Table 2.
Changes in biomarkers of inflammation in plasma of colorectal adenoma patients
| Biomarkers | Baseline | 6-month follow-up | Absolute treatment effect† | Relative treatment effect‡ | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n | Mean | SD | P* | n | Mean | SD | P § | Mean | 95% CI | P* | ||
| Pro-inflammatory | ||||||||||||
| CRP# (μg/ml)
|
||||||||||||
| Placebo | 22 | 1.77 | 3.80 | N/A | 21 | 1.88 | 4.16 | 0.77 | N/A | N/A | N/A | 1.00 |
| Calcium | 21 | 1.13 | 3.50 | 0.21 | 21 | 1.09 | 4.32 | 0.85 | −0.09 | (−0.40, 0.56) | 0.71 | 0.92 |
| Vitamin D | 22 | 1.39 | 2.79 | 0.49 | 22 | 0.99 | 1.97 | 0.05 | −0.39 | (−0.91, 0.86) | 0.11 | 0.68 |
| Calcium + Vit D | 21 | 1.93 | 2.94 | 0.82 | 21 | 2.21 | 3.06 | 0.42 | 0.08 | (−0.40, 0.57) | 0.74 | 1.09 |
| TNF-α# (pg/ml)
|
||||||||||||
| Placebo | 23 | 4.13 | 1.92 | N/A | 21 | 4.57 | 2.05 | 0.09 | N/A | N/A | N/A | 1.00 |
| Calcium | 23 | 3.04 | 1.94 | 0.28 | 21 | 3.35 | 1.88 | 0.67 | 0.06 | (−0.21, 0.33) | 0.66 | 1.06 |
| Vitamin D | 22 | 2.92 | 1.78 | 0.09 | 22 | 2.73 | 2.52 | 0.46 | −0.14 | (−0.40, 0.13) | 0.30 | 0.87 |
| Calcium + Vit D | 23 | 3.62 | 1.75 | 0.50 | 21 | 4.00 | 1.62 | 0.28 | 0.03 | (−0.23, 0.30) | 0.81 | 1.03 |
| IL-6# (pg/ml)
|
||||||||||||
| Placebo | 23 | 1.13 | 4.54 | N/A | 21 | 1.41 | 2.67 | 0.30 | N/A | N/A | N/A | 1.00 |
| Calcium | 23 | 1.09 | 3.65 | 0.45 | 21 | 0.85 | 3.29 | 0.27 | −0.46 | (−1.07, 0.14) | 0.13 | 0.63 |
| Vitamin D | 22 | 0.78 | 4.68 | 0.42 | 22 | 0.67 | 3.76 | 0.47 | −0.38 | (−0.98, 0.23) | 0.22 | 0.68 |
| Calcium + Vit D | 23 | 1.39 | 4.49 | 0.63 | 21 | 1.62 | 3.25 | 0.50 | −0.08 | (−0.69, 0.53) | 0.80 | 0.92 |
| IL-8# (pg/ml)
|
||||||||||||
| Placebo | 23 | 4.74 | 1.59 | N/A | 21 | 5.01 | 1.78 | 0.10 | N/A | N/A | N/A | 1.00 |
| Calcium | 23 | 5.97 | 1.72 | 0.51 | 21 | 5.34 | 1.52 | 0.56 | −0.12 | (−0.49, 0.22) | 0.45 | 0.89 |
| Vitamin D | 22 | 5.60 | 1.52 | 0.30 | 22 | 5.03 | 1.79 | 0.62 | −0.15 | (−0.62, 0.08) | 0.13 | 0.85 |
| Calcium + Vit D | 23 | 5.61 | 1.68 | 0.63 | 21 | 5.09 | 1.54 | 0.60 | −0.14 | (−0.50, 0.21) | 0.42 | 0.87 |
| IL-1β# (pg/ml)
|
||||||||||||
| Placebo | 23 | 0.22 | 2.03 | N/A | 21 | 0.23 | 2.64 | 0.56 | N/A | N/A | N/A | 1.00 |
| Calcium | 23 | 0.27 | 3.82 | 0.56 | 21 | 0.22 | 3.06 | 0.62 | −0.32 | (−1.16, 0.51) | 0.44 | 0.73 |
| Vitamin D | 22 | 0.16 | 2.04 | 0.30 | 22 | 0.13 | 2.28 | 0.07 | −0.70 | (−1.53, 0.12) | 0.09 | 0.50 |
| Calcium + Vit D | 23 | 0.27 | 2.62 | 0.59 | 21 | 0.23 | 2.24 | 0.40 | −0.43 | (−1.27, 0.41) | 0.31 | 0.65 |
| Anti-inflammatory | ||||||||||||
| IL-10# (pg/ml)
|
||||||||||||
| Placebo | 23 | 0.54 | 1.57 | N/A | 21 | 0.53 | 1.96 | 0.63 | N/A | N/A | N/A | 1.00 |
| Calcium | 23 | 0.58 | 1.68 | 0.63 | 21 | 0.50 | 1.56 | 0.16 | −0.07 | (−0.29, 0.15) | 0.52 | 0.93 |
| Vitamin D | 22 | 0.48 | 1.53 | 0.37 | 22 | 0.43 | 1.38 | 0.23 | −0.05 | (−0.27, 0.16) | 0.62 | 0.95 |
| Calcium + Vit D | 23 | 0.26 | 1.49 | 0.66 | 21 | 0.55 | 1.55 | 0.35 | −0.04 | (−0.26, 0.19) | 0.75 | 0.96 |
Abbreviations: C-reactive protein, CRP; Tumor necrosis factor alpha, TNF-α; Interleukin-6, IL-6; Interleukin-8, Il-8; Interleukin-1 beta, IL-1β; Interleukin-10, IL-10.
Absolute treatment effect is the absolute change from baseline to follow-up in the treatment group minus the absolute change from baseline to follow-up in the placebo group from mixed model.
Relative treatment effect is defined as: (treatment group follow-up /treatment group baseline)/(placebo follow-up /placebo baseline). The interpretation of the relative effect is similar to that of an odds ratio (e.g., a relative effect of 2.0 would mean that the relative proportional change in the treatment group was twice as great as that in the placebo group).
P values for difference between each treatment group and placebo group from mixed model.
P values for difference between follow-up visit and baseline visit from mixed model.
Geometric means with standard errors are reported, calculated by exponentiating the mean of the log transformed values.