Published May 18, 2011 OTC MEDICATIONS Alleviating Menstrual Discomfort: PMS and Dysmenorrhea W. Steven Pray, PhD, DPh Bernhardt Professor, Nonprescription Products and Devices College of Pharmacy Southwestern Oklahoma State University Weatherford, Oklahoma Gabriel E. Pray, PharmD Candidate College of Pharmacy Southwestern Oklahoma State University Weatherford, Oklahoma US Pharm. 2011;36(5):12-19. Female patients may approach the pharmacist with questions about treatment of menstrual problems. The only conditions that are amenable to self-treatment are premenstrual syndrome and primary dysmenorrhea.1 Other concerns must be referred. Premenstrual Syndrome (PMS) PMS is the term applied to a rather comprehensive list of psychological and somatic problems affecting the emotions and the body.1,2-4 To qualify as PMS, these symptoms must occur during the premenstrual days of the cycle and typically cease following onset of the menstrual flow. Prevalence of PMS: PMS is experienced by at least 75% to 85% of females who have menstrual flow.1,5,6 Approximately 31% to 61% of adolescents have the condition.3,4 Epidemiology of PMS: PMS is more common in females aged from the late 20s to the early 40s.5 Symptom severity often worsens during the late 30s to 40s as menopause approaches. PMS is less common in those who have never been pregnant. Certain mental disorders increase the risk, such as a personal or family history of major depressive disorder, postpartum depression, or any affective mood disorder (e.g., seasonal affective disorder).5 Manifestations of PMS: Symptoms include a lengthy list of problems, which often vary greatly from patient to patient and from cycle to cycle in the same patient.5-7 Some involve emotional states, such as depression, crying spells, feelings of sadness or hopelessness, a tense or irritable feeling, edginess, anxiety, difficulty in handling stressful situations, and mood swings. The woman may exhibit overt hostility and aggression, displaying outbursts of anger directed at herself or others. She may experience confusion, difficulty in concentrating, forgetfulness, impaired judgment, and memory lapses. Lights and noises may cause discomfort. She may feel tired or fatigued, and her movements may alter to become slow, sluggish or lethargic; these changes can result in an abnormal clumsiness in carrying out routine tasks, whether they are new or have previously been mastered. She may experience lowered self-image, feelings of guilt, and increased fears. Some women report difficulty in sleeping; others sleep to excess.6 The woman may notice problems related to water retention, such as edema of the hands and feet, weight gain, and swelling and/or tenderness of the breasts. Gastrointestinal (GI) problems such as upset stomach, abdominal fullness, bloating, and constipation or diarrhea may arise. Unusual hunger may result in food cravings. The sex drive can be increased or decreased. Discomfort includes headache, joint and muscle pain, and backache. Acne can appear or existing acne can worsen. Women are advised to keep a calendar with a list of symptoms and the days they were present so it can be taken to her physician to assist in PMS diagnosis.6 Premenstrual Dysphoric Disorder (PMDD) PMDD is a diagnosis applied to approximately 3% to 8% of females who have a more severe version of PMS.6,8,9 Some symptoms overlap with PMS, such as bloating, breast tenderness, headaches, muscle/joint pain, trouble sleeping, tiredness/low energy, food cravings/binge eating, trouble thinking/focusing, mood swings, frequent crying, tension, and anxiety.8 Others go beyond simple PMS, such as feelings of sadness or despair so intense that they may invoke suicidality, lasting irritability or anger that affects others, lack of interest in normal daily activities and relationships, and feeling out of control. If five or more of the above are present, PMDD is diagnosed (TABLE 1).8 Symptoms begin the week prior to onset of the menstrual flow and remit with the beginning of the flow. Dysmenorrhea Dysmenorrhea refers to discomfort that begins several days before or at the onset of menstrual flow.10 Prevalence: Perhaps 90% of adolescents suffer from dysmenorrhea.11 It is the most common cause of lost time from school and work in women aged in their teens or 20s.10 Epidemiology: Dysmenorrhea is most common in younger patients. Due to a lower occurrence with aging, the overall prevalence is 25%.11 There are no racial epidemiologic differences in the occurrence of dysmenorrhea.11 However, smoking, obesity, and a positive family history of the condition all increase the risk of dysmenorrhea.11 Manifestations: The pain of dysmenorrhea includes cramping pain in the lower abdominal area, a sharp intermittent pain, aching pain, or back pain.10 The discomfort tends to remit as menstrual flow decreases. Primary Versus Secondary: Primary dysmenorrhea is the only self-treatable