Table 3.
Baseline score (SD, n) | 5 year score (SD, n) | Difference between groups over 5 years (95% CI)a, P-value | Change within group (95 % CI), P-value | ||||
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UMT | LNG-IUS | UMT | LNG-IUS | UMT | LNG-IUS | ||
SF-36b | |||||||
Physical functioning | 77.8 (24.7, 264) | 80.0 (20.4, 272) | 83.0 (26.3, 208) | 85.4 (23.5, 216) | 1.6 (−2.7 to 5.9), 0.5000 | 5.6 (1.8 to 9.5), 0.0040 | 5.9 (2.8 to 9.1), 0.0003 |
Physical role | 68.9 (26.2, 264) | 72.1 (24.7, 276) | 80.6 (27.2, 208) | 83.9 (25.5, 217) | 2.7 (−2.1 to 7.5), 0.3000 | 12.6 (7.9 to 17.2), <0.0001 | 13.3 (9.5 to 17.1) <0.0001 |
Emotional role | 69.8 (26.8, 264) | 71.9 (25.1, 276) | 83.3 (25.3, 208) | 81.4 (26.9, 217) | −2.0 (−6.8 to 2.9), 0.4000 | 13.1 (8.7 to 17.6), <0.0001 | 10.9 (6.7 to 15.1), <0.0001 |
Social functioning | 62.4 (25.9, 268) | 64.3 (24.5, 277) | 76.9 (25.5, 207) | 79.5 (25.1, 214) | 2.2 (−2.5 to 6.9), 0.4000 | 14.0 (9.4 to 18.5), <0.0001 | 15.6 (11.6 to 19.6), <0.0001 |
Mental health | 59.0 (19.8, 267) | 60.3 (19.3, 277) | 72.6 (19.4, 206) | 71.4 (20.5, 214) | −1.6 (−5.2 to 2.0), 0.4000 | 13.6 (10.5 to 16.7), <0.0001 | 11.4 (8.5 to 14.3), <0.0001 |
Energy/vitality | 40.8 (21.7, 268) | 40.7 (20.9, 277) | 56.6 (23.1, 206) | 59.2 (21.0, 213) | 2.8 (−1.2 to 6.9), 0.2000 | 15.7 (11.9 to 19.4), <0.0001 | 18.6 (15.2 to 22.0), <0.0001 |
Pain | 49.5 (24.9, 268) | 54.2 (24.9, 278) | 71.3 (28.6, 207) | 76.1 (24.8, 214) | 3.7 (−1.3 to 8.7), 0.1000 | 21.4 (16.9 to 25.8), <0.0001 | 22.7 (18.6 to 26.9), <0.0001 |
General health perception | 60.3 (21.9, 264) | 61.8 (21.4, 274) | 61.9 (23.8, 207) | 67.8 (22.1, 214) | 4.7 (0.6 to 8.8), 0.0200 | 2.0 (−1.5 to 5.6), 0.2600 | 5.1 (2.0 to 8.3), 0.0020 |
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EuroQoL | |||||||
EQ-5D descriptive systemc | 0.71 (0.28, 269) | 0.76 (0.24, 277) | 0.82 (0.25, 207) | 0.81 (0.25, 214) | −0.02 (−0.06 to 0.02), 0.4000 | 0.10 (0.06 to 0.14), <0.0001 | 0.06 (0.02 to 0.09), 0.0030 |
EQ-5D visual analogue scaled | 69.7 (19.8, 246) | 70.3 (19.1, 250) | 76.1 (18.8, 198) | 77.3 (19.9, 207) | 0.6 (−3.2 to 4.5), 0.8000 | 6.3 (2.9 to 9.8), 0.0004 | 6.5 (3.0 to 9.9), 0.0003 |
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Sexual activity questionnairee | |||||||
Pleasure | 10.9 (4.9, 199) | 10.8 (4.9, 210) | 11.8 (4.6, 100) | 11.2 (4.5, 111) | −0.4 (−1.7 to 0.9), 0.6000 | 0.6 (−0.6 to 1.7), 0.4000 | 0.1 (−1.0 to 1.2), 0.9000 |
Discomfort | 4.6 (1.7, 201) | 4.7 (1.5, 209) | 4.8 (1.6, 101) | 4.8 (1.6, 111) | 0.0 (−0.4 to 0.4), 0.9000 | 0.1 (−0.2 to 0.4), 0.7000 | 0.1 (−0.3 to 0.4), 0.7000 |
Mean score (standard deviation, n) shown at each time-point. Point estimates (95% CI, P-values) shown for differences between groups and changes within group. Estimates >0 from differences between groups favour LNG-IUS. Results at each time-point adjusted for baseline score. Change within group compared with baseline.
Estimated values >0 favour LNG-IUS.
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) is a general health-related quality-of-life questionnaire. Scores in each of the eight domains range from 0 (severely affected) to 100 (not affected).
The EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D) descriptive system is a general health-related quality-of-life questionnaire. Scores range from −0.59 (state of health worse than death) to 1.00 (perfect state of health).
Scores on the EQ-5D visual-analogue scale range from 0 (worst health state imaginable) to 100 (most perfect health state imaginable).
The Sexual Activity Questionnaire is designed to assess the possible effect of treatment on sexual functioning. Scores for pleasure range from 0 (lowest level) to 18 (highest level), and scores for discomfort range from 0 (greatest) to 6 (none). LNG-IUS = levonorgestrel-releasing intrauterine system. UMT = usual medical treatment.