International hysterectomy rates vary considerably; by the age of 60 years, a third of women in the United States will have undergone a hysterectomy and menorrhagia is one of the most common indications.1 Satisfaction rates with hysterectomy have been consistently reported as 95% or higher.2 Quality-of-life measures have also been reported to improve following hysterectomy.3 It is perceived as a permanent solution to the problem of menorrhagia. However, short-term complications following hysterectomy are not uncommon; recent studies report rates of moderately severe complications of 16% while in hospital.4 The IUS is an intrauterine system that can be sited during a clinic visit and its duration of action is five years. The IUS contains 52 mg of levonorgestrel which is released through a rate-limiting membrane (20 μg/24 h), resulting in endometrial shrinkage and a reduction in menstrual bleeding. As the IUS has been proposed as an alternative to hysterectomy, it was important to establish if improvements in quality of life are reported with the IUS.

The trial was well conducted and reported according to published guidelines.5 Patients were allocated to the two treatment groups without the prior knowledge of the investigators, although blinding of patients and investigators was not possible in the follow-up period. An instrument measuring disease-specific QOL may have made QOL differences between the two groups more apparent; however, no disease-specific QOL measure exists. The completeness of follow-up was 97% (228/236), and an intention-to-treat analysis was done. In the IUS group, a third of devices were removed and 20% of the women underwent hysterectomy during the first year of follow-up. Reasons for removal included spotting and other bleeding disorders. This removal rate is higher than the two smaller trials comparing IUS with endometrial resection, which report a 20% removal rate, possibly reflecting the severity of symptoms among women who seek hysterectomy instead of endometrial resection.6,7 The use of health-related quality of life (EuroQol) and other measures of psychological wellbeing was appropriate, and the measures had been validated in the population before the study. Not all women referred for menorrhagia were included. Most of those not participating either did not want to take part or did not meet the eligibility criteria for either of the two treatments. Therefore, it is likely that the study group was representative of women who were candidates for both treatments, and the results can be generalised to the population of women with menorrhagia. The planned five-year follow-up will be welcome.

Two small trials had previously reported that the IUS was an alternative to hysterectomy.8 However, this large randomised trial has improved on those studies, as it included a wider range of outcomes, and shows that, after a year, no statistically significant differences were present between the treatment groups in terms of health status, health-related quality of life, and psychological wellbeing. Cost-effectiveness data favour the IUS.