Natural treatments for menopause

DEFINITION: Treatment of symptoms related to the cessation of a woman’s menstrual cycle.

• PRINCIPAL PROPOSED NATURAL TREATMENTS: Black cohosh, isoflavones, soy

• OTHER PROPOSED NATURAL TREATMENTS: Acupuncture, alfalfa, chasteberry, dehydroepiandrosterone, dong quai, estriol, evening primrose oil, flaxseed, gamma oryzanol, grass pollen, licorice, lignans, oligomeric proanthocyanidins, Pueraria mirifica, progesterone cream, red clover, royal jelly, St. John’s wort, suma, traditional Chinese herbal medicine, vitamin C, vitamin E, yoga

Introduction

Hormonal changes during menopause can produce a variety of symptoms—hot flashes, vaginal dryness, night sweats, anxiety, depression, and insomnia. Many of these symptoms are undoubtedly caused by the natural decrease in estrogen production that occurs during menopause, but the human body is so complex, other hormonal factors also play a role.

Hormone replacement therapy (HRT) is a common treatment that can alleviate many problems associated with menopause. However, it creates counterbalancing risks. One of the more severe issues is the increased risk of breast cancer and uterine cancer that appears to be associated with replacement estrogen. In addition, HRT can cause blood clots in the legs, and it appears to raise the risk of heart disease rather than lower it (as previously thought). The decision to use HRT for menopausal symptoms should involve a careful examination of the risks and benefits in consultation with a physician.

Principal Proposed Natural Treatments

Several natural treatments, compared to a placebo, may reduce menopausal symptoms. (The comparison is essential, as a placebo itself is dramatically effective for menopause, generally reducing the rate of hot flashes by fifty percent.) It is not known if any of these treatments reduce the risk of osteoporosis.

Soy and soy (or other source) isoflavones. Both soy and red clover contain phytoestrogens (naturally occurring substances with estrogen-like actions) called isoflavones. It is thought that the isoflavones in these herbs may offer some benefits of estrogen with less risk. However, the evidence base for this hypothesis is conflicting.

Improvements in hot flashes and other symptoms, such as vaginal dryness and mood, have been seen in many studies of soy, mixed soy isoflavones, aglycone isoflavones, and the isoflavone genistein alone. However, many studies of soy or concentrated isoflavones have failed to find significant benefit compared to a placebo.

For example, a double-blind study of 247 women with menopausal hot flashes compared the effects of the placebo and genistein over a period of one year. The results indicated that the use of genistein significantly reduced hot flashes compared with a placebo. In addition, isoflavones from red clover have shown inconsistent results in studies, with the best and largest study finding no benefit.

What can one make of this mixed evidence? One problem here is that the placebo treatment has a strong effect on menopausal symptoms. In such circumstances, statistical “noise” can easily drown out the real benefits of a treatment under study. Unlike estrogen, which has such a powerful effect on hot flashes and other menopausal symptoms that its benefits are almost always clear in studies, soy and concentrated isoflavones likely have a modest effect, one that does not always show itself above the background noise of statistical variation. It has also been suggested that the placebo used in many of these studies, polyunsaturated fatty acids, may have efficacy of its own; this would tend to hide actual benefits.

Another explanation may be that certain women benefit from soy isoflavones more than others. In about one-third of people, isoflavones are converted by intestinal bacteria into a substance called equol. A minimum of two studies suggests that these equol producers may experience greater reduction in their menopausal symptoms than non-equol producers.

Evidence regarding whether soy or soy isoflavones are helpful for osteoporosis remains conflicting. On balance, it is probably fair to summarize evidence as indicating that isoflavones (either as soy, genistein, mixed isoflavones, or tofu extract) have a modestly beneficial effect on bone density. One small but long-term study suggests that progesterone cream (another treatment proposed for use in preventing or treating osteoporosis) may decrease the bone-sparing effect of soy isoflavones.

Black cohosh. The herb black cohosh is widely used for treatment of menopause, but the evidence that it works remains incomplete and inconsistent. The best study was a twelve-week, double-blind, placebo-controlled trial of 304 women with menopausal symptoms. This study appeared to find that black cohosh was more effective than the placebo. The best evidence was for a reduction in hot flashes. However, the statistical procedures used in the study were somewhat unusual and open to question.

During menopause, which may last for several years, estrogen production diminishes; after menopause, estrogen is no longer produced by the body.

Promising results were also seen in a three-month double-blind study of 120 menopausal women. Participants were given either black cohosh or fluoxetine (Prozac). Over the course of the trial, black cohosh proved more effective than fluoxetine for hot flashes, but fluoxetine was more effective than black cohosh for menopause-related mood changes.

