Table 1.
Study outcome measures
| Single‐Blind Crossover Study (Outcome Measures Obtained on Two Different Days, Separated by a 1‐Day Washout) | ||||||||
|---|---|---|---|---|---|---|---|---|
| Outcome Measures | Placebo Binder | Abdominal Binder | Difference Between Δb | P Value | ||||
| Baseline | Placebo Binder | Δ Placebo Bindera | Baseline | Abdominal Binder | Δ Abdominal Bindera | |||
| Primary outcome | ||||||||
| Δ3rd minute tilt mean BP (mm Hg); n = 12c | −6.6 (±14.9; −16, +2.9) | −8.9 (±13.6; −17.5, −0.2) | −2.3 (±9.6; −8.4, +3.8) | −10 (±13.5; −18.6, −1.4) | −2.3 (±10.2; −8.8, +4.2) | +7.7 (±6.6; +3.5, +11.9) | +10.0 (±10.2; +3.5, +16.5) | 0.006 |
| Secondary outcomes | ||||||||
| 10th minute supine mean BP (mm Hg); n = 12 | 93.1 (±13.2; 84.7, 101.5) | 91 (±13.5; 82.3, 99.5) | −2.2 (±12.8; −10.3, +5.9) | 93.1 (±16.3; 82.8, 103.5) | 95.8 (±18.7; 83.8, 107.7) | +2.6 (±13.7; −6.1, +11.3) | +4.8 (±15.3; −4.9, +14.5) | 0.3 |
| Δ3rd minute tilt systolic BP (mm Hg); n = 12c | −14.8 (±19.5; −27.2, −2.3) | −21 (±19.2; −33.2, −8.8) | −6.2 (±14.7; −15.6, +3.1) | −17.7 (±16.4; −28.1, −7.3) | −8.4 (±15.4; −18.2, +1.4) | +9.3 (±5.6; +5.7, +12.8) | +15.5 (±15.1; +5.9, +25.1) | 0.005 |
| Δ3rd minute tilt diastolic BP (mm Hg); n = 12c | −2.5 (±13.1; −10.9, +5.9) | −2.8 (±11.2; −10, +4.3) | −0.3 (±8.2; −5.6, +4.9) | −6.1 (±12.4; −14.1, +1.7) | +0.8 (±8.2; −4.5, +6) | +6.9 (±8.2; +1.7, +12.1) | +7.3 (±9.9; +1, +13.5) | 0.027 |
| Δ3rd minute standing mean BP; n = 10 (mm Hg)d | −0.4 (±10.2; −7.7, +7) | −6.8 (±15.3; −17.7, +4.1) | −6.4 (±12.8; −15.6, +2.7) | −5.3 (±12.1; −14; +3.3) | +1.2 (±11.0; −6.7, +9.1) | +6.5 (±7.9; +0.9, +12.2) | +13 (±10.2; −0.3, +26.2) | 0.054 |
| Other tilt‐test parameters | ||||||||
| 10th minute supine systolic BP (mm Hg); n = 12 | 121 (±17.3; 106.7, 133.9) | 121.4 (±18.1; 107.2, 135.8) | 122.8 (±21.4; 105.3, 138.5) | 122.0 (±24.3; 101.3, 138.5) | ||||
| 10th minute supine diastolic BP (mm Hg); n = 12 | 79.3 (±13; 68.0, 88.0) | 75.7 (±11.8; 65.9, 84.3) | 78.3 (±15.0; 65.9, 88.7) | 82.6 (±16.1; 68.9, 93.7) | ||||
| 3rd minute tilt mean BP (mm Hg); n = 12 | 86.6 (±14.1; 77.5, 98.9) | 82 (±15.6; 74.7, 95.7) | 83.1 (±16.8; 72.9, 97.5) | 93.4 (±18.0; 81.1, 107.9) | ||||
| 3rd minute tilt systolic BP (mm Hg); n = 12 | 106.2 (±19.3; 94.3, 123.1) | 100.4 (±22.3; 90.3, 120.0) | 105.1 (±24.9; 89.1, 126.3) | 113.6 (±25.6; 95.9, 134.7) | ||||
| 3rd minute tilt diastolic BP (mm Hg); n = 12 | 76.8 (±12.5; 68.3, 87.5) | 72.8 (±12.7; 66.5, 84.0) | 72.2 (±14.4; 63.5, 84.5) | 83.3 (±14.6; 73.4, 94.9) | ||||
| 5th minute supine mean BP (mm Hg); n = 10 | 91.5 (±11.3; 82.5, 99.4) | 97.3 (±17.8; 83.8, 110.6) | 95.9 (±14.5; 84.1, 104.3) | 99.2 (±17.1; 85.7, 111.1) | ||||
| 3rd minute standing mean BP (mm Hg); n = 10 | 90.6 (±15.3; 79.6, 101.6) | 90.4 (±14.4; 80.1, 100.7) | 88.9 (±14.5; 78.5, 99.2) | 99.6 (±21; 84.6, 114.6) | ||||
| 4‐Week Open‐Label Follow‐up Study | ||||
|---|---|---|---|---|
| Outcome Measures | Baseline | Follow‐up | Change From Baseline to Follow‐up | P value |
| OHQ score; n = 12 | 5.2 (5.2 ± 1.6) | 2.4 (2.7 ± 1.5) | −2.2 (−2.5 ± 1.5) | 0.003 |
| OHSAs ubscore; n = 12 | 5.0 (4.8 ± 1.6) | 3.2 (2.8 ± 1.3) | −1.7 (−2.1 ± 1.5) | 0.003 |
| OHDAS subscore; n = 12 | 5.0 (5.6 ± 2.0) | 2.1 (2.2 ± 1.6) | −3.9 (−3.4 ± 2.6) | 0.007 |
Study outcome measures of the single‐blind crossover study are summarized in the first part of the table as mean (±SD; 95% CI). Study outcome measures of the 4‐week open‐label follow‐up study are reported in the second part of the table as median (mean ± SD).
Δ placebo binder = (BP with placebo binder) − (BP at respective baseline examination without any binder); Δ abdominal binder = (BP with abdominal binder) − (BP at respective baseline examination without any binder).
i.e. = (Δ abdominal binder) − (Δ placebobinder).
Δ3rd minute tilt mean/systolic/diastolic BP (mm Hg): calculated by subtracting 10th minute supine mean/systolic/diastolic BP (mm Hg) from mean/systolic/diastolic BP (mm Hg) at third minute of head‐up tilt.
Δ3rd minute standing mean BP (mm Hg): calculated by subtracting fifth minute supine mean BP from mean BP at third minute standing.