Table 3.
Mean outcomes at week 0 and week 12 and changes in safety outcomes for all participants in ITT approach (n = 80), by treatment group
| Control |
Ginseng |
Ginseng vs. control | p | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Safety measures | Week 0 | Week 12 | Change from baseline | p | Week 0 | Week 12 | Change from baseline | p | ||
| Creatinine (mmol/L) | 74.08 ± 2.3 | 71.46 ± 2.3 | –2.62 ± 3.2 | 0.41 | 74.63 ± 2.4 | 72.63 ± 2.5 | –2.00 ± 3.5 | 0.56 | –1.17 ± 1.6 | 0.47 |
| Alanine aminotransferase (U/L) | 28.61 ± 2.2 | 26.54 ± 2.3 | –2.07 ± 3.2 | 0.51 | 31.24 ± 2.7 | 27.64 ± 2.7 | –3.60 ± 3.9 | 0.35 | 0.46 ± 2.2 | 0.92 |
| QT Interval (s) | 400.47 ± 4.2 | 406.66 ± 4.3 | 6.19 ± 6.0 | 0.31 | 387.24 ± 4.2 | 398.31 ± 4.2 | 11.07 ± 5.9 | 0.06 | 0.62 ± 5.5 | 0.89 |
| International normalized ratio | 1.04 ± 0.01 | 1.04 ± 0.01 | -–0.00 ± 0.01 | 0.84 | 1.04 ± 0.01 | 1.04 ± 0.01 | 0.00 ± 0.01 | 1.00 | 0.00 ± 0.02 | 0.94 |
| Prothrombin time (s) | 2.81 ± 0.05 | 2.82 ± 0.05 | 0.01 ± 0.1 | 0.84 | 1.82 ± 0.03 | 1.79 ± 0.03 | –0.02 ± 0.04 | 0.61 | 0.05 ± 0.5 | 0.91 |
All values are mean ± SE. Abbreviations: QT interval-start of Q wave to end of T wave on the 12-lead electrocardiogram; Missing data were obtained by five-fold averaged Multiple Imputations. The p-values for change from baseline determined using Least Squares Means in PROC MIXED. The p-values in the last column indicate the comparison between control and ginseng at 12 weeks corrected for center and baseline by ITT analysis using PROC MIXED.