8creen all menstruating women during routine exams for symptoms of premenstrual syndrome. Consider dietary regimens, calcium supplementation, exercise, and cognitive therapy.
8creen all menstruating women during routine exams for symptoms of premenstrual syndrome. Consider dietary regimens, calcium supplementation, exercise, and cognitive therapy.
8creen all menstruating women during routine exams for symptoms of premenstrual syndrome. Consider dietary regimens, calcium supplementation, exercise, and cognitive therapy.
1. Prevention: Not applicable to this module. ...................................... 2
2. 8creening: 8creen all menstruating women during routine exams for symptoms of premenstrual syndrome. ............................... 2 2.1 Screen all menstruating women routinely for emotional, behavioral, or physical symptoms that fluctuate with their menstrual cycle. ............................ 3 3. Diagnosis: Diagnose PM8 and PMDD when emotional, behavioral, and physical symptoms that are distressing to the patient appear in the second half of the menstrual cycle and resolve post-menses. .................................................................................... 3 3.1 Diagnose PMS or PMDD by history and careful charting of symptoms. ......3 3.2 Use a validated questionnaire to do a prospective symptom inventory and consider laboratory testing to exclude other diagnoses. ....................................4 3.3 Consider other psychiatric or medical disorders in patients with the diagnosis of PMS or PMDD. .............................................................................. 5 4. Consultation for Diagnosis: Obtain appropriate consultation if severe psychiatric or medical symptoms are present. ..................... 5 4.1 Consider consultation with a psychiatrist or medical specialist if severe psychiatric or medical premenstrual symptoms are present. .............................6 5. Hospitalization: Hospitalize patients in whom outpatient treatment is ineffective who are at risk of harming themselves or others. ................................................................................................................ 6 5.1 Consider inpatient or partial hospitalization if premenstrual symptoms lead to compromised safety for the patient or others. ................................................6 6. Non-drug Therapy: Consider dietary regimens, calcium supplementation, exercise, and cognitive therapy in patients with PM8 and PMDD. ............................................................................................... 7 6.1 Consider dietary recommendations to increase complex carbohydrate consumption and to make other dietary changes. ............................................. 7 6.2 Consider recommending calcium supplements. .......................................... 7 6.3 Consider vitamins and multinutrients. .......................................................... 8 6.4 Consider recommending regular exercise. .................................................. 8 6.5 Consider cognitive therapy to reduce premenstrual symptoms. .................. 9 6.6 Recognize the uncertain role of complementary/alternative therapies in the http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 1 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The preponderance of data supporting this statement is derived from level 1 studies, which meet all of the evidence criteria for that study type The preponderance of data supporting this statement is derived from level 2 studies, which meet at least one of the evidence criteria for that study type The preponderance of data supporting this statement is derived from level 3 studies, which do meet none of the evidence criteria for that study type or are derived from expert opinion, commentary or consensus Study types and evidence criteria are defined at http://pier.acponline.org/ criteria.html The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. treatment of PMS. .............................................................................................. 9 6.7 Recognize that there is some preliminary research suggesting the use of other non-drug treatments for PMS. ................................................................ 10 7. Drug Therapy: Consider the use of antidepressant medication as first-line treatment for PMDD and ovulation suppression as second-line treatment. ............................................................................... 10 7.1 Consider SSRs as first-line treatment for severe PMS and PMDD. ......... 10 7.2 Consider luteal phase SSR treatment as an alternative to continuous treatment for severe PMS and PMDD. ............................................................ 12 7.3 Consider GnRH agonists as second-line treatment for PMS or PMDD. .... 12 7.4 Do not use oral contraceptives as a first-line treatment for PMS or PMDD. .......................................................................................................................... 13 7.5 Do not recommend luteal phase progesterone for treatment of PMS or PMDD. ............................................................................................................. 14 7.6 Consider anxiolytics, either alone or as adjunctive treatment, for decreasing premenstrual tension and irritability. ................................................................ 15 7.7 Consider other pharmacologic treatments for specific premenstrual symptoms. ........................................................................................................15 8. Patient Education: Provide information to patients with PM8 or PMDD about lifestyle modifications, self-management techniques, peer support, and overall management. ............................................... 16 8.1 Encourage patients to adopt lifestyle modification and self-management techniques as an alternative or adjunct to drug therapy. ................................. 16 9. Consultation for Management: Consider consulting appropriate specialists for help in managing patients with severe premenstrual emotional or physical symptoms that do not respond to conventional treatments. .................................................... 17 9.1 Obtain psychiatric or gynecologic consultation if SSRs, anxiolytics, or hormonal treatments do not significantly reduce premenstrual symptoms. .....17 10. Follow-up: Follow patients through several menstrual cycles to determine treatment effectiveness and need for ad]ustment to therapy. ............................................................................................................ 17 10.1 After initiating drug therapy and non-drug therapy, maintain contact with patients with severe PMS or PMDD after each menses to determine response to treatment. ..................................................................................................... 17 1. Prevention: Not applicable to this module. 2. 8creening: 8creen all menstruating women during routine exams for symptoms of premenstrual syndrome. http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 2 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. 2.1 Screen all menstruating women routinely for emotional, behavioral, or physical symptoms that fluctuate with their menstrual cycle. Specific recommendation: f a woman complains of symptoms such as mood swings, irritability, or physical symptoms before her menstrual periods, ask: Do the symptoms resolve after the period? To what degree is functioning or quality of life impaired? Recognize that women whose symptoms do not resolve after menses may have an exacerbation of an underlying psychiatric or medical disorder. Recognize that women with a previous history of major depressive disorder or postpartum depression, as well as a family history of PMS, may be at increased risk for having severe PMS. RationaIe: Premenstrual emotional, behavioral, and physical symptoms appear in most women between menarche and menopause. Many women with moderate to severe PMS may benefit from treatment, but if they are not screened during routine exams, they may not volunteer their symptoms. Women may be more likely to seek treatment for the emotional symptoms of PMS rather than the physical symptoms, particularly for irritability, which is the most frequent premenstrual complaint. Evidence: Premenstrual symptoms are problematic for 20% to 50% of women with PMS (1). Approximately 4% of women have multiple, severe premenstrual symptoms that interfere with daily functioning and quality of life, and may have premenstrual dysphoric disorder (PMDD), which has a specific set of diagnostic criteria (1). Comments: None. 3. Diagnosis: Diagnose PM8 and PMDD when emotional, behavioral, and physical symptoms that are distressing to the patient appear in the second half of the menstrual cycle and resolve post-menses. 