ALTERNATIVE DIETS AND NUTRITIONAL SUPPLEMENTS:
DO COMPLEMENTARY AND ALTERNATIVE MEDICINE THERAPIES HELP MENOPAUSAL SYMPTOMS?

Menopause is a natural process for women as they age. Menopause also can occur as a result of certain medical treatments that affect a woman's ovaries. Many women and their health care providers have become interested in complementary and alternative medicine (CAM) for menopausal symptoms. This article is based on findings from a 2005 National Institutes of Health State-of-the-Science conference on the management of menopause-related symptoms. It answers some frequently asked questions and lists resources for more information.

What Is Menopause?

Menopause (also called the "change of life") is a normal part of a woman's aging. It is the time when her ability to have children comes to an end. In American women, the transition into menopause usually begins around age 47, with the final menstrual period usually around age 51. However, some women experience it earlier. Menopause occurs over a period of time because the levels of a hormone called estrogen, which is produced by the ovaries, begin to decline slowly. A woman is said to have completed natural menopause when she has not had a period for 12 months in a row. Menopause will occur immediately if a woman has her uterus and/or both ovaries removed surgically (an operation to remove the uterus is called a hysterectomy). This is because at least one ovary and the uterus are needed for a woman to have menstrual periods. Menopause also begins right away if a woman's ovaries are damaged by cancer treatment with radiation therapy or certain anticancer drugs.

What Are the Most Common Symptoms That Women Have During the Menopausal Transition?

Some symptoms that women experience are related to menopause and decreased activity of the ovaries. Others are related to aging in general. The scientific evidence that certain symptoms are linked to menopause is strongest for the following symptoms:

· Hot flashes, night sweats or perspiring excessively (these are examples of what are called vasomotor symptoms, because they involve expansion of the blood vessels)

· Sleep difficulties

· Vaginal dryness, which can lead to painful intercourse and sexual problems

It is not certain whether the following symptoms are due to menopause, other factors that can come with aging (such as stress, economic concerns or changes in personal relationships), or a combination of them:

· Changes in mood, such as depression, anxiety and/or irritability

· Problems in thinking or in remembering things

· Urinary incontinence (that is, loss of ability to control urination)

· Painful joints or muscles, or other physical complaints, such as tiredness and stiff joints

The expert panel assembled for the NIH SoS conference noted that menopause is a normal part of women's aging and advised that menopause not be viewed as a disease (that it be "demedicalized").

What Treatment Does Conventional Medicine Offer for Menopausal Symptoms?

For many decades, estrogen (available by prescription with or without another hormone called progestin) has been the main treatment in conventional medicine for menopausal symptoms.1 For a long time, this treatment was called hormone replacement therapy (HRT), but the preferred term now is menopausal hormone therapy (MHT). MHT has been the most effective therapy to date for women who have severe or long-lasting problems related to menopause. It is especially effective against hot flashes and night sweats.

MHT has some other beneficial effects as well. For example, it helps to protect against osteoporosis, an age-related disease in which the bones become brittle and can break more easily. The risk for osteoporosis goes up in both men and women as they age, but it is greater for women after menopause. Drug treatments other than MHT, however, are available for reducing the risk of osteoporosis in both men and women, and certain lifestyle changes also may help.

1Conventional medicine is medicine as practiced by holders of M.D. (medical doctor) or D.O. (doctor of osteopathy) degrees and by their allied health professionals such as nurses, physical therapists and dietitians. CAM is a group of diverse medical and health care systems, practices and products that are not currently considered to be part of conventional medicine. Complementary medicine is used along with conventional medicine. Alternative medicine is used instead of conventional medicine. Some conventional medicine practitioners also practice CAM.

Why Are Many People Concerned About the Effectiveness and Safety of MHT?

MHT was widely prescribed until a few years ago. In 2002, findings from a large study called the Women's Health Initiative raised concerns about its safety and side effects. Researchers found increased risks for serious health problems (including heart disease, breast cancer, stroke and blood clots) in women who had taken a combination of estrogen and progestin for several years. Women who were taking estrogen alone had an increased risk for stroke and blood clots.

MHT is being used more cautiously now. The U.S. Food and Drug Administration recommends that it be used at the lowest dose for the shortest period of time possible. However, the specific risks and benefits of these low doses, and how long to use them, are not known. The NIH SoS conference panel noted that estrogen may not be an appropriate treatment for some menopausal complaints. This situation is one reason that many women and their health care providers have become interested in whether CAM treatments could be helpful for menopausal symptoms.

