Table 1.
Characteristics and questionnaire scores at baseline (before randomisation in original trial) between responders and women not followed-up at 10 yearsa
| Characteristic | All women followed-up at 10 years (n = 206) | All women not followed-up (n = 365) |
|---|---|---|
| Age at start, years | ||
| Mean (SD) | 41.9 (4.9) | 41.1 (5.4) |
| Age ≥35 years, n (%) | 188 (91.2) | 324 (88.7) |
|
| ||
| Ethnicity, n (%) | ||
| White | 178 (86.4) | 293 (80.2) |
| Asian | 11 (5.3) | 40 (10.9) |
| Black | 9 (4.4) | 21 (5.7) |
| Other | 8 (3.8) | 11 (3.0) |
|
| ||
| BMI, kg/m2 | ||
| Mean (SD) | 29.4 (6.4) | 29.1 (6.4) |
| BMI ≥25, n (%) | 146 (70.8) | 255 (69.9) |
|
| ||
| Blood pressure | ||
| Systolic blood pressure, mean (SD) | 129.7 (17.0) | 128.5 (16.3) |
| Diastolic blood pressure, mean (SD) | 78.8 (10.2) | 78.7 (10.5) |
|
| ||
| Presentation to primary care for HMB, n (%) | ||
| Initial | 157 (76.2) | 279 (76.4) |
| Subsequent | 49 (23.8) | 86 (23.6) |
| Duration of HMB >1 year | 164 (79.6) | 296 (81.1) |
| Menstrual pain | 151 (73.3) | 273 (74.8) |
| Contraception requirement | 35 (16.9) | 75 (20.5) |
| Copper or non-hormonal coil | 7 (3.4) | 12 (3.3) |
|
| ||
| Treatment at randomisation, n (%) | ||
| LNG-IUS | 110 (53.4) | 175 (47.9) |
| Usual medical treatments | 96 (46.6) | 190 (52.1) |
|
| ||
| Questionnaire scores, mean (SD) n | ||
| SF-36 | ||
| Physical functioning | 82.5 (19.4) 205 | 76.2 (24.6) 339 |
| Physical role | 71.7 (24.3) 205 | 69.6 (26.2) 340 |
| Emotional role | 72.0 (24.9) 204 | 70.2 (26.6) 339 |
| Social functioning | 65.7 (23.7) 205 | 61.9 (26.0) 342 |
| Mental health | 60.7 (19.6) 205 | 59.1 (19.5) 340 |
| Energy and vitality | 40.8 (21.9) 205 | 40.7 (20.9) 340 |
| Pain | 48.5 (22.6) 205 | 45.6 (22.3) 342 |
| Perception of general health | 62.2 (21.8) 205 | 60.2 (21.7) 342 |
| EuroQoL EQ-5D | ||
| Descriptive system | 0.769 (0.228) 206 | 0.714 (0.276) 340 |
| EQ-5D visual analogue scale | 71.6 (18.9) 185 | 69.0 (19.7) 311 |
| Sexual Activity Questionnaire | ||
| Pleasure | 10.5 (5.0) 166 | 11.1 (4.9) 248 |
| Discomfort | 4.8 (1.4) 166 | 4.5 (1.7) 248 |
| Menorrhagia Multi-Attribute Score | 42.8 (19.4) 206 | 39.7 (21.8) 206 |
a
If information was partially missing but over half of questions in a domain were answered; the average score of the responses was used, otherwise they were classed as missing. The mean scores and number of contributing participants are slightly different from the original ECLIPSE trial because of this method. BMI = body mass index. HMB = heavy menstrual bleeding. LNG-IUS = levonorgestrel-releasing intrauterine system. SD = standard deviation. SF-36 = 36-item Short-Form Health Survey.