Direct to consumer hormone panels risk misleading patients and undermining evidence-based practice, warn researchers.
Direct to consumer hormone panel tests are being sold to women as a gateway to personalised care – but they don’t diagnose menopause and they don’t guide treatment say experts.
But despite clear guidance from international societies, costly blood, saliva and urine tests are gathering momentum and threatening to derail evidence-based care, they warn.
Writing in an editorial in the BMJ, authors led by Assistant Professor Marie Christakis, of the University of Toronto’s Obstetrics and Gynaecology Department, said digital health technologies that were available direct to consumer (such as mobile applications, telehealth clinics, podcasts, and websites) had targeted menopause management, raising concerns about the reliability and potential commercial bias of the information.
“A decade ago, the global ‘femtech’ market was valued at $500m (£375m; €430m); today, it is estimated at $28bn and is continuing to grow,” they wrote.
“One of the most troubling trends arising from this surge is the promotion of routine hormone panel testing for the evaluation of menopausal symptoms – often including serum, salivary, or urine assays for oestradiol, progesterone, testosterone, dehydroepiandrosterone, thyroid hormones and even cortisol.
“These tests can cost hundreds of dollars and are marketed to patients and clinicians as necessary for ‘individualising’ hormone therapy.
“Many women who access this type of testing are unaware of the limited supporting evidence and are influenced by trust in their healthcare provider.
“In reality, these tests are of limited clinical use because there is no clearly defined therapeutic window for MHT, and some testing techniques do not offer accurate or precise assessment of hormone levels.”
One of Australia’s leading menopause experts, Professor Rod Baber, clinical professor of Obstetrics and Gynaecology at The University of Sydney and past president of both the International and Australasian Menopause Societies, welcomed the editorial, saying it identified a growing problem for menopausal women.
“I think it is shameful that opportunists can promote such tests via social media. I wish I knew how to stop it,” he told Rheumatology Republic.
“I think much of the growth in femtech worldwide has been driven by financial gain more than anything else.”
MHT use was rising fast on a global scale, the editorial authors wrote. Prescribing has jumped by up to 50% in parts of Europe, while Canadian data show a 21% increase in insured claims in just three years.
Postmenopause, no test can predict who will benefit from therapy, however. Guidelines from NICE, the British Menopause Society, The Menopause Society, and the American College of Obstetricians and Gynecologists are unequivocal – menopause after 45 is diagnosed on symptoms alone “and hormone testing is unnecessary”.
“Despite this, many women now present with detailed hormone panels from wellness providers or online services,” the authors wrote.
“When this testing is used to make treatment decisions, it can mislead women into believing they are not candidates for MHT or prompt the use of unsupported interventions.
“In our experience, these panels are often used to justify taking compounded hormone regimens or supplements based on marginal deviations from hormone thresholds that are not grounded in evidence.
“Compounded bioidentical hormone therapy lacks standardisation and regulatory oversight and has not been tested for safety or efficacy. There is concern that inconsistencies in the quantities of oestrogen or progestogen in compounded bioidentical hormone therapy regimens can result in endometrial hyperplasia or carcinoma, particularly in women with an intact uterus who are receiving inadequate progestogen.”
Professor Baber said that as there was little to no regulation of the DTC market as it related to health in Australia, “just about anyone can establish a web presence and promote their own versions of the truth when it comes to women’s health and, in this case, management of perimenopause and menopause”.
“I am all in favour of enabling women to readily access information about their own health but I also believe this can be harmful at times and that government should be making efforts to ensure that those who provide on line information be required to comply with the same regulations as apply health care professionals and pharmacy,” he told RR.
“Basically, stick to the truth. The classic claim of ‘this product may help your condition’ is not good enough but that’s how so many complementary treatments get around legal requirements.”
As noted in the BMJ editorial, he said the natural fluctuations seen in women’s sex hormone levels during the perimenopause made testing for them a “useless endeavour which also wastes money and resources”.
“Whilst testing a woman’s oestrogen and FSH levels more than a year after the final period may ‘prove’ she is menopausal it in no way helps to determine what doses of MHT might be best for her,” he explained.
“Salivary testing is subject to so many confounders that it has never been regarded as a reliable assessment of human hormones in any circumstances.
“As mentioned in the editorial, the management of menopausal symptoms involves careful assessment of those symptoms and, if MHT is thought to be appropriate, starting with a low dose and titrating up as required. There is no evidence to support the ‘more must be better’ theory.”
In fact, testing could lead to harm, Professor Baber warned.
“Testing for hormones when they are fluctuating, or attributing clinical findings to unreliable results from blood, urine or salivary testing can lead to inappropriate use of various hormones which may cause harms such as increasing risks of short-term headaches, bloating, unplanned bleeding and thromboembolic disease,” he said.
“Of course, the other harms are loss of money, loss of faith in the treating person and delay in getting appropriate treatment.”
In recent years, Professor Baber said he had seen a number of patients who had gone down the path of private testing of their hormones.
“Often I fear they have done so because they believe that those offering these tests are in some way smarter and more sympathetic to their problems than their family doctor. Of course nothing could be further from the truth,” he said.
“The only way to educate or re-educate these women is to explain the folly of the principals behind these tests. This must be done in a thoughtful and sympathetic manner by demonstrating the physiology of what is going on during perimenopause.”
The editorial authors said that until individualised target hormone levels could be established, accounting for pharmacokinetics, receptor specific pharmacodynamics, and differentiating between endogenous and exogenous hormones, there was no role for commercial hormonal panel testing to guide therapy.
“In the meantime, such testing offers only a false sense of precision,” they wrote.
“Although innovation is needed, the normalisation of hormone panel testing could be a symptom of a larger problem: the commercialisation of women’s health and a movement away from evidence-based practice. For midlife women, effective treatment begins not with numbers, but with listening.”
