Researchers randomly assigned 571 women with menorrhagia to treatment with levonorgestrel-IUS (Mirena) or usual medical treatment: tranexamic acid, mefenamic acid, combined oestrogen–progestogen, or progesterone alone. The primary outcome was the patient-reported score on the Menorrhagia Multi-Attribute Scale (MMAS) which ranges from 0 (most severe) to 100 (least severe). The researchers were part of the Effectiveness and Cost-Effectiveness of Levonorgestrel-Containing IUS in Primary Care against Standard Treatment for Menorrhagia (ECLIPSE) Trial Collaborative Group.
MMAS scores improved from baseline to 6 months in both the Mirena group and the usual-treatment group with a mean increase of 33 and 21 points, respectively. The improvements were maintained over two years but were significantly greater (by 13 points) in the Mirena group than in the usual-treatment group. Improvements in all MMAS domains – practical difficulties, social life, family life, work and daily routine, psychological well-being, and physical health – were significantly greater with Mirena and this was also true for seven of the eight quality-of-life domains.
At two years,64% of the women using Mirena were still on treatment compared to 38% of those in the usual medical treatment group.
There were no significant differences in the rates of surgical intervention or sexual-activity scores – or serious adverse events – between the two groups.
What does it mean for GPs?
In women with menorrhagia presenting to GPs, Mirena was more effective than usual medical treatment in reducing the effect of heavy menstrual bleeding on quality of life. But the other medical therapies were also largely effective. Although many women were still using Mirena at two years follow-up, a third were not.
Dr Ann Williams – a GP in Birmingham and a GPSI in women’s health – said: “This is a very well designed, pragmatic and extremely useful study – which you might expect from the fact that it’s funded by the Health Technology Assessment Programme, rather than a pharma company.
‘And one of the most useful things is that it tells us that even the more conventional treatments – like tranexamic acid and mefenamic acid – are both clinically effective and improve women’s quality of life- and we didn’t know that before.
‘But this will really help us when women with menorrhagia are trying to make a treatment decision – either to opt for a hormonal treatment which will also provide contraception or another treatment. Overall I think it will mean we use Mirena more often for menorrhagia but remember that still a third of women didn’t persist with it.’