Table 2.
Means ± standard deviation of immunological parameters before, during and after exposition with Iscucin® Populi (IP), Viscum Mali e planta tota (VM) and placebo (Pl) in the ITT population, nd = not done.
| Group | Baseline | Exposure | Exposure | Exposure | Follow-up | |
|---|---|---|---|---|---|---|
| Week 4 | Week 8 | Week 12 | Week 16 | |||
| Leukocytes (1000/μl) | IP | 6.2 ± 2.0 | 5.9 ± 1.2 | 7.2 ± 2.0 * | 6.7 ± 1.6 * | 5.8 ± 1.5 |
| VM | 5.7 ± 1.4 | 5.8 ± 1.2 | 6.0 ± 1.2 | 5.6 ± 1.4 | 5.7 ± 1.0 | |
| Pl | 6.4 ± 1.7 | 6.2 ± 1.6 | 6.5 ± 1.7 | 6.1 ± 1.7 | 6.5 ± 1.8 | |
| Eosinophils (1000/μl) | IP | 0.1 ± 0.0 | 0.2 ± 0.1** | 1.1. ± 0.7*** | 0.8 ± 0.5*** | 0.2 ± 0.1 |
| VM | 0.1 ± 0.0 | 0.1 ± 0.0 | 0.2 ± 0.0* | 0.2 ± 0.0** | 0.2 ± 0.1 | |
| Pl | 0.2 ± 0.1 | 0.2 ± 0.1 | 0.2 ± 0.1 | 0.2 ± 0.1 | 0.2 ± 0.1 | |
| Neutrophils (1000/μl) | IP | 3.8 ± 1.7 | 3.3 ± 0.9 | 3.7 ± 1.4 | 3.5 ± 1.3 | 3.4 ± 1.3 * |
| VM | 3.3 ± 1.1 | 3.3 ± 0.9 | 3.5 ± 1.2 | 3.2 ± 1.1 | 3.3 ± 0.7 | |
| Pl | 3.9 ± 1.5 | 3.8 ± 1.3 | 4.0 ± 1.4 | 3.8 ± 1.6 | 4.1 ± 1.5 | |
| Lymphocytes (1000/μl) | IP | 1.9 ± 0.5 | 2.0 ± 0.4* | 2.1 ± 0.5* | 2.0 ± 0.5* | 1.9 ± 0.5 |
| VM | 1.9 ± 0.6 | 2.0 ± 0.5 | 1.9 ± 0.5 | 1.9 ± 0.5 | 1.9 ± 0.6 | |
| Pl | 1.9 ± 0.3 | 1.9 ± 0.4 | 1.9 ± 0.4 | 1.8 ± 0.3 | 1.8 ± 0.3 | |
| Monocytes (1000/μl) | IP | 0.4 ± 0.1 | 0.3 ± 0.0 | 0.4 ± 0.1 | 0.4 ± 0.1 | 0.3 ± 0.0** |
| VM | 0.3 ± 0.0 | 0.3 ± 0.0 | 0.4 ± 0.1 | 0.3 ± 0.1 | 0.3 ± 0.1 | |
| Pl | 0.3 ± 0.1 | 0.3 ± 0.0 | 0.3 ± 0.1 | 0.3 ± 0.1 | 0.4 ± 0.1 | |
| Natural killer cells (1000/μl) | IP | 0.3 ± 0.1 | 0.3 ± 0.1 | 0.3 ± 0.1 | 0.3 ± 0.1 | 0.2 ± 0.1 |
| VM | 0.2 ± 0.1 | 0.2 ± 0.1 | 0.2 ± 0.0 | 0.2 ± 0.1 | 0.2 ± 0.1 | |
| Pl | 0.3 ± 0.0 | 0.3 ± 0.0 | 0.3 ± 0.1 | 0.2 ± 0.0 | 0.2 ± 0.0 | |
| CD4 cells (1000/μl) | IP | 0.8 ± 0.3 | 0.9 ± 0.3* | 0.9 ± 0.3* | 0.9 ± 0.3* | 0.9 ± 0.3* |
| VM | 0.8 ± 0.2 | 0.9 ± 0.2 | 0.8 ± 0.2 | 0.9 ± 0.2 | 0.8 ± 0.3 | |
| Pl | 0.9 ± 0.2 | 0.8 ± 0.1 | 0.8 ± 0.2 | 0.8 ± 0.1 | 0.8 ± 0.2 | |
| CD8 cells (1000/μl) | IP | 0.4 ± 0.1 | 0.5 ± 0.1 | 0.5 ± 0.1 | 0.5 ± 0.1* | 0.5 ± 0.1 |
| VM | 0.5 ± 0.2 | 0.6 ± 0.2 | 0.5 ± 0.2 | 0.5 ± 0.1 | 0.5 ± 0.1 | |
| Pl | 0.5 ± 0.1 | 0.5 ± 0.1 | 0.5 ± 0.1 | 0.5 ± 0.1 | 0.5 ± 0.1 | |