3.1 Diagnose PMS or PMDD by history and careful charting of symptoms. Specific recommendation: nstruct women to prospectively chart their emotional, behavioral, and physical symptoms daily for two menstrual cycles by: Using an existent daily rating form to confirm the diagnosis of PMS or PMDD http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 3 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. Selecting her own most problematic premenstrual symptoms and rating them daily; for example, from 1 = "none to 4 = "severe Diagnose PMDD if at least 5 of 11 symptoms required for the PMDD diagnosis as well as functional impairment and decreased quality of life are present. Diagnose PMS if symptoms are present and there is associated functional impairment and decreased quality of life. See table History and Physical Examination Elements for Premenstrual Syndrome/Premenstrual Dysphoric Disorder. See table Diagnostic Criteria for Premenstrual Dysphoric Disorder. See table Diagnostic Criteria for Premenstrual Syndrome. RationaIe: Up to 60% of women who retrospectively identify premenstrual symptoms do not have PMS after prospective charting. Often what is perceived by the patient to be PMS is an exacerbation of an underlying psychiatric or medical disorder, or a disorder whose symptoms are not related to menstrual cycle phases. Charting confirms the nature and timing of the symptoms (presence of symptoms in the luteal, or premenstrual, phase; and absence of symptoms in the follicular, or postmenstrual phase), the regularity of menses, and the absence of an underlying disorder. Evidence: Diagnostic criteria are specified in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (1). Several diagnostic criteria exist for PMS, and most require prospective symptom charting and the resolution of symptoms after menses (2). Comments: None. 3.2 Use a validated questionnaire to do a prospective symptom inventory and consider laboratory testing to exclude other diagnoses. Specific recommendation: Use a reliable and valid instrument to prospectively document symptoms compatible with PMDD, such as: Daily Record of Severity of Problems (DRSP) (http://www.pmdd.factsforhealth.org/drsp/drsp_month.pdf) Daily Symptom Report (DSR) Daily Rating Form (DRF) Prospective Record of mpact of Menstrual Symptoms (PRSM) See figure Visual Analogue Scale (VAS) Obtain at least two cycles of daily ratings (Likert scales or visual analog scales) to establish absence of follicular phase symptoms and appearance of premenstrual symptoms. Be aware that a three-point Likert scale daily rating form, which includes all PMDD symptoms, is available with illustrative examples of "PMS, http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 4 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. "PMDD, and "depression to aid the clinician in differential diagnosis from the daily ratings. Perform laboratory tests to exclude other diagnoses, such as hypothyroidism or hyperthyroidism. See figure Premenstrual Daily Symptom Chart. See figure Example of Premenstrual Syndrome on Daily Symptom Chart. See figure Example of Premenstrual Dysphoric Disorder on Daily Symptom Chart. See figure Example of Depression on Daily Symptom Chart. RationaIe: nstruments (questionnaires such as DRSP, DSR, DRF, COPE, PRSM, VAS) have been utilized in studies to confirm the diagnosis of PMS or PMDD. Evidence: Research studies have used multiple daily rating questionnaires to differentiate women with severe PMS or PMDD from women with other depressive or anxiety disorders, such as the DRSP (3), DSR (4), DRF (5), COPE (6), PRSM (7) VAS (8; 9). A fast, retrospective screening tool provides an important starting point (10). Comments: None. 3.3 Consider other psychiatric or medical disorders in patients with the diagnosis of PMS or PMDD. Specific recommendation: Ask about: Chronic low mood, such as current or previous major depression, or manic-depressive illness, or anxiety symptoms that may be exacerbated premenstrually Chronic medical disorders that may be exacerbated premenstrually, such as headaches, asthma, or other conditions See table Differential Diagnosis of Premenstrual Syndrome or Premenstrual Dysphoric Disorder. RationaIe: Many women with chronic diseases that are exacerbated premenstrually perceive their increase in symptoms as PMS. Evidence: When women prospectively chart their symptoms on a daily basis, a large proportion will have another disorder whose symptoms are increased premenstrually, or a disorder whose symptoms do not, in fact, fluctuate with the menstrual cycle (9). Comments: None. 4. Consultation for Diagnosis: Obtain appropriate http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 5 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. consultation if severe psychiatric or medical symptoms are present. 4.1 Consider consultation with a psychiatrist or medical specialist if severe psychiatric or medical premenstrual symptoms are present. Specific recommendation: Recommend referral to a psychiatrist in women with: Severe premenstrual depressive symptoms and impaired functioning Premenstrual suicidal ideation Recommend consultation with a psychiatrist for diagnosis or treatment of premenstrual exacerbation of another underlying mood and anxiety. Recommend consultation with a gynecologist for changes in menstrual pattern or galactorrhea. Recommend consultation with an internist for premenstrual exacerbation of a medical condition. RationaIe: Psychiatrists and gynecologists are most likely to have the greatest experience with diagnosis of the disorder. Evidence: Consensus. Comments: None. 5. Hospitalization: Hospitalize patients in whom outpatient treatment is ineffective who are at risk of harming themselves or others. 5.1 Consider inpatient or partial hospitalization if premenstrual symptoms lead to compromised safety for the patient or others. Specific recommendation: Hospitalize all patients in whom there is risk of suicide or assault in an unsupervised setting. RationaIe: Premenstrual suicidal, self-injurious, or assaultive behavior is rare in women with severe PMS or PMDD, but it can occur. Even though suicidal and assaultive ideation may be transitory during the premenstrual phase, women need to be in a setting in which such impulses can be controlled and treatment instituted. Evidence: Suicidal ideation and attempts are elevated during the premenstrual phase in women with PMS (11), and psychiatric admission rates are elevated in the premenstrual phase (12). Comments: http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 6 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. None. 6. Non-drug Therapy: Consider dietary regimens, calcium supplementation, exercise, and cognitive therapy in patients with PM8 and PMDD. 6.1 Consider dietary recommendations to increase complex carbohydrate consumption and to make other dietary changes. Specific recommendation: nstruct patients to: ncrease consumption of complex carbohydrates Decrease consumption of refined sugar and artificial sweeteners Eliminate caffeine and alcohol Eat three to six small meals per day RationaIe: t has been proposed that premenstrual increased appetite and carbohydrate cravings are a homeostatic mechanism to increase the ingestion of tryptophan, a precursor for serotonin synthesis, leading to increased serotonin availability. Caffeine anecdotally may exacerbate anxiety and tension. The rationale for eating small, frequent meals is to maintain a fairly constant glucose level, but this theory has yet to be studied in PMS. Evidence: One controlled, double-blind crossover study of a drink containing simple and complex carbohydrates indicated efficacy in reducing premenstrual dysphoria and other symptoms (13; 14). L-tryptophan, 6 g/d, was superior to placebo in reducing symptoms of PMDD (15). Comments: No other controlled trials of a single dietary regimen have been conducted in women with PMS or PMDD. 6.2 Consider recommending calcium supplements. Specific recommendation: Recommend oral calcium supplementation, 1200 mg/d, to reduce premenstrual emotional and physical symptoms. RationaIe: Researchers have proposed that PMS may involve a cyclical, transient, secondary hyperparathyroidism with peri-ovulatory decrease in calcium and increase in parathyroid hormone levels following the pre-ovulatory estrogen peak. Evidence: t has been suggested that normalizing calcium levels may normalize calcium effects on monoamine neurotransmitter synthesis and release, thus decreasing affective and anxiety symptoms (16). http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 7 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. The largest randomized, controlled treatment trial conducted to date in women with PMS involved the daily administration of calcium, 600 mg bid, or placebo in 466 subjects. Premenstrual emotional symptoms and physical symptoms improved with a 48% efficacy rate, with the exception of insomnia and fatigue. Patients receiving oral contraceptives, however, had somewhat lower response rates. Patients receiving other treatments were not excluded, and concurrent psychiatric illness was not rigorously excluded (17). Comments: None. 6.3 Consider vitamins and multinutrients. Specific recommendation: Recognize that the effectiveness of vitamin B6, vitamin E, magnesium, and multinutrients in treating PMS and PMDD is uncertain. RationaIe: There are studies suggesting that there is a luteal phase decrease in magnesium, which could affect neuronal stability, leading to premenstrual mood and anxiety symptoms. Evidence: Studies of vitamin B6 (100 mg/d) have been extensively reviewed, and there is minimal efficacy compared to placebo (18; 19). Neurotoxicity is possible in doses above 200 mg/d. Magnesium supplementation may offset lowered premenstrual phase magnesium (20; 21; 22). One older study suggested that vitamin E reduced premenstrual symptoms (23). Comments: None. 6.4 Consider recommending regular exercise. Specific recommendation: Consider recommending aerobic exercise for 30 minutes, three to five times per week. RationaIe: Exercise may reduce premenstrual symptoms by its effect on the endorphin system, the serotonin system, or through an increase in feelings of self-efficacy. Exercise is helpful in improving mood in women and men with major depression. Evidence: There are no controlled trials of exercise in women with PMS or PMDD published to date, but premenstrual emotional and physical symptoms are decreased with regular exercise in women in general (24; 25). Comments: http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 8 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. t is unclear if aerobic exercise is superior to nonaerobic exercise. Exercise may decrease premenstrual symptoms in women in general, but it has not been studied in a population of women with PMS or PMDD. 6.5 Consider cognitive therapy to reduce premenstrual symptoms. Specific recommendation: Recommend individual or group cognitive therapy as an efficacious treatment for PMS. RationaIe: Components of cognitive therapy that may be helpful include alteration of dysfunctional attitudes, cognitive restructuring, and increasing coping strategies, such as assertiveness training. Evidence: A randomized, controlled trial in women with prospectively confirmed PMS have reported improvement in psychological and social functioning with individual cognitive therapy (26), and another controlled trial demonstrated a decrease in anxiety, depression, negative thoughts, and physical changes with group cognitive-behavioral therapy (27). A recent randomized, controlled trial suggested that cognitive therapy had different