236 women (aged 35 - 49 years, mean age 43 years), referred for menorrhagia to 5 university hospitals in Finland, were randomised to treatment with a 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) or hysterectomy «Hurskainen R, Teperi J, Rissanen P, Aalto AM, Gren...»1. Of the women assigned to the hysterectomy group, 107 underwent the operation. Health-related quality of life (HRQOL) improved significantly in both the LNG-IUS and hysterectomy groups (change 0.10, 95% CI 0.06 to 0.14 in both groups). There were no significant differences in the treatment groups except that the women with hysterectomy suffered less pain. Overall costs at one year were about three times higher for the hysterectomy group than the LNG-IUS group. Mean menstrual blood loss measured in 25 women a year after insertion of the device was 13 mL (SD 23.5, range 1 - 92). The remaining women had amenorrhoea or negligible bleeding.
A total of 221 (94%) women of the above study «...»2 were followed for 10 years. Although 55 (46%) women assigned to the LNG-IUS subsequently underwent hysterectomy, the overall costs in the LNG-IUS group ($3 423) were substantially lower than in the hysterectomy group ($4 937). Overall, levels of HRQOL and psychosocial well-being improved during first 5 years but diminished between 5 years and 10 years and the improved HRQOL returned close to the baseline level. There were no significant differences between LNG-IUS and hysterectomy groups.
A Health Technology Assessment «...»3 included 16 trials examining the effectiveness and cost-effectiveness of the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) as a treatment alternative for idiopathic heavy menstrual bleeding. The LNG-IUS improved quality of life and reduced menstrual blood loss better than usual medical therapy. There was no evidence of a significant difference in these outcomes compared with the improvements offered by endometrial ablation or hysterectomy. Mild hormonal side effects were the most commonly reported. Results from the economic evaluation in 9-year time horizon showed the LNG-IUS was less costly (incremental saving of Canadian $372 per person) and more effective providing higher quality-adjusted life years (incremental value of 0.05) compared with endometrial ablation. Similarly, the LNG-IUS costs less (incremental saving of Canadian $3,138 per person) and yields higher quality-adjusted life-years (incremental value of 0.04) compared with hysterectomy.
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