Heliövaara-Peippo and colleagues have recently reported on a randomized controlled trial in five Finnish university hospitals to compare the effect of treatment with a levonorgestrel-releasing intrauterine system (LNG-IUS) and the effect of hysterectomy in women with menorrhagia ([I]n[/I] = 221) . The studied population that fulfilled the inclusion criteria, initially aged 35–49 years, was monitored for 10 years and the endpoints were health-related quality of life (HRQoL), psychosocial well-being, and cost-effectiveness. Instruments to measure quality of life and psychosocial well-being were used periodically, including the five-dimensional EuroQoL, the 36-item RAND Health Survey, the Spielberger 20-Item State-Trait Anxiety Inventory, the Beck Depression Inventory and the McCoy Sex Scale. Direct and indirect costs, sick-leave days and out-of-pockets costs were calculated from the time of randomization up to the 10-year follow-up control. There have been several previous publications concerning this trial, including the 12-month and the 5-year follow-up results.
HRQoL and psychosocial well-being were improved during the initial 5 years but diminished between 5 and 10 years; the improved HRQOL returned close to the baseline level without any significant difference between the LNG-IUS-treated and hysterectomy-treated groups. The overall costs in the LNG-IUS group ($ 3423/patient) were lower than in the surgery group ($ 4937/patient), despite the fact that 55 women (46%) assigned to the LNG-IUS group subsequently underwent surgery: 24 (44%) during the first year, 26 (47%) between 12 months and 5 years and five (9%) between 5 and 10 years. The main reasons for hysterectomy were bleeding problems during the first 5 years and fibroids and bleeding problems in the five hysterectomies performed between 5 and 10 years.
At the 10-year follow-up, 44 women had a LNG-IUS [i]in situ[/i]; of these 40 women (91%) reported amenorrhea or oligomenorrhea, two hypomenorrhea, one normal menstrual bleeding and one irregular bleeding. In 18 women, the LNG-IUS was removed but hysterectomy was not performed; of these 18 women, 12 women reported amenorrhea or oligomenorrhea, three normal menstrual bleeding, two irregular bleeding, and one woman submitted to thermoablation after reported hypomenorrhea.
Faustino R. Pérez-López
Professor of Obstetrics and Gynecology, University of Zaragoza Faculty of Medicine & Lozano Blesa University Hospital, Zaragoza, Spain