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