Clearing up the confusion – Compounded vs Regulated Hormone Replacement Therapy (HRT)

HRT stands for Hormone Replacement Therapy. Depending on the Menopause symptoms, one or two of the female hormones (oestrogen, progesterone and sometimes testosterone) can be replaced in a continuous or cyclical method to treat the symptoms of menopause.

Menopause is a natural event that every woman will experience. HRT is often explored to help ease the symptoms. Women who are choosing to start hormone replacement therapy often ask if they would be better off taking ‘compounded’ HRT as they may have come across information that it is ‘safer’, more in tune with what the body produces and carries a smaller risk compared to conventional or regulated hormone therapy.

It is essential to understand that both types of hormone replacement therapy are synthesized in a laboratory and are not natural.

Compounded bio-identical hormones are produced in independent specialist pharmacies as duplicates of human hormones. They come in a cream, vaginal pessary or troche form. They do not follow a regulatory pathway.

Regulated body-identical HRT contains duplicates of human hormones produced by pharmaceutical companies in a conventional way and under strict conditions. Production is regulated by a central regulatory authority such as the MHRA in the UK. It is the recommended choice by menopause societies worldwide due to its safety.

Compounded HRT

Contains bio-identical hormones – estrogen (as estradiol -E2, estriol -E3 and estrone -E1) in its three forms, progesterone, and may contain other hormones like testosterone, pregnenolone or DHEA. The logic behind ‘compounding’ these are to obtain a particular ratio between the different hormones and create a custom-made preparation to treat a woman’s menopausal symptoms. Contents can vary between pharmacies.

Regulated body identical HRT

• Contains estrogen or progesterone/ progestogen as a standard preparation.
• Testosterone may be added for specific indications.
• There are some particular benefits with this type of HRT.

Benefits of body identical progesterone:

No increase or possibly a lower risk of breast cancer. Micronised progesterone has been shown in studies not to affect the risk of breast cancer (perhaps even lower the risk, but further studies are required to confirm this finding). Dydrogesterone is another progesterone with similar benefits.

Relief from insomnia – Oral micronised progesterone passes through the liver after ingestion and produces a calming intermediate substance that relieves anxiety and brings on sleep – a desirable effect for most women around menopause.

Compounded bio-identical hormones contain progesterone as a gel or cream applied to the skin. Unfortunately, this does not seem to help with sleep as much as oral micronised progesterone.

Favourable effect on lipids and the heart – Micronised progesterone and another progesterone called dydrogesterone can be safer from the cardiovascular perspective and not affect cholesterol levels.

Certain synthetic types of progesterone may produce more side effects (water retention and mood changes). Hence, the body identical micronized form is a great choice to offer women.

Benefits of Body identical estrogen:

Oral estrogen hormone increases the risk of deep vein thrombosis, whereas transdermal estrogen, a body identical preparation in a gel or patch form does not carry this risk. This has makes it safe to try in women who are at risk of deep vein clots and those with certain types of migraine ( with visual symptoms etc).

Menopause societies all over the world do not recommend compounded bio-identical HRT due to the following concerns:

• The purity, potency and efficacy can be variable as individual specialist pharmacies are not regulated when compared to pharmaceutical grade HRT. Dosing errors and contamination are possible.

• There isn’t clear evidence that combining hormones by compounding them is the best practice for treating menopausal symptoms.

• The dosage of estrogen to manage menopausal symptoms could end up being too high or too low and is harder to determine in compounded preparations. This can place a woman at risk of side effects. Furthermore, no studies prove that compounded estrogen can provide adequate protection against weakening of the bones ( osteoporosis).

• Progesterone is the hormone that protects the uterine lining from becoming too thick and opposes the effect of estrogen. There is a concern that progesterone in a cream form in compounded HRT may have erratic absorption placing the woman at risk of uterine cancer.

• Including DHEA, testosterone or other hormones in custom-made compounded preparations runs a risk of side effects.

• The cost of compounded HRT is often higher than regulated body identical HRT. The latter is affordable for most.

• Expensive hormone testing (blood or saliva) can often be a part of prescribing ‘bio-identical’ HRT as prescribers want to provide ‘precise/individualised treatment. There is no evidence that these levels are accurate and should not be used to guide treatment.

To summarise:

• Opt for regulated body identical HRT over compounded bio-identical HRT. The former is regulated and has been well studied for efficacy and safety.

• Relief from menopausal symptom control and maintenance of bone density is often enough to judge if adequate doses are being administered.

• Regulated body identical HRT appears to have some advantages over other types of HRT, but further studies are needed.

Contact us if you’d like to find out more information on the HRT options we have available at IMC.

Dr Charu Narayanan is a family practitioner who has trained and worked in the UK and is now based in IMC – Katong. Please call 6342 4440 to make an appointment with Dr Charu.

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