Table 4.
Changes in plasma CRP and inflammation z-score levels stratified by sex and NSAID use in colorectal adenoma patients
| Baseline | 6-month follow-up | Absolute treatment effect† | Relative treatment effect‡ | ||||||
|---|---|---|---|---|---|---|---|---|---|
| CRP (μg/ml) | n | Mean | SD | Mean | SD | Mean | 95% CI | P* | |
| Women | |||||||||
| Placebo | 7 | 3.55 | 3.50 | 2.99 | 2.85 | N/A | N/A | N/A | 1.00 |
| Calcium | 7 | 1.78 | 4.51 | 2.07 | 5.66 | 0.32 | (−0.91, 1.55) | 0.60 | 1.38 |
| Vitamin D | 6 | 1.52 | 3.32 | 0.98 | 1.89 | −0.27 | (−1.55, 1.00) | 0.66 | 0.76 |
| Calcium + Vit D | 7 | 2.65 | 4.13 | 2.37 | 4.06 | −0.06 | (−1.17, 1.28) | 0.92 | 0.94 |
| Men | |||||||||
| Placebo | 16 | 1.28 | 3.61 | 1.48 | 4.79 | N/A | N/A | N/A | 1.00 |
| Calcium | 16 | 0.90 | 2.98 | 0.79 | 3.51 | −0.28 | (−0.74, 0.19) | 0.24 | 0.76 |
| Vitamin D | 16 | 1.34 | 2.70 | 0.99 | 2.04 | −0.45 | (−0.90, −0.01) | 0.05 | 0.63 |
| Calcium + Vit D | 16 | 1.65 | 2.42 | 2.14 | 2.74 | 0.11 | (−0.36, 0.57) | 0.64 | 1.12 |
| Non-NSAID users# | |||||||||
| Placebo | 19 | 1.37 | 3.59 | 1.51 | 4.13 | N/A | N/A | N/A | 1.00 |
| Calcium | 20 | 1.13 | 3.80 | 1.07 | 4.47 | 0.22 | (−0.70, 0.37) | 0.43 | 1.25 |
| Vitamin D | 20 | 1.55 | 2.64 | 1.02 | 1.90 | −0.53 | (−1.05, −0.01) | 0.05 | 0.59 |
| Calcium + Vit D | 16 | 2.19 | 2.83 | 3.05 | 2.82 | −0.17 | (−0.34, 0.78) | 0.53 | 0.84 |
|
Inflammation Z-Score§
|
|||||||||
| Women | |||||||||
| Placebo | 7 | 2.15 | 3.91 | 2.32 | 3.94 | N/A | N/A | N/A | 1.00 |
| Calcium | 7 | −1.39 | 2.78 | −1.45 | 3.39 | −0.23 | (−1.91, 1.44) | 0.77 | 0.79 |
| Vitamin D | 6 | −1.07 | 2.50 | −1.68 | 3.70 | −0.78 | (−2.52, 0.96) | 0.36 | 0.46 |
| Calcium + Vit D | 7 | −0.06 | 3.74 | 0.37 | 3.12 | −0.14 | (−1.54, 1.81) | 0.87 | 0.87 |
| Men | |||||||||
| Placebo | 16 | −0.72 | 1.94 | −0.12 | 3.05 | N/A | N/A | N/A | 1.00 |
| Calcium | 16 | 0.17 | 2.75 | −0.03 | 2.69 | −0.85 | (−2.09, 0.39) | 0.18 | 0.42 |
| Vitamin D | 16 | −0.71 | 2.79 | −1.82 | 2.44 | −1.75 | (−2.95, −0.55) | 0.01 | 0.17 |
| Calcium + Vit D | 16 | 0.88 | 2.77 | 0.86 | 3.03 | −0.67 | (−1.91, 0.57) | 0.29 | 0.51 |
| Non-NSAID users# | |||||||||
| Placebo | 19 | −0.10 | 2.84 | 0.20 | 3.19 | N/A | N/A | N/A | 1.00 |
| Calcium | 20 | −0.60 | 3.57 | −0.84 | 2.88 | −0.56 | (−1.57, 0.46) | 0.28 | 0.57 |
| Vitamin D | 20 | −0.80 | 2.51 | −1.89 | 2.67 | −1.42 | (−2.41, −0.45) | 0.01 | 0.42 |
| Calcium + Vit D | 16 | 0.02 | 2.42 | 1.08 | 3.01 | −0.08 | (−1.14, 0.98) | 0.89 | 0.92 |
Abbreviations: C-reactive protein, CRP; nonsteroidal anti-inflammatory drug, NSAID.
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).
P values for difference between each treatment group and the placebo group from mixed model.
Inflammation z-score: Z-score of pro- and anti-inflammatory markers (CRP, IL6, IL-1β, TNF-α, IL-8 and IL-10) calculated by 1) subtracting the mean and dividing by the standard deviation (thus creating a mean of zero and standard deviation of 1.0) for each participants individual biomarker value at each visit, and then 2) summing the biomarker z-score values for each participant at each visit (IL-10 was included with a negative sign).
NSAID user status at baseline (NSAID use by treatment group did not change during the course of the trial).