subtype. It refers to menstrual discomfort that is not due to any underlying condition. It typically begins within a short time after the female’s first menstrual period, particularly after her body has established a regular menstrual cycle.11 The cause is hypothesized to be prostaglandin-induced uterine contractions forcing menstrual discharge through the cervical os.1,10 As the female ages and has children, the cervical opening enlarges, easing expulsion and reducing the incidence of cramps. Secondary dysmenorrhea is caused by an underlying condition. It often develops in women in their later 20s or 30s who have not had menstrual discomfort for years. It can be caused by endometriosis, uterine fibroids (leiomyomata), adenomyosis, ovarian cysts, pelvic inflammatory disease, sexually transmitted disease, or a copper-containing intrauterine device.10,11 Clues to secondary dysmenorrhea include the following: pain that is sudden or severe or occurs at times other than menstruation (e.g., midcycle, during ovulation), pain that begins more than 5 days preperiod, pain that continues after the period is over, pain during defecation, presence of fever or other symptoms, infertility, dyspareunia, foul-smelling or excessive vaginal discharge, or passing of blood clots.1,10,11 If the pharmacist suspects at any time during the counseling session that the woman has secondary dysmenorrhea, she must be referred to her physician at once.1 Nonprescription Products Nonprescription products may provide relief for patients with mild-to-moderate symptoms of PMS or primary dysmenorrhea. All FDA-approved nonprescription analgesics are approved for the pain and/or cramping of PMS and primary dysmenorrhea.1,11 NSAIDs (e.g., ibuprofen, naproxen) are a more logical choice for dysmenorrheal cramping than acetaminophen due to their ability to inhibit prostaglandin.11 However, acetaminophen may be useful for PMS-related discomfort and also for the extrauterine discomforts associate with dysmenorrhea. Single-entity ibuprofen products include Advil, Motrin IB, and Midol Liquid Gels. Single-entity naproxen products include Aleve, Midol Extended Relief, and Pamprin All Day Relief. Heat can be applied to the lower abdomen to ease dysmenorrheal cramping.10 Heating pads or therapeutic heat wraps (e.g., ThermaCare Menstrual) can be recommended.1 Therapeutic heat wraps placed over the abdomen are more effective for dysmenorrheal cramping than placebo, acetaminophen, and ibuprofen.1 Diuretics are also safe and effective for relieving temporary water weight gain, bloating, swelling, and the full feeling that can often accompany PMS.1 They have little role in dysmenorrhea. The only diuretic commonly included in products sold for premenstrual syndrome is pamabrom, a safe and effective xanthine derivative. Single-entity pamabrom tablets include Aqua-Ban, Diurex Aquagels, and Diurex Water Capsules. The dose is 50 mg four times daily, up to a maximum of 200 mg daily.1 Pyrilamine is an antihistamine often included in menstrual products. It is alleged to provide relief of emotional or mood changes (e.g., anxiety, nervous tension, irritability), reduce water-retention symptoms, and reduce severity of cramps and backache.1 However, it is not yet proven to be safe and effective for any menstrual symptom.1 It also carries the risk of drowsiness. Until the FDA approves studies demonstrating its safety and efficacy, products containing pyrilamine should be avoided. They include Premsyn pms, Pamprin Multi-Symptom, Diurex PMS, and Midol Complete. If the patient has found little relief from nonprescription products, she should be referred to a physician. Oral contraceptives reduce the frequency of cramps and headaches and may lighten flow.5 Selective serotonin reuptake inhibitors (e.g., sertraline, fluoxetine, paroxetine) may provide relief of PMDD. Beyaz and Yaz are oral contraceptives that are FDA-approved to treat PMDD.12 Conditions to Refer Older women may ask for relief of the symptoms of menopause. No nonprescription product is known to be safe or effective for these symptoms. An example is Rejuvex, which claimed to “support menopausal comfort.” This essentially meaningless phrase was never evaluated by the FDA and the product was not known to be safe and effective for any menopausal symptom. Its unproven formula included boron and dong quai.13 Currently, it appears to be unavailable, although its former widespread availability may have spawned imitators. Parents may express worries about their daughter’s menstrual flow. They may be concerned that it has ceased. There are several reasons for this. The young woman may be pregnant, engaging in long-distance running, or have a serious medical condition. Parents may also be concerned that their daughter’s first period has not begun at the expected time. The patient may have an imperforate hymen or a serious glandular condition. These patients should be seen by a