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Title The ASA report on Bioidenticals
Date 11 September 2017
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The British Menopause Society issued a consensus statement in March 2017 regarding the safety of custom-compounded bioidentical hormones:

"Trustees and Members of the Medical Advisory Council of the British Menopause Society are concerned about the safety of unregulated compounded bioidentical hormonal therapy which is being prescribed by clinicians who do not usually have any recognised menopause training and provided from compounding pharmacies. It should be noted that such products are not regulated, licensed nor monitored by the MHRA, which is the regulatory body in the UK with responsibility to ensure that medicines meet applicable standards of safety, quality and efficacy. The term "bioidentical hormones" is misleading to clinicians and to patients: when Hormone Replacement Therapy (HRT) is indicated, women should be advised to take only those hormone therapies that are regulated and approved by the MHRA, which include hormones which are natural and identical to those produced in the body.

This view is supported by international bodies: "The use of custom-compounded hormone therapy is not recommended because of lack of regulation, rigorous safety and efficacy testing, batch standardization, and purity measures." (T. J. de Villiers, J. E. Hall, J. V. Pinkerton, S. Cerdas Pérez, M. Rees, C. Yang & D. D. Pierroz (2016): Revised Global Consensus Statement on Menopausal Hormone Therapy, Climacteric, DOI: 10.1080/13697137.2016.1196047)"

These concerns are now further supported by the Advertising Standards Agency (ASA) in a recently published ruling on an investigation into a clinic promoting bioidentical hormone replacement therapy treatment.

The ASA challenged whether:

  1. The claim that bioidentical hormone replacement therapy was "considered a safer option than synthetic hormones as used in conventional hormone replacement therapy" was misleading and could be substantiated and

  2. The claim "we decipher your unique hormonal make-up based on specific blood tests, so that we can tailor the treatment to your specific needs" and accompanying claims about blood tests were misleading

Point 1: In conclusion, the relative safety and harm of compounded hormones - where untested bespoke combinations, doses and concentrations of hormones were provided to patients - were unknown. Therefore the claim that bioidentical HRT was safer than non-bioidentical HRT could not be substantiated.

With regards to uncompounded HRT, the evidence provided indicated that the bioidentical progestogen, progesterone, was safer than non-bioidentical progestogens in relation to the risks of developing breast cancer. However, there was not sufficient evidence that oestrogen-only bioidentical HRT was safer than oestrogen-only non-bioidentical HRT in relation to developing the risk of breast cancer. Nor was there sufficient evidence that any form of bio-identical HRT was safer than non-bioidentical HRT in relation to the risks of developing venous thromboembolism, cardiovascular disease or other relevant conditions such as ovarian cancer, womb cancer blood clot and stroke. Because consumers were likely to understand the claim to relate to all forms of bioidentical HRT and all relevant conditions, we concluded that the claim that bioidentical HRT was "considered a safer option than synthetic hormones as used in conventional hormone replacement therapy" was misleading.

Point 2: While we acknowledged that blood tests could reveal an individual's hormonal composition, we considered that that did not in itself demonstrate the efficacy of tailored, individualised treatments. We had not seen any evidence that compounded, individualised HRT had any greater effect than non-compounded HRT. For instance, we had not seen any randomised, controlled trials that compared compounded and non-compounded HRT.

Because the ad suggested that compounded, individualised HRT that were tailored to the needs of each patient based on their blood tests were more effective in treating hormonal conditions than conventional uncompounded HRT, when there was no evidence that it was more effective, we concluded that the ad was misleading.

The ASA has ruled that the ad must not appear again in its current form. The clinic must notstate or imply that bioidentical HRT was safer than non-bioidentical HRT in relation tocompounded hormones. The clinic must not use the claim in relation to uncompounded hormones with the exception of the bioidentical progestogen hormone, progesterone, which was safer than non-bioidentical progestogens in relation to the risks of developing breast cancer.

The clinic was also instructed not to state or imply that compounded HRT that provided tailored treatments to patients had any greater effect than conventional HRT that was not compounded.

It is very much hoped that this ruling will influence other clinics to cease from providing misleading information to patients with immediate effect.

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