The preferred treatment option for menorrhagia has been hysterectomy. The surgical risks, adverse long-term effects, and substantial costs of this invasive procedure are well known. The levonorgestrel-releasing intrauterine system (LNG-IUS) is an effective alternative that has become increasingly popular. Previous randomized controlled trials conducted by these authors compared LNG-IUS and hysterectomy for the treatment of menorrhagia with follow-up data for 1 and 5 years. The data showed no difference between the 2 procedures between 1 and 5 years in the level of patient satisfaction or health-related quality of life (HRQOL), but LNG-IUS was more cost-effective. There are no comparative HRQOL and cost data at follow-ups longer than 5 years.
The aim of this randomized controlled trial was to compare the HRQOL and costs of LNG-IUS or hysterectomy in the treatment of menorrhagia over a 10-year follow-up. Participants were 236 eligible women, aged 35 to 49 years, who had been referred for menorrhagia to 5 university hospitals in Finland from 1994 through 1997. Subjects were randomized to receive treatment with LNG-IUS (n = 119) or hysterectomy (n = 117). The follow-up visits after randomization took place at 6 and 12 months and again at 5 and 10 years. Health-related quality of life, psychosocial well-being, and cost-effectiveness were the main outcome measures.
Although 46% (55/119) of the women in the LNG-IUS group eventually underwent hysterectomy during the 10-year follow-up, the overall costs in this group remained substantially lower than in the hysterectomy group ($3423 vs $4937). Health-related quality of life and psychosocial well-being improved significantly during first 5 years, but both declined between 5 and 10 years, and by 10 years, there were no significant differences between groups in either outcome measure.
These data show that both LNG-IUS and hysterectomy improved HRQOL. The most striking improvement occurred during the first 5 years. Although nearly half of the women in the LNG-IUS group eventually had hysterectomy, LNG-IUS remained cost-effective.