Sarafem Nation

A visibly irritated woman yanks on a supermarket shopping cart that's stuck in its stack while a soothing female voice-over recites a litany of PMS symptoms. She asks, "Think it's PMS? Think again. . . . It could be PMDD."

Premenstrual Dysphoric Disorder, or PMDD, is a fresh-minted mental illness that purportedly affects 3 to 10 percent of all menstruating women. Mood symptoms like depression, anxiety, anger, irritability, or sensitivity to rejection are said to be so severe the week before a woman's period that it impairs her functioning. According to Dr. Jean Endicott, professor of clinical psychology at Columbia University's College of Physicians and Surgeons, "What's ordinarily irritating becomes enraging."

To be diagnosed with PMDD, women must keep a daily diary of their symptoms for the duration of two menstrual cycles. The symptoms must kick in after ovulation and disappear once menstruation begins. "The timing is exquisite," remarks Endicott.

The timing is also exquisite for Eli Lilly and Company to make a financial killing off of PMDD. Next year, the drug company will lose its patents on the antidepressant Prozac, and with them its monopoly on the market. To ward off declining profits, Lilly has found another use for its wonder drug—treating PMDD.

In July, Lilly got Food and Drug Administration approval to market Prozac under the new name Sarafem. The company is packaging the drug in pretty pink and lavender capsules, exclusively for women, most in their late twenties or early thirties. Says Laura Miller, a spokesperson for Lilly, "Women told us they wanted treatment that would differentiate PMDD from depression."

According to Endicott, the symptoms of PMDD primarily interrupt "interpersonal relationships"—basically, those involving spouses, children, and coworkers. In one group of women with self-described premenstrual symptoms, researchers found no increase in absenteeism or decline in work performance, although the women themselves perceived that to be the case.

"PMDD is unique because there is virtually no other disease that people insist upon having," says Dr. Nada Stotland, chair of psychiatry at Illinois Masonic Medical Center. According to Stotland, the majority of women who go to PMS clinics have symptoms that aren't in fact related to their periods. "Most are depressed everyday. Others have anxiety and personality disorders. Some are in psychological pain because they are being abused."

That women might seek help on the pretense their problems are hormonally based makes PMDD more slippery to recognize and study. Stotland says she's particularly concerned that Lilly is targeting almost exclusively OB-GYNs as Sarafem prescribers, which puts gynecologists in the position of treating mental illness. She says Lilly's advertising campaign may convince enough women they need Sarafem, leading them to pressure their doctors to skip the two months needed for diagnosis and instead send them straight to the pharmacy. And since Sarafem will also work for those with chronic depression, a misdiagnosis can go undetected.

Proponents of Sarafem downplay the potential for misuse. "I doubt that a lot of people who don't need the treatment would get it," argues Endicott. "First, it's a prescription drug. Second, women are not big pill poppers." Sherry Marts, scientific director of the Society for Women's Health Research—a nonprofit organization that promotes research in women's health issues—concurs. "This is a real medical condition that requires treatment for a small percentage of women," she says."Not, 'I'm a little bloated, I'm gonna pop some Prozac.' "

But critics claim that 3 to 10 percent of all menstruating women is no small number. "That's a minimum of half a million North American women suffering from PMDD," says Paula Caplan, a psychologist and affiliated scholar at Brown University's Pembroke Center for Research and Teaching on Women.

Whether PMDD is a real condition is still subject to debate. Although both sides agree that a certain subset of women may be sensitive to normal hormonal changes, that's about all they agree on. The question remains, if women sometimes snap at their husbands if they don't pick up after themselves, or at their kids if they do poorly in school, should they be branded with a mental disorder? "Women are commonly in situations defined by stress—responsibility without authority," says Stotland. 'That's almost the definition of a typical woman's job."

Some doctors fear that women who have legitimate reasons to be unhappy will be silenced by the PMDD diagnosis, and that Sarafem could prove to be the Valium of the naughts. "Ordinary, healthy changes in mood and emotion are being pathologized when they happen to women, and since women believe they shouldn't feel irritable, angry, or depressed, they are quick to blame themselves," says Caplan. For men, "There's no testosterone-based aggressive disorder."

Endicott disagrees. "If men had PMDD, it would have been studied a long time ago."

But would it? "To say that a huge proportion of the female population is disabled represents a potentially horrendous setback for women in the workplace," says Stotland. She points to the woman who finally speaks up to her boss and in return is asked, "Oh, is it that time of the month?" Agreeing to that kind of put-down might save the woman her job. PMDD could reinforce the stereotype of the hysterical woman not only to employers, but to women themselves.

Caplan says that a diagnosis of PMDD will have far-reaching legal implications as well. Might women who've been labeled as mentally ill be deprived of the right to make their own decisions? Might they lose custody of their children in divorce cases? In other words, will PMDD sufferers be seen as the biological equivalent of Dr. Jekyll and Mr. Hyde?

That's already the most common complaint of PMDD sufferers, says Endicott, who reports women saying over and over, "This isn't me." Lilly promotional literature echoes this sentiment. "The good news is there is treatment available that can help you feel more like the woman you are every day of the month," the brochures say. But who is this woman? And why are we so concerned with her hormones?

