A series of papers in a prominent medical journal claiming menopause is being over-medicalised has set the cat among the pigeons in one of the most debated areas of women’s health.
By Cathy O’Leary
Hormone replacement therapy and controversy seem to go hand in hand. HRT has been one of the most common menopause treatments for women faced with debilitating symptoms such as mood swings and hot flushes, but it has faced a bumpy road.
Back in 2002, a big US study of women triggered a huge rethink of HRT, when the Women’s Health Initiative uncovered an apparent link between the risk of breast cancer, venous thromboembolism and coronary heart disease in women taking oral oestrogen plus progestogen.
It scared off millions of women and their doctors around the world from using the pills, leading to a dramatic reduction in prescribing – and many distraught patients.
Since then, the findings have been put into perspective, with a more balanced picture of risks and benefits, encouraging many women to take up hormone therapy again.
But now, more than 20 years after the WHI furore, debate has been re-ignited by a series of articles in The Lancet in March suggesting the use of menopausal hormone therapy (the newer term for HRT) is overdone.
Four literature reviews and opinion pieces argue that menopause is being over-medicalised and treatment options are too simplistic and often swayed by commercial interests. The writers argue menopause is wrongly being treated like a disease, with some women getting unnecessary treatment, and this disempowered them.
“One problem is that a normal event that affects [women] has been turned into a disease, a hormone deficiency disease, which requires diagnosis and treatment,” said lead author Professor Martha Hickey, from the Department of Obstetrics and Gynaecology at the University of Melbourne.
MHT should be available for those who need it, Professor Hickey said, but it should not be seen as a “solve all” and the risks needed to be weighed against its benefits.
Views in hot dispute
But not everyone has agreed with those views, sparking strong debate among some doctors who are worried the claims will further discourage women from seeking treatment and undo years of work trying to reassure women ‘they’re not going mad.’
They say it is far more likely that women with severe symptoms are not offered evidence-based treatment than for women to be overtreated, compounded by the fact that some MHT products are not PBS-listed which creates equity issues for those struggling with cost of living pressures.
Among those hitting back against The Lancet series is psychiatrist Professor Jayashri Kulkarni, director of the HER Centre at Monash University, who works at the coalface and is now questioning why women are still missing out on help.
She is calling out what she believes is a preoccupation with governments and others to do population surveys, rather than fund meaningful clinical studies that could really help women.
Professor Kulkarni spoke at a menopause summit organised by Menopause Alliance Australia in Perth in March and was recently announced winner of the Royal Australian and New Zealand College of Psychiatrists’ Ian Simpson Award for research over 30 years to improve the care for women with mental illnesses.
She says midlife women have a big increase in depression, with 4-16 times increased rate between the ages of age 45 to 55, and an associated increased suicide rate.
Menopausal depression is poorly understood, under-recognised and poorly treated, she argues. And to compound the problem, antidepressants in many menopausal women are not very effective, nor are the psychotherapies.
Professor Kulkarni said there is considerable brain biology research showing the impact of fluctuating gonadal hormones changing brain chemistry and circuitry causing mental ill health.
Clinically, menopause hormone therapy is used in women with other symptoms of menopause, and not usually for menopausal depression. But in many women, it worked and improved panic, anxiety, brain fog, rage, and tearfulness.
“There is very scant understanding and recognition that menopausal mental health issues exist, and they are different to standard depression in men or even younger women,” she told Medical Forum.
“That is a problem among the general community but it’s a bigger problem in the health professional community and it’s an even bigger problem in the psychiatric community.
“It’s been a long time of trying to campaign to even get any kind of recognition, but we’re held back by the lack of good clinical trial evidence.”
Enough of the surveys
The Lancet researchers said the pendulum had swung from ‘put up and shut up’ about menopause to sensationalising it, and claimed the widely held belief that menopause was associated with poor mental health did not stack up.
But Professor Kulkarni says the research that is done in menopause continues to be survey-style, which is not helpful because it is difficult to pick up the exact percentage of women in the general community who experience mental health issues. The definition of it in this group is very fluctuating and unusual, and it does not meet the criteria for major depressive disorder, which all the standard tools for measuring depression use.
“So, the epidemiological surveys are always going to have a regression to the mean, because you’ll get women who will sail through menopause and don’t even notice it, and at the other end women who are very disabled by a severe depression,” she said.
“When you’re forced to take the average, it means that most women are okay, and that’s what’s been touted and put about, and that the evidence doesn’t show any mental illness.
“But there is a significant population affected and that number varies anywhere between 20% to 60%, depending on which surveys you’re looking at.
“In clinical mode, for example for the people who work in the menopause area in London and in our work which is a mental health clinic, there is no doubt there is a different beast called menopausal depression that has different types of symptoms and presentations that can fluctuate, and have a partial response to standardised antidepressants, and unless you’re actually in the area of mental health of menopause you’re not going to be in the position to understand that.”
