Pregabalin | Usual care | p between groups | ||||||
---|---|---|---|---|---|---|---|---|
N = 486 | N = 239 | |||||||
Baseline | Final | Change (95% CI) | Baseline | Final | Change (95% CI) | Baseline | Final a | |
MOS-sleep scale, mean (SD) | ||||||||
Sleep disturbance (0–100) | 58.1 (18.9) | 27.1 (17.5) | −29.3 (−31.1, −27.4)** | 50.1 (20.7) | 32.0 (21.2) | −22.4 (−24.9, −19.9)** | <0.001 | <0.001 |
Snoring while sleep (0–100) | 32.5 (29.0) | 23.9 (26.0) | −7.1 (−9.0, −5.2)** | 30.2 (30.3) | 24.7 (26.9) | −4.8 (−7.4, −2.2)** | 0.175 | 0.142 |
Awakening short of breath (0–100) | 39.9 (22.8) | 17.7 (19.6) | −20.3 (−22.2, −18.4)** | 30.6 (23.9) | 20.9 (22.9) | −13.2 (−15.7, −10.6)** | <0.001 | <0.001 |
Optimal sleep (0–1) | 0.19 (0.39) | 0.65 (0.48) | 0.46 (0.41, 0.51)** | 0.26 (0.44) | 0.61 (0.49) | 0.41 (0.34, 0.48)** | <0.050 | 0.268 |
Sleep quality (0–100) | 28.3 (19.7) | 61.3 (24.0) | 31.1 (28.7, 33.5)** | 35.7 (22.6) | 55.1 (26.1) | 22.8 (19.5, 26.1)** | <0.001 | <0.001 |
Daytime sleepiness (0–100) | 38.6 (18.6) | 21.6 (15.9) | −16.0 (−17.6, −14.4)** | 33.7 (19.3) | 23.6 (18.5) | −12.5 (−14.6, −10.3)** | <0.001 | 0.006 |
Sleep hours per night (0–24) | 5.53 (1.25) | 6.91 (1.05) | 1.27 (1.16, 1.38)** | 5.95 (1.53) | 6.91 (1.13) | 1.14 (0.98, 1.31)** | <0.001 | 0.170 |
General index sleep problems (0–100) | 55.0 (15.0) | 27.0 (16.0) | −26.4 (−28.1, −24.7)** | 47.5 (16.8) | 31.2 (19.1) | −19.6 (−22.0, −17.3)** | <0.001 | <0.001 |
EQ-5D questionnaireb | ||||||||
Mobility | 1.40 (0.50) | 1.22 (0.44) | −0.17 (−0.21, −0.13)* | 1.29 (0.50) | 1.17 (0.39) | −0.17 (−0.22, −0.12)* | 0.002 | 0.922 |
[39.4] | [21.4] | [27.1] | [17.0] | <0.001 | 0.375 | |||
Personal care | 1.26 (0.45) | 1.09 (0.29) | −0.15 (−0.18, −0.12)* | 1.19 (0.42) | 1.12 (0.36) | −0.12 (−0.16, −0.08)* | 0.027 | 0.174 |
[26.0] | [8.7] | [18.4] | [10.3] | 0.032 | 0.196 | |||
Activities of daily living | 2.14 (0.50) | 1.56 (0.54) | −0.52 (−0.58, −0.47)** | 1.88 (0.49) | 1.59 (0.58) | −0.43 (−0.51, −0.36)** | <0.001 | 0.047 |
[93.3] | [53.3] | [81.5] | [54.7] | <0.001 | 0.221 | |||
Pain/discomfort | 2.11 (0.63) | 1.57 (0.60) | −0.51 (−0.56, −0.45)** | 1.90 (0.63) | 1.58 (0.62) | −0.42 (−0.49, −0.35)** | <0.001 | 0.043 |
[85.4] | [51.5] | [74.6] | [50.8] | <0.001 | 0.789 | |||
Anxiety/depression | 2.52 (0.52) | 1.54 (0.58) | −0.94 (−1.00, −0.64)** | 2.37 (0.57) | 1.75 (0.61) | −0.72 (−0.80, −0.64)** | 0.001 | <0.001 |
[98.8] | [50.0] | [95.8] | [65.7] | 0.002 | <0.001 | |||
Self-valuation quality of life (EQ-VAS; 0–100) | 42.7 (15.5) | 70.0 (17.3) | 26.4 (24.7, 28.1)** | 48.9 (15.7) | 65.5 (18.3) | 19.4 (17.1, 21.6)** | <0.001 | <0.001 |
Health status (utility index; 0–1) | 0.40 (0.30) | 0.78 (0.25) | 0.36 (0.34, 0.38)** | 0.53 (0.31) | 0.75 (0.28) | 0.29 (0.26, 0.33)** | <0.001 | <0.001 |