physician. PATIENT INFORMATION There are some steps you can take to lessen the impact of PMS and dysmenorrhea on your life, including simple lifestyle adjustments and the use of nonprescription products. Lifestyle Changes for PMS The first step to managing the discomfort of PMS is to pay attention to simple, healthy lifestyle choices. Many women with mild symptoms improve markedly with these interventions. You should drink lots of fluid to help reduce the bloated feeling, lessen water that your body retains, and improve breast tenderness. However, the best fluids are water or juices. Soft drinks are not recommended, especially those with caffeine. Rather than two or three large meals, you should eat frequent small meals, with no more than 3 hours between meals or snacks. Increase the amount of complex carbohydrates (as found in whole grains, cereals, breads, pasta, vegetables, and fruit) in your diet. Avoid eating too much. Many women find that a low-salt diet is helpful, but it is best to check with your physician before beginning this on your own. You should set the goal of avoiding caffeine, alcohol, and simple sugars (e.g., candy, soda). Stop use of all tobacco products, as smoking worsens PMS. You should engage in regular, aerobic exercise each day of the month. A good weekly goal is: 1) 2.5 hours of moderate to intense physical activity, and 2) 75 minutes of vigorous-intensity aerobic physical activity. You may choose to combine the moderate and vigorous activities and add muscle-strengthening exercises on two or more days. Try to get 8 hours of sleep each night. Learn healthy sleep habits and sleep hygiene steps to control insomnia before taking medications. Contact a health provider if these simple steps do not cause the symptoms to disappear, or if your symptoms are so severe that your ability to carry out normal activities is limited. You could be experiencing premenstrual dysphoric disorder (PMDD), which is a more severe form of PMS and includes symptoms such as depression, irritability, and tension before menstruation. PMS Medications If the lifestyle changes are not helpful, you may choose to try nonprescription products. You may find pain relievers will provide relief from backache, headache, and muscle and joint pains. Ibuprofen (e.g., Advil, Motrin IB) and naproxen (e.g., Aleve) are good choices. Naproxen has a longer duration of action than ibuprofen. Ibuprofen tablets must usually be repeated every 4 to 6 hours (check the dosing frequency on your product’s label), while naproxen tablets are repeated only every 8 to 12 hours. These products can also help alleviate the pain of menstrual cramping. You may also choose a diuretic to draw out excess fluid, treating breast tenderness and swelling of the feet. Products with pamabrom in the formula are safe and effective for removing excess fluid. They include Aqua-Ban and Diurex Aquagels. Follow all dosing directions for these products. If nonprescription medications do not help relieve symptoms, you may need to see a physician for treatment with oral contraceptives or antidepressants. REFERENCES 1. Pray WS. Nonprescription Product Therapeutics. 2nd ed. Baltimore, MD: Lippincott Williams & Wilkins; 2006. 2. Fothergill DJ. Common menstrual problems in adolescence. Arch Dis Child Educ Pract Ed. 2010;95:199-203. 3. Singleton G. Premenstrual disorders in adolescent females—integrative management. Aust Fam Physician. 2007;36:629-630. 4. Freeman EW. Therapeutic management of premenstrual syndrome. Expert Opin Pharmacother. 2010;11:2879-2889. 5. Premenstrual syndrome. MedlinePlus. www.nlm.nih.gov/medlineplus/ ency/article/001505.htm. Accessed March 31, 2011. 6. Premenstrual syndrome. The National Women’s Health Information Center. www.womenshealth.gov/faq/ premenstrual-syndrome.cfm. Accessed March 31, 2011. 7. Premenstrual syndrome (PMS). Office on Women’s Health. U.S. Department of Health and Human Services. www.girlshealth.gov/body/ period/pms.cfm. Accessed March 31, 2011. 8. Premenstrual dysphoric disorder. PubMed Health. www.ncbi.nlm.nih.gov/ pubmedhealth/PMH0004461/. Accessed March 31, 2011. 9. Zukov I, Ptácek R, Raboch J, et al. Premenstrual dysphoric disorder—review of actual findings about mental disorders related to menstrual cycle and possibilities of their therapy. Prague Med Rep. 2010;111:12-24. 10. Painful menstrual periods. MedlinePlus. www.nlm.nih.gov/medlineplus/ ency/article/003150.htm. Accessed March 31, 2011. 11. Holder A, Edmundson LD. Dysmenorrhea in emergency medicine. Medscape. http://Emedicine.medscape.com/ article/795677-overview. Accessed March 31, 2011. 12. Beyaz. Bayer HealthCare Pharmaceuticals. www.yaz-us.com. Accessed March 31. 2011. 13. Rejuvex. Dietary Supplements Labels Database. http://dietarysupplements.nlm. nih.gov/dietary/detail.jsp? name=Rejuvex&contain=03002012& pageD=brand. Accessed March 31, 2011. To comment on this article, contact rdavidson@uspharmacist.com.