US Pharm. 2016;41(9):8-11.
Sudden flashes of heat, drenching sweat, mood swings, and disruption of sleep—these are all common experiences amongst women as they begin “The Change,” otherwise known as menopause. This occurrence is a natural physiologic transition when a woman stops producing eggs and ovarian function is diminished. The age at which menopause occurs varies widely, usually from 40 years to 55 years, but the average age of occurrence in the United States is approximately 51 years; cigarette smokers undergo this transition about 2 years earlier.1 An official diagnosis of menopause is given once 12 months have elapsed since the last menstrual cycle.
The time leading up to menopause is known as perimenopause or the menopausal transition, usually beginning in the mid-to-late 40s and lasting approximately 4 years.1 During this phase, hormone levels are variable, causing most of the associated symptoms. Most women experience some or all of the symptoms associated with menopause (TABLE 1); however vasomotor menopausal symptoms (VMS; e.g., hot flushes, hot flashes, and night sweats) are the most common and are considered the hallmark symptoms, affecting almost 80% of women.2-4
A hot flush describes the sudden onset of a sensation of extreme heat, particularly in the face, neck, and chest area; a hot flash describes this episode accompanied by sweating, sometimes followed by a chill.5 These terms are often used inter-changeably. These sensations typically last 1 to 5 minutes and may also be accompanied by flushing, clamminess, anxiety, and heart palpitations.6 Approximately 87% of women report experiencing hot flushes daily, with almost 33% experiencing 10 or more episodes a day.6 Symptoms range in severity, but can be severe enough to impair psychological and general well-being, adversely affecting normal daily activities.7 Typically, these symptoms can last anywhere from 5 to 7 years, but may persist for decades or even lifelong in up to 15% of women.3,4,8
Hormone replacement therapy (HRT) was once the treatment of choice for VMS but has since fallen out of favor due to its negative impact on cardiovascular health and breast cancer. Many women are now seeking alter-natives for the management of VMS; approximately 50% are choosing to use complementary therapies, and millions of dollars are spent every year on OTC products.9,10 With the growing number of women who will be transitioning through menopause in the next decade, pharmacists will most likely encounter patients seeking relief from hot flashes and night sweats. Pharmacists need an understanding of the efficacy and safety of the various nonprescription options available to patients.
There are many lifestyle changes that can be implemented and should be encouraged to help women alleviate the vasomotor symptoms associated with menopause. Many women have identified triggers such as alcohol, spicy foods, and hot foods or drinks; simple avoidance of such substances may help reduce their occurrence. If the patient is a smoker, smoking cessation should strongly be encouraged; smokers suffer from more severe symptoms due to the antiestrogenic effect of cigarette smoke.2 Other suggestions include lifestyle changes that will help lower or help prevent an increased core body temperature (TABLE 2).
There has been much debate over whether exercise has a clinical impact on the severity and frequency of VMS. Many observational studies have demonstrated fewer episodes in those women who exercised regularly, but recent systematic reviews of randomized, controlled trials have failed to show any benefit of exercise on VMS.11-13 However, that is not to say there is no benefit at all in perimenopausal and menopausal women. Moderate exercise should still be recommended; maintaining a healthy exercise regimen has been shown to increase quality of life, improve cognitive and physical function, reduce mortality, promote weight loss, prevent heart disease, and prevent bone resorption.14
Isoflavone Supplements and Extracts
Isoflavones are a group of naturally occurring compounds found in fruits, grains, and vegetables that are structurally similar to estrogen and have an affinity for estrogen receptors. These chemicals have been shown to elicit both estrogen-agonist and estrogen-antagonistic properties when ingested orally in large quantities.4,15 Two specific dietary isoflavones, genistein and daidzein, are found in high concentrations in legumes such as soy, chick peas, lentils, and red clover. Initial interest in these compounds for the management of VMS stemmed from the observation that Asian women, who traditionally consume large quantities of soy in their diet, appear to have lower rates of menopausal symptoms.6,15
Multiple studies have been performed evaluating the efficacy of dietary soy, as well as soy isoflavonoid supplements and extracts, on VMS. Most of these studies were limited by small sample sizes as well as other study design defects, including short study duration and an inability to account for batch-to-batch product variability in the manufacturing of these products. Although some studies reported a slight reduction in symptomatology, most studies failed to demonstrate these products to be more effective than placebo.4,6,9,15
A 2013 Cochrane meta-analysis was performed on 43 randomized, controlled studies of 4,084 patients to assess the efficacy and safety of food products, extracts, and supplements containing high levels of phytoestrogens in the amelioration of VMS in perimenopausal and postmenopausal women. Although these products were well-tolerated and failed to show any detrimental adverse effects, there was no indication that they were of any significant clinical benefit.15
