HRT and menopause treatments

Negative publicity about HRT led to a flood of alternatives. Do they work?
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  • Updated:20 Jan 2009

01 .Introduction


In brief

  • For many women suffering moderate to severe symptoms of menopause, the benefits of HRT are likely to outweigh the risks.
  • Of the alternatives to HRT, black cohosh appears to be the most effective option, and is also among the cheapest.
  • Health authorities have warned women to avoid using bio-identical or 'natural' hormones.
  • Clinical trials in China have found that Chinese herbal medicines are effective at reducing the symptoms of menopause, but there's no "one-size-fits-all" remedy.

In 2002, a major American study involving hormone replacement therapy – the Women’s Health Initiative (WHI) trial – was stopped early because researchers were concerned about the increased incidence of breast cancer, heart disease and blood clots among women taking the hormones.

The ensuing media frenzy prompted many women to abandon the treatment, instead either putting up with the discomfort caused by menopause symptoms, or perhaps turning to alternatives.

CHOICE re-examines the WHI study and its implications in light of new analyses of the research, and weighs up the various alternatives.

Please note: this information was current as of January 2009 but is still a useful guide today.

Pros and cons of HRT

One of the main criticisms of the 2002 Women’s Health Initiative (WHI) study is that the subject women ranged in age from 50-79, with an average age of 63, yet the average age at which women experience menopause is 51, so the majority had no symptoms and were taking HRT many years after menopause.
With this in mind, the results have been reanalysed, taking the age of women into account. In particular, the reanalysis focused on women under 60 – those most likely to use HRT to reduce symptoms at or near the time of menopause.

Breast cancer

That HRT increases the risk of breast cancer isn’t denied. However, that increased risk is small in absolute terms. Analysis of the WHI study found that among women in their 50s who took HRT for the first time, there was no increase in the risk of getting breast cancer.

After more than five years, the risk appears to increase, and is comparable with the increased risk of that of women who:

  • Had their first pregnancy after the age of 35.
  • Drink more than two alcoholic drinks a day.
  • Are overweight (have a body mass index of 25-30)

Within five years of stopping HRT, the risk returns to normal levels. Some epidemiological studies have reported that rates of breast cancer have decreased among women over 50, coinciding with decreased use of HRT since the WHI uproar.

Blood clots

There is concern about HRT and the increased risk of blood clots either in the lungs or presenting as deep vein thrombosis, especially among women who are obese or have other risk factors for clotting – something for which women should ideally be screened before commencing therapy.

Cardiovascular disease

Among the younger group, it was concluded that HRT doesn’t increase the risk of cardiovascular disease, and may in fact reduce it. However, there’s evidence that if HRT is started when women are older and already have cardiovascular disease, it can increase the risk of cardiac events.

Reducing the risks

There are ways of reducing the risks of side-effects, including lowering HRT doses, using oestrogen-only therapy (only women who’ve undergone hysterectomy) and starting HRT near menopause. There’s some evidence that using skin patches, rather than tablets, can reduce the risk of clots.

Apart from reducing the severity of symptoms associated with menopause, the benefits of HRT include a reduced rate of fractures related to osteoporosis, although the risk returns to normal after HRT is stopped, and reduced rates of colorectal cancer.

Essentially, it’s up to individual women, in consultation with their doctor, to weigh up their personal risks versus the potential benefits of taking HRT, the most significant of which being a reduction (not necessarily elimination) of menopause symptoms.

What about 'natural' hormones?

Uncomfortable with taking so-called synthetic hormones in HRT, many women prefer the idea of 'natural' or bio-identical hormones. Some swear by them, finding they’re very effective at relieving menopause symptoms. A doctor tests your blood or saliva for hormone levels and tops them up to so-called natural levels by having a compounding pharmacist tailor-make a preparation for you.

They’re more expensive than HRT, partly because they’re not subsidised by the government. And some medical authorities, including the Jean Hailes Foundation for Women’s Health warn against them.

The main risk with bio-identical hormones is that they’re not regulated in the same way as other hormonal treatments, and the pharmacists making the preparations aren’t required to abide by the conduct codes of Medicines Australia (the peak body for pharmaceutical companies). They could be ineffective, or worse, dangerous. One major concern is uterine cancer, due to the ineffectiveness of progesterone in opposing the effects of oestrogen on the endometrium. Several such cases have been reported.

Legal loopholes mean they may also contain hormones that aren’t approved by the Therapeutic Goods Administration (TGA) for use in Australia. Critics also point out that just because the hormones come from natural sources such as yam or soy, by the time the active hormone is extracted it’s chemically no different from the equivalent so-called synthetic hormone in HRT, which also happens to be extracted from natural sources – yam, soy or horse urine.

