title: Levonorgestrel intrauterine system versus medical therapy for menorrhagia.
abstract: BACKGROUND
  Menorrhagia is a common problem, yet evidence to inform decisions about therapy is limited. In a pragmatic, multicenter, randomized trial, we compared the levonorgestrel-releasing intrauterine system (levonorgestrel-IUS) with usual medical treatment in women with menorrhagia who presented to their primary care providers.
  
  
  METHODS
  We 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.
  
  
  RESULTS
  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<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; 95% confidence interval, 9.9 to 16.9; P<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<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.
  
  
  CONCLUSIONS
  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. (Funded by the National Institute of Health Research Health Technology Assessment Programme; ECLIPSE Controlled-Trials.com number, ISRCTN86566246.).
authors.affiliation: School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, United Kingdom.
authors.forename: Janesh
authors.initials: J
authors.lastname: Gupta
authors.forename: Joe
authors.initials: J
authors.lastname: Kai
authors.forename: Lee
authors.initials: L
authors.lastname: Middleton
authors.forename: Helen
authors.initials: H
authors.lastname: Pattison
authors.forename: Richard
authors.initials: R
authors.lastname: Gray
authors.forename: Jane
authors.initials: J
authors.lastname: Daniels
mesh_terms: D000328:Adult; D000933:Antifibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use; D003271:Contraceptive Agents, Female / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004967:Estrogens / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007436:Intrauterine Devices, Medicated; D016912:Levonorgestrel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008528:Mefenamic Acid / Q000009:adverse effects / Q000627:therapeutic use; D008595:Menorrhagia / Q000188:drug therapy* / Q000601:surgery; D008875:Middle Aged; D011372:Progestins / Q000009:adverse effects / Q000627:therapeutic use; D011788:Quality of Life; D012720:Severity of Illness Index; D012725:Sexual Behavior; D014148:Tranexamic Acid / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000933:Antifibrinolytic Agents; D003271:Contraceptive Agents, Female; D004967:Estrogens; D011372:Progestins; D008528:Mefenamic Acid; D016912:Levonorgestrel; D014148:Tranexamic Acid