One thing is for sure: Eli Lilly and Company has a financial stake in PMDD. Lilly's Prozac patents are expiring in 2001 and 2003. This means the market will open up to cheaper generic competitors. Analysts have estimated that Prozac sales will decline drastically—from about $2.51 billion in 2000 to $625 million in 2003. Sarafem will provide a significant new market—women—to boost profits. That's a smart move, since women are the primary users of drugs that alter mood. And, according to documents posted on the FDA's Web site, Lilly has proposed a "pilot study of PMDD in adolescents to estimate its response to treatment with fluoxetine." Fluoxetine, by the way, is the generic name for Sarafem (and Prozac).

Another plus for Lilly is that creating a new and separate trademark for Prozac lessens the stigma associated with antidepressants, and lets the company dodge some recent bad press, from the publication of Harvard's Joseph Glenmullen's Prozac Backlash to a new study in Brain Research that suggests the antidepressant may cut off axons of the nerves they target—in effect causing brain damage.

By 2004, Sarafem sales are expected to climb to $250 million a year, according to Bear Stearn's Bottle Report. Lilly would not divulge projected sales nor the amount of money spent marketing, researching, and developing Sarafem, but their financial report shows a lot of zeroes. For the first three quarters of this year, the corporation spent close to $2.3 billion in marketing and administrative costs, much more than its research and development, which totalled about $1.5 billion.

But most extraordinary is that the federal government is convinced of the existence of PMDD, while the psychiatric community isn't so sure at all. PMDD is currently listed in the appendix of the DSM-IV—the psychiatrist's bible of mental illnesses—as "needing further study."

The controversy began in 1987, when the compendium first included specific criteria for Late Luteal Phase Dysphoric Disorder—the former name for PMDD—in its appendix as a "proposed diagnostic category" needing more research. In 1993, as the American Psychiatric Association's task force was compiling the fourth edition of the manual, the category was revisited. Should it remain in the appendix, get moved to the body as a recognized diagnostic category, or be removed altogether?

The committee decided to keep PMDD in the appendix. According to Psychiatric News, the APA's professional newsletter, "Members of the task force agreed there were a number of problems with methodology within the PMDD literature. The problems included unclear definitions, small sample sizes, lack of control groups, lack of prospective daily ratings of symptoms, no documentation of the timing and duration of symptoms, and failure to collect appropriate hormonal samples." However, the committee suggested specific criteria for diagnosing PMDD, including specs for symptoms and timing.

Five years later, the fate of PMDD was still unclear. In October 1998, the Society for Women's Health Research organized a discussion, headed by Endicott, to answer this question: "Is premenstrual dysphoric disorder a distinct clinical entity?" Once again, experts reviewed the PMDD literature, this time in the company of FDA and Lilly representatives.

Dr. Sally Severino, a now retired professor of psychiatry at the University of New Mexico, reiterated flaws in the research. First, just because women can be identified by PMDD criteria "is not proof that PMDD exists as a valid diagnosis." Second, although cross-cultural studies identified physical complaints related to menstruation, mood symptoms like anger and irritability were not found worldwide to the same degree as in America. Severino argued that if PMDD can't be identified in other populations, then "consideration must be given to the criticism that PMDD is a culturally bound syndrome or an unnecessary pathologizing of cyclical changes in women."

Ignoring these objections, the round table concluded that PMDD was a "distinct entity with clinical and biologic profiles dissimilar to those seen in other disorders." In other words, a mental illness.

What changed between 1993 and 1998? For one thing, Lilly funded a 1995 study that showed Prozac was effective in treating PMDD. Published in The New England Journal of Medicine, the study had a large sample size, and was placebo-controlled and double-blind (meaning neither the doctor nor the participant knows who's getting drugs or a sugar pill)—all the makings of a pristine scientific inquiry. A slate of studies followed suit, all with the same results: About 60 percent of women diagnosed with PMDD respond to Prozac.

Yet one 1998 study discussed by Endicott's roundtable found that 55 percent of women diagnosed with premenstrual symptoms got significant relief from increased calcium intake. The group went on to comment that "the area of calcium is not well explored." That leads critics to wonder why other treatment options are getting the cold shoulder. "Why not spend pages and pages pushing calcium?" asks Caplan, who served on the 1993 DSM committee. And although there is evidence that people with PMDD can feel better with only intermittent doses of Prozac—and suffer fewer side effects like sexual dysfunction—the studies Lilly presented to the FDA looked solely at the effectiveness of daily doses, or roughly double the amount some researchers say is needed.

According to Caplan, almost all of the data the roundtable evaluated fell into two categories: the old problematic studies available to the DSM-IV group or the new research into using Prozac to treat PMDD. "There was nothing that looked at the validity of the PMDD construct," says Caplan.