The TGA is considering regulating compounding pharmacists, and hormones that are not approved by the regulator would be banned.


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02.Herbal remedies - are they effective?


We found more than 20 herbal remedies on the market that claim to relieve the symptoms of menopause. Following are some of the main ingredients and their likely effectiveness.

  • Black cohosh This North American root and rhizome is the most well-researched herbal product on the market. However, the results of clinical trials are mixed, with some studies finding it’s better than a placebo and others finding that while symptoms are indeed reduced, the effect is not much better than a placebo.

    Two studies testing a preparation of St John’s wort combined with black cohosh found the treatment improved menopausal symptoms, with one study also reporting improvements in depression. In Australia, the market-leading black cohosh product is Schaper & Brummer Remifemin. Flordis’ Femular is another such product. Several products contain black cohosh mixed with other ingredients.
  • SoySoy isoflavone extracts Both Blackmores Phytolife and Herron Menopause Relief contain soy isoflavones as their main active ingredient. In some products they’re mixed with other ingredients. Soy extracts came to prominence after it was observed that Asian women, who typically eat a lot of soy, don’t experience the same discomfort from menopausal symptoms as Western women. While it’s possible this has a cultural basis, or could have more to do with the relatively high vegetable/low meat intake of Asian women, soy’s mild oestrogenic properties could be at least partly responsible.

    A review of studies of soy extracts found that about half had evidence they helped, and half didn’t. The differences in results could not be explained by the quality of studies, dosage or severity of symptoms. The contradictory evidence makes it difficult therefore to provide an overall conclusion. It’s suggested that about one in three people respond better to these isoflavones than others, because they are able to convert one of the isoflavones, daidzein (which is also in red clover extracts, below), into equol, a more potent oestrogenic substance.
  • CloverRed clover isoflavones Like soy, red clover is a legume rich in isoflavones. There is some evidence it works, but it’s not conclusive. While a few small studies, of questionable quality and/or funded by the manufacturer, concluded it was effective in reducing symptoms, a placebo was also found to be effective. An analysis of results pooled from all available studies found there was no difference between red clover supplements and a placebo. The market-leading red clover product in Australia is Novogen Promensil.
  • Other herbs Dong quai root, licorice root, maca, evening primrose oil, Vitex agnus-castes (chaste tree), sage leaf, wild yam root (in tablets and topical creams) and ginseng are found in menopause herbal treatments, with a strong history of use in traditional medicine. However, scientific evidence for their effectiveness is lacking. A very small, short-term study of maca found it reduced anxiety and depression in menopausal women. A study of dong quai found it was no better than a placebo, but in Chinese medicine it’s usually combined with other herbs.

Traditional Chinese medicine

Clinical trials in China of Chinese herbal medicines have found them very effective in reducing the symptoms of menopause. As traditional Chinese medicine (TCM) becomes more popular in the West, Chinese herbs are becoming more widely researched.

The main stumbling block for TCM in Western evidence-based medicine is that there’s no one-size-fits-all formulation that can be tested for its ability to treat particular symptoms. Some companies have attempted to make a standard Chinese medicine formulation in a pill or similar, based on a combination of typically used herbs. One study of such a preparation showed it was no more effective than a placebo.

However, this doesn’t surprise TCM experts, who argue that women experience menopause differently and require different herbal combinations. A qualified TCM practitioner assesses each woman and her symptom profile and prescribes particular herbs accordingly.

Trials conducted in China operate according to the same principle; researchers look at herbal preparations (which are raw herbs, not pills) and if necessary they are altered over the course of the study according to individual responses – a very different approach from Western clinical trials.

Reviewing the evidence

We approached 13 companies that market herbal treatments that claim to relieve the symptoms of menopause, and asked them to provide evidence for these claims – eight responded, although one, Totally Natural Products, declined to provide information. The five companies who did not respond are Ethical Nutrients, Greenridge, Microgenics, Nature’s Way and Naturopathica (MenoEze).

Evidence from Blackmores, Flordis, Herron, Novogen and Schaper & Brummer was mainly in the form of clinical trials showing their respective active ingredients were effective. However, as noted previously, some studies have found these ingredients not so effective.

Clear Menopause and Fusion Health Menopause Free are multi-ingredient preparations with several active ingredients. The evidence provided by these companies was mainly in the form of references to traditional herbal pharmacopaeias. There were some references to clinical trials, but for individual ingredients only, so if you want to use either of them you won’t know if the product as sold has been proven to work in clinical trials.

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