Endpoint values for secondary outcome measures. Sleep quality is based on an 11-point numerical rating scale, with higher scores indicating better sleep quality. Values are least squares mean (standard error) unless otherwise specified.
| Variables | Pregabalin, n = 181 | Placebo, n = 177 | Difference | 95% CI | p |
|---|---|---|---|---|---|
| HADS scores | |||||
| HADS-A | 6.01 (0.28) | 6.96 (0.28) | −0.95 | −1.40 – −0.50 | < 0.0001 |
| HADS-D | 6.17 (0.31) | 7.05 (0.31) | −0.88 | −1.37 – − 0.39 | 0.0005 |
| FIQ scores | |||||
| Total | 43.78 (1.42) | 50.38 (1.43) | −6.60 | −9.33 – −3.87 | < 0.0001 |
| Subscales | |||||
| Physical impairment | 3.35 (0.17) | 3.77 (0.17) | −0.42 | −0.74 – −0.11 | 0.0078 |
| Feel good | 4.69 (0.23) | 5.53 (0.23) | −0.85 | −1.36 – −0.33 | 0.0014 |
| Work missed | 2.02 (0.21) | 2.62 (0.21) | −0.59 | −1.01 – −0.18 | 0.0050 |
| Do work | 4.56 (0.20) | 5.31 (0.20) | −0.75 | −1.14 – −0.36 | 0.0002 |
| Pain | 4.91 (0.17) | 5.54 (0.17) | −0.64 | −1.00 – −0.28 | 0.0006 |
| Fatigue | 6.32 (0.19) | 6.76 (0.19) | −0.44 | −0.85 – −0.04 | 0.0315 |
| Rested | 5.64 (0.19) | 6.41 (0.19) | −0.76 | −1.17 – −0.35 | 0.0003 |
| Stiffness | 5.24 (0.19) | 5.95 (0.19) | −0.71 | −1.11 – −0.31 | 0.0007 |
| Anxiety | 3.80 (0.20) | 4.35 (0.21) | −0.55 | −0.93 – −0.17 | 0.0048 |
| Depression | 3.20 (0.20) | 4.13 (0.20) | −0.92 | −1.32 – −0.53 | < 0.0001 |
| SSQ scores | |||||
| Sleep quality | 6.15 (0.14) | 5.57 (0.14) | 0.57 | 0.31 – 0.84 | < 0.0001 |
| sWASO | 33.38 (2.73) | 41.18 (2.76) | −7.81 | −12.66 – −2.96 | 0.0018 |
| LSO | 33.54 (2.68) | 39.33 (2.71) | −5.80 | −10.29 – −1.31 | 0.0117 |
| sTST | 422.98 (5.42) | 414.63 (5.48) | 8.35 | −0.04–16.74 | 0.0511 |
| sNAASO | 0.48 (0.07) | 0.61 (0.07) | −0.13 | −0.29–0.03 | 0.1139 |
| PSGA score | 5.83 (0.17) | 5.27 (0.17) | 0.55 | 0.14–0.97 | 0.0085 |
| EQ-5D score | 0.58 (0.02) | 0.56 (0.02) | 0.02 | −0.02–0.06 | 0.3854 |
HADS: Hospital Anxiety and Depression Scale; HADS-A: HADS-Anxiety; HADS-D: HADS-Depression; FIQ: Fibromyalgia Impact Questionnaire; SSQ: subjective sleep questionnaire; sWASO: subjective wake after sleep onset; LSO: latency to sleep onset; sTST: subjective total sleep time; sNAASO: subjective number of awakenings after sleep onset; PSGA: Patient Static Global Assessment.