treatment effects on PMDD than fluoxetine. Fluoxetine had a more rapid effect and greater impact on anxiety, and cognitive therapy was more helpful in adopting behavioral coping strategies (28). Comments: None. 6.6 Recognize the uncertain role of complementary/alternative therapies in the treatment of PMS. Specific recommendation: Note that there is some evidence that the agnus castus fruit (chasteberry) may reduce premenstrual symptoms. RationaIe: t is possible that chasteberry may reduce some emotional and physical symptoms of PMS. Other herbs and homeopathic medications have been studied in women with PMS, but there is no current compelling evidence to recommend any single treatment. Evidence: Chasteberry reduced emotional and physical symptoms in 170 women with PMS, but how the diagnosis was confirmed in the sample was not stated in the manuscript (29). Chasteberry did not differ from fluoxetine in overall treatment response in a preliminary study but reduced more physical than mood symptoms (30). Open and controlled studies with several herbal treatments, including http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 9 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. hypericum and gingko biloba, have been reviewed, and several may deserve further study (31; 32; 33). A controlled clinical trial of oral homeopathic medicine was recently reported to be beneficial in improving scores on a daily menstrual distress questionnaire by more than 30% in 90% of the study group as compared to 37.5% of those patients receiving placebo (34). n a meta-analysis of seven trials, lack of homogeneity and inconsistent quality made pooling of data impossible, but the two most well-controlled trials failed to show beneficial effects of evening primrose oil (35). n another systematic review of randomized, controlled trials of complementary/alternative therapies, there was insufficient evidence among the 27 trials to recommend any of the therapies in the treatment of PMS (31). Comments: None. 6.7 Recognize that there is some preliminary research suggesting the use of other non-drug treatments for PMS. Specific recommendation: Consider discussing preliminary data on: Light therapy Sleep deprivation Relaxation techniques Massage Chiropractic manipulation Biofeedback Reflexology Acupuncture RationaIe: There is some preliminary research data to suggest efficacy of light therapy, sleep deprivation, relaxation techniques, massage or chiropractic manipulation, biofeedback, and reflexology. Evidence: There is some positive preliminary research support for light therapy (36), sleep deprivation (37), relaxation (38), reflexology (39), massage (40), biofeedback (41), acupuncture (42) and chiropractic manipulation (43). Comments: These treatments require further study. 7. Drug Therapy: Consider the use of antidepressant medication as first-line treatment for PMDD and ovulation suppression as second-line treatment. 7.1 Consider SSRs as first-line treatment for severe PMS and PMDD. http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 10 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. Specific recommendation: Consider: Fluoxetine, 20 mg/d, or during the luteal phase only, for the treatment of the emotional and physical symptoms of PMDD Sertraline, 50 to 100 mg/d, or during the luteal phase only Paroxetine CR, 12.5 mg/d or 25 mg/d, or during the luteal phase only Prescribe the same SSR doses for PMS or PMDD as for major depression. n women with premenstrual exacerbation of chronic mood and anxiety disorders, consider increasing the SSR dose during the premenstrual weeks, and returning to the lower dose at menses. Recognize that there are no evidence-based recommendations for length of treatment with SSRs, but premenstrual symptoms recur in many women when treatment is stopped. Be aware that the FDA has recommended a black box warning for antidepressant drugs for pediatric and adolescent patients under age 18. See table Drug Treatment for Premenstrual Syndrome or Premenstrual Dysphoric Disorder. RationaIe: Multiple studies have reported that SSRs reduce premenstrual mood, anxiety, behavioral, and physical symptoms. The efficacy rate averages 65% for SSRs vs. 30% for placebo in most studies. The action of SSRs in enhancing serotonin is unique in PMDD compared to depression, due to the rapid onset of action and the selective superiority of serotonergic antidepressants compared to non-serotonergic antidepressants. Evidence: Superior efficacy of daily dosing of SSRs compared to placebo for the reduction of premenstrual emotional and physical symptoms have been reported in 12 randomized, controlled trials with fluoxetine (44; 45; 46; 47; 48; 49; 50), sertraline (51; 52), paroxetine (53; 54), and citalopram (55), as recently reviewed (56; 57). Two large, multisite, randomized, controlled trials have confirmed efficacy for fluoxetine (44) and sertraline (51). A Cochrane review concluded that very good evidence supports the use of SSRs for PMS (58). Multiple serotonin abnormalities have been reported in women with PMDD (59; 60), and it is presumed that SSRs are effective by their enhancement of serotonin (61). A consensus panel of experts reported that SSRs are the treatment of choice for prominent premenstrual mood and anxiety symptoms (62). A multisite trial reported that daily venlafaxine was superior to placebo in reducing PMDD symptoms (63). A recent small trial reported that nefazodone was not superior to placebo for PMS (64). Serotonergic antidepressants are selectively effective in PMDD. Three randomized, controlled trials comparing SSRs to non-serotonergic http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 11 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. antidepressants have reported that the non-serotonergic antidepressants are not significantly superior to placebo (45; 52; 53). t has been proposed that the rapid relief of symptoms achieved with SSRs may possibly involve an alteration in allopregnanolone levels, an anxiolytic metabolite of progesterone that acts at the GABA receptor (60; 65). Comments: Fluoxetine, sertraline, and paroxetine are FDA-approved for the treatment of PMDD. 7.2 Consider luteal phase SSR treatment as an alternative to continuous treatment for severe PMS and PMDD. Specific recommendation: Consider luteal phase (or intermittent) dosing of an SSR, administering from ovulation to menses only. Before initiating luteal phase dosing, review the symptom chart to rule out a chronic mood or anxiety disorder, to confirm PMS or PMDD, and to avoid inadequate antidepressant therapy. See table Drug Treatment for Premenstrual Syndrome or Premenstrual Dysphoric Disorder. RationaIe: Due to the quick onset of action of SSRs for the alleviation of premenstrual symptoms, it may not be necessary to administer the SSR daily. t has been proposed that the rapid relief of symptoms achieved with SSRs may possibly involve an increase in allopregnanolone, an anxiolytic metabolite of progesterone that acts at the y-aminobutyric acid receptor. Evidence: Four randomized, controlled trials of intermittent dosing with sertraline (66; 67; 68) and citalopram (55) and a comparison of intermittent vs. continuous dosing with sertraline (69) indicate efficacy rates comparable to daily dosing (56; 57). Three large multisite studies have indicated that fluoxetine, 20 mg/d, from ovulation to menses (70); fluoxetine, 90 mg/wk, 14 days and 7 days before next expected menses (71); and sertraline, 50 to 100 mg/d, from ovulation to menses (72) are beneficial for PMDD. There are currently no published studies of the efficacy of "symptom-onset SSR dosing, such as administration of the SSR from the first day of symptoms until menses or of weekly fluoxetine administration in PMDD. Comments: None. 7.3 Consider GnRH agonists as second-line treatment for PMS or PMDD. http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 12 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. Specific recommendation: Consider ovulation suppression with GnRH agonists, such as leuprolide or goserelin. Note that GnRH agonists can have hypoestrogenic effects, and that adding back estrogen and progesterone may induce mood and anxiety symptoms. See table Drug Treatment for Premenstrual Syndrome or Premenstrual Dysphoric Disorder. RationaIe: Suppression of ovulation may be effective for PMS due to the elimination of the interaction of gonadal hormone fluctuation at ovulation with neurotransmitter and neuroendocrine parameters. The use of GnRH agonists may, however, be limited by their hypoestrogenic effects. Evidence: Eight randomized, controlled trials of GnRH agonists report efficacy compared to placebo (73; 74; 75; 76; 77; 78; 79; 80); two do not report efficacy compared to placebo (81; 82). Attempts to decrease hypoestrogenic effects of prolonged anovulation with add-back estrogen and progesterone has led to the induction of low mood and anxiety symptoms (76; 77), limiting the long-term usefulness of GnRH agonists for PMS or PMDD. A meta-analysis indicates that GnRH analogs appear to be an effective treatment for PMS/PMDD. The addition of hormonal add-back therapy did not reduce the efficacy of GnRH analogs (83). GnRH agonists may be less useful for premenstrual exacerbation of chronic depression (74) or severe premenstrual depression (75). The addition of a synthetic compound, tibolone, to a GnRH agonist reduced hot flashes compared to placebo in women with PMS, without compromising the symptomatic relief obtained from the GnRH agonist (84). Comments: None. 7.4 Do not use oral contraceptives as a first-line treatment for PMS or PMDD. Specific recommendation: Note that: The effect of long-term oral contraceptive use on PMS, such as for 3 months followed by a placebo week, is an unstudied option Hormone replacement regimens administered for perimenopausal physical and emotional symptoms, such as hot flushes, insomnia, poor concentration, and irritability, may improve or worsen premenstrual symptoms See table Drug Treatment for Premenstrual Syndrome or Premenstrual Dysphoric Disorder. RationaIe: http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 13 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. Although oral contraceptives are widely used, their efficacy