Black cohosh (Actaea racemosa or Cimicifuga racemosa) is a popular herbal supplement that is widely used for the management of the vasomotor symptoms associated with menopause.4,16 It is available in several preparations; one popular commercially available product is Remifemin. Despite its widespread popularity, the active ingredient in black cohosh is unknown and the proposed mechanism of its perceived beneficial effects remains unclear. Although it was once believed to possess estrogen-like activity, the product is now believed to have a more complex pharmacologic profile that includes anti-inflammatory and antioxidant activity as well as the ability to modify serotonergic pathways.4
Several studies have been performed evaluating the effec-tiveness of black cohosh in the management of the symptoms of menopause. Although some studies have conflicting results, it appears that black cohosh, either alone or in combination with soy isoflavones or other herbal supplements, does not reduce the frequency or severity of hot flashes.17-19 A 2012 Cochrane review of 16 controlled trials also failed to demonstrate a clinical benefit associated with the herbal supplement.4
Several reports of possible hepatotoxicity have been associated with the use of black cohosh. As such, products containing black cohosh carry a warning statement declaring “discontinue use and consult a healthcare practitioner if you have a liver disorder or develop symptoms of liver trouble, such as abdominal pain, dark urine, or jaundice.”4
Based upon the lack of documented efficacy and the potential safety concerns regarding the use of black cohosh, the American College of Obstetricians and Gynecologists (ACOG) has concluded that there is insufficient evidence to support the use of black cohosh for menopausal symptoms at this time. However, the society believes that further study of this herbal product is warranted.6
Various supplements that have been used in the management of VMS include Dioscorea villosa or wild yams, evening primrose, dong quai (Chinese herbal), American ginseng, kava kava, and St. John’s wort. The evidence from clinical trials demonstrating benefit is conflicting and limited.4,20-22 Current guidelines do not support the use of such agents at this time.4,6
It is estimated that more than 50 million U.S. women will be older than 51 years of age by 2020.23 Menopause is a time of transition for many women, and pharmacists can be a valuable source of support and information. Pharmacists will be encountering many patients inquiring about therapies regarding the management of VMS. Current guidelines and existing data do not support the use of popular nonprescription alternative products that are commercially available. Pharmacists can help patients assess the level of severity of menopausal symptoms and provide counseling on the various lifestyle modifications and professional referrals when appropriate.
What Are Menopausal Symptoms?
Women will generally start to experience menopausal symptoms about 4 years before their final menstrual period. During this time, periods may be irregular. They may be longer, shorter, heavier, lighter, or less frequent. In addition, pregnancy is still possible.
The most common symptoms associated with menopause include hot flashes or flushes, vaginal dryness, night sweats, mood changes, weight gain, thinning hair, dry skin, and loss of breast fullness. Hot flashes/flushes are sudden sensations of heat around the upper chest and face, but they can spread to other parts of the body. This sensation usually lasts 2 to 4 minutes, and it may cause sweating and palpitations, followed by chills, shivering, and anxiety. When these occur at night, they may disrupt sleep and cause low energy levels.
How Can I Alleviate Menopausal Symptoms?
Menopausal symptoms are usually temporary for most women. Hot flashes can be alleviated by dressing in layers of clothing that can easily be removed. Drinking a cold glass of water, or cooling the environment by using an air conditioner or fan, may help relieve these sensations. It is also important to know what triggers these hot flashes, so that they can be avoided. Common triggers include hot foods and drinks, spicy foods, caffeinated beverages, alcohol, stress, and warm weather.
Hot flashes can cause women to wake up during the night, which can lead to insufficient sleep. Caffeine, exercise, and excess alcohol should be avoided before bedtime.
Women who experience vaginal dryness can use OTC water-based vaginal lubricants or moisturizers. Avoid glycerin-containing products, as they can cause burning and irritation.
Relaxation techniques, such as deep breathing, paced breathing, guided imagery, and massage, may relieve symptoms. Smoking cessation may also be beneficial in women experiencing menopause because smoking can cause women to experience menopause earlier and have more hot flashes.
Do Herbal Supplements and Alternative Medicine Actually Work?
When experiencing menopausal symptoms, many women tend to try a variety of foods and OTC products. These include foods that contain phytoestrogens (isoflavones and lignans). Isoflavones can be found in soybeans, chickpeas, lentils, and other legumes. Lignans can be found in flaxseed, whole grains, and some fruits and vegetables. Although these foods may be healthy, they have not been proven to be effective in alleviating menopausal symptoms.
Two of the most popular OTC products that women use to treat menopausal symptoms are black cohosh and evening primrose oil. Neither product has been shown to be effective, and black cohosh may be harmful to the liver.
Studies have shown that yoga, tai chi, and Qigong may decrease the number of hot flashes women experience. If attempting any of these, it is important to take classes to learn about proper techniques. Another alternative that women can try is acupuncture. This may reduce hot flashes, but may not work in all women.
What Should I Do If My Symptoms Do Not Improve?
It is important to keep track of your symptoms. If you feel that they are not improving despite trying various self-care techniques and supplements, contact your healthcare provider, who may be able to prescribe medications to help alleviate your menopausal symptoms.
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