Tuesday, March 28, 2023
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In the not too distant past, when women sought treatment for severe premenstrual problems or for "premenstrual syndrome," they were sometimes told the condition did not exist or that they "just had to live with it" because no effective treatment was available. This is no longer the case. Not only are there widely accepted methods and criteria for making a differential diagnosis of the condition now referred to as premenstrual dysphoric disorder or PMDD,[1] there are several US Food and Drug Administration (FDA) approved medications that have been shown to be effective for the treatment of PMDD.
Most menstruating women experience some physical and emotional changes during the premenstrual phase of the cycle. These changes are usually mild and are not associated with impaired functioning. However, a subset of women, approximately 5% to 8%, regularly report having dysphoric mood and behavioral changes that occur during the premenstrual phase of their menstrual cycle.[2] They describe experiencing, to a marked degree, anger or irritability, depressed mood, feelings of hopelessness or self-deprecating thoughts, anxiety, tension, feelings of being "on edge," and affective lability. In addition, they are likely to manifest behavioral changes such as tearfulness, anger dyscontrol, interpersonal conflicts, or social withdrawal.
They also report that these premenstrual changes are of sufficient severity to cause clinically significant impairment in functioning at home, at work, with family, socially, or in other aspects of daily life. Their quality of life is greatly decreased during the premenstrual phase of their cycles, and the consequences of their severe mood changes and behavior often have lasting negative impact on their relationships with others and on their usual level of life satisfaction and enjoyment.
When a patient seeks treatment for problems such as those described above, there is a clear need for differential diagnosis prior to consideration of a treatment approach and possible management issues. A large percentage of the women who seek treatment for premenstrual problems with mood are found to have another mental or other medical disorder that is ongoing with exacerbation or added symptoms occurring during the premenstrual phase of their cycles. Such women do not have a "pure" severe premenstrual syndrome or PMDD, and this may have implications for differential treatments. The most common ongoing mental disorders associated with mood symptoms are major depression, dysthymia, an anxiety disorder, or a personality disorder.[3]
Prior to the mid l980s, no treatment for premenstrual syndrome had been shown to be superior to placebo.[4] The criteria used to select participants for study tended to be quite variable and vague, without specification, and were usually dependent upon "self-diagnosis."[5] Beginning in the late '80s, investigators began to use specified criteria and prospective daily ratings to select participants for treatment studies; and in l986, the initial findings of the first study to demonstrate superiority of a medication to placebo were published.[6]
That study and most subsequent controlled clinical trials used criteria very similar to those later included in the fourth edition of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM IV).[1] The diagnostic criteria in DSM IV require that 5 or more of 11 types of symptoms be present during the last week of the luteal phase. The symptoms must begin to remit within a few days after the onset of the follicular phase and be absent in the week postmenses. At least 1 of the symptoms must be from the 4 dysphoric mood states listed. The symptoms must markedly interfere with work or school or with usual social activities and relationships with others. The symptoms and impairment must not merely be an exacerbation of the symptoms of another disorder.
In addition to inquiry regarding the nature and severity of the symptoms and their effects on functioning, the initial clinical interview should focus upon the timing of onset (after mid-cycle?) and offset (by end of menses?) of the symptoms as well as the patient's level of symptoms and functioning during the mid-follicular phase of the cycle (days 6-10). She should report being essentially symptom free during that phase. It is often helpful to ask about her condition during the best week of the cycle.
Unfortunately, many women have not made systematic observations of their symptoms and behavior and are somewhat unclear about the nature and timing. It is very helpful to have the patient make daily ratings of the level of severity of her premenstrual problems as well as the degree of impaired functioning to help confirm the specific pattern and severity of the symptoms, the timing of onset and offset, and whether there is evidence of an ongoing mental disorder. Most women find a request for daily ratings to be quite reasonable if the value of these for better understanding of her condition is explained.
Ideally, at least 2 cycles of ratings should be completed. It is rare to find that a patient does not have any symptoms and at least some premenstrual changes. If the patient is found to have symptoms and impaired functioning throughout the month, the availability of her daily ratings can be an aid in the discussion of diagnosis and treatment approaches.
There are a number of interventions that may prove to be therapeutic, at least partially, during the cycles when the patient is making daily ratings. They include an increased intake of calcium carbonate 1200-1500 mg,[7] increased exercise,[8] dietary modifications of more frequent and smaller meals and reduced caffeine and alcohol intake, and efforts at stress management. The last 2 lifestyle modifications have not been systematically studied, but many clinicians report that they can be helpful.
FDA-approved treatments for PMDD. Women can now expect their clinician to not only be aware of the diagnostic criteria for PMDD but also to know that the FDA has recognized the condition and approved treatments for the disorder. Certainly patient expectations that efforts will be made to diagnose and treat their premenstrual problems are warranted.
Between 2000 and 2006, four different compounds were approved by the FDA for the treatment of PMDD. Therefore, women and their healthcare providers have a choice of therapeutic agents.
Three of the compounds approved during this time period were selective serotonin reuptake inhibitors (SSRIs): fluoxetine (Prozac/Sarafem), sertraline (Zoloft), and paroxetine CR (Paxil CR). All 3 have been approved for full-cycle and intermittent (half-cycle) dosing.
The fourth agent approved is an oral contraceptive (OC) that contains 3 mg drospirenone and 20 mcg ethinyl estradiol (YAZ) administered for 24 days of active pills followed by 4 days of placebo pills. This OC was approved for the treatment of the emotional and physical symptoms of PMDD in women who choose an OC as their method of contraception. Since some women find the side effects of SSRIs or the idea of taking an antidepressant to be troublesome,[9,10] the availability of another class of medication is likely to increase the number of women who will find an effective treatment for their PMDD.
All 4 pharmacologic agents have been shown to be considerably more effective than placebo for the symptoms and impairment in functioning seen in patients with PMDD.[11-14] In addition, those who have responded to treatment of their PMDD have reported improved quality of life in that they experienced greater enjoyment and satisfaction in many areas of their life.[15,16] Improved quality of life, while correlated with severity of symptoms and impairment, has been shown to be an important and independent dimension of change. Women can now have the expectation that they will experience the "bonus" of enhanced satisfaction and enjoyment in their lives now that effective treatments for PMDD have been identified and officially approved.
Supported by an independent educational grant from Bayer