Did Lilly railroad Sarafem through? Two members of the 16-person roundtable conducted PMDD research funded by Lilly, and another member has received honoraria as a speaker for Lilly. Endicott, who hasn't received research funds or speaking fees from Lilly, opened the company's November 1999 presentation to an FDA advisory committee, which voted unanimously in favor of the new PMDD indication for Prozac. In addition, the Society for Women's Health Research trumpets on its Web site an "unrestricted educational grant from Eli Lilly and Company," which they've used to promote PMDD awareness, including a national survey conducted in November to gauge women's awareness of PMDD and available treatment (i.e., Sarafem). "Lilly had done an extraordinary job of getting this to the public," says Stotland.

Researchers taking a ride on the drug-company gravy train is not unique to those who studied PMDD, but it can have effects on scientific research. "I don't think people falsify results. But what kinds of questions do you ask? Which results do you publish?" asks Stotland. "When I was a resident it was the departments who had money to bring in speakers. Now, it's the drug companies who are flying people around."

Incidently, at the time of the interview, Stotland was attending a PMDD conference held at a Palm Springs resort, courtesy of Eli Lilly.

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Yaz for PMDD

Yaz (drospirenone 3mg/ethinyl estradiol 20mcg) has been approved for the treatment of the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. In a clinical trial, Yaz was significantly superior to placebo in improving interpersonal relationships, work productivity and enjoyment of hobbies/social activities.

The FDA based its action on clinical trial results showing that Yaz cut PMDD symptoms by at least half. Women taking Yaz reported twice as much improvement in PMDD symptoms as women taking inactive placebo pills.

Yaz improved both physical and emotional symptoms of PMDD, including interpersonal relationships, work productivity, and enjoyment of hobbies and social activities.

Like other birth control pills, Yaz uses the female hormones estrogen and progestin. Unlike other versions of the pill, Yaz uses a form of progestin that has unique properties. This, plus its 24-day dosing regimen, may help account for its positive effect on PMDD, says Andrea Rapkin, MD, in a news release from Berlex Inc., the U.S. affiliate of Schering that manufactures Yaz.

"For my PMDD patients who need a treatment to reduce their symptoms -- as well as a safe and effective contraceptioncontraception to prevent pregnancypregnancy -- YAZ is an important option that can meet both of their health care needs in a single pill," says Rapkin, professor of obstetrics and gynecology at UCLA's David Geffen School of Medicine.

While most women have some PMS symptoms, PMDD occurs when these symptoms are at their most severe. PMDD affects about 5% of women.

PMDD: PMS Squared

Think of PMDD as PMS squared. Women with PMDD have at least five severe premenstrual symptoms. These may include:

* Feelings of sadness, hopelessness, or worthlessness
* Anxiety or tension
* Unstable mood and frequent crying
* Persistent irritability causing conflict in relationships
* Loss of interest in usual activities or relationships
* Lack of concentration
* Lack of energy
* Changes in appetite, possibly including cravings or binge eating
* Sleeping too much or too little
* Feeling out of control
* Physical symptoms including breast tenderness, breast swelling, headache, joint/muscle aches, bloating, and weight gain.

At least one of the first four symptoms must be present for a diagnosis of PMDD. The symptoms occur during the week before a woman's period and resolve within a few days after her period starts.

Because PMDD is so severe, doctors usually prescribe antidepressants, antianxiety medications, hormonal treatments, and/or water pills. While doctors have used other oral contraceptives as treatments for PMDD, Yaz is the first drug of this class to receive specific FDA approval for this purpose.

The most common side effects seen in women taking Yaz are headache and breast pain.


Is PMDD real?

Researchers, physicians and psychologists fall on various sides of the debate over premenstrual dysphoric disorder.

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"I'm so bloated."
"I'm so depressed."
"I'm so irritable."
"One minute I'm fine, the next I'm crying."
"I'm so tired."

The list of complaints that goes with many women's menstrual cycle can be long. Most women--and men for that matter--are quick to diagnose these symptoms as premenstrual syndrome (PMS)--a catchall diagnosis that's tossed around to describe all sorts of minor mood and menses-related maladies in women.

But approximately 3 to 9 percent of women experience premenstrual changes so severe they can't keep up their daily routines. Some experts say these women suffer from premenstrual dysphoric disorder (PMDD), a condition characterized by intense emotional and physical symptoms that occur between ovulation and menstruation. In other words, PMDD is like supercharged PMS.

"It's a real biological condition for which women seek treatment--and for which effective treatment is available," says Jean Endicott, PhD, director of the premenstrual evaluation unit at Columbia Presbyterian Medical Center. Eight years ago it was included in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). But many health professionals say PMDD does not exist, that it can be confused with other mental health disorders, such as depression. Psychologists in this camp contend women shouldn't have to be diagnosed with a mental illness in order for others to believe they are uncomfortable or unhappy or to get help and support.

"PMS and PMDD are both 'culture-bound' syndromes," says Joan Chrisler, PhD, a psychology professor at Connecticut College and president of the Society for Menstrual Cycle Research. "There is no evidence [that PMDD exists], though people have to find such evidence," says Paula Caplan, PhD, author of "They Say You're Crazy" (1995, Perseus Books). "It is really appalling that using PMDD for women who want recognition for discomfort is a very clear message that goes something like: 'OK, OK, we'll believe you are feeling bad if we get to call you mentally ill for feeling bad.' Can you imagine if we did that to men?"

