Table 7.
Inflammatory markers baseline, post 6 or 12 weeks, and change data after placebo or SXRG (Study 2).
| AA Baseline to 6 Weeks (Placebo) n = 30 |
AB Baseline to 12 Weeks (Placebo then Active) n = 30 |
BB Baseline to 6 Weeks (Active) n = 34 |
BA Baseline to 12 Weeks (Active then Placebo) n = 34 |
p-Value * | |
|---|---|---|---|---|---|
| C-Reactive Protein (mg/L) | |||||
| Baseline ¥ | 0 (0, 4.5) | 0 (0, 4.5) | 0 (0, 0.6) | 0 (0, 0.6) | 0.409 |
| Post | 0 (0, 6.9) | 0.1 (0, 5.1) | 0 (0, 4.5) | 0 (0, 0.2) | 0.240 |
| Change | 0 (0, 1.4) | 0 (−0.5, 0.6) | 0 (0, 3.5) | 0 (0, 0) | |
| IFN-gamma (pg/mL) | |||||
| Baseline ¥ | 3.2 (1.8, 5.4) | 3.2 (1.8, 5.4) | 3.4 (1.8, 4.8) | 3.4 (1.8, 4.8) | 0.877 |
| Post | 3.0 (2.2, 5.8) a | 2.7 (1.9, 4.0) b | 3.6 (2.0, 4.2) a,b | 2.3 (1.3, 3.1) b | 0.014 |
| Change | 0.4 (−0.6, 1.6) | −0.4 (−2.2, 0.6) | 0.2 (−1.3, 0.8) | −1.0 (−2.0, 0.0) | |
| IL-1 beta (pg/mL) | |||||
| Baseline ‡ | 17.5 (9.4, 27.7) | 17.5 (9.4, 27.7) | 14.7 (9.9, 23.3) | 14.7 (9.9, 23.3) | 0.547 |
| Post | 17.6 (13.0, 25.1) a | 15.2 (9.9, 21.7) b | 16.4 (13.3, 21.3) a,b | 10.6 (8.0, 18.3) b | 0.005 |
| Change | −0.3 (−3.9, 8.9) | −1.1 (−9.0, 4.6) | 1.4 (−5.9, 5.9) | −3.7 (−11.0, 0.8) | |
| IL-6 (pg/mL) | |||||
| Baseline ‡ | 11.8 (8.3, 20.8) | 11.8 (8.3, 20.8) | 12.9 (7.9, 22.3) | 12.9 (7.9, 22.3) | 0.896 |
| Post | 14.8 (10.5, 19.5) | 12.0 (9.4, 16.5) | 13.8 (9.3, 17.1) | 10.3 (7.0, 16.1) | 0.226 |
| Change | 1.3 ± 8.1 | −2.0 ± 7.8 | −1.5 ± 8.7 | −2.3 ± 8.0 | |
| TNF-alpha (pg/mL) | |||||
| Baseline § | 7.7 (4.0, 12.1) | 7.7 (4.0, 12.1) | 5.4 (2.9, 10.0) | 5.4 (2.9, 10.0) | 0.528 |
| Post | 8.1 (6.3, 16.9) a | 8.0 (3.6, 13.1) b | 8.7 (6.1, 11.6) a,b | 4.5 (2.8, 10.1) b | 0.005 |
| Change | 1.7 (−1.4, 7.6) | 0.3 (−2.0, 3.3) | 1.3 (−2.3, 5.0) | −1.2 (−6.2, 2.4) | |
| IL-10 (pg/mL) | |||||
| Baseline ¥ | 1.3 (0.8, 2.4) | 1.3 (0.8, 2.4) | 1.1 (0.7, 2.1) | 1.1 (0.7, 2.1) | 0.780 |
| Post | 1.5 (1.2, 2.5) a | 1.3 (0.8, 2.2) b,c | 1.6 (1.2, 2.0) a,b | 1.0 (0.7, 1.9) c | 0.009 |
| Change | 0.3 (−0.3, 1.1) | 0.0 (−0.3, 0.5) | 0.1 (−0.4, 0.8) | −0.2 (−0.9, 0.3) | |
| IL-8 (pg/mL) | |||||
| Baseline § | 5.2 (3.5, 10.1) | 5.2 (3.5, 10.1) | 4.7 (2.7, 8.5) | 4.7 (2.7, 8.5) | 0.607 |
| Post | 5.7 (3.9, 8.8) | 3.9 (3.0, 6.9) | 5.2 (4.0, 7.0) | 3.9 (1.7, 9.2) | 0.254 |
| Change | 0.2 (−1.3, 3.0) | −1.1 (−2.8, 0.2) | −0.2 (−2.6, 2.6) | −0.5 (−2.1, 0.9) |
Data are presented as median (25th and 75th percentile). AA = Placebo for 6 weeks; AB = Placebo for 6 weeks then SXRG treatment for 6 weeks; BB = SXRG treatment for 6 weeks; BA = SXRG treatment for 6 weeks then placebo for 6 weeks. Change determined by median post value (6 or 12 weeks) minus median baseline value. * p-value at baseline determined by T-test on normal, log-transformed (§), square root-transformed data (‡), or Wilcoxon signed rank test (¥) between the two baseline regime groups. p-value for post measure determined by ANCOVA using absolute data from 6 weeks (for placebo and active group) and 12 weeks (for placebo then active group and active then placebo group) using baseline data as a covariate. Values with different superscript letters denotes statistical significance (p < 0.05).