Table 2.
Primary outcome measure of office SBP
| Outcome | FMT group (N = 63) | Placebo group (N = 61) | P value |
|---|---|---|---|
| Primary outcome, office SBP, mmHg | |||
| Baseline | 146.05 ± 5.13 | 147.61 ± 5.88 | |
| Day 30 | 139.78 ± 11.04 | 141.93 ± 11.81 | |
| Change | 6.28 ± 11.83 | 5.77 ± 10.06 | 0.62 |
| Subgroup analysis, change in office SBP (baseline–Day 30), mmHg | |||
| Age, years | |||
| < 38 | 4.38 ± 10.04 | 6.20 ± 12.18 | 0.63 |
| 38– < 48 | 2.91 ± 10.81 | 6.27 ± 8.72 | 0.35 |
| ≥ 48 | 12.81 ± 13.07 | 5.14 ± 10.21 | 0.029 |
| Sex | |||
| Female | 8.34 ± 15.14 | 7.59 ± 10.94 | 0.43 |
| Male | 5.57 ± 10.58 | 5.07 ± 9.74 | 0.88 |
| BMI, kg/m2 | |||
| 18.5– < 24 | 3.47 ± 9.32 | 5.50 ± 13.24 | 0.98 |
| ≥ 24 | 7.15 ± 12.36 | 5.83 ± 9.48 | 0.43 |
| Baseline office SBP, mmHg | |||
| < 143.7 | 3.44 ± 11.01 | 7.21 ± 11.98 | 0.20 |
| 143.7– < 149 | 5.65 ± 10.06 | 4.80 ± 9.38 | 0.16 |
| ≥ 149 | 11.28 ± 13.50 | 5.76 ± 9.70 | 0.11 |
| Baseline office DBP, mmHg | |||
| < 93.5 | 6.31 ± 13.25 | 6.54 ± 10.09 | 0.72 |
| 93.5– < 97.5 | 2.37 ± 9.85 | 5.90 ± 10.73 | 0.29 |
| ≥ 97.5 | 8.72 ± 10.92 | 5.24 ± 9.76 | 0.16 |
| 10-year risk of CVD on the basis of Framingham risk scoring | |||
| < 15% | 5.09 ± 11.68 | 5.96 ± 10.58 | 0.84 |
| ≥ 15% | 8.82 ± 12.04 | 5.51 ± 9.47 | 0.30 |
The covariance analysis with adjusting center, baseline effect, and interactive term between the center and treatment group (if applicable) is used in above analysis. The baseline refers to the baseline office SBP. Mean and SD are presented. Difference and 95% CI of change in office SBP are estimated by ANCOVA in ITT dataset after missing data imputed by LOCF method