"Women are supposed to be cheerleaders," she adds. "When a woman is anything but that, she and her family are quick to think something is wrong."

Meanwhile, for women, the controversy can be frustrating and confusing. Those who experience severe premenstrual changes just want some relief.

Defining the condition

PMDD is listed in the DSM-IV as a "depressive disorder not otherwise specified." The symptoms of PMDD are remarkably similar to those of Major Depressive Disorder (MDD). PMDD symptoms include:
  • Markedly depressed mood. A symptom of MDD is depressed mood most of the day, nearly every day.
  • Decreased interest in usual activities. One criterion for MDD is markedly diminished interest or pleasure in all activities.
  • Lethargy, fatigability or lack of energy. Similarly, patients with MDD have fatigue or loss of energy.
  • Hypersomnia or insomnia--also symptoms of MDD.

The difference between PMDD and MDD is that PMDD symptoms are cyclical, subsiding with onset of menses, points out Endicott. The DSM-IV also notes that some mood disorders, somatoform disorders, personality disorders and general medical conditions, such as thyroid and other endocrine disorders, migraine, anemia or various infections can be exacerbated during the premenstrual phase.

Endicott and a panel of experts determined in 1999 that PMDD is a distinct clinical entity, based on studies they examined that suggested that PMDD sufferers have "normal functioning of the hypothalamic-pituitary-adrenal axis, show biologic characteristics generally related to the serotonin system, and a genetic component unrelated to major depression." The roundtable group--which included psychiatrists, psychologists and a representative from Eli Lilly--also cited studies that showed that at least 60 percent of patients respond to selective serotonin reuptake inhibitors (SSRIs) as evidence of PMDD's distinct clinical entity.

Interestingly, a 1998 (American Journal of Obstetrics and Gynecology, Vol. 179, No. 2) study showed that calcium carbonate could improve PMDD symptoms. Out of approximately 500 women, 55 percent experienced some relief from some symptoms within three months.

Some research suggests a link between depression and PMDD. Psychologist Shirley Ann Hartlage, of Rush Medical College in Chicago, who is a principal co-investigator on an epidemiological study of PMDD sponsored by the National Institute of Mental Health, and colleagues found that women with PMDD appear to be at greater risk for developing major depression (Journal of Clinical Psychology, Vol. 57, No. 12).

Most experts insist that daily self-ratings by the patient for two or more menstrual cycles must be completed before a PMDD diagnosis can be confirmed. "It's the timing of the symptoms that makes a difference," Hartlage notes. "And very few women, if they are rating their symptoms every day, have symptoms as severe as required [by the criteria]."

Bad for women?

Some feminist psychologists like Caplan believe that the language surrounding PMDD is misleading and that its classification as a psychiatric disorder stigmatizes women as mentally ill and covers up the real reasons of women's anguish. "It's a label that can be used by a sexist society that wants to believe that many women go crazy once a month," Caplan explains.

By including PMDD in the DSM-IV, she says, emotional displays that are considered normal in men are seen as a mental disorder in women. "Any normal hormonal change in people of either sex can exacerbate migraines, thyroid problems, etc., but no one suggests's hormonal changes kinds of mental illness."

Chrisler agrees, noting that not only is the diagnosis part of a "backlash against feminism," it undermines women's self-concepts and feeds into stereotypes about women. "It's convenient for women to use this," says Chrisler. "The discourse is me, not me, my real self, my PMS self. It allows you to hold onto a view of yourself as a good mother who doesn't lose her temper."

Caplan cites research by Sheryle Gallant and colleagues "that demonstrates without question that the category of PMDD is neither valid nor helpful to women." The study (Psychosomatic Medicine, 1992) asked women--a group that said they had severe symptoms and a group with none--to keep a checklist of PMDD symptoms. In the end, the checklist responses failed to differentiate the two groups.

Perhaps most interesting, some men were asked to participate in the study and their checklist results didn't differ from the women's. Caplan says that's "dramatic proof" that classifying PMDD as mental disorder is "unjustified."

Chrisler and Caplan say that health professionals are all too ready to diagnose women with PMS or PMDD. "The diagnosis is vastly overextended," Chrisler says. "The definition says it has to be severe and interrupt your life. No one thinks about that anymore."

Caplan says that when someone believes they have PMDD, a psychologist should say, "'Yes, maybe that's it. But let's look at your life, maybe it's something else.'"

Indeed, some research seems to show that many women who seek treatment for PMS or PMDD are often abused. At the least, Chrisler says, they might be experiencing stress that exacerbates premenstrual changes--but they don't really have PMDD. She adds: "We're conditioned to want a pill. Instead of something you might need more, like a nap or a divorce, or the ERA."

Enter the drug treatments

Two medications are approved by the Food and Drug Administration to treat PMDD: Sarafem (fluoxetine) and Zoloft (sertraline HTL). Sarafem--repackaged Prozac--was marketed heavily by its manufacturer, Eli Lilly, for PMDD treatment after it acquired another patent--Prozac's patent was due to expire. Lilly spent more than $33 million promoting the drug to consumers. In the seven-month period after the medication's approval, physicians doled out more than 200,000 prescriptions for Sarafem.

