ARE ‘BIO-IDENTICAL’ HORMONES SAFE AND ARE THEY NATURAL?

December 11, 2011 by  
Filed under Health Blog, Healthy Lifestyle

Standard, synthetic hormone replacement therapy (HRT) made worldwide headlines when a study released in 2002 found it increased the risk of breast cancer, heart attacks, and strokes.

Indeed, the study had to be stopped prematurely due to the dangers that HRT posed to women. Therefore, vast numbers of women that were using synthetic HRT’s such as Premarin, Prempro, Provera and other similar pharmaceutical hormone treatments at the time, were stopping therapy in their droves and began seeking safer alternatives. Some women turned to bio-identical hormones. However, are the so-called natural, ‘bio-identical’ hormone treatments any safer and are they really ‘natural’? I’ll let you decide.

On the ABC show, Catalyst (16/08/2007), they ran a story titled ‘Natural HRT – magic bullet or clever con?’ This story illustrated the dangers of these so-called ‘natural’ hormones know as ‘Bio-Identical’ hormones. The story recognized that the general public are being led to believe that these bio-identical hormones are totally natural and safe –but it seems this could not be further from the truth. So let’s take a look at the results of this investigation:

One doctor that prescribes these so-called “natural alternatives” stated that the word ‘bio-identical’ just means that the hormones used are the same shape and structure as the ones that we produce in our bodies. However, if these hormone treatments are synthesized from chemicals and are not 100% derived from plant sources, how are they ‘all natural’?

So What Exactly Are ‘Bio-Identical’ Hormones?

They are chemical substances that have been derived from molecules taken from plant sources, such as soy or yams (Dioscora composita), but they are then biochemically converted to molecules that are supposedly identical to human hormones. The term “natural” is actually based on the chemical structure of the molecules – not their source. In other words, although one stage of the manufacturing process involves deriving molecules from plants, the rest of the process does not – and the industry does not seem to be very forthcoming with information about the rest of the chemical processes involved with the synthesis of these hormone therapies. It seems misleading that the general public would believe that they were receiving a naturopathic or herbal treatment when in fact it appears to be nothing of the sort.

The claims from those involved in the ‘Bio-Identical’ hormone industry are that they are much safer than synthetic hormone replacement therapy (HRT), which has been proven to increase the risk of heart disease, strokes and cancer. However, one lady that was interviewed on Catalyst (16/08/2007), doesn’t believe that ‘Bio-Identical’ hormones are safe at all – in fact she almost died from taking these so-called safe and natural hormones:

“I was a code blue” (which means that a patient is close to dying). “I remember they cut my beautiful nightgown off. There was a nurse kneeling on the bed holding an oxygen bottle to my face.” Without warning, a large blood clot in this lady’s groin exploded sending hundreds of tiny clots through her body and causing her lungs to collapse. The explanation given by the doctor for this woman’s collapse was due to the massive doses of testosterone that were in the tablets she was taking (which were ‘Bio-Identical’ hormones).

One doctor interviewed on Catalyst believed that these situations are inevitable given the lack of testing of these hormones. He stated that  “There’s no independent regulated quality control, such as the therapeutic goods administration of the hormones coming in – or of the actual compounding”. The doctor was also concerned about the concentrations of the hormones and mixtures that have never been tested for their safety and long-term efficacy, and therefore felt that they were dangerous.

Catalyst explained that ‘Bio-identical’ hormones aren’t pre-packaged like most drugs. They’re individually made up in compounding pharmacies. The question was asked about whose job it was to monitor the use of these unapproved hormones:

The Therapeutic Goods Administration (TGA) says it’s their job to set standards for drug companies, however, compounding pharmacies don’t need to comply with these standards.

The doctor on Catalyst stated that “It’s very disconcerting that we don’t have adequate TGA regulation. This industry is based on pseudo-science and monetary gain at the disadvantage of menopausal women. I believe it is a scam”. He went on to say that “They make incredible claims that I feel they’re completely un-validated. It’s very important to know that the bio-identical hormones have not been tested in legitimate double blind randomised controlled trials that we would expect of any product”.

