Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term ranomised pragmatic trial in primary care

Background: Heavy menstrual bleeding (HMB) is a common, chronic problem burdening women and health services. However long-term evidence on treatment in primary care is lacking.Aim: To assess the effectiveness of commencing levonorgestrel intra-uterine system (LNG-IUS) or usual medical treatments for women presenting with HMB in general practice.Design: Pragmatic, multicentre, parallel, open-label randomised controlled trialSetting: 63 primary care practicesMethods: 571 women, aged 25-50, 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, work and family life; scores from 0 -100). Secondary outcomes included surgical intervention (endometrial ablation/hysterectomy), general quality-of-life, sexual-activity and safety.Results: At five 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% CI: -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;