What Should Women Consider If They Are Thinking About Using CAM for Menopausal Symptoms?

There is very little scientific evidence to support the effectiveness of CAM therapies for menopausal symptoms. However, it is possible that some CAM therapies, while not as effective as MHT, may provide some relief to women during the menopausal transition. Here are some points to keep in mind about these therapies:

· It is important for women who are considering or using CAM therapies for any health reason to discuss them with their health care provider. This is to help ensure safety and a comprehensive treatment plan.

· Botanical and other dietary supplements can interact with prescription and over-the-counter drugs, affecting how the body reacts. Supplements can pose other safety issues as well. Some have been found to be contaminated, contain unlabeled ingredients, or have different amounts of ingredients than are listed on the label. "Natural" does not automatically mean "safe."

· Pharmacists can be a helpful source of information about supplements. However, their advice should not be viewed as a substitute for the advice of a health care provider.

· The claims for many CAM therapies can be attractive, ranging from enhancing well-being to producing health results that might seem unbelievable. Check whether such claims are based only on personal stories (testimonials) or on the results of controlled research studies. It is important to know whether scientific research has proven that a therapy works.

· The cost of a CAM therapy may be a concern, as many CAM therapies are not covered by insurance.

About Dietary Supplements Dietary supplements were defined in a law passed by Congress in 1994. A dietary supplement must meet all of the following conditions: · It is a product (other than tobacco) intended to supplement the diet, which contains one or more of the following: vitamins; minerals; herbs or other botanicals; amino acids; or any combination of the above ingredients. · It is intended to be taken in tablet, capsule, powder, softgel, gelcap or liquid form. · It is not represented for use as a conventional food or as a sole item of a meal or the diet. · It is labeled as being a dietary supplement. Other important information about dietary supplements: · They are regulated as foods, not drugs, so there could be quality issues in the manufacturing process. · Supplements can interact with prescribed or over-the-counter medicines, and other supplements. · "Natural" does not necessarily mean "safe" or "effective." · Consult your health care provider before starting a supplement, especially if you are pregnant or nursing, or considering giving a supplement to a child.

CAM therapies are not the only alternatives to MHT to consider. Certain lifestyle changes can contribute to healthy aging, including during the menopausal transition. For example, quitting smoking, eating a healthy diet and exercising regularly have been shown to reduce the risks of heart disease and osteoporosis. Women may want to try one or more of these changes as well.

What Are Phytoestrogens?

Some botanical products, such as soy and red clover, are called phytoestrogens. Plants rich in phytoestrogens may help relieve some symptoms of menopause. However, it is uncertain whether this relief comes from actual estrogens or from other compounds in the plant. Much remains to be learned about these plant products, including exactly how they work in the human body. Doctors caution that certain women need to be particularly careful before using phytoestrogens, especially:

· Women who have had or are at increased risk for diseases or conditions that are affected by hormones, such as breast, uterine or ovarian cancer; endometriosis; or uterine fibroids

· Women who are taking drugs that increase estrogen levels in the body, such as birth control pills; MHT; or a type of cancer drug called selective estrogen receptor modulators (SERMs), such as tamoxifen

What Is the Scientific Evidence on the CAM therapies Considered by the NIH SoS Conference Panel?

The panel discussed the evidence on 10 of these therapies:

· Six botanicals — black cohosh, red clover, dong quai root, ginseng, kava and soy

· DHEA (dehydroepiandrosterone), a dietary supplement

· Exercise

· Paced respiration

· Health education

Readers can find science-based information on these or any CAM therapy that interests them through the National Center for Complementary and Alternative Medicine, a part of the National Institutes of Health, or the Pubmed database, which are listed in the "Additional Resources."

What Is Known About the Effectiveness and Safety of These Therapies for Menopausal Symptoms?

Very little well-designed research has been done on CAM therapies for menopausal symptoms. A small number of studies have been published, but they have had limitations (such as the way the research was done or treatment periods that may not have been long enough). As a result, the findings from these studies are not strong enough for scientists to draw any conclusions. Also, many studies of botanicals have not used a standardized (that is, chemically consistent) product. NCCAM is sponsoring a number of studies on botanicals using products that are both well characterized and well standardized (that is, their ingredients have been carefully studied and the dosages are controlled), and on other CAM therapies that have shown possible promise for reducing menopausal symptoms. The aim is to learn more about their safety and effectiveness and how they work in the body.

It is important to know that botanicals and other supplements can have side effects and can interact with herbs, other supplements or drugs. A small number of these issues are listed below.

