Table 2 Summary of efficacy analyses at study endpoint

MeasurePregabalinPlaceboEndpoint comparison
No.Least squares meanSENo.Least squares meanSEDifference95% CIp Value
* Endpoint mean pain and mean sleep interference measures were derived from patients’ last 7 days of diary entries while taking study drug.
† Higher values reflect greater sleep impairment.
‡ Higher values reflect better quality of life.
MOS = Medical Outcomes Study; SF = Short Form.
Endpoint mean pain score*883.600.24845.290.24−1.69(−2.33, −1.05)0.0001
Short-form McGill Pain Questionnaire
    Sensory score898.150.738411.900.74−3.75(−5.71, −1.79)0.0002
    Affective score891.750.27842.820.28−1.07(−1.81, −0.33)0.0047
    Total score899.850.958414.720.96−4.87(−7.41, −2.34)0.0002
    Visual analogue scale8938.682.908456.302.93−17.62(−25.37, −9.86)0.0001
    Present pain intensity891.580.12841.980.12−0.40(−0.71, −0.09)0.0127
Endpoint mean sleep interference score*881.930.23843.510.23−1.58(−2.19, −0.97)0.0001
MOS Sleep Scale sleep problem index8526.631.778236.431.75−9.80(−14.49, −5.11)0.0001
SF-36 Health Survey
    Physical functioning8562.251.968361.411.900.84(−4.25, 5.93)0.7449
    Physical role limitations8647.044.128344.434.092.60(−8.27, 13.48)0.6369
    Social functioning8678.152.448374.682.443.47(−3.02, 9.96)0.2920
    Bodily pain8655.142.138346.142.139.00(3.33, 14.66)0.0021
    Mental health8677.531.548373.731.543.81(−0.28, 7.89)0.0676
    Emotional role limitations8673.553.978364.623.978.93(−1.60, 19.46)0.0960
    Vitality8649.991.898348.941.881.05(−3.96, 6.05)0.6798
    General health perception8567.611.588163.401.584.21(0.02, 8.40)0.0488