Clinical Outcomes and Costs With the Levonorgestrel-Releasing Intrauterine System or Hysterectomy for Treatment of Menorrhagia
Randomized Trial 5-Year Follow-up
- Ritva Hurskainen, MD, PhD;
- Juha Teperi, MD, PhD;
- Pekka Rissanen, PhD;
- Anna-Mari Aalto, PhD;
- Seija Grenman, MD, PhD;
- Aarre Kivelä, MD, PhD;
- Erkki Kujansuu, MD, PhD;
- Sirkku Vuorma, MD;
- Merja Yliskoski, MD, PhD;
- Jorma Paavonen, MD, PhD
- Author Affiliations: Departments of Obstetrics and Gynecology, University of Helsinki (Drs Hurskainen and Paavonen), University of Turku (Dr Grenman), University of Oulu (Dr Kivelä), University of Tampere (Dr Kujansuu), and University of Kuopio (Dr Yliskoski); School of Public Health, University of Tampere (Dr Rissanen); and STAKES (National Research and Development Center for Welfare and Health), Helsinki (Drs Hurskainen, Teperi, Aalto, and Vuorma), Finland.
Abstract
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-IUS) 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 [SD] 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-IUS (n = 119) or hysterectomy (n = 117) and were monitored for 5 years.
Main Outcome Measures Health-related quality of life (HRQL) 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.