Botanicals

· Black cohosh (Actaea racemosa, Cimicifuga racemosa). This herb has received more scientific attention for its possible effects on menopausal symptoms than have other botanicals. Studies of its effectiveness in reducing hot flashes have had mixed results. Recent research suggests that black cohosh does not act like estrogen, as once was thought. Black cohosh has had a good safety record over a number of years. Some concerns have been raised about whether it may cause liver problems, but an association has not been proven.

· Red clover (Trifolium pratense). The panel reported that five controlled studies found no consistent or conclusive evidence that red clover leaf extract reduces hot flashes. Clinical studies in women report few side effects, and no serious health problems have been discussed in the literature. However, there are some cautions. Animal studies have raised concerns that red clover might have harmful effects on hormone-sensitive tissue (for example, in the breast and uterus).

· Dong quai (Angelica sinensis). Only one randomized clinical study of dong quai has been done. The researchers did not find it to be useful in reducing hot flashes. Dong quai is known to interact with, and increase the activity in the body of, the anticoagulant drug warfarin. This can lead to bleeding complications in women who take this medicine.

· Ginseng (Panax ginseng or Panax quinquefolius). The panel concluded that ginseng may help with some menopausal symptoms, such as mood symptoms and sleep disturbances, and with one's overall sense of well-being. However, it has not been found helpful for hot flashes.

· Kava (Piper methysticum). Kava may decrease anxiety, but there is no evidence that it decreases hot flashes. It is important to note that kava has been associated with liver disease. The FDA has issued a warning to patients and providers about kava because of its potential to damage the liver.

· Soy. The scientific literature includes both positive and negative results for soy extracts on hot flashes. When taken as a food or dietary supplement for short periods of time, soy appears to have few if any serious side effects. However, long-term use of soy extracts has been associated with thickening of the lining of the uterus.

DHEA
DHEA (dehydroepiandrosterone) is a naturally occurring substance that is changed in the body to the hormones estrogen and testosterone. It also is manufactured and sold as a dietary supplement. The only randomized clinical trial of DHEA that has been done so far found no benefit for hot flashes. The NIH SoS conference panel added that a few small, nonrandomized studies have suggested that DHEA might possibly have some benefit for hot flashes and decreased sexual arousal, but this has not been confirmed. The side effects, risks and benefits of using DHEA for longer than a few months have not been well studied.

Concerns have been raised about whether DHEA is safe and effective. For this reason, NCCAM is providing additional information. DHEA has been used in conventional medicine for a range of health problems other than symptoms of menopause, but there is no good scientific evidence to support these uses. Because levels of natural DHEA in the body decline with age, some people believe that taking DHEA as a supplement can help treat or prevent conditions related to aging. However, there is no good scientific evidence to support this popular notion.

NCCAM does not recommend that consumers use over-the-counter DHEA supplements for any health concerns, including for menopausal symptoms. Little is known about the long-term safety of DHEA, and scientists are not certain whether it might increase the risk for breast or prostate cancer. Therefore, consumers who have questions about whether DHEA could be of benefit for their personal situation should discuss those questions with their health care provider.

Other CAM Therapies
The NIH SoS conference panel chose to address the three other therapies below, which they considered CAM "behavioral interventions." They noted that these treatments may be an important area for further research because they cause few, if any, health problems. However, their effectiveness has not yet been proven through large, well-designed studies.

Exercise has improved the quality of life in women with menopausal symptoms. However, it has not had any effect on vasomotor symptoms or vaginal dryness.

Paced respiration (also called paced breathing) is a technique of slow, deep breathing. One small study found that it appeared to be helpful for hot flashes.

Health education involves educating women about what to expect from menopause and what they themselves can do. It has been found to improve women's knowledge, but not to have effects on menopausal symptoms.

Does NCCAM Support Research on CAM for Menopausal Symptoms?

NCCAM supports a number of studies on CAM treatments for menopausal symptoms, as do some of the other institutes and centers at NIH. A few recent examples of NCCAM-funded projects include:

· An initiative to improve measures of hot flashes, which is expected to add to the understanding of hot flashes and to aid future clinical studies

· A study of whether black cohosh can help with the anxiety that may be experienced as a symptom of menopause

· A study to identify botanicals from Central America that have been used by the native population for menopausal symptoms and to develop and test standardized extracts from these plants

· Several studies looking at the effect of acupuncture on the recurrence and severity of hot flashes in postmenopausal women and other groups that suffer from hot flashes, such as men being treated for prostate cancer

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