Study supports first-line use of levonorgestrel-releasing coil for heavy menstrual bleeding
The levonorgestrel-releasing coil is more effective than usual medical treatment in reducing the impact of heavy menstrual bleeding on daily life, a recent randomised controlled trial suggests (New England Journal of Medicine 2013;368:128).
The trial, which involved 571 women aged between 25 and 50 years who consulted their GP about menorrhagia, compared the levonorgestrel-releasing intrauterine system (IUS) with usual medical care (tranexamic acid, mefenamic acid, combined estrogen-progestogen, or progesterone alone).
The primary outcome was patient reported score on the Menorrhagia Multi-Attribute Scale (MMAS — see Panel) over two years. Secondary outcomes were general health-related quality of life, sexual activity and surgical intervention.
Improvements greater in the coil group
The researchers found that total MMAS scores improved for both groups over two years but improvements in the scores were significantly greater in the coil group than in the usual treatment group (mean difference in scores 13.4 points, 95 per cent confidence interval 9.916.9; P<0.001). All six domains of the MMAS favoured the intrauterine device at every time point, say the researchers.
Similarly, scores for quality of life for women in the coil group were better than for women in the usual treatment group in seven out of eight domains over all time points.
There was no difference between the two groups in sexual activity scores or rates of surgical interventions or adverse events, they found.
The researchers say that, given the long natural history of menorrhagia, the outcomes need to be assessed over a longer period. Additional analyses are planned at five and 10 years, they add.
Study adds strength to evidence base
Chloe Benn, principal pharmacist, women’s and children’s services, Royal Free London NHS Foundation Trust, said the trial adds strength to the evidence base supporting use of levonorgestrel-IUS as first line therapy in heavy menstrual bleeding.
“Despite a significant removal rate (mainly for inefficacy or irregular/prolonged bleeding) over the two-year study period, the levonorgestrel-IUS was shown to be the more effective treatment compared to usual medical therapy, which may help women make decisions about their options. Women can be reassured that any irregular bleeding usually settles within six months.”
Ms Benn pointed out that use of the levonorgestrel-IUS in women who do not require contraception is off-label. “It has been suggested that the licensed indications should be extended to include this,” she said.
The Menorrhagia Multi-Attribute Scale (MMAS) is designed to measure the effect of menorrhagia on six aspects of daily life, including practical difficulties, social life, psychological health, physical health, work and daily routine, and family life and relationships. Scores range from 0 (severely affected) to 100 (not affected) and were assessed at six, 12 and 24 months. Secondary outcomes were measured at the same time points.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.11115249
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