Earlier, smaller studies have found improvements not only in hot flashes but also in other symptoms of menopause. For example, in a double-blind, placebo-controlled study, ninety-seven menopausal women received black cohosh, estrogen, or a placebo for three months. The results indicated that the herb reduced overall menopausal symptoms (including hot flashes) to the same extent as the drug. In addition, microscopic analysis showed that black cohosh had an estrogen-like effect on the cells of the vagina. This is a positive result because it suggests that black cohosh might reduce vaginal thinning. However, black cohosh did not affect the cells of the uterus in an estrogen-like manner; this too is a positive result, as estrogen’s effects on the uterus are potentially harmful. Finally, the study found hints that black cohosh might help protect bone. However, a great many of the study participants dropped out, making the results less than reliable.

One study, too small to have reliable results from a statistical point of view, found black cohosh just as effective as 0.6 mg daily of conjugated estrogens. One study found that black cohosh has weak estrogen-like effects on vaginal cells and possible positive effects on bone (specifically, stimulating new bone formation).

A substantial (244-participant) double-blind study compared black cohosh with the synthetic hormone tibolone and found them equally effective for treating menopausal symptoms. Though not approved as a drug in the United States, tibolone does appear to be effective for menopausal symptoms, and, therefore, these results are somewhat promising. However, this study lacked a placebo group, and because the placebo effect is powerful for menopausal symptoms, this omission significantly reduces the meaningfulness of the results.

One double-blind study evaluated a combination therapy containing black cohosh and St. John’s wort in 301 women with general menopausal symptoms and depression. The results showed that the use of the combination treatment was significantly more effective than the placebo for both problems. A smaller study using a combination of the same two herbs found improvements in overall menopausal symptoms and in cholesterol profile.

In contrast, there have been several studies that failed to find benefit. For example, in a twelve-month, double-blind, placebo-controlled study of 350 women, participants were given either black cohosh, a supplement containing ten herbs, the multibotanical plus soy, standard hormone replacement therapy, or placebo. The results showed significant benefits compared with placebo for hormone replacement therapy, but only slight, nonsignificant benefits with the other treatments. In addition, a double-blind study of 122 women failed to find statistically significant benefits with black cohosh compared with placebo, as did another study enrolling 132 women and one double-blind, placebo-controlled study that involved 124 women given a black cohosh-soy isoflavone combination. These negative outcomes were quite possibly caused by the relatively small sizes of the black cohosh groups. In a condition like menopausal symptoms, where the placebo effect is strong and treatment is relatively weak, large numbers of participants are necessary to show benefit above and beyond the placebo effect. Nonetheless, this is an impressive number of negative studies, and some question must remain about the efficacy of this herb. Black cohosh may be modestly effective, however, for reducing hot flashes and other symptoms of menopause, but doubts remain.

Some information has developed regarding how black cohosh might work. In the past, the herb was described as a phytoestrogen. However, subsequent evidence indicates that black cohosh is not a general phytoestrogen, but that it may act like estrogen in only a few parts of the body: the brain (reducing hot flashes), bone (potentially helping to prevent or treat osteoporosis), and possibly the vagina (alleviating dryness and thinning). It does not appear to act like estrogen in the breast or the uterus, as estrogen is carcinogenic in those tissues. If this theory is true, black cohosh is a selective-estrogen receptor modifier, somewhat like the drug raloxifen (Evista). However, more evidence is needed.

Other Proposed Natural Treatments

Grass pollen extracts have shown promise for treatment of benign prostate enlargement. Their benefits in that condition may result from a hormonal effect. On this basis, grass pollens have been proposed for treatment of menopausal symptoms. One double-blind, placebo-controlled study followed fifty-four women with menopausal symptoms and found benefits with a supplement containing grass pollen extract.

The herb Pueraria mirifica, which contains numerous phytoestrogens, is promoted as an effective treatment for menopausal symptoms. In one double-blind study, the herb showed promise for improving vaginal dryness. In another trial comparing P. mirifica to standard estrogen treatment (0.625 mg conjugated equine estrogen), researchers found the herb to be equally effective at relieving a range of menopausal symptoms. In addition, another double-blind study found benefit with a combination product containing standardized extracts of black cohosh, dong quai, milk thistle, red clover, American ginseng, and chasteberry.

For many years, the hormone progesterone (“natural progesterone,” as distinguished from the synthetic progestins used in birth control pills and HRT) was aggressively promoted by some alternative medicine practitioners as the true cure for osteoporosis. However, at that time, there was no meaningful evidence that progesterone helps prevent osteoporosis (these claims were based largely on anecdotes, plausible reasoning, and “studies” that did not come close to modern scientific standards). When the subject was finally studied properly, the first results indicated that progesterone does not work for osteoporosis after all. However, it may work for other menopausal symptoms. A one-year, double-blind, placebo-controlled study of 102 women found that cream containing twenty mg of the hormone progesterone may be effective against hot flashes, though it did not appear to protect bone from breakdown. However, another double-blind trial failed to find thirty-two mg daily effective for osteoporosis or any other menopause-related symptoms.

