title: Satisfaction and health-related quality of life in women with heavy menstrual bleeding; results from a non-interventional trial of the levonorgestrel-releasing intrauterine system or conventional medical therapy.
abstract: OBJECTIVE
  To evaluate the patient satisfaction and health related quality of life (HRQoL) for levonorgestrel-releasing intrauterine system (LNG-IUS) versus conventional medical treatments ([CMTs] combined oral contraceptives, oral progestins, and antifibrinolytics, alone or in combination) in Asian women with heavy menstrual bleeding (HMB).
  
  
  METHODS
  A total of 647 patients diagnosed with HMB were recruited to this non-interventional study from the eight participating countries in Asia. Patient satisfaction was recorded at the last visit (at 12 months or premature discontinuation). At each visit (at 3, 6, and 12 months), patients completed the menorrhagia multi-attribute scale (MMAS) to assess HRQoL.
  
  
  RESULTS
  A total of 83.5% of patients on the LNG-IUS were "very satisfied" or at least "satisfied" with the therapeutic effect of HMB treatment, compared with 59.2% of patients with CMTs (P<0.05). The mean (± standard deviation) MMAS score increased from 41.4±24.5 to 87.7±21.4 in the LNG-IUS arm, and from 44.1±24.9 to 73.1±25.3 in the CMTs arm. This increase was significantly higher in patients on the LNG-IUS, as compared with those on CMTs (P<0.05). The improvement in HRQoL in both treatment groups correlated with the body mass index of the patient, with larger improvement obtained in women with a higher body mass index.
  
  
  CONCLUSIONS
  The majority of women using the LNG-IUS or CMTs for HMB were satisfied with their treatment, and both treatment modalities were associated with significant improvements in HRQoL over time. The improvement was greater with the LNG-IUS, compared with CMTs.
authors.affiliation: Department of Gynecology and Obstetrics, Peking Union Medical College Hospital, Beijing, People's Republic of China.
authors.forename: Ling
authors.initials: L
authors.lastname: Xu
authors.affiliation: Department of Obstetrics and Gynecology, Yonsei University College of Medicine, Gangnam Severance Hospital, Seoul, Korea.
authors.forename: Byung Seok
authors.initials: BS
authors.lastname: Lee
authors.affiliation: Department of Gynaecology and Obstetrics, Surgimed Hospital, Lahore, Pakistan.
authors.forename: Shaheena
authors.initials: S
authors.lastname: Asif
authors.affiliation: Global Medical Affairs Excellence and Operations, Berlin, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Kraemer
authors.affiliation: Global Medical Affairs Women's Healthcare, Bayer HealthCare, Berlin, Germany.
authors.forename: Pirjo
authors.initials: P
authors.lastname: Inki
keywords: HRQoL; MMAS; dysfunctional uterine bleeding; menorrhagia; tranexamic acid