Latest HRT study findings flawed, say Australian experts
28 February 2003
The latest results from the Women's Health Initiative (WHI) study, showing that hormone replacement therapy (HRT) does not improve well-being, are flawed, Australian specialists say.
The trial results, which were rushed to publication online on March 17 2003, showed that 3 years of HRT had no meaningful impact on quality of life.
But most of the 16,000 women enrolled in the WHI study had no menopausal symptoms prior to taking HRT. Investigators had discouraged women with moderate to severe menopausal symptoms from participating, and only 12 per cent of the participants showed symptoms at baseline (before the start of HRT therapy).
The women, aged 50 to 79 years, were randomised to combined HRT (0.625 mg of conjugated equine oestrogen plus 2.5 mg of medroxyprogesterone acetate) or placebo (a dummy medication).
Little difference was found between the two groups in general health, vitality, mental health, depressive symptoms or sexual satisfaction (New England Journal of Medicine 2003; 348).
The women on HRT showed a benefit in sleep disturbance scores, physical functioning and bodily pain after a year, but this was not clinically meaningful, the authors concluded.
Perth endocrinologist Dr Bronwyn Stuckey, from the Keogh Institute for Medical Research, said that HRT improved quality of life in the women in this study who had vasomotor symptoms (e.g. hot flushes).
'But if you're going to start someone who's 70 on HRT for their bones, there's going to be a period of time where they get breast tenderness, and that will [negatively] affect their quality of life,' Dr Stuckey said. 'You can't expect HRT in that case to positively alter quality of life, all you can expect it to do is alter the risk of a fracture, which it does.'
Associate Professor Susan Davis, research director of Melbourne's Jean Hailes Foundation, criticised the study's use of 'inappropriate' assessment tools.
A 4-point scale of sexual satisfaction was completely inadequate as it did not address specifics such as vaginal dryness, dyspareunia (painful intercourse) or arousal, she said.
A golden opportunity to study the effect of HRT on cognition (thought processes) had been lost because a scale designed to detect dementia was used. And nuances of lowered mood were unlikely to be picked up by a scale designed to screen for major depression, she said.
Last Reviewed: 31 March 2003
- 1. Medical Observer Weekly 28/03/03
