title: Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term randomised pragmatic trial in primary care.
abstract: BACKGROUND
  Heavy menstrual bleeding (HMB) is a common, chronic problem affecting women and health services. However, long-term evidence on treatment in primary care is lacking.
  
  
  OBJECTIVE
  To assess the effectiveness of commencing the levonorgestrel-releasing intrauterine system (LNG-IUS) or usual medical treatments for women presenting with HMB in general practice.
  
  
  METHODS
  A pragmatic, multicentre, parallel, open-label, long term, randomised controlled trial in 63 primary care practices across the English Midlands.
  
  
  METHODS
  In total, 571 women aged 25-50 years, with HMB were randomised to LNG-IUS or usual medical treatment (tranexamic/mefenamic acid, combined oestrogen-progestogen, or progesterone alone). The primary outcome was the patient reported Menorrhagia Multi-Attribute Scale (MMAS, measuring effect of HMB on practical difficulties, social life, psychological and physical health, and work and family life; scores from 0 to 100). Secondary outcomes included surgical intervention (endometrial ablation/hysterectomy), general quality of life, sexual activity, and safety.
  
  
  RESULTS
  At 5 years post-randomisation, 424 (74%) women provided data. While the difference between LNG-IUS and usual treatment groups was not significant (3.9 points; 95% confidence interval = -0.6 to 8.3; P = 0.09), MMAS scores improved significantly in both groups from baseline (mean increase, 44.9 and 43.4 points, respectively; P<0.001 for both comparisons). Rates of surgical intervention were low in both groups (surgery-free survival was 80% and 77%; hazard ratio 0.90; 95% CI = 0.62 to 1.31; P = 0.6). There was no difference in generic quality of life, sexual activity scores, or serious adverse events.
  
  
  CONCLUSIONS
  Large improvements in symptom relief across both groups show treatment for HMB can be successfully initiated with long-term benefit and with only modest need for surgery.
authors.affiliation: Faculty of Medicine & Health Sciences, School of Medicine, University of Nottingham, Nottingham.
authors.forename: Joe
authors.initials: J
authors.lastname: Kai
authors.affiliation: Birmingham Clinical Trials Unit, University of Birmingham, Birmingham.
authors.forename: Lee
authors.initials: L
authors.lastname: Middleton
authors.affiliation: Birmingham Clinical Trials Unit, University of Birmingham, Birmingham.
authors.forename: Jane
authors.initials: J
authors.lastname: Daniels
authors.affiliation: School of Life and Health Sciences, Aston University, Birmingham.
authors.forename: Helen
authors.initials: H
authors.lastname: Pattison
authors.affiliation: Birmingham Clinical Trials Unit, University of Birmingham, Birmingham.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Tryposkiadis
authors.forename: Janesh
authors.initials: J
authors.lastname: Gupta
mesh_terms: D000328:Adult; D003271:Contraceptive Agents, Female / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007436:Intrauterine Devices, Medicated; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000627:therapeutic use*; D008595:Menorrhagia / Q000188:drug therapy*; D008875:Middle Aged; D011788:Quality of Life; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D003271:Contraceptive Agents, Female; D016912:Levonorgestrel
keywords: general practice; levonorgestrel intrauterine system; medical treatment; menorrhagia; menstrual; primary health care