Table 4.
Effect sizes and 95% confidence intervals for measures of pain in subgroups of interest in per protocol analyses
| Change during Placebo (95% Confidence Interval) |
Change during Milnacipran (95% Confidence Interval) |
Difference between Placebo & Milnacipran (95% Confidence Interval) |
|
|---|---|---|---|
| BPI-sf Average Pain Intensitya≥ 4 at baseline (n=29) | |||
| BPI-sf Pain Intensity a | −0.31 (−1.07, 0.45) | −0.76 (−1.41, −0.10) | −0.45 (−1.51, 0.61) |
| SIS b | −0.87 (−1.62, −0.12) | −0.69 (−1.31, −0.07) | 0.18 (−0.87, 1.23) |
| Thumbnail PPT c | 0.06 (−0.60, 0.72) | 0.78 (0.23, 1.34) | 0.72 (0.03, 1.42) |
| Trapezius PPT c | 0.42 (−0.13, 0.97) | 0.72 (0.10, 1.35) | −0.30 (−1.06, 0.45) |
| Regional Pain Scale ≥ 7 at baseline (n=25) | |||
| BPI-sf Pain Intensity a | −0.08 (−0.96, 0.80) | −0.48 (−1.22, 0.26) | −0.40 (−1.64, 0.84) |
| SIS b | −0.64 (−1.48, 0.20) | −0.91 (−1.60, −0.22) | −0.27 (−1.41, 0.87) |
| Thumbnail PPT c | 0.20 (−0.55, 0.95) | 0.73 (0.13, 1.33) | 0.53 (−0.20, 1.26) |
| Trapezius PPT c | 0.67 (0.10, 1.24) | 0.36 (−0.28, 1.00) | −0.31 (−1.05, 0.44) |
| Swollen joint count ≤ 1 at baseline (n=22) | |||
| BPI-sf Pain Intensity a | 0.09 (−0.76, 0.94) | −1.05 (−1.78, −0.32) | −1.14 (−2.26, −0.01) |
| SIS b | −0.45 (−1.23, 0.32) | −1.02 (−1.71, −0.34) | −0.57 (−1.68, 0.55) |
| Thumbnail PPT c | 0.06 (−0.60, 0.73) | 0.95 (0.28, 1.62) | 0.89 (0.16, 1.61) |
| Trapezius PPT c | 0.65 (0.01, 1.29) | 0.82 (0.17, 1.47) | 0.17 (−0.61, 0.94) |
Abbreviations: BPI-sf, Brief Pain Inventory – short form; SIS, Symptom Intensity Scale; PPT, pressure pain threshold.
a
Based on a 0–10 scale with 10 being worse pain
b
Based on 0–9.75 scale with 9.75 being greater intensity of symptoms consistent with fibromyalgia
c
Units are kg/cm2