| Ratio T4/T8 | IP | 2.0 ± 0.7 | 2.0 ± 0.7* | 2.0 ± 0.7 | 2.0 ± 0.7 | 2.0 ± 0.7 |
| VM | 1.7 ± 0.7 | 1.8 ± 0.7 | 1.8 ± 0.7 | 1.8 ± 0.7 | 1.8 ± 0.6 | |
| Pl | 1.8 ± 0.5 | 1.8 ± 0.5 | 1.8 ± 0.5 | 1.9 ± 0.6 | 1.8 ± 0.5 | |
| B-cells (1000/μl) | IP | 0.2 ± 0.1 | 0.2 ± 0.1 | 0.2 ± 0.1 | 0.3 ± 0.1 | 0.2 ± 0.1 |
| VM | 0.2 ± 0.0 | 0.2 ± 0.0 | 0.2 ± 0.1 | 0.2 ± 0.0 | 0.2 ± 0.0 | |
| Pl | 0.2 ± 0.0 | 0.2 ± 0.0 | 0.2 ± 0.0 | 0.2 ± 0.0 | 0.2 ± 0.1 | |
| Immunoglobulin A (g/l) | IP | 1.9 ± 0.7 | 1.8 ± 0.7 | 1.8 ± 0.7 | 1.8 ± 0.7 | 1.8 ± 0.7 |
| VM | 2.2 ± 0.9 | 2.2 ± 0.8 | 2.2 ± 0.9 | 2.2 ± 0.9 | 2.2 ± 0.8 | |
| Pl | 1.9 ± 0.7 | 1.9 ± 0.7 | 1.9 ± 0.7 | 1.9 ± 0.7 | 1.8 ± 0.7 | |
| Immunoglobulin G (g/l) | IP | 11.3 ± 2.4 | 11.1 ± 2.3 | 11.0 ± 2.1 | 11.1 ± 2.2 | 11.1 ± 2.4 |
| VM | 11.1 ± 1.8 | 11.2 ± 1.7 | 11.1 ± 1.9 | 11.1 ± 1.7 | 11.0 ± 1.7 | |
| Pl | 11.0 ± 2.4 | 11.0 ± 2.3 | 11.0 ± 2.4 | 11.0 ± 2.3 | 11.0 ± 2.4 | |
| Immunoglobulin M (g/l) | IP | 1.3 ± 0.5 | 1.3 ± 0.5 | 1.3 ± 0.5 | 1.3 ± 0.5* | 1.3 ± 0.6* |
| VM | 1.3 ± 0.6 | 1.3 ± 0.7** | 1.3 ± 0.7 | 1.3 ± 0.6 | 1.3 ± 0.6 | |
| Pl | 1.2 ± 0.6 | 1.2 ± 0.6 | 1.2 ± 0.6 | 1.1 ± 0.6 | 1.2 ± 0.6 | |
| Interleukin-6 (pg/ml) | IP | 0.8 ± 0.8 | 0.6 ± 0.3 | 0.9 ± 1.3 | 1.3 ± 1.7 | 0.7 ± 0.5 |
| VM | 0.6 ± 0.4 | 0.5 ± 0.2 | 1.0 ± 1.2 | 0.6 ± 0.4 | 0.6 ± 0.4 | |
| Pl | 1.0 ± 0.7 | 0.8 ± 0.7 | 0.9 ± 0.8 | 1.0 ± 0.8 | 1.7 ± 3.0 | |
| C-reactive protein (mg/l) | IP | 2.7 ± 4.4 | 1.8 ± 1.1 | 2.1 ± 1.4 | 3.6 ± 5.5 | 1.6 ± 1.2* |
| VM | 2.5 ± 3.0 | 1.8 ± 1.1 | 3.4 ± 3.5 | 1.6 ± 1.2** | 1.8 ± 1.2* | |
| PL | 4.6 ± 9.2 | 3.0 ± 3.4 | 3.0 ± 2.6 | 4.2 ± 3.4 | 4.3 ± 5.0 | |
| Tumor necrosis factor-alpha (ng/l) | IP | 10 ± 3 | 10 ± 3 | 11 ± 3 | 12 ± 3 * | 11 ± 3 |
| VM | 10 ± 3 | 10 ± 3 | 11 ± 4 | 11 ± 4 | 11 ± 3 | |
| Pl | 10 ± 3 | 10 ± 2 | 11 ± 3 | 10 ± 2 | 11 ± 2 | |
| Mistletoe lectin antibodies (optical density) | IP | nd | nd | nd | 971 ± 143*** | nd |
| VM | nd | nd | nd | 51 ± 31 | nd | |
| Pl | nd | nd | nd | 33 ± 30 | nd | |
| Viscotoxin antibodies (optical density) | IP | nd | nd | nd | 544 ± 289*** | nd |
| VM | nd | nd | nd | 76 ± 98 | nd | |
| Pl | nd | nd | nd | 13 ± 9 | nd | |
* p < 0.05 compared to placebo, ** p < 0.01 compared to placebo, *** p < 0.001 compared to placebo. Significant deviations are bold typed.