Abstract
As we write the editorial for this edition, a very public row has broken out over the principal findings of the Million Women Study (MWS). 1
It was this study, in combination with the principal findings of the Women's Health Initiative (WHI), that completely transformed the opinion of professionals and patients worldwide with regard to almost any hormone therapy. Various estimates of the quantitative effect on hormone-replacement therapy (HRT) prescribing exist depending on the markets examined but it is clear that the overall effect is a halving in the use of HRT globally.
It is highly likely that most HRT prescribers reduced the numbers of prescriptions immediately after the publication of these studies. Thus, was what many of us did right? Before we changed our prescribing habits or advice to patients, did we look at the data with the same level of scrutiny we would apply were we personally to be the ones about to start or continue therapy? Did we follow the investigators’ conclusions, or worse the conclusions from the media to influence our actions?
Most of us recall the frenzy of sensationalism that accompanied these publications. Newspaper front pages screamed about the dangers of HRT and interviews with lead investigators promulgated their conclusions further. It was all too easy to take the path of least resistance and accept the indirect recommendations from investigators and press and the more direct guidance from some regulatory authorities.
What we all should have done right from the start is to make our own minds up, either sit down, read the papers in detail or discuss them in a practice or multiprofessional meeting. Following the herd may have been the safest thing to do from a purely professional point of view but did we do the right thing for our patients?
Without a doubt there may have been patients taking HRT who were not being regularly assessed and having their risk profiles assessed yearly who should have considered stopping. The worrying thing is the number of patients who had their treatment stopped suddenly without an option to discuss things further. With this probably well-intentioned risk-reducing manoeuvre, many women were plunged suddenly into a hormone-free hell.
Many women suffered a significant and sudden reduction in quality of life, seeking out alternatives such as phytoestrogens and other drugs that are largely less well researched than HRT. It was easy to see the immediate effects on quality of life but other unwanted effects of cessation such as bone loss, vulvovaginal atrophy and short-term cognitive effects would take longer to present.
Thus, what should we do with the reawakened debate about the validity of the MWS? Firstly, it should be considered that the recent publication 2 does not actually provide new factual challenge to the MWS, it provides challenges to the methodological processes that lead to the main conclusion that HRT causes breast cancer. This conclusion has been challenged in several publications since the MWS was published and now adds further concern that the validity of the data and subsequent recommendations from regulatory authorities may need urgent review.
Professionals new to the area of menopause are right to be confused. Have we been practising proper evidence-based medicine? Has there been a formal revision of the advice that arose from the main conclusions of the WHI and MWS?
Whether a revision is needed or not we should all be practising an individualized approach to HRT prescribing, known risks and benefits should be carefully discussed prior to the decision to prescribe with effectiveness, tolerance and both short- and long-term effects monitored to facilitate continued prescription.
What is urgently required is a formal expert group reappraisal resulting in a balanced assessment of whether women can feel safer on HRT and whether prescribers can have a greater degree of professional support from a regulatory body.
In the meantime, please encourage colleagues to be aware of the debate, keep their professional ears to the ground and remain open to the possibility that HRT administration to the right woman at the right time in her life might actually be good for her.