Flawed HRT study

  • Health
  • Sunday, 26 Jan 2003

A renowned expert in breast cancer and menopause and a consultant obstetrician and gynaecologist address the frailties of the Women’s Health Initiative (WHI) study that has led to the current controversy over hormone replacement therapy (HRT) and breast cancer. MARTIN VENGADESAN has this report. 

Smoking is a high risk factor for breast cancer and more than 50% of the women involved in the study had smoked before.

AFTER having treated menopausal women with Hormone Replacement Therapy (HRT) for over 40 years, many doctors were shocked to learn of the Women’s Health Initiative study (which was made public in July 2002) linking the treatment with a 26% increase in rates of breast cancer and other fatal illnesses.  

However, a recent interview with Dr Barry Wren, a senior consultant gynaecologist who founded the Sydney Menopause Centre and the Australasian Menopause Society and Dr Nor Ashikin Mokhtar, a consultant obstetrician and gynaecologist and member of the National Advisory Council on Women for the Women & Family Development Ministry revealed that some doctors are openly expressing their scepticism over the study’s findings and questioning the methods employed in reaching the conclusions. 

Firstly, Dr Wren explained what going through menopause is and why he felt it should be treated. “Most women between the ages of 45 and 55 go through a stage in which their ovaries stop producing oestrogen and progesterone, which are the two hormones that make them distinctly female. During puberty, which occurs between the ages of 10 and 15, these hormones allow women to develop “mature” female characteristics. She goes on producing these hormones throughout her reproductive life. After menopause, because of the lack of hormones, tissues around areas such as the breast, hips and belly begin to turn to fat, and this fat is not good for you. In addition, symptoms such as hot flashes and sweats, dry vagina, mood changes and depression are also clearly related to the absence of these hormones. 

“Until now, Hormone Replacement Therapy (HRT) has been used to try and reverse these symptoms, and as a bonus we found that HRT improved a woman’s ability to combat osteoporosis, bowel cancer and Alzheimer’s disease as well a improving her general well-being. On average, women who take HRT live four years longer.”  

Given those beliefs about HRT, Dr Wren was jolted when the findings of the WHI study were made public in July 2002. “This study indicates that breast cancer, heart attack and stroke have very high rates of occurrence in a woman who undergoes HRT. In particular, the figure of 26% increase in breast cancer caused great concern. And frankly, these adverse findings have crippled the HRT industry ?” he explained. 

However, upon closer examination of the process under which the study was conducted, Dr Wren now feels that the findings are flawed. “The WHI study was done at US retirement villages using a group of approximately 8,800 women. These women were followed for a significant amount of time, for some 17 years I believe, and it is in fact the only study of its magnitude.  

“Many doctors now feel that these studies are flawed for a number of reasons. I personally am very critical of the study. I’m not ignoring it, but to begin with, the age group that should be studied is 45-55. The women in the study included a fair number of those over 70, and the average age was 63. I have never started hormonal therapy for anyone after 70.”  

Dr Barry Wren: 'There are two ways to report the percentage increase ... if you divide 38 by 30 you get 1.26 and you can claim an alarming increase of 26%. Howere the actual numerical increase is 8 per 10,000 women, which comes to less than 1%, which is not a terribly significant difference at all.'

Dr Nor Ashikin concurred. “Yes, it is very rare. I would say that a small fraction, far less than 1% of my patients, have been started on HRT after the age of 70.” 

Dr Wren added: “Another factor is that the average Body Mass Index of women undergoing the study was 28.5 when the accepted range for healthy women is between 20-25. In fact 34.5% of these ladies were obese. We also know that smoking is a high risk factor for breast cancer and more than 50% of the women involved in the study had smoked before, which resulted in high rates of hypertension, high cholesterol, diabetes and major endothelial damage (damage to the inner walls of blood vessels). In fact, another study has shown that women on hormonal therapy who had suffered a prior heart attack have an increased mortality rate. 

“Finally, I would like people to look at the actual numbers of women getting breast cancer. The placebo group had a breast cancer rate of 30 per 10,000 women while the HRT group had a rate of 38 per 10,000 women.  

“There are two ways to report the percentage increase ? if you divide 38 by 30 you get 1.26 and you can claim an alarming increase of 26%. However the actual numerical increase is 8 per 10,000 women, which comes to less than 1%, which is not a terribly significant difference at all.”  

As a senior figure in the treatment of menopause in Australia, Dr Wren was initially greatly perturbed by the study. “When I first heard of the study results, I was truly alarmed and upset, because I’ve been practising medicine for 40 years and have treated women with HRT for a lot of that time.  

“But when I got the paper, I realised that it’s a good study, but with flaws. It’s a good study of fat old ladies who smoke, not really representative of the menopausal group. The tragedy of it all is that there are unlikely to be any other studies of this kind with younger women because no one is ever going to fund such a study.” 

Clearly, there are strong feelings in the medical community over this study. Those who have long felt that HRT has unpleasant side-effects are no doubt supportive of the study’s findings, while those who rely on HRT as the main source of treating menopausal women would obviously feel that the study is flawed.  

Dr Wren commented: “I’m not the only one who feels that this is a questionable study. I wouldn’t want to speculate publicly about whether or not somebody wanted to draw this conclusion, but this study was released eight days early to the media before the medical community had access to the full details, and by that time, the damage was done.” 

Dr Nor Ashikin added: “Doctors were in the dark for a week. There was, and still is, panic, confusion and anger. A lot of women don’t know what to do. They ask: ‘What do I do? I’ve been undergoing HRT and feeling good and now it’s supposed to be dangerous.’ As a woman, as a doctor, even as a daughter who has put her own mother on HRT, I say the risk is small and the general well-being of my patients show a marked difference. Maybe women who take HRT are more health-conscious but I haven’t had anyone coming to me with breast cancer.” 

But does that mean that the doctors are totally confident that HRT does not cause breast cancer?  

Dr Nor Ashikin Mokhtar: 'Doctors were in the dark for a week. There was, and still is, panic, confusion and anger. A lot of women don't know what to do.'

Dr Nor Ashikin responded: “The use of HRT has to be tailored to the individual patient. When I meet a patient, I say sit down, let’s talk about family history, other factors like weight, smoking and other risk factors. We also have to be aware that breast cancer does occur earlier in Malaysia women. In Malaysia, it tends to occur between 40 and 50, whereas it’s much later in the West. But again I emphasise that none of my HRT patients have come to me with breast cancer.”  

Dr Wren added: “It’s not very different in Australia. In fact, a lot of women have even been given HRT after recovering from breast cancer and they’ve done better. If I thought HRT was the cause of breast cancer, I’d be the first to stop it.  

“If you think about it, if hormones are connected to cancer, you would expect that pregnant women, who have an increase in hormones, would be at greater risk, but the opposite effect is true. Furthermore women who take contraceptive pills, which also affect hormonal balance, demonstrate no increase in rates of breast cancer.” 

While Dr Wren acknowledged that some patients may feel more safe with other alternatives, he still feels that HRT is the best option.  

“Our department has done a lot of studies with soy extract and black cohosh, but none of them seem to be of any value at all, except for remifemin, which has slight benefits in alleviating hot flashes. That’s all. In fact, possibly some of them might be harmful.” 

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