is not substantiated by currently available research studies. Women anecdotally report improvement, worsening, and no change in their premenstrual symptoms with oral contraceptives. There are currently no predictors of the influence of oral contraceptives on premenstrual symptoms. Evidence: A recent study of 82 women with PMDD reported that a new oral contraceptive containing ethinyl estradiol, 30 g, and drospirenone, 3 mg, was superior to placebo for alleviating the premenstrual symptoms of increased appetite, food cravings, and acne only (85). This study reported a placebo response rate of 43%, and was not originally powered to detect a significant difference from placebo. As reviewed, early studies of women with confirmed PMS have not reported improvement of PMS with monophasic or triphasic oral contraceptives, although monophasic may be better tolerated than triphasic oral contraceptives for low mood symptoms (86). These authors suggest that the influence of oral contraceptives on premenstrual symptoms may involve the type of progestin, the androgenic properties of the progestin component, and the estrogen/progesterone ratio. Women receiving oral contraceptives may have PMS or PMDD, and oral contraceptives were recently reported to not alter the response to sertraline in women with PMDD (87). Oral contraceptives are not recommended as a first-line treatment (2; 62). Comments: None. 7.5 Do not recommend luteal phase progesterone for treatment of PMS or PMDD. Specific recommendation: Be aware that luteal phase progesterone, administered as vaginal suppositories or oral micronized tablets, and progestogens are not clinically indicated for the treatment of PMS or PMDD. See table Drug Treatment for Premenstrual Syndrome or Premenstrual Dysphoric Disorder. RationaIe: Although multiple trials have failed to correlate premenstrual symptoms with abnormal fluctuations of gonadal hormone levels, the administration of luteal phase progesterone is one of the oldest treatments of PMS. t has been theorized that oral micronized progesterone might be beneficial due to its conversion to allopregnanolone, which may be beneficial for premenstrual anxiety due to its action at the GABA receptor in the brain. Evidence: A recent systematic review of published, randomized, placebo-controlled trials of progesterone and progestogens reported that neither treatment http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 14 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. leads to clinically significant, superior efficacy compared to placebo (88). This review did report a slight, statistically significant, but not clinically significant, advantage of progesterone over placebo. Oral micronized progesterone was slightly more effective than vaginal suppositories or progestogens (88). Comments: None. 7.6 Consider anxiolytics, either alone or as adjunctive treatment, for decreasing premenstrual tension and irritability. Specific recommendation: Consider one of the following anxiolytic drugs: Alprazolam, 0.25 mg bid, administered from ovulation to menses with a taper at menses: Do not administer alprazolam to women with previous substance abuse problems Note that sedation may be an unwelcome adverse effect of alprazolam Buspirone, up to 25 mg/d, either in the luteal phase or continually See table Drug Treatment for Premenstrual Syndrome or Premenstrual Dysphoric Disorder. RationaIe: Alprazolam may reduce premenstrual anxiety, irritability, and tension through its action as a benzodiazepine; however, it is less effective than SSRs and does not improve the same range of symptoms, such as food cravings. Evidence: Alprazolam has been reported to have positive efficacy with luteal phase dosing in four randomized, controlled trials (89; 90; 91; 92); another randomized, controlled trial reported no improvement (93). Buspirone was recently reported to reduce premenstrual irritability with daily dosing (64), and an older study reported efficacy for several premenstrual symptoms with luteal phase dosing (94). Comments: None. 7.7 Consider other pharmacologic treatments for specific premenstrual symptoms. Specific recommendation: Consider the use of bromocriptine or danazol for mastalgia. Consider the use of prostaglandin inhibitors to treat premenstrual pain and emotional and physical symptoms. Consider the use of spironolactone to reduce premenstrual bloat and some emotional symptoms. See table Drug Treatment for Premenstrual Syndrome or Premenstrual http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 15 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. Dysphoric Disorder. RationaIe: Mastalgia, bloating, and some emotional symptoms may respond to nonhormonal and non-psychopharmacotherapy. Evidence: Premenstrual mastalgia may be reduced by bromocriptine (95), danazol (96), or lisuride maleate, a dopamine agonist (97). Prostaglandin inhibitors have been reported to treat both pain (98) and emotional or other physical symptoms (99). Spironolactone may reduce premenstrual bloat and some emotional symptoms (100). Comments: None. 8. Patient Education: Provide information to patients with PM8 or PMDD about lifestyle modifications, self-management techniques, peer support, and overall management. 8.1 Encourage patients to adopt lifestyle modification and self-management techniques as an alternative or adjunct to drug therapy. Specific recommendation: Provide patients with access to the recommended lifestyle modifications found in self-help literature and patient education pamphlets or make recommendations in an individual or group format. Advise patients that PMS symptoms generally: Recur with cessation of treatment May increase with age or after childbirth Are absent during pregnancy and after menopause Advise patients who may conceive while receiving drug therapy to choose a treatment option with lower risk to the pregnancy (e.g., medication with short half-life that will be eliminated sooner upon discontinuation after pregnancy confirmed). RationaIe: Women may receive validation of their PMS by participating in peer support groups. Professionally administered individual or group patient education usually encompasses multimodalities, including diet and exercise recommendations, cognitive techniques, relaxation, and other self-management techniques. Evidence: Minimal research has been conducted on the components of multimodality patient education, lifestyle changes, and self-monitoring that is helpful, except for a small amount of literature indicating that cognitive therapy is helpful. A four-session group treatment http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 16 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. encompassing diet, exercise, self-monitoring, self-regulation, relaxation, and cognitive techniques was superior to wait-list control (104). Women randomly assigned to the wait-list control had their symptoms monitored while "waiting for group treatment. A four-session group treatment encompassing diet, exercise, and positive reframing of menstrual cycle experiences was superior to wait-list control (105). Comments: Many women with PMS anecdotally report that peer support groups are helpful. 9. Management Consultation: Consider consulting appropriate specialists for help in managing patients with severe premenstrual emotional or physical symptoms that do not respond to conventional treatments. 9.1 Obtain psychiatric or gynecologic consultation if SSRs, anxiolytics, or hormonal treatments do not significantly reduce premenstrual symptoms. Specific recommendation: Recommend psychiatric consultation for assessment of acute risks, adjustment of antidepressant treatment, or treatment of an underlying disorder in women with: Severe premenstrual depressive symptoms and impaired functioning Premenstrual suicidal ideation Premenstrual exacerbation of underlying mood and anxiety disorders Recommend consultation with an internist when patients have premenstrual exacerbation of underlying medical disorders. Recommend consultation with a gynecologist when hormonal therapy is contemplated. RationaIe: There may be a need for further expertise in difficult cases. Evidence: Consensus. Comments: None. 10. Follow-up ssues: Follow patients through several menstrual cycles to determine treatment effectiveness and need for ad]ustment to therapy. 10.1 After initiating drug therapy and non-drug therapy, maintain contact with patients with severe PMS or PMDD after each menses to determine response to treatment. http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 17 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. Specific recommendation: nstruct patients who start drug therapy for severe PMS or PMDD to contact their physician after each menses for medication adjustment until symptom remission is achieved. Consider changing from daily dosing to luteal phase dosing if side effects are problematic. Consider adding one or more non-drug measures as adjunctive therapy. Recognize that drug therapy may need to be altered if the patient is planning to conceive. Taper or discontinue drug therapy if the patient has already conceived. See table Elements of Follow-up for Premenstrual Disorder or Premenstrual Dysphoric Disorder. RationaIe: n general, women have recurrence of premenstrual symptoms after treatment is discontinued. Women do not have PMS or PMDD when pregnant or after menopause. Evidence: There are no current guidelines as to optimal length of treatment. After 3 months of fluoxetine luteal phase therapy was discontinued, recurrence of premenstrual symptoms was immediate (106). Comments: Drug therapy is generally long-term due to the recurrence of PMS or PMDD following discontinuation of treatment. http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 18 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. PremenstruaI DaiIy Symptom Chart This image cannot be displayed. See the online version of PIER to view this figure Copyright 2000 Eli Lilly and Company. All rights reserved. Used with permission. http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 19 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. ExampIe of PremenstruaI Syndrome on DaiIy Symptom Chart This image cannot be displayed. See the online version of PIER to view this figure Copyright 2000 Eli Lilly and Company. All rights reserved. Used with permission. http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 20 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. ExampIe of PremenstruaI Dysphoric Disorder on DaiIy Symptom Chart This image cannot be displayed. See the online version of PIER to view this figure Copyright 2000 Eli Lilly and Company. All rights reserved. Used with permission. http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 21 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. ExampIe of Depression on DaiIy Symptom Chart This image cannot be displayed. See the online version of PIER to view this figure Copyright 2000 Eli Lilly and Company. All rights reserved. Used with permission. http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 22 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. VisuaI AnaIogue ScaIe This image cannot be displayed. See the online version of PIER to view this figure Reprinted from 107. Copyright 1987, with permission from Elsevier Science. http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 23 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. References 1 Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington, DC: American Psychiatric Association; 1994:715-8. 