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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)

From: Efficacy of transoral fundoplication for treatment of chronic gastroesophageal reflux disease incompletely controlled with high-dose proton-pump inhibitors therapy: a randomized, multicenter, open label, crossover study

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
  1. Values represent means (standard deviation). PPI, proton pump inhibitor; TF, transoral fundoplication.