Table 2.
Mean outcomes at wweek-0 and wweek-12 and changes in efficacy outcomes for all participants (n = 80) in ITT approach, by treatment group
| Control |
Ginseng |
Ginseng vs. control | p | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week 0 | Week 12 | Change from baseline | p | Week 0 | Week 12 | Change from baseline | p | |||
| Primary: | ||||||||||
| 24-h Systolic BP | 127.14 ± 1.7 | 128.22 ± 1.7 | 1.08 ± 2.4 | 0.65 | 123.46 ± 1.6 | 121.76 ± 1.6 | - 1.70 ± 2.2 | 0.44 | - 3.98 ± 2.0 | 0.044 |
| Secondary: | ||||||||||
| HbA1c (%) | 7.07 ± 0.1 | 7.15 ± 0.1 | 0.09 ± 0.2 | 0.61 | 6.86 ± 0.1 | 6.61 ± 0.13 | - 0.25 ± 0.2 | 0.15 | - 0.35 ± 0.2 | 0.019 |
| Exploratory: | ||||||||||
| Ambulatory Blood Pressure (mmHg) | ||||||||||
| 24-h Diastolic BP | 73.69 ± 1.3 | 74.66 ± 1.3 | 0.96 ± 1.8 | 0.59 | 73.97 ± 1.1 | 73.33 ± 1.1 | - 0.65 ± 1.5 | 0.67 | - 0.96 ± 1.6 | 0.541 |
| Daytime Systolic BP | 29.50 ± 1.8 | 129.95 ± 1.8 | 0.45 ± 2.5 | 0.86 | 125.51 ± 1.5 | 123.12 ± 1.6 | - 2.39 ± 2.2 | 0.28 | - 4.47 ± 2.1 | 0.033 |
| Daytime Diastolic BP | 76.08 ± 1.3 | 76.41 ± 1.3 | 0.32 ± 1.9 | 0.86 | 75.58 ± 1.1 | 74.41 ± 1.1 | –1.18 ± 1.6 | 0.46 | –1.54 ± 1.7 | 0.364 |
| Night-time Systolic BP | 117.36 ± 1.7 | 121.32 ± 1.7 | 3.95 ± 2.4 | 0.10 | 114.29 ± 2.1 | 117.59 ± 2.2 | 3.30 ± 3.1 | 0.29 | –2.52 ± 2.8 | 0.369 |
| Night-time Diastolic BP | 64.83 ± 1.4 | 68.05 ± 1.5 | 3.22 ± 2.1 | 0.12 | 65.91 ± 1.3 | 68.37 ± 1.3 | 2.46 ± 1.89 | 0.19 | –0.23 ± 2.1 | 0.914 |
| Office Blood Pressure | ||||||||||
| Office Systolic BP (mmHg) | 131.72 ± 2.1 | 132.63 ± 2.1 | 0.91 ± 2.9 | 0.76 | 134.68 ± 1.8 | 129.46 ± 1.8 | –5.22 ± 2.6 | 0.02 | –4.46 ± 2.5 | 0.071 |
| Office Diastolic BP (mmHg) | 78.33 ± 1.7 | 76.11 ± 1.7 | - 2.22 ± 2.4 | 0.36 | 81.58 ± 1.5 | 75.27 ± 1.5 | –6.32 ± 2.2 | 0.001 | –2.41 ± 2.2 | 0.265 |
| Heart Rate (bpm) | 69.1 ± 2.7 | 69.3 ± 2.3 | 0.34 ± 4.1 | 0.93 | 69.7 ± 2.6 | 72.3 ± 2.1 | 2.98 ± 4.0 | 0.45 | 3.99 ± 2.1 | 0.060 |
| Glycemic Measure | ||||||||||
| Fasting Glucose (mmol/L) | 7.61 ± 0.2 | 8.03 ± 0.2 | 0.42 ± 0.3 | 0.22 | 7.76 ± 0.2 | 7.99 ± 0.2 | 0.22 ± 0.3 | 0.26 | −0.02 ± 0.3 | 0.946 |
| Fasting Insulin (pmol/L) | 80.92 ± 13.7 | 97.64 ± 14.2 | 16.72 ± 19.8 | 0.40 | 69.75 ± 10.2 | 93.78 ± 10.9 | 24.03 ± 14.8 | 0.10 | 2.72 ± 18.7 | 0.884 |
| Lipids | ||||||||||
| Total C (mmol/L) | 5.12 ± 0.2 | 4.94 ± 0.2 | –0.18 ± 0.2 | 0.45 | 5.09 ± 0.2 | 4.47 ± 0.2 | –0.62 ± 0.2 | 0.01 | –0.5 ± 0.2 | 0.007 |
| LDL-C (mmol/L) | 2.90 ± 0.1 | 2.74 ± 0.1 | –0.17 ± 0.2 | 0.43 | 2.88 ± 0.1 | 2.40 ± 0.1 | –0.48 ± 0.2 | 0.03 | –0.35 ± 0.2 | 0.062 |
| HDL-C (mmol/L) | 1.28 ± 0.04 | 1.25 ± 0.04 | –0.03 ± 0.1 | 0.54 | 1.29 ± 0.04 | 1.31 ± 0.04 | 0.02 ± 0.1 | 0.70 | 0.06 ± 0.04 | 0.187 |
| Non-HDL-C (mmol/L) | 3.84 ± 0.2 | 3.69 ± 0.2 | –0.15 ± 0.2 | 0.50 | 3.80 ± 0.2 | 3.16 ± 0.2 | –0.64 ± 0.2 | 0.01 | –0.54 ± 0.2 | 0.009 |
| Triglycerides (mmol/L) | 2.16 ± 0.2 | 2.14 ± 0.2 | –0.02 ± 0.3 | 0.93 | 2.26 ± 0.2 | 1.78 ± 0.2 | –0.49 ± 0.2 | 0.06 | –0.43 ± 0.2 | 0.017 |
All values are mean ± SE. Abbreviations: HbA1c-glycated hemoglobin A1c; BP-blood pressure; C-cholesterol; LDL-low density lipoprotein; HDL-high density lipoprotein; 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.