The doctor also commented that “The main scientific societies around the world including the International Menopause Society, the American Menopause Society and the Australasian Society are all very concerned about the safety and efficacy of bio-identical hormones and they advocate that women should not use them”. The doctor also said “I think it’s very important that women who have been taking bio-identical hormones ask themselves, were they informed fully that there were the same risks for this type of hormone therapy as conventional hormone therapy and were they told that the actual products they’re using have not been fully tested”.

Catalyst also pointed out that late last year the Australian Competition and Consumer Commission launched action against the ‘Menopause Institute of Australia’. They admitted to making around 75 medical claims about “natural” hormones that were misleading and deceptive. However, others are still making false statements and therefore, many people continue to mistakenly believe that they are receiving a herbal or naturopathic hormone treatment.

An article in The Sydney Morning Herald (Chantal Rumble, August 16, 2006) also slammed the so-called ‘natural Bio-Identical’ hormone therapy industry:

This is an extract from the article:

Fears over hand-made hormones

THOUSANDS of menopausal women are being prescribed dangerous hormone therapies that have not been approved for use and may contain banned substances.

Women are being urged to avoid so-called natural hormone replacement therapy (NHRT), also known as bio-identical hormones, because of safety fears.

Two cases of uterine cancer in women taking NHRT have been referred to the Therapeutic Goods Administration in the past year by Dr John Eden, director of the Sydney Menopause Centre.

Dr Eden said the “hand-made hormones” were prepared by pharmacists known as “compounding chemists” without scrutiny. Although the process is legal, it is beyond the regulatory control of the TGA and state-based pharmacy boards. “There’s a whole stack of women being treated out there with hand-made hormones. It’s untested hormone replacement therapy,” he said.

“Many women think they are getting a herbal treatment and are shocked to learn they are getting a hormone treatment.”

Other women using NHRT have suffered elevated hormone levels. Side effects can include excessive bleeding, increased cancer risk and blood clots………..

And an extract taken from Oprah Winfrey’s website includes the following:

Official Statement from the FDA on Bio-Identical Hormones

“The FDA respects a healthcare provider’s decision that his or her patient should receive a pharmacy-compounded hormone replacement drug, but the FDA also wants to assure that women and their healthcare providers understand the risks and benefits of those drugs. The FDA has seen claims that compounded bio-identical hormone drugs avoid the risks of FDA-approved treatments for the symptoms of menopause, and that these drugs can prevent or reduce the risk of serious illnesses such as heart disease, stroke and breast cancer. The FDA knows of no credible scientific evidence supporting these claims”.

“Some bio-identical hormone replacement drugs contain an ingredient called estriol. The safety and effectiveness of estriol has not been credibly proven and the FDA does not condone estriol use for compounding without an FDA-sanctioned investigational drug application”.

If you have been taking bio-identical hormones or standard, synthetic HRT and you are looking for safer alternatives, I recommend that you consult a qualified naturopathic physician that specialises in balancing the hormonal system naturally. Naturopathic physicians that specialise in hormonal imbalances will aim to identify the underlying causes of your hormonal imbalances and will let you know which hormones your body needs to be taking, as well as which specific herbs and nutrient therapies can help your body to increase these hormone levels naturally, safely and effectively.

I have been specialising in naturopathic endocrinology (hormonal system) imbalances for many years so if you are seeking professional alternative advice on how to balance your hormonal system naturally, I look forward to assisting you.

Yours In Great Health,

Sar Rooney BHSc., ND., DC., DASc., GDSc. (Hons), MATMS, MNHAA, MHATO

Naturopathic Medicine Practitioner, Lecturer, Researcher

 

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Sar Rooney is a Naturopathic Medicine Practitioner specialising in Anxiety and Depression |Women’s Health| Hormonal Imbalances | Thyroid Disorders | Digestive Health | Genetic Polymorphisms (MTHFR/Pyroluria) | Nutritional Medicine | Optimal Wellness & Disease Prevention 

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Disclaimer: The information provided is not intended to replace medical advice or treatment. Please note: I am not a medical practitioner.

 

 

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