Table 4.
48-hour pH parameters through the phases of the study in patients initially randomized to the high-dose proton-pump inhibitors (PPIs) group (A) and to the transoral fundoplication (TF) group (B)
| A Parameters | Screening (off PPIs) | 6-month on high-dose PPIs | 6-month after TF (off PPIs) | p value (6-month PPIs vs. screening) | p value (6-month after TF vs. screening) | p value (PPIs vs.TF) |
|---|---|---|---|---|---|---|
| Number of refluxes | 190.43 (89.36) | 91.33 (68.01) | 120.52 (64.25) | < 0.001 | 0.010 | 0.420 |
| Number of long refluxes (>5 minutes) | 12.52 (7.22) | 4.62 (5.07) | 10.00 (6.02) | < 0.001 | 0.387 | 0.017 |
| Duration of longest reflux, minutes | 26.48 (14.29) | 23.76 (21.77) | 24.86 (14.71) | 0.867 | 0.950 | 0.977 |
| Fraction time pH <4, % | 10.50 (3.51) | 5.01 (4.55) | 7.87 (4.20) | < 0.001 | 0.070 | 0.104 |
| DeMeester score | 35.79 (13.05) | 19.29 (16.07) | 28.60 (14.71) | 0.002 | 0.258 | 0.108 |
| B Parameters | Screening (off PPIs) | 6-month (off PPIs) | 12-month (off PPIs) | p value (6-month vs. screening) | p value (12-month vs. screening) | p value (6-month vs. 12-month) |
| Number of refluxes | 160.72 (76.71) | 100.80 (83.58) | 115.26 (61.28) | 0.002 | 0.023 | 0.672 |
| Number of long refluxes (>5 minutes) | 12.62 (5.48) | 8.54 (7.68) | 10.24 (7.89) | 0.030 | 0.297 | 0.536 |
| Duration of longest reflux, minutes | 31.36 (14.15) | 23.41 (20.75) | 23.82 (15.04) | 0.010 | 0.128 | 0.994 |
| Fraction time pH <4, % | 10.19 (3.55) | 6.77 (5.41) | 7.45 (4.86) | 0.005 | 0.031 | 0.800 |
| DeMeester score | 35.28 (11.80) | 23.64 (18.54) | 25.32 (15.50) | 0.004 | 0.016 | 0.883 |
Values represent means (standard deviation). PPI, proton pump inhibitor; TF, transoral fundoplication.