2 Premenstrual syndrome. American College of Obstetrics and Gynecology. ACOG Practice Bulletin, no. 15; 2000. 3 Endicott J, Harrison W. Daily Rating of Severity of Problems Form. New York: Dept. of Research Assessment and Training, New York State Psychiatric nstitute; 1990. 4 Freeman EW, DeRubeis RJ, Rickels K. Reliability and validity of a daily diary for premenstrual syndrome. Psychiatry Res. 1996;65:97-106. (PMD: 9122290) 5 Endicott J, Nee J, Cohen J, Halbreich U. Premenstrual changes: patterns and correlates of daily ratings. J Affect Disord. 1986;10:127-35. (PMD: 2941469) 6 Mortola JF, Girton L, Beck L, Yen SS. Diagnosis of premenstrual syndrome by a simple, prospective, and reliable instrument: the calendar of premenstrual experiences. Obstet Gynecol. 1990;76:302-7. (PMD: 2371035) 7 Reid RL. Premenstrual syndrome. Curr Probl Obstet Gynecol Fertil. 1985;8:1-57. 8 Casper RF, Powell AM. Premenstrual syndrome: documentation by a linear analog scale compared with two descriptive scales. Am J Obstet Gynecol. 1986;155:862-7. (PMD: 3766642) 9 Rubinow DR, Roy-Byrne P, Hoban MC, Gold PW, Post RM. Prospective assessment of menstrually related mood disorders. Am J Psychiatry. 1984;141:684-6. (PMD: 6538762) 10 Steiner M, Macdougall M, Brown E. The premenstrual symptoms screening tool (PSST) for clinicians. Arch Women Ment Health. 2003;6:203-9. (PMD: 12920618) 11 Chaturvedi SK, Chandra PS, Gururaj G, Pandian RD, Beena MB. Suicidal ideas during premenstrual phase. J Affect Disord. 1995;34:193-9. (PMD: 7560547) 12 O'Dwyer J, Friedman T, Clifford E. The relationship between menstruation and psychiatric admissions. r J Psych Med. 1997;14:46-8. 13 Sayegh R, Schiff , Wurtman J, Spiers P, McDermott J, Wurtman R. The effect of a carbohydrate-rich beverage on mood, appetite, and cognitive function in women with premenstrual syndrome. Obstet Gynecol. 1995;86(4 Pt 1):520-8. (PMD: 7675373) 14 Freeman EW, Stout AL, Endicott J, Spiers P. Treatment of premenstrual syndrome with a carbohydrate-rich beverage. nt J Gynaecol Obstet. 2002;77:253-4. (PMD: 12065140) 15 Steinberg S, Annable L, Young SN, Liyanage N. A placebo-controlled clinical trial of L-tryptophan in premenstrual dysphoria. Biol Psychiatry. 1999;45:313-20. (PMD: 10023508) 16 Thys-Jacobs S. Micronutrients and the premenstrual syndrome: the case for calcium. J Am Coll Nutr. 2000;19:220-7. (PMD: 10763903) 17 Thys-Jacobs S, Starkey P, Bernstein D, Tian J. Calcium carbonate and the premenstrual syndrome: effects on premenstrual and menstrual symptoms. Premenstrual Syndrome Study Group. Am J Obstet Gynecol. 1998;179:444-52. (PMD: 9731851) 18 Wyatt KM, Dimmock PW, Jones PW, Shaughn O'Brien PM. Efficacy of vitamin B-6 in the treatment of premenstrual syndrome: systematic review. BMJ. 1999;318:1375-81. (PMD: 10334745) http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 24 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 Studies that meet all of the evidence criteria for that study type Studies that meet at least one of the criteria for that study type Studies that meet none of the evidence criteria for that study type or are derived from expert opinion, commentary, or consensus Study types and evidence criteria are defined at http://pier.acponline.org/ criteria.html The number in parentheses at the end of the reference citations identify PubMed abstracts, which can be found on the National Library of Medicine's web site http://www.ncbi.nlm.nih.gov/entrez/query.fcgi The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. 19 Kleijnen J, Ter Riet G, Knipschild P. Vitamin B6 in the treatment of the premenstrual syndrome--a review. Br J Obstet Gynaecol. 1990;97:847-52. (PMD: 2242373) 20 De Souza MC, Walker AF, Robinson PA, Bolland K. A synergistic effect of a daily supplement for 1 month of 200 mg magnesium plus 50 mg vitamin B6 for the relief of anxiety-related premenstrual symptoms: a randomized, double-blind, crossover study. J Womens Health Gend Based Med. 2000;9:131-9. (PMD: 10746516) 21 Walker AF, De Souza MC, Vickers MF, Abeyasekera S, Collins ML, Trinca LA. Magnesium supplementation alleviates premenstrual symptoms of fluid retention. J Womens Health. 1998;7:1157-65. (PMD: 9861593) 22 Facchinetti F, Borella P, Sances G, Fioroni L, Nappi RE, Genazzani AR. Oral magnesium successfully relieves premenstrual mood changes. Obstet Gynecol. 1991;78:177-81. (PMD: 2067759) 23 London RS, Murphy L, Kitlowski KE, Reynolds MA. Efficacy of alpha-tocopherol in the treatment of the premenstrual syndrome. J Reprod Med. 1987;32:400-4. (PMD: 3302248) 24 Scully D, Kremer J, Meade MM, Graham R, Dudgeon K. Physical exercise and psychological well being: a critical review. Br J Sports Med. 1998;32:111-20. (PMD: 9631216) 25 Pearlstein T. Nonpharmacologic treatment of premenstrual syndrome. Psychiatric Annals. 1996;26:590-4. 26 Blake F, Salkovskis P, Gath D, Day A, Garrod A. Cognitive therapy for premenstrual syndrome: a controlled trial. J Psychosom Res. 1998;45:307-18. (PMD: 9794277) 27 Christensen AP, Oei TP. The efficacy of cognitive behaviour therapy in treating premenstrual dysphoric changes. J Affect Disord. 1995;33:57-63. (PMD: 7714309) 28 Hunter M, Ussher J, Cariss M, Browne S, Jelley R, Katz M. Medical (fluoxetine) and psychological (cognitive-behavioural therapy) treatment for premenstrual dysphoric disorder: a study of treatment processes. J Psychosom Res. 2002;53:811-7. (PMD: 12217456) 29 Schellenberg R. Treatment for the premenstrual syndrome with agnus castus fruit extract: prospective, randomised, placebo controlled study. BMJ. 2001;322:134-7. (PMD: 11159568) 30 Atmaca M, Kumru S, Tezcan E. Fluoxetine versus Vitex agnus castus extract in the treatment of premenstrual dysphoric disorder. Hum Psychopharmacol. 2003;18:191-5. (PMD: 12672170) 31 Stevinson C, Ernst, E. Complementary/alternative therapies for premenstrual syndrome: a systematic review of randomized controlled trials. Am J Obstet Gynecol. 2001;185(1):227-35. (PMD: 11483933) 32 Bendich A. The potential for dietary supplements to reduce premenstrual syndrome (PMS) symptoms. J Am Coll Nutr. 2000;19:3-12. (PMD: 10682869) 33 Dog TL. ntegrative treatments for premenstrual syndrome. Altern Ther Health Med. 2001;7:32-9. (PMD: 11565400) 34 Yakir M, Kreitler S, Brzezinski A, Vithoulkas G, Oberbaum M, Bentwich Z. Effects of homeopathic treatment in women with premenstrual syndrome: a pilot study. Br Homeopath J. 2001;90:148-53. (PMD: 11479782) 35 Budeiri D, Li Wan Po A, Dornan JC. s evening primrose oil of value in the treatment of premenstrual syndrome? Control Clin Trials. 1996;17:60-8. (PMD: 8721802) 36 Lam RW, Carter D, Misri S, Kuan AJ, Yatham LN, Zis AP. A controlled study of light therapy in women with late luteal phase dysphoric disorder. Psychiatry Res. 1999;86:185-92. (PMD: 10482337) http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 25 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. 37 Parry BL, Cover H, Mostofi N, LeVeau B, Sependa PA, Resnick A, et al. Early versus late partial sleep deprivation in patients with premenstrual dysphoric disorder and normal comparison subjects. Am J Psychiatry. 1995;152:404-12. (PMD: 7864267) 38 Goodale L, Domar AD, Benson H. Alleviation of premenstrual syndrome symptoms with the relaxation response. Obstet Gynecol. 1990;75:649-55. (PMD: 2179779) 39 Oleson T, Flocco W. Randomized controlled study of premenstrual symptoms treated with ear, hand, and foot reflexology. Obstet Gynecol. 1993;82:906-11. (PMD: 8233263) 40 Hernandez-Reif M, Martinez A, Field T, Quintero O, Hart S, Burman . Premenstrual symptoms are relieved by massage therapy. J Psychosom Obstet Gynaecol. 2000;21:9-15. (PMD: 10907210) 41 Van Zak DB. Biofeedback treatments for premenstrual and premenstrual affective syndromes. nt J Psychosom. 1994;41:53-60. (PMD: 7843868) 42 Habek D, Habek JC, Barbir A. Using acupuncture to treat premenstrual syndrome. Arch Gynecol Obstet. 2002;267:23-6. (PMD: 12410369) 43 Walsh MJ, Polus B. A randomized, placebo-controlled clinical trial on the efficacy of chiropractic therapy on premenstrual syndrome. J Manipulative Physiol Ther. 1999;22:582-5. (PMD: 10626701) 44 Steiner M, Steinberg S, Stewart D, Carter D, Berger C, Reid R, et al. Fluoxetine in the treatment of premenstrual dysphoria. Canadian Fluoxetine/Premenstrual Dysphoria Collaborative Study Group. N Engl J Med. 1995;332:1529-34. (PMD: 7739706) 45 Pearlstein TB, Stone AB, Lund SA, Scheft H, Zlotnick C, Brown WA. Comparison of fluoxetine, bupropion, and placebo in the treatment of premenstrual dysphoric disorder. J Clin Psychopharmacol. 1997;17:261-6. (PMD: 9241004) 46 Stone AB, Pearlstein TB, Brown WA. Fluoxetine in the treatment of late luteal phase dysphoric disorder. J Clin Psychiatry. 1991;52:290-3. (PMD: 2071558) 47 Menkes DB, Taghavi E, Mason PA, Howard RC. Fluoxetine's spectrum of action in premenstrual syndrome. nt Clin Psychopharmacol. 1993;8:95-102. (PMD: 8345163) 48 Su TP, Schmidt PJ, Danaceau MA, Tobin MB, Rosenstein DL, Murphy DL, et al. Fluoxetine in the treatment of premenstrual dysphoria. Neuropsychopharmacology. 