Introduction

Menopause can be a smooth transition--sometimes. In some women, however, menopause can be a bumpy road. Although menopause is not new, doctors actually have very little research to rely on when counseling women about what to expect.

Women frequently ask what symptoms they can anticipate during menopause. In reality, each woman experiences menopause differently. While one woman is certain that insomnia is a symptom of menopause for her, another is certain that joint aches are her symptom of menopause. Doctors are not even able to tell women what to expect because research into the symptoms of menopause is in its infancy. Moreover, it is not understood how menopause causes many of the symptoms. For example, medical science cannot explain how the declining hormone levels of menopause could cause joint aches.

Menopause is not a disease but a natural transition, yet many of the symptoms of menopause also may be caused by diseases. We are not always certain which symptoms are due to menopause, and women differ in their symptoms. How, then, do we decide when women undergoing menopause need treatment in the first place? The same pattern of hot flashes in two different women can have a very different psychological impact. For one woman, they can disturb her daily functioning greatly, but for another, they may hardly be bothersome.

Generally, the symptoms of menopause can be divided into early (in the process of menopause) and late symptoms. Treatment is directed toward the particular symptoms that are present. Early symptoms include abnormal vaginal bleeding , hot flashes, and mood changes. Late symptoms include vaginal dryness and irritation, osteoporosis , and heart disease.

What are hot flashes?

Hot flashes are experienced by many but not all women undergoing menopause. A hot flash is a feeling of warmth, sometimes associated with flushing, that spreads over the body and may be accompanied by perspiration. Menstruating women in their 40's often develop hot flashes. Hot flashes may last for a decade or more in some women. There is no way to predict when hot flashes will cease in an individual woman; however, they decrease in frequency with time. Although the cause of hot flashes is not completely understood, they may be related more to the fluctuations of hormone levels as opposed to low hormone levels per se.

Traditionally, hot flashes have been treated with either oral (by mouth) or transdermal (patch) forms of estrogen. Both oral and transdermal estrogen are available either as estrogen alone or estrogen combined with progesterone. All available prescription estrogen replacement medications, whether oral or transdermal, are effective in reducing the frequency of hot flashes and their severity. Generally, these medications decrease the frequency of hot flashes by about 80 to 90%.

How are hot flashes usually treated?

The treatments discussed below are divided into prescription and non-prescription treatments for hot flashes. Nothing so far has been more effective than estrogen replacement in relieving hot flashes, but some other treatments work as well or nearly as well.

This background information is important in being able to evaluate research about treatments for hot flashes. In research that is scientifically well-designed, women take either medication or a placebo (sugar pill). Neither the researcher nor the woman volunteering for the study knows which she is taking. (This is called a double-blind study.) However, the interesting thing is that in almost every study of treatments for menopause that includes a sugar pill, the sugar pill provided 20% to 50% relief of hot flashes after about 4 weeks. There is obviously much to be understood about why this occurs and how to "tap into" the tremendous power that the brain seems to have over hot flashes.

How are prescription medications evaluated?

To be able to recommend a prescription medication for hot flashes, a physician has to first conclude that the medication works. There are many herbal remedies available for menopause symptoms; the number of different pills is overwhelming. The remedies may work, and they may work well; however, most of them have not been studied in a proper type of research study. A proper research study has certain requirements, outlined below.

Which prescription medications are effective in treating hot flash symptoms of menopause?

A few prescription medications, in addition to estrogen, have been tested scientifically. They are listed below. It should be noted that none of these medications is approved by the U.S. Food and Drug Administration (FDA) for the treatment of hot flashes.

Why are some doctors reluctant to recommend nonprescription therapies for menopause symptoms?

Nonprescription products are not controlled by the FDA because they are considered food supplements by law. Because they are not regulated like prescription medications, their ingredients and potency vary from manufacturer to manufacturer and even from bottle to bottle from the same manufacturer. Also, careful testing and proof of safety is not required as it is with prescription medications. (The only way the FDA can recall a nonprescription product is by proving that it is dangerous!) Furthermore, there are so many nonprescription products available that a doctor cannot possibly know exactly what is in each preparation. Moreover, not one of these products has been proven to be safe!

So, how well have the nonprescription alternatives to hormone therapy been tested? Not one study has adhered to all of requirements listed above that are necessary for approval of prescription medicines. Women deserve better! Specifically, sugar pills have not been included in most of the studies. Therefore, it is not possible to know if the product worked at all. Any effects seen with the product might have been seen with a placebo. Second, many studies evaluated women who were taking products without supervision. Obviously, these women were aware that they were taking something to improve their symptoms. Thus, the element of objectivity was eliminated, and bias was introduced. Third, available studies have been for only a few months. Physicians do not want to recommend a product that hasn't been proven safe over the long-term. Lastly, each study seems to have a different way of judging whether the medication helps. Some analyze hot flashes alone while others evaluate a group of symptoms without specifically segregating out hot flashes. Other studies examine multiple but individual symptoms. Even the studies that evaluate hot flashes may record different factors; the number of hot flashes per day, the severity of the hot flashes, or the duration of the hot flashes, etc. It is confusing, even for doctors who are experts in the field, to evaluate these studies and properly counsel women.

What alternative treatments for menopause have been scientifically studied?

The alternative treatments for menopause that have been studied in well-designed trials include black cohosh, dong quai, oil of primrose, vitamin E, and soy. The following comments refer only to well-designed studies of hot flashes.

Black cohosh does not work any better than a sugar pill, but on the other hand, it seems to be safe in the short-term (up to 60 days). It can, however, cause gastrointestinal symptoms. The one good study that was done found no benefit of dong quai as compared to a sugar pill. The active ingredient of oil of primrose was not effective and may cause nausea. Vitamin E worked, but the difference between vitamin E and sugar pills was only one hot flash per day. Vitamin E caused no side effects over the few months of the study.

Several studies of soy have shown relief of hot flashes, but several of the most recent studies have suggested that soy does not relieve hot flashes. Perhaps this is because soy is not available by prescription. Thus, the ingredients and potency of the products vary from study to study and manufacturer to manufacturer. Soy contains hormones, and it may be the hormones, that are relieving the hot flashes. Therefore, women should not think that taking soy is an alternative to hormones. Although women from countries that consume a lot of soy tend to have lower rates of breast cancer , a few studies have shown that an active ingredient of soy actually causes breast cells to multiply. Thus, the safety of soy in the long-term is in question.

On a final note, wild yam cream contains progesterone. The oral prescription form of progesterone may increase breast cancer risk, but there is no information on safety and effectiveness of yam progesterone in well-designed research

Conclusion

Doctors obviously must make decisions on how to counsel women about non-prescription products that are worth trying. Yet they must consider the lack of research on the long-term safety and effectiveness of such products. If a woman has decided that she wants to try a non-prescription product and asks a doctor's opinion, the most cautious approach would be to conclude that vitamin E may work very well and is safe over the short-term, but may not work much better than a sugar pill. The other products either do not work, cause side effects, or have not been adequately evaluated scientifically. Soy may work, but it does contain hormones and its long-term safety is unknown.

Alternatives for Treating Hot Flashes In A Glance