lilly, Indianapolis) as the first prescription medication indicated for the treatment of PMDD.
Clinicians might recognize the drug as Prozac, which has been in use for several years under approved indications for depression, obsessive-compulsive disorder, and bulimia. The company sought the additional trademark since depression and PMDD are distinct disorders with different diagnostic and treatment approaches.
Fluoxetine’s effectiveness for the treatment of PMDD was established in two double-blind placebo-controlled trials.4 Common side effects were similar to those experienced by other fluoxetine users and included nausea, tiredness, nervousness, dizziness, and difficulty concentrating.4
Scientists are conducting ongoing research on several psychotropic drugs in efforts to identify more treatments and thus provide more choices, says Endicott. Drugs under review include sertraline hydrochloride (Zoloft, Pfizer, New York City), paroxetine hydrochloride (Paxil, SmithKline Beecham Pharmaceuticals, Philadelphia), and venlafaxine hydrochloride (Effexor, Wyeth-Ayerst Laboratories, Philadelphia).
"I think there is a potential that newer birth control pills with different progestational agents may have the potential of being helpful," adds Sondheimer. "There is some evidence that PMS can be helped by calcium supplementation in some patients."
Check new guidelines
While much of the research on the diagnosis and treatment of PMDD has been conducted in mental health settings, since dysphoric mood is the primary complaint, women usually bring up the condition and the desire for treatment in an OB/GYN setting, states Endicott. The Washington, DC-based American College of Obstetricians and Gynecologists revised its practice bulletin on premenstrual syndrome in 2000 to guide its members in appropriate treatment of the condition.
"The recently published guidelines are likely to be seen by many, if not most, obstetricians and gynecologists," says Endicott. "Hopefully, this will result in more women obtaining appropriate treatment for PMDD."
1. Endicott J, Freeman E, Kielich A, et al. PMS: New treatments that really work. Patient Care 1996; 30:193.
2. American College of Obstetricians and Gynecologists. ACOG Issues Guidelines on Diagnosis and Treatment of PMS. Washington, DC; March 31, 2000.
3. Karpa K. For women only. Drug Topics 2001; 2:51.
4. Food and Drug Administration. Talk paper. FDA Approves Fluoxetine to Treat Premenstrual Dysphoric Disorder (PMDD). Rockville, MD; July 6, 2000.