Table 4.
Change in HAM-D-17 Score from Baseline to Treatment Week 8 by High vs. Low Inflammation Status on Each of Five Biomarkers at Baseline for Subjects Treated with EPA or Placebo, Based on Mixed Model Repeated Measures Analysis1
| Treatment Group and Inflammatory Marker | Change from Baseline to Treatment Week 8
|
High vs. Low Inflammation Effect Size2 at Treatment Week 8 (95% CI) | High vs. Low Inflammation at Treatment Week 8 | Significance of High/Low- by-Time Interaction | ||
|---|---|---|---|---|---|---|
| High Inflammation | Low Inflammation | |||||
| EPA: | ||||||
| hs-CRP | LS-Mean (SEM) [N] | −11.94 (1.37) [15] | −9.50 (0.78) [37] | −0.497 (−1.105 to +0.111) | t= −1.55 | F=2.04 |
| df=125 | df=1, 188 | |||||
| P=0.124 | P=0.155 | |||||
| IL-6 | LS-Mean (SEM) [N] | −9.90 (1.42) [15] | −10.17 (0.78) [37] | +0.04 (−0.556 to +0.644) | t= +0.17 | F=0.01 |
| df=127 | df=1, 189 | |||||
| P=0.869 | P=0.913 | |||||
| IL-1ra | LS-Mean (SEM) [N] | −11.96 (1.03) [23] | −8.72 (0.89) [29] | −0.667 (−1.230 to −0.104) | t= −2.39 | F=3.10 |
| df=123 | df=1, 188 | |||||
| P=0.018 | P=0.080 | |||||
| Leptin | LS-Mean (SEM) [N] | −9.28 (1.21) [19] | −10.50 (0.83) [33] | +0.246 (−0.320 to +0.813) | t= +0.82 | F=0.23 |
| df=121 | df=1, 187 | |||||
| P=0.412 | P=0.633 | |||||
| Adiponectin | LS-Mean (SEM) [N] | −11.93 (1.06) [21] | −8.86 (0.87) [31] | −0.633 (−1.201 to −0.065) | t= −2.24 | F=2.71 |
| df=125 | df=1, 189 | |||||
| P=0.027 | P=0.102 | |||||
|
| ||||||
| Placebo: | ||||||
| hs-CRP | LS-Mean (SEM) [N] | −8.04 (1.57) [8] | −10.18 (0.71) [44] | +0.458 (−0.301 to +1.217) | t= +1.25 | F=0.24 |
| df=122 | df=1, 185 | |||||
| P=0.215 | P=0.626 | |||||
| IL-6 | LS-Mean (SEM) [N] | −8.09 (1.32) [12] | −10.37 (0.74) [40] | +0.490 (−0.163 to +1.142) | t= +1.50 | F=0.91 |
| df=126 | df=1, 188 | |||||
| P=0.136 | P=0.342 | |||||
| IL-1ra | LS-Mean (SEM) [N] | −9.81 (1.41) [11] | −9.82 (0.74) [41] | +0.002 (−0.663 to +0.667) | t= +0.01 | F=0.03 |
| df=122 | df=1, 186 | |||||
| P=0.996 | P=0.865 | |||||
| Leptin | LS-Mean (SEM) [N] | −6.18 (1.30) [13] | −10.91 (0.72) [39] | +1.042 (+0.382 to +1.702) | t= +3.20 | F=4.71 |
| df=129 | df=1, 185 | |||||
| P=0.002 | P=0.031 | |||||
| Adiponectin | LS-Mean (SEM) [N] | −8.77 (1.01) [21] | −10.55 (0.85) [31] | +0.379 (−0.179 to +0.938) | t= +1.35 | F=1.13 |
| df=124 | df=1, 187 | |||||
| P=0.181 | P=0.289 | |||||
Measures (MMRM) analyses were performed on change from Baseline to Week 8 for subsets of N=155 evaluable subjects with all 5 biomarkers present at baseline, testing the significance of effects of high/low inflammatory status, time, and high/low-by-time interaction, covarying for the Baseline HAM-D-17 score.
By Cohen’s d effect size = (difference between LS-Mean change) / pooled sd for each pair of treatments (sd per group computed from se of LS-Mean from MMRM). A negative effect size indicates that the group with high inflammation improved more than the low inflammation group (had a larger negative LS-mean change).