Photo: Well-known obstetrician-gynaecologist, Prof Alan Alperstein
Professor Alan Alperstein, a part-time obstetrician gynaecologist at the University of Cape Town and Groote Schuur Hospital said the media reports caused inestimable damage to highly beneficial HRT worldwide.
He was speaking at the first live annual congress of the South African Menopause Society in Stellenbosch since the Covid outbreak in March 2020.
Reports on the controversial Compounded Bio-identical Hormone Therapy, (CBHT), a study by the Women’s Health Initiative, (WHI), leaked in July 2002, (just before its scientific publication), saw HRT prescriptions plummet and antidepressant prescriptions soar.
Alperstein provided scientific perspective on the watershed controversy which has echoed down to the present day.
He said the media sensationalised a very limited WHI study where the average age of the women was 63, a full 16% were within the last five years of their last menses and most already had silent cardio-vascular disease.
Also omitted in the media reporting was that half of the women studied were current or former smokers, had an average body mass index, (BMI), of 28,5 (with many of them obese), while the average participant was an older, overweight smoker – and asymptomatic.
“So, it was a study of fat, unfit, asymptomatic, older, smoking women – hardly a healthy cohort,” he quipped.
Dramatic impact
He displayed a WHI graph, July 17, 2002 (date of the study publication) marked, showing how HRT prescriptions subsequently tracked down while anti-depressant prescriptions rose. Prior to this, the two tracked] more evenly, with HRT prescriptions well above anti-depressants.
The consequences of the initial WHI-linked controversy were that both doctors and patients became fearful of HRT, many doctors advised discontinuation of HT and half of its users stopped. The pivotal media ‘event’ fuelled a multi-billion-dollar market in alternative and complementary products for the relief of menopausal vasomotor symptoms. However, as many as 25% of those who stopped HT, returned to their doctors for ‘permission’ to resume treatment, he noted.
An aggressive and highly seductive advertising campaign promoting bioidentical hormones as a ‘safer and more effective’ option and touting them as ‘exact replicas” of those produced by the female body prior to menopause, rubbished synthetic versions as having ‘dangerous side effects.”
In South Africa alone, 1.7 million women googled bioidentical hormone use and within a few years, 2.5 million women over the age of 40 in the USA were using CBHT.
Many women thought CBHT was safe because it was touted as ‘natural.’
Alperstein said CBHT products were not FDA-approved, while ‘bioidentical’ was a marketing term by clinics punting the benefits of CBHT.
“It has been proposed by menopause specialists that rBHRT (r = regulated) should be referred to as ‘body identical’ – to distinguish regulated hormone therapy from the compounded varieties,” he said.
He explained that with bioidenticals, dosage was adjusted according to salivary or blood hormone levels unlike commercial HR, which was adjusted based on symptom relief.
Additionally, supposed anti-aging, sexual vibrancy and energising effects were similar to structure/function claims made for dietary supplements, rather than disease treatment/prevention claims made for drugs.
He explained that some bioidentical hormones were made by drug companies and were FDA approved (eg. Estradiol pills, patches, gels, sprays, vaginal ring and oral micronized progesterone).
However, compounded bioidentical hormones were custom-made by a pharmacy, according to a doctor’s orders. Compounding involved ingredients being combined or altered to meet the needs of an individual. The compounded forms were not tested nor approved by the FDA. Although these products were advertised as ‘natural choices’ because they were made from plants, they were actually altered in a laboratory.
Multi-billion-dollar industry
Pharmacy compounding of BHT was now a multi-billion dollar-a-year industry. Bio-identical HR drugs were prescription drugs, not over-the-counter and physicians should always be part of the patient, pharmacist, doctor triad, he emphasised.
Most bioidentical hormones were made and sold without controls for safety, quality or purity and a plethora of medical organisations had taken a stand against them. While CBHT was often touted as being safer and more effective than synthetic hormones, the FDA and most doctors cautioned that these claims were unproven in any reputable studies – and that they could even be potentially dangerous in some cases.
Digging for reasons for the huge surge in CBHT prescriptions (beyond the initial media alarmism), Alperstein said there was a societal suspicion of traditional medicine, a dislike of pharmaceutical companies and a perception that CBHT was a safer alternative.
“Natural is equated with safer, there’s wider and more aggressive advertising via the internet and other media plus a patient preference for alternative medicine – which begs the question of just how ‘alternative’ CBHT is,” he said.
By far the least likely reason was that patients were still symptomatic on properly prescribed commercial HR products.
Given the uncertainty as to whether South Africa’s Medicines Control Council, (MCC), or the South Africa Health Products Regulatory Authority, (SAHPRA), could effectively regulate, there was no real incentive for anyone to do randomized controlled or comparative studies locally.
“It would be great if somebody did because there’s little or no substantive data comparing BHT with commercial HT. Those that exist all have deficiencies,” he stressed.
Alperstein said almost all potential patients could obtain adequate medical therapy/symptom relief with commercial HR were they ‘prescribed properly and patients so inclined to take them.”
Some healthcare professionals who prescribed CBHRT claimed to be able to determine the precise requirement of each individual woman via a series of complex serum and saliva tests. However, this costly practice had never been substantiated through rigorous research and was not recommended by the menopause societies and was ‘largely unnecessary.”
He cited the North America Menopause Society position statement that CBHT presented safety concerns, such as minimal government regulations and monitoring, overdosing and underdosing, the presence of impurities and a lack of sterility, lack of scientific and safety data and the lack of a label outlining risks.
Higher risk possible
Most experts agreed that the risks for BHRT and HRT were similar but compounded bioidentical hormones “may carry even more risk – there’s no credible evidence that BHRT is more effective than HRT,” he said.
Alperstein said intelligent, aware women often spent an inordinate amount of time with their physician or with ‘Dr Google,” researching the efficacy and adverse events associated with the medicines they were prescribed.
Curiously, the same women were happy to take various unregistered and unregulated hormones which had not undergone controlled trials and for which there were no efficacy or safety studies.
Prescribers were often not gynaecologists or even medical practitioners, but homeopaths and compounding pharmacists, so ‘patients are therefore often not adequately examined or even examined at all,” he added.
Healthcare practitioners should explain to women that the efficacy and safety of unregulated CBHT were unknown, as were the quality, purity and its constituents.
Those women with a history of, or at high risk of breast cancer, should be told that although there was some evidence that St John’s wort may be of benefit in the relief of vasomotor symptoms, there was uncertainty about appropriate doses, persistence of effect, the variation in the nature and potency of preparations and potentially serious interactions with other drugs (including tamoxifen, anticoagulants and anticonvulsants).’
Alperstein said physicians hurt patients by taking them off meds with known safety and efficacy to place them on BHT where these were unknown. They also wasted scarce patient financial resources on meaningless hormone level testing and more expensive BHT that offered no therapeutic advantage. Just because patients wanted this therapy and were willing to pay for it did not mean physicians had to go along with it.
“You prescribe only when it’s indicated. It’s the medical profession’s job to place real limits on this. It’s our fiduciary duty to do so” he asserted.
The trade-off was patient autonomy versus evidence-based medicine, and, “you have to ask, what do we stand for as a profession really?” he added.
The South African Menopausal Society did not recommend the use of BHT. No hormonal preparation, or a preparation presumed to have a hormonal effect, should be prescribed for a woman without a full history and examination. This included a breast exam and periodic mammogram, plus a pelvic exam, which not infrequently would also require a transvaginal U/S scan of the ovaries and endometrial thickness.
“I guess to be old and wise, you first have to be young and stupid,” he quipped.