Menopause specialists warn of the dangers of bioidentical hormone therapy – Health

Menopause experts have warned women who use bioidentical hormone therapy, saying the treatment is very inefficient, expensive and could put women at risk for cancer.

Sold as a menopausal treatment, bioidentical hormone therapy is often marketed as a "natural" alternative to hormone replacement therapy (HRT) and consists of a combination of estrogens, progestins and others. hormones.

The treatment is prescribed to women by a general practitioner, who is then transformed into cream, lozenge or implant by a pharmacist specializing in the composition. (who personalizes the drug).

Experts say that the appeal of treatment is that it is marketed as a natural hormone therapy, made to measure and biologically identical to the hormones that our body produces.

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

"The problem is that the dose is a better estimate, that the mode of administration has not been developed properly, that it is simply a concept and that, therefore, rates that could enter the bloodstream could be negligible or huge, "said Dr. Davis at RN Life Matters.

Elizabeth Farrell, gynecologist and medical director of Jean Hailes for Women's Health, explains to women who are prescribed the wrong dose of hormones that there is a significant risk of endometrial cancer, a cancer that comes from the uterine lining.

"An inappropriate dosage can lead to the 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 institutions in the field of menopause are expected to issue a global position statement warning against the use of compound treatment.

Critical HRT

In 2002, when the Women's Health Study was released, HRT was reported as a possible risk for bad cancer, which prompted many women seek alternative treatments.

"They were looking for some form of treatment … and these were marketed and pharmacies started to compound these substances, and the doctors started prescribing them," Dr. Farrell said.

However, it is now widely accepted that the study of the Women's Health Initiative was misleading.

"What was said was that there was a risk of bad cancer, whereas we now know that the data was published really falsely and presented to the media in a way that frightened women", she said.

But Dr. Davis said that women were still wary of HRT and were looking for alternatives such as bioidentical hormone therapy.

What exactly are bio-identical hormones?

Although bioidentical hormone therapy is marketed as "biologically compatible" with the hormones our body produces naturally, Dr. Davis says that several bio-approved products already exist, including HRT.

"So, the difference is that the approved products were tested and the doses were determined by medical research," she said.

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

"There is a little testosterone, a little DHEA [dehydroepiandrosterone, a steroid hormone], a little thyroid extract, and even a little hydrocortisone, which looks like adrenal production or cortisone, "said Dr. Davis.

"Security [of products] is very worrying ".

In addition, the products are marketed as a natural alternative herbal treatment, which, according to Dr. Farrell, is misleading.

"We can only have a human hormone if it was synthetically made in a laboratory, otherwise we would extract human ovarian hormones," she said.

Like HRT, Dr. Farrell says that bioidentical hormones are synthesized.

She also rejects the claim that the treatment is personalized for each patient, which is virtually impossible.

"If I could adapt 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 treatment for menopause.

"I have a woman who sat in my rooms and cried, she said that she sold her car to pay the cost over several years," she said.

What harm can they cause?

According to Dr. Farrell, women taking bioidentical hormones have a number of risks, but her The main concern is the increased risk of cancer of the uterus.

Bioidentical hormone treatments are mainly creams and progesterone is not absorbed by the skin.

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

"If you only consume estrogen, you have a uterus and you have no added progesterone, the risk of thickening of the uterine lining is increased, and then, for many years, development of uterine cancer. "

The unregulated prescription of bioidentical hormone therapy also involves a risk of excessive dosage of estrogen, according to Dr. Davis.

Dr. Farrell is concerned that hormones in the pharmaceutical formulation have been prescribed to women with a history of bad cancer.

"Now we know that all hormones are contraindicated in women with bad cancer," she said.

"There are exceptions where women suffer so much that we should perhaps put them back into therapy, but that's a risk."

In addition, Dr. Davis stated that some of the risks badociated with the use of this treatment were still unknown.

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

"These are all on private prescription – we do not even know how much it is dispensed."

Why are they prescribed?

According to Dr. Davis, it is the generalists who prescribe a majority, although large medical companies have condemned the use of treatments.

She said some general practitioners were "misinformed" about the risks of bioidentical hormone therapy, and called for greater education of doctors.

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

"The FDA has 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 use by a patient do not have to be listed on the Australian Therapeutic Products Registry (ARTG) and, therefore, their safety and efficacy do not occur. have been evaluated. "

The TGA also stated that the Pharmacy Board of Australia (PBA) was the body responsible for "developing standards … and guidelines on drug composition and guidelines on drug distribution".

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

But Dr. Davis explained that the PBA and the PGA were reluctant to call practitioners who did not follow the guidelines, "the situation that has fallen apart."

She added that she would like to see Australian medical council do more to remedy this problem.

In response, a spokesman for the Medical Board of Australia said: "The Medical Board of Australia is very concerned about the dangerous treatments that put patients at risk." We have just seen draft guidelines to more clearly regulate practitioners. providing complementary and unconventional services, drugs and emerging treatments.These guidelines would directly address the issues raised. "

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