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


METHODS
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.


METHODS
Participants were randomly assigned to treatment with the LNG-IUS (n = 119) or hysterectomy (n = 117) and were monitored for 5 years.


METHODS
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 dollars [95% confidence interval, 2222 dollars-3530 dollars] per participant) remained substantially lower than in the hysterectomy group (4660 dollars [95% confidence interval, 4014 dollars-5180 dollars]). 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.
Hurskainen
Ritva
R
Department of Obstetrics and Gynecology, University of Helsinki, Finland. ritva.hurskainen@stakes.fi
Teperi
Juha
J
Rissanen
Pekka
P
Aalto
Anna-Mari
AM
Grenman
Seija
S
Kivelä
Aarre
A
Kujansuu
Erkki
E
Vuorma
Sirkku
S
Yliskoski
Merja
M
Paavonen
Jorma
J
D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007044:Hysterectomy / Q000191:economics; D007436:Intrauterine Devices, Medicated / Q000191:economics; D016912:Levonorgestrel / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D008595:Menorrhagia / Q000188:drug therapy* / Q000601:surgery*; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D018434:Sickness Impact Profile
D016912:Levonorgestrel