Review the options for premenstrual syndrome
When is "that time of month" a problem for some women? When symptoms such as depression, wide mood swings, breast tenderness, or muscle pain enter into the picture, a diagnosis of premenstrual syndrome (PMS) may be in order. However, when symptoms are more severe, clinicians may consider a diagnosis of premenstrual dysphoric disorder (PMDD).
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 these 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.1
The Food and Drug Administration (FDA) has just given approval to use of Yaz (Berlex; Montville, NJ), an oral contraceptive with 24 days of active hormones and four days of placebo pills, for the treatment of emotional and physical symptoms of PMDD. The drug was approved for contraceptive use in March 2006. How will the new indication aid health care providers?
"In the past, most clinicians treated women with PMS, severe PMS, and even those with PMDD, with oral contraceptives; in general, they were not effective," observes Andrea Rapkin, MD, professor of obstetrics and gynecology at the David Geffen School of Medicine at the University of California Los Angeles (UCLA). "So now there is a situation where something that comes naturally to an OB/GYN [prescribing an oral contraceptive) will actually in certain cases — the response rate is probably in the 60-65% range— be effective for PMDD."
In a clinical trial of Yaz, 64 women were randomized to the study drug or placebo for three cycles; after a washout period of one treatment-free cycle, they were switched to the alternate treatment.2 Researchers report the mean decrease from baseline for total Daily Record of Severity of Problems scores while using Yaz was significantly greater than for placebo (-12.47, 95% CI= -18.28, -6.66; p< .001). A positive response was recorded in 61.7% and 31.8% of subjects while taking the study drug and placebo, respectively (p=.009), researchers report.2
Look at progesterone
For women with PMS, some clinicians have looked to progesterone therapy for relief of symptoms. Such treatment has been based on the hypothesis that the ratio of progesterone and its derivatives in women with PMS is lower than that found in women without the syndrome.3
A new review of the current research on progesterone therapy indicates there is only a little good evidence for treating premenstrual syndrome with progesterone.4 While reviewers found some evidence for relief with progesterone in the included studies, they determined that the trials differed in route of administration, dose, duration of treatment and selection of participants. With such variations in study design, the outcomes differed, they report.4
If women are treated with progesterone for PMS, they should be counseled about possible changes in cycle length and sedative effects, the reviewers note. Women who have considered themselves infertile could conceive when treated with progesterone for PMS They should be advised about contraceptive options if pregnancy is not wanted, the reviewers state.
Better study design is needed to more completely capture the impact of progesterone on PMS, says Olive Ford, who served as lead author for the review. Ford is the former honorary research officer for the National Association for Premenstrual Syndrome, a British-based organization.
"My own experience with women in self-help groups and answering the National Association for Premenstrual Syndrome telephone helpline suggests that women may have little help with two 400 mg suppositories daily, but have complete relief with three or four," states Ford. "If they were participants in one of the clinical trials reviewed, their data would be negative."
SSRIs as option?
Selective serotonin reuptake inhibitors (SSRIs) represent another therapy for premenstrual syndrome. Standard SSRIs include fluoxetine (Prozac, Sarafem, both from Eli Lilly of Indianapolis), sertraline (Zoloft, Pfizer, New York City), paroxetine (Paxil CR, GlaxoSmithKline, Philadelphia), and escitalopram (Lexapro, Forest Laboratories, New York City). The FDA has approved indications for Sarafem and Paxil CR for treatment of PMDD symptoms.
According to a recent review of current research, there is now very good evidence to support the use of selective serotonin reuptake inhibitors in the management of severe premenstrual syndrome.5
Reviewers included 15 trials in the systematic review, with 10 trials examined in the main analyses. SSRIs were found to be highly effective in treating premenstrual symptoms, the reviewers concluded. Secondary analysis showed the drugs were effective in treating physical and behavioral symptoms.5
- Karpa K. For women only. Drug Topics 2001; 2:51.
- Pearlstein TB, Bachmann GA, Zacur HA, et al. Treatment of premenstrual dysphoric disorder with a new drospirenone-containing oral contraceptive formulation. Contraception 2005; 72:414-421.
- Greene R, Dalton K. The premenstrual syndrome. BMJ 1953;1:1,007-1,014.
- Ford O, Lethaby A, Mol B, et al. Progesterone for premenstrual syndrome. Cochrane Database Syst Rev 2006; 4:CD003415.
- Wyatt KM, Dimmock PW, O'Brien PMS. Selective serotonin reuptake inhibitors for premenstrual syndrome. Cochrane Database Systematic Reviews 2006; 4:DOI:10.1002/14651858. CD001396.