Table 4.
Biochemical parameters in the placebo group and PMBE group at baseline, 6 weeks and 12 weeks (post-intervention) and changes in biochemical parameters from baseline at 6 weeks and 12 weeks 1.
| Time | Change 2 | ||||||
|---|---|---|---|---|---|---|---|
| Outcomes | Baseline | 6-Weeks | n | 12-Weeks | n | ∆1 (95% CI) 2 | ∆2 (95% CI) 3 |
| MDA (nmol/mL) | |||||||
| Placebo | 7.58 (0.12) | 7.57 (0.12) | 22 | 7.75 (0.14) | 0.05 (−0.39, −0.48) | 0.18 (−0.22, 0.57) | |
| PMBE | 8.23 (0.19) | 7.02 (0.27) | 22 | 6.85 (0.14) | 30 | −1.19 (−1.62, −0.75) *** | −1.35 (−1.74, −0.96) *** |
| Difference 4 | −1.23 (−1.84, −0.62) *** | −1.53 (−2.09, −0.98) *** | |||||
| hsCRP (mg/dL) 5 | |||||||
| Placebo | 1.26 (0.71. 2.21) | 1.44 (0.89, 2.45) | 22 | 1.43 (0.86, 3.22) | 0.01 (−0.23, 0.26) | 0.18 (−0.04, 0.40) | |
| PMBE | 0.92 (0.53, 1.72) | 0.68 (0.42, 1.34) | 22 | 0.75 (0.49, 1.36) | 30 | −0.20 (−0.44, 0.05) | −0.10 (−0.32, 0.12) |
| Difference | −0.21 (−0.56, 0.14) | −0.28 (−0.59, 0.03) | |||||
| IL-6 (pg/mL) | |||||||
| Placebo | 1.00 (0.63, 1.56) | 0.85 (0.58, 1.27) | 22 | 0.83 (0.58, 1.27) | −0.21 (−0.44, 0.01) | −0.13 (−0.33, 0.07) | |
| PMBE | 0.93 (0.51, 1.41) | 0.91 (0.65, 1.19) | 22 | 1.04 (0.62, 1.46) | 30 | 0.05 (−0.18, 0.27) | 0.17 (−0.03, 0.37) |
| Difference | 0.26 (−0.06, 0.58) | 0.30 (0.02, 0.59) * | |||||
| IL-10 (pg/mL) | |||||||
| Placebo | 0.49 (0.23, 1.21) | 0.65 (0.29, 1.26) | 22 | 0.65 (0.38, 0.97) | 0.12 (−0.09, 0.34) | 0.02 (−0.19, 0.23) | |
| PMBE | 1.13 (1.06, 1.18) | 1.17 (1.03, 1.22) | 22 | 1.16 (1.11, 1.31) | 30 | 0.01 (−0.03, 0.06) | 0.02 (−0.03, 0.08) |
| Difference | −0.11 (−0.33, 0.10) | 0.001 (−0.22, 0.22) | |||||
| ICAM-1 (ng/mL) | |||||||
| Placebo | 11.66 (0.35) | 11.67 (0.46) | 22 | 11.80 (0.41) | −0.23 (−0.71, 0.25) | 0.16 (−0.26, 0.59) | |
| PMBE | 11.03 (0.46) | 11.80 (0.49) | 22 | 11.13 (0.53) | 30 | 0.11 (−0.36, 0.57) | 0.12 (−0.23, 0.47) |
| Difference | 0.34 (−0.34, 1.01) | −0.04 (−0.64, 0.56) | |||||
| Fibrinogen (g/L) | |||||||
| Placebo | 3.56 (0.09) | 3.55 (0.12) | 22 | 3.37 (0.11) | −0.05 (−0.19, 0.09) | −0.18 (−0.38, −0.009) | |
| PMBE | 3.17 (0.08) | 3.22 (0.08) | 22 | 2.90 (0.09) | 30 | −0.02 (−0.14, 0.10) | −0.25 (−0.39, −0.11) *** |
| Difference | 0.03 (−0.16, 0.21) | −0.07 (−0.31, 0.17) | |||||
1 Baseline data are for all participants who commenced the trial (n = 30 placebo, n = 32 active). Data at 6 and 12 weeks are presented for all participants unless otherwise specified in respective table columns and presented as mean (SEM) or median or interquartile range (25th percentile, 75th percentile) depending on data distribution. Mixed models were used to examine the effect of time within treatment groups as well as the interaction between time and treatment across groups. Data for mixed models are presented as mean estimates (95% confidence intervals). All data presented are for adjusted models only using pre-specified variables. Significant findings are indicated * p < 0.05 and *** p < 0.0001. 2 Effect of time within treatment group from baseline to 6 weeks. 3 Effect of time within treatment group from baseline to 12 weeks (post-intervention). 4 Interaction between time x treatment is presented as intervention minus control. 5 Data were log-transformed because the model did not fulfill the assumptions for mixed linear modelling. hsCRP, high sensitive C-Reactive protein; ICAM-1, intercellular adhesion molecule-1; IL, interleukin; MDA, malondialdehyde; PMBE, Pinus massoniana bark extract.