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Pharmacological Therapy for Emotional and Psychological Symptoms

Often, nonpharmacological interventions are insufficient for adequate menstrual relief for patients suffering from premenstrual dysphoric disorder. Dietary modifications that may then be recommended include daily calcium, magnesium, and L-tryptophan supplementation. These modifications have been clinically studied in premenstrual syndrome patients and are therefore assumed to be beneficial to the PMDD patient. Recommendations supported by controlled studies include 1,200 mg of calcium carbonate per day in divided doses, 50 to 100 mg of magnesium twice a day (up to 60 mg/day), 400 U of vitamin E per day, or 50 to 100 mg of vitamin B₆ per day. Supplementation of L-tryptophan to reduce symptoms of PMDD has been indicated with limited data. The daily recommended amount of L-tryptophan is 6 g from the time of ovulation until day 3 of menses.

In addition to nutritional supplements, herbal products have also been studied to treat premenstrual dysphoric disorder. Dong quai is a coumarin derivative widely used in China for menstrual cramps and irregular menses. Black cohosh is often recommended to patients who suffer from dysmenorrhea and hot flashes associated with menopause. Similarly, blue cohosh can be used for menstrual cramps and stimulation of menstrual flow. Valerian is indicated for patients with insomnia related to PMDD. Although these herbal products may relieve some symptoms of premenstrual dysphoric disorder, they cannot be recommended because little is known regarding their dosing, efficacy, and safety. If a patient insists on the use of herbal products, it is essential to evaluate her current drug therapy (both prescription and nonprescription) to prevent significant drug­herb interactions. Some herbal products most commonly used by patients for PMDD include evening primrose oil (contains prostaglandin to reduce breast pain), kava kava (anxiety, stress, restlessness, and premenstrual cramps), melatonin (sleep-wake cycle disorder or insomnia), passion flower (anxiety and restlessness), St. John’s wort (depression), and valerian (insomnia and restlessness). With patients using herbals, it is important to discuss the specific drug­herb interactions that may decrease or increase drug levels in the body, resulting in toxicity or subtherapeutic levels of drug.

Pharmacological therapies in patients with premenstrual dysphoric disorder in whom lifestyle modifications fail include prescribed SSRIs, antidepressants, anxiolytics, and ovulation suppressors. According to ACOG, an SSRI is considered a first-line agent in treating PMDD.Its effectiveness is strongly supported by the association between reduced serotonin neurotransmission and PMDD symptoms such as depression, sleep impulse, anxiety, and carbohydrate cravings.As can be expected, many hypotheses suggest that serotonergic dysregulation may be partly responsible for symptoms of premenstrual dysphoric disorder. Most studies performed during the last 10 years have shown SSRIs to be efficacious for its treatment. Fluoxetine was the first SSRI that was approved by the FDA for this disorder. Placebo-controlled studies have concluded that serotonergic antidepressants, particularly fluoxetine and sertraline, are more effective than placebo. Both have been shown to improve emotional and physical symptoms associated with PMDD and also to enhance psychosocial functioning, work performance, and quality of life. Results of randomized clinical trials of fluoxetine and sertraline conclude that their effectiveness in PMDD treatment is clinically significant.Fluoxetine, at doses of 20 to 60 mg per day, and sertraline, at doses of 50 to 150 mg per day, have been studied and recommended for premenstrual dysphoric disorder. Results of the fluoxetine studies concluded that when larger doses were used in some patients, no clinically significant advantage in efficacy was observed. Instead, patients given 60 mg of fluoxetine per day experienced more side effects than those given the smaller doses. However, no similar clinical findings were reported in those studies using higher doses of sertraline.

Although fluoxetine and sertraline are the two antidepressants most widely studied for PMDD, other antidepressants have also been used. For example, venlafaxine is a newer antidepressant that works slightly differently than SSRIs by inhibiting both serotonin and norepinephrine reuptake. Treatment with 50 to 200 mg per day of venlafaxine in a small number of female patients has been shown to be more effective than placebo.Finally, paroxetine and citalopram have also been studied as antidepressants to treat premenstrual dysphoric disorder.

Using anxiolytic agents, particularly alprazolam, for PMDD has been controversial. Some studies have shown it to be more beneficial than placebo, whereas others have indicated alprazolam to be as effective as placebo. However, these studies focused more on the premenstrual symptoms associated with premenstrual syndrome. Thus far, no large study has been performed to examine anxiolytic agents as premenstrual dysphoric disorder treatment. Because alprazolam is a triazolobenzodiazepine anxiolytic, the obvious caution is the risk of dependence and tolerance. Buspirone is another anxiolytic considered as treatment. Few studies have shown that buspirone, at a dose of 20 mg per day, is more effective than placebo. Significantly, although anxiolytic agents are being studied for PMDD, serotonin agents remain the drugs of choice and should be first-line therapy before initiating anxiolytic therapy. To date, fluoxetine and sertraline are the only FDA-approved SSRIs for the treatment of premenstrual dysphoric disorder. Anxiolytic agents should only be considered if a patient does not tolerate the SSRIs or as adjunctive therapy.

Pharmacologically, when treating patients, it is crucial to understand the menstrual cycle and rise and fall of sex steroids. Many drugs have only been studied in the administration of certain phases of the menstrual cycle. Research has shown that taking these drugs “intermittently” or “semi-intermittently” has been more effective than continuous administration. Intermittent doses require administration only during the luteal phase, whereas semi-intermittent require lower doses during the follicular phase and higher doses during the luteal phase. Fluoxetine and sertraline are recommended during the luteal phase. Alprazolam has been found to be beneficial in both the luteal and follicular phases. Buspirone has also been shown as more effective during the luteal phase. Overall, a luteal phase administration of these agents mentioned previously has been found to not only reduce the side-effect profile but also to reduce the cost of treatment.

Some physicians prefer to use medications at higher doses during the luteal phase and then employ lower doses during the follicular phase. It is important to understand the patient’s cycle and review the menstrual calendar and symptoms experienced at particular phases to provide optimal relief. Patients should be very specific and thorough when recording symptoms associated with their menstrual cycle, as it is extremely helpful to pharmacists and physicians in tailoring their medication regimen. Tables 4 and 5 summarize the drugs currently available that are studied for premenstrual dysphoric disorder treatment.