Abstract
Purpose
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).
Patients and 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.
Conclusion
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.
Acknowledgments
The present study was funded by an unrestricted educational grant from Bayer HealthCare Pharmaceuticals. The authors thank all investigators involved in the study for their valuable contribution.
Disclosure
PK and PI are employees of Bayer HealthCare Pharmaceuticals. The study was sponsored by Bayer HealthCare, which was also involved in protocol development. Data analysis was conducted by an external clinical research organization (Institute Dr Schauerte, Oberhaching, Germany). For this study, the English questionnaire was translated into the respective local language and then back-translated into English, wherever needed, according to standard local requirements. BSL, XL, and SA report no conflicts of interest in this work.