1997;16:346-56. (PMD: 9109106) 49 Wood SH, Mortola JF, Chan YF, Moossazadeh F, Yen SS. Treatment of premenstrual syndrome with fluoxetine: a double-blind, placebo-controlled, crossover study. Obstet Gynecol. 1992;80(3 Pt 1):339-44. (PMD: 1495689) 50 Ozeren S, Corakci A, Yucesoy , Mercan R, Erhan G. Fluoxetine in the treatment of premenstrual syndrome. Eur J Obstet Gynecol Reprod Biol. 1997;73:167-70. (PMD: 9228499) 51 Yonkers KA, Halbreich U, Freeman E, Brown C, Endicott J, Frank E, et al. Symptomatic improvement of premenstrual dysphoric disorder with sertraline treatment. A randomized controlled trial. Sertraline Premenstrual Dysphoric Collaborative Study Group. JAMA. 1997;278:983-8. (PMD: 9307345) 52 Freeman EW, Rickels K, Sondheimer SJ, Polansky M. Differential response to antidepressants in women with premenstrual syndrome/premenstrual dysphoric disorder: a randomized controlled trial. Arch Gen Psychiatry. 1999;56:932-9. (PMD: 10530636) http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 26 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. 53 Eriksson E, Hedberg MA, Andersch B, Sundblad C. The serotonin reuptake inhibitor paroxetine is superior to the noradrenaline reuptake inhibitor maprotiline in the treatment of premenstrual syndrome. Neuropsychopharmacology. 1995;12:167-76. (PMD: 7779245) 54 Cohen LS, Soares CN, Yonkers KA, Bellew KM, Bridges M, Steiner M. Paroxetine controlled release for premenstrual dysphoric disorder: a double-blind, placebo-controlled trial. Psychosom Med. 2004;66:707-13. (PMD: 15385695) 55 Wikander , Sundblad C, Andersch B, Dagnell , Zylberstein D, Bengtsson F, et al. Citalopram in premenstrual dysphoria: is intermittent treatment during luteal phases more effective than continuous medication throughout the menstrual cycle? J Clin Psychopharmacol. 1998;18:390-8. (PMD: 9790157) 56 Dimmock PW, Wyatt KM, Jones PW, O'Brien PM. Efficacy of selective serotonin-reuptake inhibitors in premenstrual syndrome: a systematic review. Lancet. 2000;356:1131-6. (PMD: 11030291) 57 Pearlstein T. Selective serotonin reuptake inhibitors for premenstrual dysphoric disorder: the emerging gold standard? Drugs. 2002;62:1869-85. (PMD: 12215058) 58 Wyatt KM, Dimmock PW, O'Brien PM. Selective serotonin reuptake inhibitors for premenstrual syndrome. Cochrane Database Syst Rev. 2002:CD001396. (PMD: 12519554) 59 Parry BL. The role of central serotonergic dysfunction in the aetiology of premenstrual dysphoric disorder: therapeutic implications. CNS Drugs. 2001;15:277-85. (PMD: 11463133) 60 Sundstrom , Backstrom T, Wang M. Olsson T, Seippel L, Bixo M. Premenstrual syndrome, neuroactive steroids and the brain. Gynecol Endocrinol. 1999;13:206-20. (PMD: 10451814) 61 Roca CA, Schmidt PJ, Smith MJ, Danaceau MA, Murphy DL, Rubinow DR. Effects of metergoline on symptoms in women with premenstrual dysphoric disorder. Am J Psychiatry. 2002;159:1876-81. (PMD: 12411222) 62 Altshuler LL, Cohen LS, Moline ML, Kahn DA, Carpenter D, Docherty JP. The Expert Consensus Guideline Series. Treatment of depression in women. The Expert Consensus Panel for Depression in Women. Postgrad Med. 2001:1-107. (PMD: 11500997) 63 Freeman EW, Rickels K, Yonkers KA, Kunz NR, McPherson M, Upton GV. Venlafaxine in the treatment of premenstrual dysphoric disorder. Obstet Gynecol. 2001;98(5 Pt 1):737-44. (PMD: 11704162) 64 Landen M, Eriksson O, Sundblad C, Andersch B, Naessen T, Eriksson E. Compounds with affinity for serotonergic receptors in the treatment of premenstrual dysphoria: a comparison of buspirone, nefazodone and placebo. Psychopharmacology (Berl). 2001;155:292-8. (PMD: 11432692) 65 Freeman EW, Frye CA, Rickels K, Martin PA, Smith SS. Allopregnanolone levels and symptom improvement in severe premenstrual syndrome. J Clin Psychopharmacol. 2002;22:516-20. (PMD: 12352277) 66 Jermain DM, Preece CK, Sykes RL, Kuehl TJ, Sulak PJ. Luteal phase sertraline treatment for premenstrual dysphoric disorder. Results of a double-blind, placebo-controlled, crossover study. Arch Fam Med. 1999;8:328-32. (PMD: 10418540) 67 Halbreich U, Smoller JW. ntermittent luteal phase sertraline treatment of dysphoric premenstrual syndrome. J Clin Psychiatry. 1997;58:399-402. (PMD: 9378691) http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 27 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. 68 Young SA, Hurt PH, Benedek DM, Howard RS. Treatment of premenstrual dysphoric disorder with sertraline during the luteal phase: a randomized, double-blind, placebo-controlled crossover trial. J Clin Psychiatry. 1998;59:76-80. (PMD: 9501889) 69 Freeman EW, Rickels K, Sondheimer SJ, Polansky M, Xiao S. Continuous or intermittent dosing with sertraline for patients with severe premenstrual syndrome or premenstrual dysphoric disorder. Am J Psychiatry. 2004;161:343-51. (PMD: 14754784) 70 Cohen LS, Miner C, Brown E, Freeman EW, Halbreich U, Sundell K, et al. Premenstrual daily fluoxetine for premenstrual dysphoric disorder: a placebo-controlled, clinical trial using computerized diaries. Obstet Gynecol. 2002;100:435-44. (PMD: 12220761) 71 Miner C, Brown E, McCray S, Gonzales J, Wohlreich M. Weekly luteal-phase dosing with enteric-coated fluoxetine 90 mg in premenstrual dysphoric disorder: a randomized, double-blind, placebo-controlled clinical trial. Clin Ther. 2002;24:417-33. (PMD: 11952025) 72 Halbreich U, Bergeron R, Yonkers KA, Freeman E, Stout AL, Cohen L. Efficacy of intermittent, luteal phase sertraline treatment of premenstrual dysphoric disorder. Obstet Gynecol. 2002;100:1219-29. (PMD: 12468166) 73 Muse KN, Cetel NS, Futterman LA, Yen SC. The premenstrual syndrome. Effects of "medical ovariectomy". N Engl J Med. 1984;311:1345-9. (PMD: 6387488) 74 Freeman EW, Sondheimer SJ, Rickels K. Gonadotropin-releasing hormone agonist in the treatment of premenstrual symptoms with and without ongoing dysphoria: a controlled study. Psychopharmacol Bull. 1997;33:303-9. (PMD: 9230648) 75 Brown CS, Ling FW, Andersen RN, Farmer RG, Arheart KL. Efficacy of depot leuprolide in premenstrual syndrome: effect of symptom severity and type in a controlled trial. Obstet Gynecol. 1994;84:779-86. (PMD: 7936512) 76 Schmidt PJ, Nieman LK, Danaceau MA, Adams LF, Rubinow DR. Differential behavioral effects of gonadal steroids in women with and in those without premenstrual syndrome. N Engl J Med. 1998;338:209-16. (PMD: 9435325) 77 Leather AT, Studd JW, Watson NR, Holland EF. The treatment of severe premenstrual syndrome with goserelin with and without 'add-back' estrogen therapy: a placebo-controlled study. Gynecol Endocrinol. 1999;13:48-55. (PMD: 10368798) 78 Hammarback S, Backstrom T. nduced anovulation as treatment of premenstrual tension syndrome. A double-blind cross-over study with GnRH-agonist versus placebo. Acta Obstet Gynecol Scand. 1988;67:159-66. (PMD: 3140572) 79 Hussain SY, Massil JH, Matta WH, Shaw RW, O'Brien PM. Buserelin in premenstrual syndrome. Gynecol Endocrinol. 1992;6:57-64. (PMD: 1580169) 80 Sundstrom , Nyberg S, Bixo M, Hammarback S, Backstrom T. Treatment of premenstrual syndrome with gonadotropin-releasing hormone agonist in a low dose regimen. Acta Obstet Gynecol Scand. 1999;78:891-9. (PMD: 10577620) 81 West CP, Hillier H. Ovarian suppression with the gonadotrophin-releasing hormone agonist goserelin (Zoladex) in management of the premenstrual tension syndrome. Hum Reprod. 1994;9:1058-63. (PMD: 7962376) http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 28 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. 82 Helvacioglu A, Yeoman RR, Hazelton JM, Aksel S. Premenstrual syndrome and related hormonal changes. Long-acting gonadotropin releasing hormone agonist treatment. J Reprod Med. 1993;38:864-70. (PMD: 8277482) 83 Wyatt KM, Dimmock PW, smail KM, Jones PW, O'Brien PM. The effectiveness of GnRHa with and without 'add-back' therapy in treating premenstrual syndrome: a meta analysis. BJOG. 2004;111:585-93. (PMD: 15198787) 84 Di Carlo C, Palomba S, Tommaselli GA, Guida M, Di Spiezio Sardo A, Nappi C. Use of leuprolide acetate plus tibolone in the treatment of severe premenstrual syndrome. Fertil Steril. 2001;75:380-4. (PMD: 11172843) 85 Freeman EW, Kroll R, Rapkin A, Pearlstein T, Brown C, Parsey K, et al. Evaluation of a unique oral contraceptive in the treatment of premenstrual dysphoria. J Womens Health Gend Based Med. 2001;10:561-9. (PMD: 11559453) 86 Kahn LS, Halbreich U. Oral contraceptives and mood. Expert Opin Pharmacother. 2001;2:1367-82. (PMD: 11585017) 87 Freeman EW, Rickels K, Sondheimer SJ, Polansky M. Concurrent use of oral contraceptives with antidepressants for premenstrual syndromes. J Clin Psychopharmacol. 2001;21:540-2. (PMD: 11593086) 88 Wyatt K, Dimmock P, Jones P, Obhrai M, O'Brien S. Efficacy of progesterone and progestogens in management of premenstrual syndrome: systematic review. BMJ. 2001;323:776-80. (PMD: 11588078) 89 Freeman EW, Rickels K, Sondheimer SJ, Polansky M. A double-blind trial of oral progesterone, alprazolam, and placebo in treatment of severe premenstrual syndrome. JAMA. 1995;274:51-7. (PMD: 7791258) 90 Berger CP, Presser B. Alprazolam in the treatment of two subsamples of patients with late luteal phase dysphoric disorder: a double-blind, placebo-controlled crossover study. Obstet Gynecol. 1994;84:379-85. (PMD: 8058235) 91 Smith S, Rinehart JS, Ruddock VE, Schiff . Treatment of premenstrual syndrome with alprazolam: results of a double-blind, placebo-controlled, randomized crossover clinical trial. Obstet Gynecol. 1987;70:37-43. (PMD: 3299178) 92 Harrison WM, Endicott J, Nee J. Treatment of premenstrual dysphoria with alprazolam. A controlled study. Arch Gen Psychiatry. 1990;47:270-5. (PMD: 2407209) 93 Schmidt PM, Grover GN, Rubinow DR. Alprazolam in the treatment of premenstrual syndrome. A double-blind, placebo-controlled trial. Arch Gen Psychiatry. 1993;50:467-73. (PMD: 8498881) 94 Rickels K, Freeman E, Sondheimer S. Buspirone in treatment of premenstrual syndrome. Lancet. 1989;1:777. (PMD: 2564578) 95 Andersch B. Bromocriptine and premenstrual symptoms: a survey of double blind trials. Obstet Gynecol Surv. 1983;38:643-6. (PMD: 6358978) 96 O'Brien PM, Abukhalil E. Randomized controlled trial of the management of premenstrual syndrome and premenstrual mastalgia using luteal phase-only danazol. Am J Obstet Gynecol. 