Managing the resource demands of a large sample size in clinical trials: can you succeed with fewer subjects?

This study has shown that, in women with menorrhagia, there were no statistically significant differences between IUS and hysterectomy for the outcomes of quality of life and psychological wellbeing. The quality-of-life data show that the IUS scored as well at 12 months as hysterectomy in seven of the eight areas assessed, with the only difference between the groups being pain scores, despite a 66% reduction in the IUS group. The IUS is by no means the final answer to the problem of menorrhagia — a third of women had the device removed by one year because of bleeding problems. Costs to both the healthcare system and the patient were reduced with the use of the IUS, although these cost differences may reduce with time. The costs of hysterectomy may be higher because of the 30% complication rate reported in this study — similar rates have been reported by others.4,9 This study provides convincing evidence that the IUS is an effective alternative for women with uncomplicated menorrhagia, and should be offered as a treatment choice.