And this year, Zoloft, manufactured by Pfizer, was also approved to treat the condition. Some research (Journal of Women's Health and Gender-based Medicine, Vol. 10, No. 8) suggests that both fluoxetine and sertraline are more effective than placebos in treating PMDD.

But drug treatments for PMDD draw controversy. Critics like Caplan think drug companies are taking advantage of women's health concerns and fears to increase their bottom lines. She thinks the decision to accept Sarafem as a treatment for PMDD just furthers "the misleading and dangerous assumption that the condition even exists"--women's underlying problems, such as depression or abuse go untreated, she says. Caplan also asserts that many drug companies have funded studies, "then insisted that, as reported by the editors of major medical journals in the past two years, researchers publish only those studies that showed their drug works, and they have suppressed the publication of others." And she notes that if a company does enough studies, "one will by statistical chance get some that seem to show the drug makes a difference.

Others, like Endicott, who was involved in some of the clinical trials, believe that the treatments work, and that some women do find relief. "It's treatable--you don't have to put up with this," she says. In response to criticism of the research, "The companies did not do large scale studies involving hundreds of women until smaller studies conducted by independent researchers had indicated that a particular treatment might have a sizable therapeutic benefit."

Hartlage, meanwhile, fears that, without the psychiatric-disorder classification, women who are truly suffering may be discounted. "Sometimes to receive the diagnosis is more helpful to women," she says. Endicott agrees, saying that many women whose lives are adversely affected by their premenstrual symptoms are relieved to find someone who knows what they are experiencing and takes them seriously. She thinks that the disbelief of PMDD belittles women and "increases the stigma of mental disorders--where problems with mood and behavior are the defining characteristics--and can discourage women from seeking help."

Regardless of their positions on PMDD, psychologists like Chrisler, Caplan, Hartlage and Endicott say it's crucial not to jump to conclusions with patients. "If a woman tells you she has PMS or PMDD, [therapists] should be supportive and shouldn't assume that it's just hormonal and nothing can be done about it," says Chrisler. "Ask about stress, ask about relationships. Explore some other things."

Whether PMDD is a mental disorder or not, the most important thing is to give women who seek help validation. "Whatever they're experiencing, they're experiencing," she says.
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Premenstrual Syndrome (PMS) vs. Premenstrual Dysphoric Disorder (PMDD)

Frederick R. Jelovsek MD

Premenstrual syndrome (PMS) refers to the variation of physical and mood symptoms that appear during the last one or two weeks of the menstrual cycle and disappear by the end of a full flow of menses. This is a diagnosis used by Ob-Gyns and primary care physicians. Psychiatrists and other mental health workers tend to use the diagnosis term of premenstrual dysphoric disorder (PMDD) to describe a specific set of mood symptoms that are also present the week before menses and remit a few days after the start of menses and also interfere with social or role functioning. Is there any difference between the two or do they represent the same entity? Most doctors believe these two terms refer to the same clinical entity.

A recent educational series from the Association of Professors of Obstetrics and Gynecology, Ling FW, Mortola JF, Pariser SF st al.: Premenstrual syndrome and premenstrual dysphoric disorder: Scope, diagnosis, and treatment. 1998 Pragmaton, Chicago IL., looked at the components that go in to each of these diagnoses.

How common is PMS?

Up to 80% of women have cyclic symptoms associated with their menses but only about 3-5% have symptoms so severe that it interferes with work, school, usual activities or relationships. The average onset is 26 years of age with symptoms often becoming worse over time. Other mental health problems and diagnoses are often associated with PMS and PMDD, especially major and minor depression.

What are some of the actual symptoms of PMS and PMDD?

PMS looks more at physical symptoms such as bloating, weight gain, breast tenderness, swelling of hands and feet, aches and pains, poor concentration, sleep disturbance, appetite change, and psychologic discomfort. Premenstrual dysphoric disorder has as part of its definition, symptoms such as depressed mood or dysphoria, anxiety or tension, emotional lability, irritability, decreased interest in usual activities, concentration difficulties, marked lack of energy, marked change in appetite, overeating or food cravings, sleepiness or insomnia, and feeling overwhelmed.

What other diagnoses can be confused with PMS and PMDD?

The differential diagnosis includes:
Psychiatric disorders
  • major depression
  • minor depression (dysthymia)
  • generalized anxiety
  • panic disorder
  • bipolar illness (mood irritability)
  • other
Medical disorders
  • anemia
  • autoimmune disorders
  • hypothyroidism
  • diabetes
  • seizure disorders
  • endometriosis
  • chronic fatigue syndrome
  • collagen vascular disease

Many times it is extremely difficult to rule out a premenstrual exacerbation of another mood or physical disease versus a primary diagnosis of PMS or PMDD, or even the possible combination of both a medical or psychologic disorder and PMS.

What causes PMS?

