Menorrhagia is a common problem, yet evidence to inform decisions about therapy is limited. In a pragmatic, multicenter, randomized trial, researchers have compared the Levonorgestrel-releasing intrauterine system ( Levonorgestrel-IUS ) with usual medical treatment in women with menorrhagia who presented to their primary care providers.
Investigators have randomly assigned 571 women with menorrhagia to treatment with Levonorgestrel-IUS or usual medical treatment ( Tranexamic acid, Mefenamic acid, combined Estrogen - Progestogen, or Progesterone alone ).
The primary outcome was the patient-reported score on the Menorrhagia Multi-Attribute Scale ( MMAS ) ( ranging from 0 to 100, with lower scores indicating greater severity ), assessed over a 2-year period.
Secondary outcomes included general quality-of-life and sexual-activity scores and surgical intervention.
MMAS scores improved from baseline to 6 months in both the Levonorgestrel-IUS group and the usual-treatment group ( mean increase, 32.7 and 21.4 points, respectively; P less than 0.001 for both comparisons ).
The improvements were maintained over a 2-year period but were significantly greater in the Levonorgestrel-IUS group than in the usual-treatment group ( mean between-group difference, 13.4 points; P less than 0.001 ).
Improvements in all MMAS domains ( practical difficulties, social life, family life, work and daily routine, psychological well-being, and physical health ) were significantly greater in the Levonorgestrel-IUS group than in the usual-treatment group, and this was also true for seven of the eight quality-of-life domains.
At 2 years, more of the women were still using the Levonorgestrel-IUS than were undergoing the usual medical treatment ( 64% vs. 38%, P less than 0.001 ).
There were no significant between-group differences in the rates of surgical intervention or sexual-activity scores. There were no significant differences in serious adverse events between groups.
In conclusion, in women with menorrhagia who presented to primary care providers, the Levonorgestrel-IUS was more effective than usual medical treatment in reducing the effect of heavy menstrual bleeding on quality of life. ( Xagena )
Gupta J et al, N Engl J Med 2013; 368:128-137