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Menopause specialists warn against dangers of bioidentical hormone therapy

Menopause experts have issued a warning to women using bioidentical hormone therapy, claiming the treatment is highly ineffective, costly, and could put women at risk of cancer.

Sold as a menopause treatment, bioidentical hormone therapy is often marketed as a “natural” alternative to hormone replacement therapy (HRT) and is a combination of oestrogen, progestogen and other hormones.

Women are prescribed the treatment by a GP, and the prescription is then made into a cream, lozenge or implant by a compounding pharmacist (who customises the medication).

Experts say the appeal of the treatment is that it is marketed as a natural, tailor-made hormone therapy that is biologically identical to the hormones our bodies produce.

But endocrinologist Susan Davis, a professor of women’s health at Monash University and President of the International Menopause Society, has serious concerns about the treatment.

“The issue is that the dose is a best guess, the method of delivery has not been properly developed, it’s just a concept and therefore the levels that might get into the bloodstream might be negligible or enormous,” Dr Davis told RN Life Matters.

Elizabeth Farrell, a gynaecologist and medical director of Jean Hailes for Women’s Health, says for women who are prescribed the wrong dose of hormones, there are serious risks of endometrial cancer — a cancer that arises from the lining of the uterus.

“Inappropriate dosing can lead to use of inadequate progesterone to protect the endometrium, and increase the risk of endometrial cancer,” Dr Farrell said.

In September, a group of major international menopause bodies are set to release a global position statement warning against the use of compounding therapy.

Criticism of HRT

In 2002 when the Women’s Health Initiative study was released, HRT was flagged as a possible breast cancer risk, prompting many women to seek out alternative treatments.

“They were looking for some form of treatment … and these became marketed and pharmacies started compounding these substances, and doctors started prescribing them,” Dr Farrell said.

It is now, however, widely understood that the Women’s Health Initiative study was misleading.

“What it was saying was there was a risk of breast cancer, whereas now we know that the data was published really falsely and presented to the media in a way that women were frightened,” she said.

But Dr Davis says women are still wary of HRT and seeking alternatives like bioidentical hormone therapy.

What exactly are bioidentical hormones?

While bioidentical hormone therapy is marketed as “biologically matching” the hormones our bodies naturally produce, Dr Davis says several bioidentical approved products already exist, including HRT.

“So, the difference is the approved products have been tried and tested, and the doses ascertained by medical research,” she said.

In contrast, bioidentical hormone treatments are individually compounded and often contain “a mixture of things, a potpourii”.

“There’s a little bit of testosterone, a little bit of DHEA [dehydroepiandrosterone, a steroid hormone], a little bit of thyroid extract, and even a little bit of hydrocortisone, which is like adrenal production or cortisone,” Dr Davis said.

“The safety [of products] is of very serious concern”.

Additionally, the products are marketed as a natural, plant-derived alternative treatment, which Dr Farrell says is misleading.

“We can’t have a human hormone unless it’s been synthetically made in a laboratory, otherwise we’d be extracting hormones from human ovaries”, she said.

Like HRT, Dr Farrell says bioidentical hormones are synthetically made.

She also rejects the claim that treatment is individually tailored to patients, which she says is virtually impossible.

“If I could tailor a hormone therapy to women’s biology I would make a fortune,” she said.

Dr Davis added that bioidentical hormone therapy is much more expensive than HRT, which is an approved menopause treatment.

“I have one woman who sat my rooms and cried, she said she sold her car to pay for the cost over several years,” she said.

What harm can they cause?

There are a number of risks for women taking bioidentical hormones, says Dr Farrell, but her primary concern is the increased risk of uterine cancer.

Bioidentical hormone treatments are mainly creams, and progesterone does not get absorbed through the skin.

“The most important thing is the role of progesterone in protecting the endometrium of the uterus,” Dr Farrell said.

“If you’re having estrogen alone, and you have a uterus, and don’t have the added progesterone, there’s an increased risk of thickening of the lining of your uterus, and then over many years, the development of a uterine cancer.”

The unregulated prescribing of bioidentical hormone therapy also means there is a risk of excessive estrogen dosage, according to Dr Davis.

Dr Farrell said she was concerned some women with a history of breast cancer had been prescribed compounded pharmacy hormones.

“Now, we know that all hormones are contraindicated in women with breast cancer,” she said.

“There are exceptions where women suffer so severely that we might have to put them back onto some form of therapy — but that is a risk.”

Additionally, Dr Davis says some of the risks of using this treatment are still unknown.

“With an approved product, we can monitor it,” she said.

“These are all on private prescription — we don’t even know how much is it being dispensed.”

Why are they being prescribed?

It’s GPs who are doing the majority of prescribing, says Dr Davis, despite major medical societies having condemned the use of the treatments.

She said some GPs were “mis-informed” about the risks of bioidentical hormone therapy, and called for greater education among medical practitioners.

Dr Davis has also called on the Therapeutic Goods Administration (TGA) to follow the lead of the Food and Drug Administration (FDA) in the US.

“The FDA have strong statements warning against … the practice, but in Australia the TGA says it’s not in the jurisdiction because it’s not an approved product.”

In a statement, the TGA said:

“Medicines that are extemporaneously compounded by a pharmacist for individual patient use are not required to be on the Australian Register of Therapeutic Goods (ARTG) and therefore, have been not been assessed for safety and efficacy.”

The TGA also said that the Pharmacy Board of Australia (PBA) was the relevant body when it comes to “developing standards … and guidelines on compounding of medicines and guidelines on dispensing of medicines.”

The PBA and the Pharmacy Guild of Australia both have guidelines stating that pharmacists should “compound a medicine only when an appropriate commercial product is unavailable or unsuitable”.

But Dr Davis says because of both the PBA and PGA’s reluctance to call out practitioners not following the guidelines, “the situation that has fallen through the cracks”.

She added that she would like to see the Australian Medical Board doing more to address this issue.

In response, a spokesperson for the Medical Board of Australia said: “The Medical Board of Australia is very concerned about unsafe treatments that put patients at risk. We have just consulted on draft guidelines that aim to more clearly regulate practitioners who provide complementary and unconventional medicine and emerging treatments. These guidelines would deal directly with the issues raised.”

The Royal Australian College of General Practitioners was contacted but declined to comment.

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