There is moderate evidence to support the theory that premenstrual symptoms are caused primarily by changes in brain chemicals that transmit between nerves and cells (neurotransmitters) brought about by cyclical fluctuations in ovarian hormones. PMS does not occur before menarche, during pregnancy and after menopause, either natural or surgical.

Is PMS hereditary?

Current research indicates that there is a possible genetic factor in the development of PMS and may explain as high as 35% of symptoms. Several studies of twins indicate a higher incidence of PMS symptoms in identical female twins versus non-identical female twins. Family environment may also play a role in that a high prevalence of a history of sexual abuse has been found in women seeking treatment for PMS.

What can I do to see if I have PMS?

You need to see your doctor to make sure none of the other problems are confusing the symptoms. The doctor will probably check your thyroid studies (TSH), blood sugar for diabetes, blood count for anemia and evaluate your history and physical findings to rule out automimmune disease, vascular disease, seizures and endometriosis among others. The doctor may want you to take some psychometric written tests to see if depression, anxiety or even panic disorder are playing a role in your symptoms.

The hallmark of PMS diagnosis is prospective symptom charting. Without it, the diagnosis of PMS cannot be accurately made. The reason for this is that retrospective recall has almost always been found to be markedly different from prospective charting. While you may think there is a one-to-one variation of symptoms with your menstrual cycle, prospective charting often shows that symptoms are present all of the time and represent basically a mood disorder more than just PMS. That mood disorder is where treatment needs to be directed. The doctor will give you a chart to track the severity of some of your symptoms over one or two months. There needs to be at least a week that is symptom free in the first part of your menstrual cycle in order to diagnose PMS.

What are some of the possible treatments for PMS?

The best treatments are often the simplest. Dietary change can help dramatically. Discontinuance of all caffeine containing products, drinks and over-the-counter-medications. A low carbohydrate diet, especially avoiding any simple sugars and only sparingly having complex carbohydrates is beneficial. Calcium supplements (1200 mg/day) also have been shown to help. Vitamin B6 (pyridoxine) has contradictory evidence of its efficacy and progesterone treatment used in the past has been shown to be no better than placebo.

Common prescription medicines used are included in the table below:

Class of drugMedicineDose
Antidepressants fluoxetine (Prozac®) 20 mg/day
sertraline (Zoloft®) 50-150 mg/day
paroxetine (Paxil®) 10-30 mg/day
clomipramine (Anafranil®) 25-75 mg/day (14 days before menses)
Antianxiety alprazolam (Xanax®) 1-2 ug/day (6-14 days before menses)
buspirone (Buspar®) 25-60 mg/day (12 days before menses)
Ovulation suppression GnRH agonist Lupron® 3.75 - 7.5 mg/monthly I.M.
GnRH agonist Buserelin 400-900 ug/day intranasal


PMS has become a household word and the brunt of many jokes. According to a recent survey, many women remain unaware of its more severe form, premenstrual dysphoric disorder or PMDD.а Among 500 women recently surveyed, 8 out of 10 did not know that severe premenstrual problems have been officially classified as PMDD, nor did they know that such problems can be diagnosed and treated.а Even more disturbing is that the one in 4 respondents who described their premenstrual symptoms as strong or severe were among those unaware of PMDD.

“We’ve got to educate women that they do not have to tolerate debilitating premenstrual symptoms,” said Phyllis Greenberger, MSW, Executive Director of the Society for Women’s Health Research, which commissioned the Yankelovich Partners survey (sponsored by a grant from Eli Lilly, manufacturers of Prozac). “Women have a right to know if what they are experiencing month to month is actually PMDD, and how to get help.”

What is PMDD?

PMDD stands for Premenstrual Dysphoric Disorder. It is the acronym for the more severe form of PMS (Premenstrual Syndrome). Like PMS, PMDD occurs the week before the onset of menstruation and disappears a few days after. PMDD is characterized by severe monthly mood swings and physical symptoms that interfere with everyday life, especially a woman’s relationships with her family and friends. PMDD symptoms go far beyond what are considered manageable or normal premenstrual symptoms.

PMDD is a combination of symptoms that may include irritability, depressed mood, anxiety, sleep disturbance, difficulty concentrating, angry outbursts, breast tenderness and bloating. The diagnostic criteria emphasize symptoms of depressed mood, anxiety, mood swings or irritability. The condition affects up to one in 20 American women who have regular menstrual periods.

What is the Difference Between PMS and PMDD?

The physical symptom list is identical for PMS and PMDD; while the emotional symptoms are similar, they are significantly more serious with PMDD. In PMDD, the criteria focus on the mood rather than the physical symptoms. With PMS, sadness or mild depression is not uncommon. With PMDD, however, significant depression and hopelessness may occur; in extreme cases, women may feel like killing themselves or others. Attributing suicidal or homicidal feelings to “it’s just PMS” is inappropriate; these feelings must be taken as seriously as they are in anyone else and should be promptly brought to the attention of mental health professionals.

Women who have a history of depression are at increased risk for PMDD. Similarly, women who have had PMDD are at increased risk for depression after menopause. In simplest terms, the difference between PMS and PMDD can be likened to the difference between a mild headache and a migraine.