Professor Kulkarni said conferences like the recent one in Perth were important because there was still a group of women who had been left behind, thinking they had bipolar disorder which was the worst differential for the diagnosis for this condition.
“Or they are just left behind in the sense of ‘here’s your antidepressant, oh it doesn’t work, well sorry there’s nothing else we can do,” she said.
“That’s what we’re trying to address but then we get caught up in the weird debates about ‘stop medicalising and pathologising menopause’ – because that’s what The Lancet articles were about – they were saying ‘look most women are fine, leave them alone, so don’t make this to be a condition’ which is fine if you’re a fortunate woman who doesn’t have any symptoms.”
She said a valid analogy might be that epidemiologists were useful in developing the association between smoking and lung cancer, but it was the research that followed – the randomised clinical trials in oncology or new treatments, molecular biology or stem cell research – that changed outcomes.
“We need to change the language somehow so that we get away from this first-base discussion that we seem to be going round and round in circles about – is there menopause depression or is there not, stop pathologising or can we use HRT,” she said.
“We’ve almost reached religious fervour at both ends, when we have groups saying under no circumstances should you pathologise, and then others saying oestrogen should be in the water supply.”
Professor Kulkarni said that while professional debate could be healthy, it was very confusing for the general community and primary health professionals to know what they were supposed to do.
“And the group who miss out are the women with severe mental illness or any incapacitating mental illness, and, okay, that’s not the general population perhaps, but it’s a proportion, and it’s not a small proportion,” she said.
“The people who are often writing these kinds of articles or involved in the research are in an epidemiological background, so they don’t take into account the clinical presentations because that’s not their work.
“And neither do they take into account the burgeoning amount of neuroscience modelling of the brain, work from animal models and also human imaging to see the impacts of what the neurosteroids do in the brain.”
Funding for randomised control trials was difficult to get because menopause depression was not well-defined and it did not have a place in the psychiatric classification books, so it did not exist.
“And because it doesn’t exist, we can’t get funding to do the trials, and then HRT or MHT don’t make it into any of the guidelines as a potential treatment,” she said.
“Then you have about 20% of women going through significant mental ill-health conditions that don’t respond to antidepressants, or antipsychotics or whatever.
“We have to break this awful cycle at some point, and it’s like we’re trying to prove that the Earth is round, and I think we have to stop trying to do that – we’ve been there, done that – can we just get on with it, because there’s still a real proportion of women that we can’t help if we don’t change our clinical approach.”
Professor Kulkarni said she was tired of surveys that asked the wrong questions, when what was needed was a focus on the people who were unwell, physically or mentally, or both.
“We’re not in the preventative game – that’s what the WHI study was trying to do back in the early 2000s, to prevent cardiovascular disease — but what we’re trying to do is treat an acute illness that has a different origin of causality, and that we can treat better if we tackle the origin.
“The group that I see – not the ones in The Lancet articles – are women who can’t get out of bed, who have lost their jobs because their brain fog means they are struggling with simple tasks they have done a thousand times before, and women who lose their families because their hostility, irritability and short-fuse ends up destroying their relationships.
“And there is so much economic burden by women across the community, from the factory floor to the highest paid CEOs of companies, dropping out of the workforce because of brain fog and anxiety primarily, with depressions secondary.”
Professor Kulkarni said effective treatments should be readily available for the women who are struggling while “we can leave the rest alone who are fine and can get on with it.”
“And with the question of how you define this group – well they define themselves, and we shouldn’t be saying to them ‘you’re a drama queen.’
“Instead, we need to say here’s a palette of treatments that we have available, and we’ll tell you the benefits and side effects, and you decide what you want.”
There has been some progress in the menopause space in the past year, as groups agitate for action. The Commonwealth’s Senate Standing Committees on Community Affairs is due to report back in September on its inquiry into menopause and perimenopause.
In its submission, the Australian Medical Association said GPs played a central role in helping women to make informed decisions about their healthcare and were also the first port of call for 90% of people with mental health issues.
The AMA argued that while for some women the transition to menopause could be uneventful, for others it was vastly different, with them suffering from prolonged and severe symptoms.
Hot flushes, insomnia, anxiety and depression, fatigue, irritability, muscle aches and pains, vaginal dryness and low libido were just some of the symptoms well documented as long-term risks.
Professor Kulkarni said she wanted targeted research to run clinical trials of antidepressants versus MHT, to get some evidence and change the treatment approach for menopausal depression.
“Of course everyone should be a certain healthy weight, eat well and exercise – they’re good health strategies for everything – but they’re not going to prevent menopause,” she said.
“We’re dealing with an important group of women, and it’s not small. And we need to be careful that we’re not invalidating them with articles that suggest that everyone should just deal with menopause by not being too dramatic.”