The hormone dehydroepiandrosterone (DHEA) has been tested as a treatment for menopausal symptoms, with some promising results in a small, preliminary trial. Because it is a naturally occurring hormone, there has been some concern regarding the safety of supplemental DHEA. However, a placebo-controlled trial with ninety-three postmenopausal women found DHEA supplementation for one year was not associated with increased adverse endometrial effects or changes in blood lipids or insulin sensitivity. Another, double-blind study found benefit with a mixture of isoflavones, lignans and black cohosh.

A small double-blind study conducted in Iran reported that vitamin E was more effective than placebo for treating menopausal hot flashes. However, a larger study in the United States failed to find vitamin E significantly helpful for hot flashes associated with breast cancer treatment.

An extract (HPE) made from human placenta is used in South Korea and other areas of East Asia as a treatment for numerous conditions. One study compared HPE with normal saline solution for treating menopause. In this eight-week trial, participants were given either normal saline or HPE as a subcutaneous injection through the skin of the abdomen. The results appear to indicate that HPE might improve some symptoms of menopause.

Evidence that is far too weak to be relied upon has been quoted in support of flaxseed, gamma oryzanol, multivitamin-multimineral combinations, and St. John’s wort. Other proposed treatments that lack meaningful supporting evidence include bioflavonoids, chasteberry, licorice, suma, and vitamin C. In one trial, a combination of St. John’s wort and chasteberry for sixteen weeks failed to produce any significant benefit compared with placebo in one hundred women with hot flashes.

Evidence regarding whether acupuncture might improve menopausal symptoms remains unconvincing. For example, one study that appears on the surface to be well designed found no benefit in the placebo group. This is so unusual as to cast significant doubt on the results. Another pilot study found no significant difference between the sham (fake) acupuncture and real acupuncture for hot flashes. A small, placebo-controlled study among women with breast cancer who also had hot flashes because of their treatments did suggest some benefit for acupuncture, though the results were inconclusive. Two studies involving 462 postmenopausal women each concluded that acupuncture, when added to usual self-care, effectively reduces the frequency of hot flashes for a minimum of two months. This effect may only be short-term, however. In one of these studies, researches reevaluating participants at six and twelve months found the acupuncture group was no better than the group who received only self-care.

A double-blind, placebo-controlled study of questionable validity reported benefits in “all menopausal symptoms” through the use of oligomeric proanthocyanidins from pine bark. Also, it has been suggested that royal jelly is beneficial for menopausal symptoms, but there is little evidence to support this claim. The same is true regarding traditional Chinese herbal medicine for menopause. One study has been widely reported as proving the effectiveness of a particular Chinese herbal formula, but it lacked a placebo group. Another study failed to find the Chinese herb Pueraria lobata helpful for menopausal symptoms. Some evidence suggests that evening primrose oil, dong quai, and ginseng are not effective for menopausal symptoms. The herb alfalfa contains strong phytoestrogens. This might make it helpful for menopause, but no studies have been reported.

One double-blind, placebo-controlled study failed to find melatonin more helpful than placebo for menopausal symptoms. (Actually, placebo did a little better than melatonin in this study.) Another study failed to find that ginkgo improved mood, general energy level, or mental function in menopausal women.

Heavy exercise causes increased calcium loss through sweat, and the body does not compensate for this by reducing calcium loss in the urine. The result can be a net calcium loss so great that it presents health concerns for menopausal women. One study found that the use of an inexpensive calcium supplement (calcium carbonate), could be sufficient to offset this loss.

In a randomized, controlled trial, eight weeks of daily supervised yoga was modestly more effective than a similar amount of supervised physical exercise in relieving menopausal symptoms (such as hot flashes), decreasing psychological stress, and improving cognitive abilities among 120 women. Another study failed to find exercise helpful for reducing menopausal symptoms.

Estriol: A Safer Form of Estrogen?

Some alternative medicine practitioners have popularized the use of a special form of estrogen called estriol, claiming that, unlike standard estrogen, it does not increase the risk of cancer. However, this claim is unfounded.

There is no real doubt that estriol is effective. Controlled and double-blind trials have found oral or vaginal estriol effective for reducing hot flashes, night sweats, insomnia, vaginal dryness, recurrent urinary tract infections, and osteoporosis.

Estriol might cause less vaginal bleeding as a side effect than other forms of estrogen, but this has not been proven. However, like other forms of estrogen, oral estriol stimulates the growth of uterine tissue. This leads to a risk of uterine cancer. In a placebo-controlled study of 1,110 women, uterine tissue stimulation was seen among women given estriol orally (one to two mg daily) compared to those given placebo. Another large study found that oral estriol increased the risk of uterine cancer. In another study of forty-eight women given estriol one mg twice daily, uterine tissue stimulation was seen in the majority of cases.

In contrast, a twelve-month double-blind trial of oral estriol (two mg daily) in sixty-eight Japanese women found no effect on the uterus. It may be that the high levels of soy in the Japanese diet altered the results. Additionally, test-tube studies suggest that estriol is just as likely to cause breast cancer as any other form of estrogen. Women who are considering using estriol should think of it as equivalent to any other form of estrogen.

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