While nearly all of the women in the survey reported experiencing premenstrual symptoms in the last 12 months, nearly half (45 percent) have never discussed PMS with their doctors. Even among women with strong or severe symptoms, more than one out of four (27 percent) had never talked with their doctors about PMS, despite the fact that most in this group reported that the symptoms interfere with their daily activities.

When asked about their reluctance to seek medical treatment even if they thought they had PMDD, nine of every 10 respondents who would not seek treatment said that they could cope with their problems on their own, and about one of every four felt their doctors would not take their complaints seriously if they did bring it up.

PMDD has recently been listed as an official psychiatric diagnosis. The fear of this stigma may contribute to women’s reluctance to discuss it with their doctors. “I frequently work with patients who have waited years to ask a doctor about premenstrual problems or have been turned away by their health care provider when they tried to discuss symptoms,” said Jean Endicott, Ph.D., Director of the Premenstrual Evaluation Unit at Columbia Presbyterian Medical Center. “They fear becoming the target of jokes or that seeking help is a sign of weakness. Informing women and providers about diagnosing and treating PMDD helps clear the way to effective medical care.”

Survey respondents reporting strong or severe symptoms revealed the classic PMDD features of impaired social functioning and predominant mood symptoms. Two out of three women (67 percent) with moderate, strong or severe symptoms reported interference with their daily activities. One third of these women said they find their mood changes, not their physical symptoms, to be most bothersome.

The survey also found that women with strong or severe premenstrual symptoms were five times as likely as those with moderate symptoms (26 percent vs. 5 percent) to experience these symptoms every month. A key part of the PMDD diagnosis is determining whether symptoms have occurred during most cycles of the past year and are clearly documented for at least two consecutive menstrual cycles.

When asked what they would do if they thought they had PMDD, two out of three women (66 percent) in the survey said they would most likely get information from their obstetrician or gynecologist, as opposed to consulting friends or using Internet resources. This is encouraging, according to Dr. Endicott, because the American College of Obstetricians and Gynecologists (ACOG) issued treatment guidelines for premenstrual symptoms earlier this year. It recommended the newer form of anti-depressant medications called “SSRIs” (selective serotonin reuptake inhibitors) as the preferred method for treating symptoms associated with PMDD.


How do you know if you really have PMS or PMDD? If you think you may, start keeping a PMS Symptom Diary. List the dates of your period, and which symptoms you have (and their severity) on the 10 days preceding, as well as following, your period. After tracking your symptoms for at least 2 cycles, bring this diary with you to consult your physician, along with a list of all medications you are taking (including prescriptions, over-the-counter medications, herbs, vitamins, and supplements). Your doctor will give you a complete history and physical exam to rule out other possibilities (such as hypothyroidism, hypoglycemia or depression); no specific physical findings or tests can confirm the diagnosis of PMS.

Treatment of PMDD:

For general PMS relief, your doctor may recommend birth control pills or switching to another pill if you already take one. Other prescription medical interventions will depend upon the types of symptoms that most affect you. For example, if you are affected by bloating and weight gain, your doctor may prescribe a certain type of diuretic (sprionolactone) to help your body eliminate the excess water. If severe breast tenderness is a major complaint, birth control pills are often recommended. If this is insufficient, your doctor may prescribe a medication called bromocriptine to lower your levels of prolactin (a hormone linked to breast tenderness) or an androgen called Danazol®. For dysmenorrhea (painful periods), prescription prostaglandin inhibitors such as Naprosyn® or Ponstel® can be very effective if over-the-counter non-steroidal anti-inflammatory drugs such as Motrin® or Advil® were not sufficient.

If you have severe PMS symptoms that interfere with your responsibilities or relationships, or if you tell your physician that you just feel out of control on those days, s/he may suggest that you try one of several prescription medications for PMDD symptoms. The choices are diverse and represent two major classes of anti-depressant medications: the selective serotonin reuptake inhibitors (SSRI’s) and the tricyclic antidepressants. The SSRI’s include medicines such as Prozac®, Effexor®, and Zoloft®. They are generally well tolerated, work quickly, and reduce or eliminate disturbing emotional symptoms for many women, often at doses significantly lower than those required to treat depression. A recent study showed that this type of antidepressant medication worked significantly better for the treatment of PMS than the tricyclics, although tricyclics (e.g. Pamelor®, Elavil®) have a role in treating women with severe insomnia or those with combined depression and PMS.

There are many advocates for “natural” progesterone therapy for PMS. However, to date, multiple controlled clinical trials of progesterone in several dosage forms has failed to show any benefit for the treatment of physical or emotional symptoms of PMS.

In addition to conventional therapies, many women with PMS report that they have been helped by modalities such as biofeedback, relaxation techniques, acupuncture, and massage. My general approach to these types of therapies is that if you find something that works for you -- great. For many patients, simple stress-reduction techniques such as taking long, hot baths or meditation are also helpful.