1999;180(1 Pt 1):18-23. (PMD: 9914571) 97 Kaleli S, Aydin Y, Erel CT, Colgar U. Symptomatic treatment of premenstrual mastalgia in premenopausal women with lisuride maleate: a double-blind placebo-controlled randomized study. Fertil Steril. 2001;75:718-23. (PMD: 11287025) http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 29 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. 98 Facchinetti F, Fioroni L, Sances G, Romano G, Nappi G, Genazzani AR. Naproxen sodium in the treatment of premenstrual symptoms. A placebo-controlled study. Gynecol Obstet nvest. 1989;28:205-8. (PMD: 2695413) 99 Mira M, McNeil D, Fraser S, Vizzard J, Abraham S. Mefenamic acid in the treatment of premenstrual syndrome. Obstet Gynecol. 1986;68:395-8. (PMD: 3526218) 100 Wang M, Hammarback S, Lindhe BA, Backstrom T. Treatment of premenstrual syndrome by spironolactone: a double-blind, placebo-controlled study. Acta Obstet Gynecol Scand. 1995;74:803-8. (PMD: 8533564) 101 Sundblad C, Modigh K, Andersch B, Eriksson E. Clomipramine effectively reduces premenstrual irritability and dysphoria: a placebo-controlled trial. Acta Psychiatr Scand. 1992;85:39-47. (PMD: 1546547) 102 Sundblad C, Hedberg MA, Eriksson E. Clomipramine administered during the luteal phase reduces the symptoms of premenstrual syndrome: a placebo-controlled trial. Neuropsychopharmacology. 1993;9:133-45. (PMD: 8216696) 103 Hahn PM, Van Vugt DA, Reid RL. A randomized, placebo-controlled, crossover trial of danazol for the treatment of premenstrual syndrome. Psychoneuroendocrinology. 1995;20:193-209. (PMD: 7899538) 104 Taylor D. Effectiveness of professional--peer group treatment: symptom management for women with PMS. Res Nurs Health. 1999;22:496-511. (PMD: 10625865) 105 Morse G. Positively reframing perceptions of the menstrual cycle among women with premenstrual syndrome. J Obstet Gynecol Neonatal Nurs. 1999;28:165-74. (PMD: 10102544) 106 Pearlstein T, Miner CM, Brown EB, Joliat MJ. Recurrence of symptoms of premenstrual dysphoric disorder (PMDD) after cessation of luteal phase fluoxetine treatment. Am J Obstet Gynecol. [n press]. 107 Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987;30:191-7. (PMD: 3670870) New References of Interest 108 Johnson SR. Premenstrual syndrome, premenstrual dysphoric disorder, and beyond: a clinical primer for practitioners. Obstet Gynecol. 2004;104:845-59. (PMD: 15458909) http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 30 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. Glossary COPE Calendar of Premenstrual Experience DRF Daily Rating Form DRSP Daily Record of Severity of Problems DSR Daily Symptom Report GABA y-aminobutyric acid GnRH gonadotropin-releasing hormone PMDD premenstrual dysphoric disorder PMS premenstrual syndrome PRSM Prospective Record of mpact of Menstrual Symptoms SSR selective serotonin reuptake inhibitor TSH thyrotropin VAS Visual Analogue Scale Terms Catamenial headaches Headaches associated with menstruation http://pier.acponline.org/physicians/diseases/d655/d655.html PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 31 of 41 Premenstrual 8yndrome Author(s): Teri Pearlstein, MD Status: Module updated 2005-02-01 The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. History and Physical Examination Elements for Premenstrual 8yndrome or Premenstrual Dysphoric Disorder Category Element Notes History Anger or irritability May be 1 of 11 symptoms present in at least two menstrual cycles, occurs during luteal phase, and resolves post-menses History Depressed mood, feelings of hopelessness, or self-deprecating thoughts May be 1 of 11 symptoms present in at least two menstrual cycles, occurs during luteal phase, and resolves post-menses History Feelings of tension, anxiety, or being keyed up May be 1 of 11 symptoms present in at least two menstrual cycles, occurs during luteal phase, and resolves post-menses History Abdominal or generalized sensation of bloating May be 1 of 11 symptoms present in at least two menstrual cycles, occurs during luteal phase, and resolves post-menses History Breast tenderness or swelling May be 1 of 11 symptoms present in at least two menstrual cycles, occurs during luteal phase, and resolves post-menses History Headaches May be 1 of 11 symptoms present in at least two menstrual cycles, occurs during luteal phase, and resolves post-menses History nterference with usual activities May be 1 of 11 symptoms present in at least two menstrual cycles, occurs during luteal phase, and resolves post-menses History Labile mood, suddenly sad or tearful, increased sensitivity to rejection May be 1 of 11 symptoms present in at least two menstrual cycles, occurs during luteal phase, and resolves post-menses History Marked change in appetite, overeating, or specific food cravings May be 1 of 11 symptoms present in at least two menstrual cycles, occurs during luteal phase, and resolves post-menses History Forgetfulness and difficulty concentrating May be 1 of 11 symptoms present in at least two menstrual cycles, occurs during luteal phase, and resolves post-menses History Lethargy, easily fatigued, or marked lack of energy May be 1 of 11 symptoms present in at least two menstrual cycles, occurs during luteal phase, and resolves post-menses Physical exam General medical and gynecologic exam for underlying medical illness or hormonal imbalance Underlying medical illness or hormonal imbalance may contribute to emotional and/or physical symptoms Author: Status: Teri Pearlstein, MD Module updated - 2005-02-01 http://pier.acponline.org/physicians/diseases/d655/d655.html Premenstrual 8yndrome The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 32 of 41 Laboratory table not applicable to this module Author: Status: Teri Pearlstein, MD Module updated - 2005-02-01 http://pier.acponline.org/physicians/diseases/d655/d655.html Premenstrual 8yndrome The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 33 of 41 Differential Diagnosis of Premenstrual 8yndrome or Premenstrual Dysphoric Disorder Disease Characteristics Notes Major depression Pervasive low mood, sadness, low energy, lack of pleasure, etc. space Present at least 2 weeks Usually mood does not fluctuate with the menstrual cycle; however, mood may be exacerbated in the premenstrual phase Dysthymia Chronic low mood, less severe than major depression space Present at least 2 years Usually mood does not fluctuate with the menstrual cycle; however, mood may be exacerbated in the premenstrual phase Generalized anxiety disorder Pervasive anxiety and worries space Present at least 3 months Usually anxiety does not fluctuate with the menstrual cycle; however, anxiety may be exacerbated in the premenstrual phase Panic disorder Panic attacks, may or may not be accompanied by agoraphobia Usually panic attacks do not fluctuate with the menstrual cycle; however, panic attacks may be exacerbated in the premenstrual phase Bipolar disorder Persistently elevated or irritable mood, often with grandiosity space Present for at least 1 week Usually manic symptoms do not fluctuate with the menstrual cycle Alcohol or drug abuse Persistent use of alcohol and/or drug use, despite negative consequences Can have anger and/or irritability, usually symptoms do not fluctuate with the menstrual cycle Bulimia nervosa Binge eating and purging Usually binge eating does not fluctuate with the menstrual cycle; however, binge eating may be exacerbated in the premenstrual phase Migraine Severe headache Catamenial headaches or premenstrual exacerbation of migraines may not be associated with emotional or other physical symptoms of PMS Chronic fatigue Consistent throughout the month, possible history of antecedent illness Less likely to consistently occur only in the luteal phase but may be exacerbated premenstrually rritable bowel syndrome Characterized by abdominal pain, chronic diarrhea, possible weight loss May flare premenstrually, not usually associated with emotional or other physical symptoms of PMS Endometriosis ncreased pain and symptoms with menses Not present during luteal phase; emotional symptoms of PMS often not present Seizure disorder Epileptic attacks Catamenial seizures or premenstrual exacerbation of seizures, not usually associated with emotional or other physical symptoms of PMS Author: Status: Teri Pearlstein, MD Module updated - 2005-02-01 http://pier.acponline.org/physicians/diseases/d655/d655.html Premenstrual 8yndrome Table Continued... The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 34 of 41 Differential Diagnosis of Premenstrual 8yndrome or Premenstrual Dysphoric Disorder Disease Characteristics Notes Hyperthyroidism/hypothyroidism May present with mood alterations Exclude with TSH test space Mood alterations of hyperthyroidism or hypothyroidism generally do not fluctuate with the menstrual cycle Asthma Lung disorder May flare premenstrually, not generally associated with emotional or physical symptoms of PMS Allergies Hypersensitivity to allergen May flare premenstrually, not generally associated with emotional or physical symptoms of PMS PMS = premenstrual syndrome; TSH = thyrotropin. Author: Status: Teri Pearlstein, MD Module updated - 2005-02-01 http://pier.acponline.org/physicians/diseases/d655/d655.html Premenstrual 8yndrome The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 35 of 41 Drug Treatment for Premenstrual 8yndrome or Premenstrual Dysphoric Disorder Agent Mechanism of Action Dosage Benefits 8ide Effects Notes Fluoxetine SSR; blocks presynaptic serotonin transporter 20 mg/d or from ovulation to menses Absence of discontinuation symptoms when used luteal phase only Long-term side effects of weight gain and sexual dysfunction f sexual dysfunction occurs, consider adjunctive bupropion, 150 mg bid.* space Daily dosing: 44; 45; 46; 47; 48; 49; 50 space Luteal phase dosing: 70; 71 Sertraline SSR; blocks presynaptic serotonin transporter 50-100 mg/d or from ovulation to menses Short half-life, absence of side effects when used luteal phase only Long-term side effects of weight gain and sexual dysfunction f sexual dysfunction occurs, consider adjunctive bupropion, 150 mg bid.