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

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.

Keywords: HRQoL; MMAS; dysfunctional uterine bleeding; menorrhagia; tranexamic acid.

Figure 1

Satisfaction with the LNG-IUS versus CMT at last visit or at end of therapy. Notes: Satisfaction was recorded by a four-point Likert-like scale (very satisfied to dissatisfied). The difference between the groups was statistically significant (P<0.05). Abbreviations: CMT, conventional medical treatment; LNG-IUS, levonorgestrel-releasing intrauterine system.

Figure 2

Treatment satisfaction with LNG-IUS or CMT, as compared to previous treatment. Notes: The questionnaire was filled out by all women. Those without a history of previous treatment are included in the “Missing” category. The difference between groups was statistically significant (P<0.05). Abbreviations: CMT, conventional medical treatment; LNG-IUS, levonorgestrel-releasing intrauterine system.

Figure 3

Menorrhagia multi-attribute scale scores (mean ± SD) in the two treatment groups, LNG-IUS versus CMT. Note: In both groups, the increase of MMAS was statistically significant (P<0.05). Abbreviations: CMT, conventional medical treatment; LNG-IUS, levonorgestrel-releasing intrauterine system; MMAS, menorrhagia multi-attribute scale; SD, standard deviation.

Figure 4

Menorrhagia multi-attribute scale scores at baseline and 12-months follow-up (mean ± SD) stratified by BMI, LNG-IUS versus CMT. Notes: P<0.0032 for between treatment difference. P<0.0001 for difference between BMI groups. Abbreviations: BMI, body mass index; CMT, conventional medical treatment; LNG-IUS, levonorgestrel-releasing intrauterine system; MMAS, menorrhagia multi-attribute scale; SD, standard deviation.

Figure 5

Menorrhagia multi-attribute scale scores at baseline and 12 months (mean ± SD) stratified by age group, LNG-IUS versus CMTs. Notes: There were too few women aged ≤25 years to allow inclusion as a separate group, and this age category is, therefore, excluded from the graph. P<0.05 for comparison between baseline and 12 months. Abbreviations: CMT, conventional medical treatment; LNG-IUS, levonorgestrel-releasing intrauterine system; MMAS, menorrhagia multi-attribute scale; SD, standard deviation.