Clinical outcomes and costs with the levonorgestrel-releasing intrauterine system or hysterectomy for treatment of menorrhagia -: Randomized trial 5-year follow-up

Context Because menorrhagia is often a reason for seeking medical attention, it is important to consider outcomes and costs associated with alternative treatment modalities. Both the levonorgestrel-releasing intrauterine system (LNG-lUS) and hysterectomy have proven effective for treatment of menorrhagia but there are no long-term comparative studies measuring cost and quality of life. Objective To compare outcomes, quality-of-life issues, and costs of the LNG-IUS vs hysterectomy in the treatment of menorrhagia. Design, Setting, and Participants Randomized controlled trial conducted between October 1, 1994, and October 6, 2002, and enrolling 236 women (mean [SDI age, 43 [3.4] years) referred to 5 university hospitals in Finland for complaints of menorrhagia. Interventions Participants were randomly assigned to treatment with the LNG-I US (n=119) or hysterectomy (n=117) and were monitored for 5 years. Main Outcome Measures Health-related quality of life (H RQQ as measured by the 5-Dimensional EuroQol and the RAND 36-Item Short-Form Health Survey, other measures of psychosocial well-being (anxiety, depression, and sexual function), and costs. Results After 5 years of follow-up, 232 women (99%) were analyzed for the primary outcomes. The 2 groups did not differ substantially in terms of HRQL or psychosocial well-being. Although 50 (42%) of the women assigned to the LNG-IUS group eventually underwent hysterectomy, the discounted direct and indirect costs in the LNG-IUS group ($2817 [95% confidence interval, $2222-$3530] per participant) remained substantially lower than in the hysterectomy group ($4660 [95% confidence interval, $4014-$5180]). Satisfaction with treatment was similar in both groups. Conclusions By providing improvement in HRQL at relatively low cost, the LNG-IUS may offer a wider availability of choices for the patient and may decrease costs due to interventions involving surgery.