* space Daily dosing: 51; 52 space Luteal phase dosing: 66; 67; 68; 72 space Comparison of luteal phase dosing and continuous dosing: 69 Paroxetine Paroxetine CR SSR; blocks presynaptic serotonin transporter Paroxetine: 10-30 mg/d space Paroxetine CR: 12.5 mg/d or 25 mg/d or from ovulation to menses Short half-life Long-term side effects of weight gain and sexual dysfunction possible, and may be most likely with this particular SSR f used during luteal phase only, unclear if there are discontinuation symptoms if abruptly stopped at menses.* space f sexual dysfunction occurs, consider adjunctive bupropion, 150 mg bid (53) Citalopram SSR; blocks presynaptic serotonin transporter 20-40 mg/d or from ovulation to menses Short half-life, decrease of side effects when used luteal phase only Long-term side effects of weight gain and sexual dysfunction possible f sexual dysfunction occurs, consider adjunctive bupropion, 150 mg bid (55)* Venlafaxine Serotonin and norepinephrine reuptake inhibitor 130 mg/d, average of immediate-release venlafaxine Dual-action antidepressant Long-term side effects of weight gain and sexual dysfunction possible f sexual dysfunction occurs, consider adjunctive bupropion, 150 mg bid (63)* Author: Status: Teri Pearlstein, MD Module updated - 2005-02-01 http://pier.acponline.org/physicians/diseases/d655/d655.html Premenstrual 8yndrome Table Continued... The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 36 of 41 Drug Treatment for Premenstrual 8yndrome or Premenstrual Dysphoric Disorder Agent Mechanism of Action Dosage Benefits 8ide Effects Notes Clomipramine Tricyclic antidepressant with predominant inhibition of serotonergic reuptake 25-75 mg/d or from ovulation to menses Largely serotonergic tricyclic antidepressant Sedation, weight gain, dry mouth, constipation, orthostatic hypotension Effective dose is less than usual effective dose for major depression.* space Daily dosing: 101 space Luteal phase dosing: 102 Leuprolide GnRH agonist causes anovulation by abolishing FSH and LH surge at ovulation 3.75-7.5 mg im monthly Effective for emotional and physical premenstrual symptoms Hypoestrogenic symptoms such as hot flushes Less effective for severe or exacerbated premenstrual depression (74; 75) space Adding back estrogen or progesterone led to induction of mood and anxiety symptoms (76) Goserelin GnRH agonist causes anovulation by abolishing FSH and LH surge at ovulation 3.6 mg sc monthly Effective for emotional and physical symptoms Hypoestrogenic symptoms such as hot flushes Adding back estrogen and progesterone led to induction of mood and anxiety symptoms (77) Buserelin GnRH agonist causes anovulation by suppressing FSH and LH surge at ovulation 100-900 g intranasally daily Effective for emotional and physical symptoms Hypoestrogenic symptoms such as hot flushes Not available in the United States (78; 79; 80) Danazol Synthetic steroid that suppresses FSH and LH surge at ovulation 200-400 mg/d Effective for emotional and physical symptoms Weight gain, hirsutism, acne, nausea, decreased high-density lipoprotein Anovulation necessary for efficacy for emotional and physical symptoms. space Side effects limit its use. space Daily dosing: 103 space Luteal phase dosing only effective for mastalgia: 96 Author: Status: Teri Pearlstein, MD Module updated - 2005-02-01 http://pier.acponline.org/physicians/diseases/d655/d655.html Premenstrual 8yndrome Table Continued... The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 37 of 41 Drug Treatment for Premenstrual 8yndrome or Premenstrual Dysphoric Disorder Agent Mechanism of Action Dosage Benefits 8ide Effects Notes Ethinyl estradiol/drospirenone Oral contraceptive, drosperinone has unique antiandrogenic and antimineralocorticoid action One combination pill daily (ethinyl estradiol, 30 g, and drospirenone, 3 mg) Effective for acne, food cravings and increased appetite Nausea, headache, breakthrough bleeding Not significantly effective for most premenstrual symptoms due to high placebo response in study (85) Alprazolam Benzodiazepine that increases GABA neurotransmission at GABAA receptor 0.25 mg bid or tid from ovulation to menses Beneficial adjunct for premenstrual anxiety symptoms Sedation, risk of tolerance, and dependence Efficacy rate ~40%. space Taper over first few days of menses. space Contraindicated if prior drug abuse or dependence (89; 90; 91; 92) Buspirone Partial 5-HT1A receptor agonist 25 mg/d Anxiolytic Dizziness, nervousness Daily dosing: 64 space Luteal phase dosing: 94 Spironolactone Aldosterone receptor antagonist 100 mg/d from ovulation to menses Reduced premenstrual irritability, depression, and bloating Gastritis, diarrhea 100 * The FDA has recommended a black box warning for antidepressant medications for use in children and adolescents under age 18. FSH = follicle-stimulating hormone; GABA = y-aminobutyric acid; GnRH = gonadotropin-releasing hormone; LH = luteinizing hormone; SSR = selective serotonin reuptake inhibitor. Author: Status: Teri Pearlstein, MD Module updated - 2005-02-01 http://pier.acponline.org/physicians/diseases/d655/d655.html Premenstrual 8yndrome The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 38 of 41 Elements of Follow-up for Premenstrual Disorder or Premenstrual Dysphoric Disorder Category ssue How? How Often? Notes History Response to treatment Ask about status of symptoms, functioning, quality of life Each visit Treatment efficacy is determined by amelioration of symptoms Physical exam General health status Routine annual exam by primary care physician or gynecologist Annually Laboratory testing General health status, comorbid disorders Pap smear and other tests depending on comorbid disorders Annually or as needed Non-drug therapy Response to therapy nitiate discussion of adjunctive non-drug therapies Every 3-6 months or as needed See Non-drug Therapy Drug therapy Medication effectiveness and side effects Consider need for second-line hormonal therapy. space Consider changing from daily dosing to luteal phase dosing if side effects are problematic, or consider adjunctive bupropion, 150 mg bid, for sexual dysfunction in patients receiving SSR Monthly for first 2-3 months, then every 3-6 months, or as needed Patient education Overall management Discuss lifestyle modifications including diet and exercise Each visit SSR = selective serotonin-reuptake inhibitor. Author: Status: Teri Pearlstein, MD Module updated - 2005-02-01 http://pier.acponline.org/physicians/diseases/d655/d655.html Premenstrual 8yndrome The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 39 of 41 Diagnostic Criteria for Premenstrual Dysphoric Disorder Research Criteria for Premenstrual Dysphoric Disorder A. n most menstrual cycles during the past year, five (or more) of the following symptoms were present for most of the time during the last week of the luteal phase, began to remit within a few days after the onset of the follicular phase, and were absent in the week post-menses, with at least one of the symptoms being either (1), (2), (3), or (4): (1) markedly depressed mood, feelings of hopelessness, or self-deprecating thoughts (2) marked anxiety, tension, feelings of being "keyed up, or "on edge (3) marked affective lability (e.g., feeling suddenly sad or tearful or increased sensitivity to rejection) (4) persistent and marked anger or irritability or increased interpersonal conflicts (5) decreased interest in usual activities (e.g., work, school, friends, hobbies) (6) subjective sense of difficulty in concentrating (7) lethargy, easy fatigability, or marked lack of energy (8) marked change in appetite, overeating, or specific food cravings (9) hypersomnia or insomnia (10) a subjective sense of being overwhelmed or out of control (11) other physical symptoms, such as breast tenderness or swelling, headaches, joint or muscle pain, a sensation of "bloating, weight gain B. The disturbance markedly interferes with work or school or with usual social activities and relationships (e.g., avoidance of social activities, decreased productivity and efficiency at work or school). C. The disturbance is not merely an exacerbation of the symptoms of another disorder, such as Major Depressive Disorder, Panic Disorder, Dysthymic Disorder, or a Personality Disorder (although it may be superimposed on any of these disorders). D. Criteria A, B, and C must be confirmed by prospective daily ratings during at least two consecutive symptomatic cycles. (The diagnosis may be made provisionally before this confirmation). Reprinted with permission from 1. Copyright 1994 American Psychiatric Association. Author: Status: Teri Pearlstein, MD Module updated - 2005-02-01 http://pier.acponline.org/physicians/diseases/d655/d655.html Premenstrual 8yndrome The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 40 of 41 Diagnostic Criteria for Premenstrual 8yndrome Premenstrual syndrome can be diagnosed in the patient reports at least one of the following affective and somatic symptoms during the 5 days before menses in each of the three prior menstrual cycles*: Affective Depression Angry outbursts rritability Anxiety Confusion Social withdrawal Somatic Breast tenderness Abdominal bloating Headache Swelling of extremities *These symptoms are relieved within 4 days of the onset of menses, without recurrence until at least cycle day 13. The symptoms are present in the absence of any pharmacologic therapy, hormone ingestion, or drug or alcohol use. The symptoms occur reproducibly during two cycles of prospective recording. The patient suffers from identifiable dysfunction in social or economic performance. Adapted from Mortola JF, Girton L, Yen SC. Depressive episodes in premenstrual syndrome. Am J Obstet Gynecol 1989;161:1682-7. Reprinted from 2. Author: Status: Teri Pearlstein, MD Module updated - 2005-02-01 http://pier.acponline.org/physicians/diseases/d655/d655.html Premenstrual 8yndrome The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP. Because all PER modules are updated regularly, printed web pages or PDFs may rapidly become obsolete. Therefore, PER users should compare the date of the last update on the website with any printout to ensure that the information being referred to is the most current available. PER is copyrighted (c) 2004 by the American College of Physicians. 190 N. ndependence Mall West, Philadelphia, PA 19106-1572, USA. Page: 41 of 41