Top Ten Tips for PMS Management:
  1. Discuss your situation with your physician. Work together to develop a comprehensive treatment plan. Follow it!
  2. If you smoke, quit.
  3. Practice stress management: many of the symptoms of PMS are unpredictable and emotionally draining. This can be very stressful and can exacerbate your condition.
  4. Regular exercise may reduce your risk of PMS altogether; exercising once you have symptoms (even though you may not feel like it) will reduce the symptoms you experience for that cycle.
  5. Take a daily, non-prescription multi-vitamin; discuss any other supplement needs with your physician.
  6. Be sure to get an adequate daily intake of calcium (1,200 mg/day).
  7. Eat a well balanced diet; don’t skip meals.
  8. Reduce intake of caffeine, alcohol, refined sugar, and salt.
  9. Enlist the support and understanding of friends and loved ones.
  10. Try to get regular, sufficient sleep.
Important Questions to Ask Your Physician if You Think You Have PMS or PMDD:
  1. Should I be taking any dietary supplements?
  2. Are there any other illnesses that could be causing my symptoms?
  3. Should I be evaluated for other conditions such as low blood sugar, under-active thyroid, or depression?
  4. Could this be related to any medications I might be taking (including birth control pills)?
  5. Do I have PMS or PMDD?
  6. Could my symptoms be related to perimenopause?
  7. Am I a candidate for prescription drug therapy for this condition?
  8. What medicines should I be taking to combat PMS?

Can PMDD be Prevented?

Because doctors are not exactly sure what causes PMS or PMDD, there is currently no proven prevention. However, you may be able to alleviate some symptoms by leading a healthier lifestyle or changing other medications.

There is no cure, per se, for PMS other than menopause. As discussed above, there are many strategies for effective management, and many interventions, which may decrease the symptoms significantly. Whatever your choice of therapy, remember that you’re not committed to that choice for life! The other good news about PMS unlike other recurrent conditions is that you won’t have it for life: PMS ends with menopause if it hasn’t already disappeared after age 40 (although many of the symptoms of perimenopause are very similar to having PMS). You and your physician will monitor your progress and your comfort level with your treatment plan. If there are factors that change -- including your level of satisfaction -- discuss this with your physician.

What Men Should Know About PMS and PMDD:

The main thing that men need to know about PMS or PMDD is that jokes about PMS may be hazardous to your health! In all seriousness, PMS is serious and PMDD is very serious. Be supportive and understanding; but most of all, be thankful that you don’t have to go through these symptoms every month.

What causes PMDD?

That's a question that researchers are still trying to answer.

The cause of PMDD has not yet been determined, but many factors may be involved, including sensitivities to normal hormone fluctuations and to chemicals in the brain.

Like mother, like daughter: the family connection

It's also likely that, to some degree, PMDD is inherited. If your mother had PMDD, the chances are greater that you'll have it too. And in studies of twins, 93% of identical twins (who share the same genetic makeup) both had PMDD, while non-identical twins (fraternal) shared the condition only 44% of the time.

The good news is that research into PMDD continues. You can look forward to a better understanding of the causes. And, hopefully, more advanced ways to treat it.


PMDD. Know what it is.

Some women describe the time before their periods as a roller coaster of emotions. Others feel like they become somebody else. And for millions, these symptoms actually significantly interfere with their daily activities.

Sound like PMS? Well, what you think is PMS may be a condition healthcare professionals call PMDD (Premenstrual Dysphoric Disorder), a more severe group of symptoms that occur one to two weeks before a woman's period. Every day, women are fighting the symptoms of PMDD that significantly interfere with their daily activities and personal lives.

Women who have PMDD experience a combination of emotional and physical symptoms that are severe enough to significantly interfere with how they function at school, work or in their personal relationships. These symptoms occur during the 14 days before a woman's period.

Think you may have PMDD? To help determine if you do, your healthcare professional will want to know:

  • What emotional and physical symptoms do you experience each month?
  • When during the month do your symptoms occur? Is it during the 1st or 2nd weeks before your period?
  • Do these symptoms significantly interfere with your daily activities or relationships?

PMDD is measured by how severe your emotional and physical symptoms are and how significantly they interfere with your relationships and daily activities.

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Let's talk symptoms

What sets PMDD apart is that some of your symptoms, especially your emotional symptoms, are so severe that they significantly interfere with the way you live your life just before your period. These symptoms can make it difficult to focus, slow you down at work or affect your personal relationships.

The list of symptoms on this page is not here for you to diagnosis yourself, but rather to find out if your symptoms are among those associated with PMDD. We're all different, and how one woman experiences symptoms of PMDD is not the same as another. The important thing to remember is that now, you and your healthcare professional can help fight the symptoms that significantly interfere with work, school or your personal relationships.

These symptoms can affect women who have PMS or PMDD. They are considered symptoms of PMDD only if they are severe enough to significantly interfere with your daily life, in the 1-2 weeks before your period.

Emotional symptoms:

Feeling sad or depressed
A sense of hopelessness
Feeling worthless/guilty
Feeling anxious/tense
Mood swings
Feeling overwhelmed/out of control
Feeling sensitive
Having conflicts
A diminished interest in activities
Difficulty concentrating

Physical symptoms:

Increased appetite
Food cravings
Sleeping more
Trouble sleeping
Breast tenderness
Breast swelling
Muscle aches

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