The British Menopause Society (BMS) and the Royal College of Obstetricians and Gynaecologists (RCOG) have warned women away from bioidentical hormone therapy (cBHRT) products, which are becoming increasingly popular, reports The Guardian. 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.
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.
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.”
Sold as a menopause treatment, cBHRT is often marketed as a “natural” alternative to hormone replacement therapy (HRT) and is a combination of oestrogen, progestogen and other hormones, reports ABC News. 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.
The ABC report says 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,” Davis is quoted as saying.
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,” Farrell said.
The report says a group of major international menopause bodies are set to release a global position statement warning against the use of compounding therapy in September.