Menopause experts say compounded HRT is unsafe

Women are being warned not to use a form of hormone replacement therapy marketed as being “more natural” than that available from NHS doctors, with experts saying it is unsafe, expensive and could increase the risk of developing cancer.

Compounded bioidentical hormone replacement therapy (cBHRT) is tailor-made for each person, using hormones identical to those produced in a woman’s body. The hormone combinations are put together, usually as creams or gels, by pharmacists working in private clinics. The dose of the different hormones used varies from one woman to the next.

The British Menopause Society (BMS) and the Royal College of Obstetricians and Gynaecologists (RCOG) have warned women away from the products, which are becoming increasingly popular.

Menopause experts said women should opt instead for the pre-packed regulated bioidentical HRT (rBHRT). These therapies, available on the NHS, are also duplicates of human hormones but are in fixed doses and licensed by the medicines regulator.

Hormone replacement therapy is the main form of treatment for severe menopause symptoms, such as hot flushes, insomnia and low mood. Taken in the form of pills, patches, gels or implants, it acts by replacing oestrogen, or oestrogen and progesterone, in the body.

The unregulated version has recently increased in popularity because of a proliferation of online pharmacies and active marketing to consumers. However the BMS and RCOG said there could be problems with overdosing or underdosing, the presence of impurities or lack of sterility, a lack of scientific efficacy and safety data (compounded products are not tested on humans) and a lack of labelling to outline risks.

The experts also said the cBHRT practice of saliva and serum hormone testing to determine dosing was unreliable.

The BMS and RCOG have become so concerned by the increasing use of cBHRT that they have taken the unprecedented step of issuing a full consensus statement.

“Every expert in the field shares the same view and concerns about compounded hormones: it’s unsafe, untested and unnecessary. We are concerned by its purity, potency and safety,” said Haitham Hamoda, the chair of the BMS, spokesperson for the RCOG and a consultant gynaecologist at King’s College hospital foundation trust.

“You can get bioidentical HRT on the NHS: 95% of my 2,500 patients at King’s are on it. But the key thing is that it’s not compounded: rBHRT is prescribed and manufactured under very strict regulations. In contrast, there is no medical evidence to support cBHRT.”

The experts say the dose of oestrogen in cBHRT may be higher or lower than it needs to be to control symptoms, and that the dose of progesterone may not always be sufficient to protect the womb. “If the womb is not sufficiently protected, there is a cancer risk,” Hamoda said.

Many cBHRT applications deliver progesterone through the skin. “Absorption is variable with fluctuating tissue availability and as a result, may not provide sufficient protection for wombs,” Hamoda said. “Again, that’s a cancer risk.”

Dr Louise Newson, a menopause expert, said: “We see many women at Newson Health clinic who have spent considerable amounts of money on these bioidentical products and have experienced numerous side effects.

“Compounded bioidentical products are not regulated or approved and so could potentially be harmful. In addition, there is no evidence that these bioidentical hormones have fewer side effects or are more effective than prescribed HRT.”

In 2017, the Advertising Standards Authority ruled against the promotion of cBHRT as having greater safety and efficacy than rBHRT, and said there was insufficient evidence to back the practice of cBHRT practitioners using expensive serum and saliva tests to individualise therapy.

However, the Marion Gluck Clinic, which claims to be the leading UK medical clinic specialising in the use of bioidentical hormones, defended cBHRT.

“Just like any other medical practice, the Marion Gluck Clinic is registered with the Care Quality Commission (CQC),” a spokesperson said. “In addition, compounding cBHRT is carried out under strict supervision of a qualified pharmacist on a named patient basis.”

The popularity of cBHRT rose after the publication of findings in 2002 that conventional HRT carried a cancer risk. In the following years, there were a number of high-profile endorsements for cBHRT, including from Oprah Winfrey and Jeanette Winterson.

There are no statistics for the use of cBHRT in the UK. But a recent national population-weighted US survey found that 35% of women currently using HRT, and 41% of American women aged 40–49 who have ever used HRT, were using the compounded version.

A survey of US pharmacies estimated there were 26m to 33m annual cBHRT prescriptions, totalling $1.3bn to $1.6bn (£1bn-£1.3bn). Most of these pharmacies projected compounding would grow by 5%-25% over the next two years.