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Table 3 Mean quality of life scores at screening (on PPIs), six months after high-dose proton-pump inhibitor (PPIs) and six months after crossover to transoral fundoplication (TF) in patients initially randomized to the PPI group

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

Parameters Screening (on PPIs) 6-month on high-dose PPIs 6-month after TF (off PPIs) p value (6-month PPIs vs. screening) p value (6-month TF vs. screening p value (6-month PPIs vs. 6-month TF)
Reflux disease questionnaire (RDQ) 3.04 (0.99) 2.14 (1.20) 1.33 (1.76) 0.089 < 0.001 0.136
 Heartburn (RDQ) 3.14 (1.31) 1.89 (1.37) 1.57 (1.96) 0.033 0.006 0.787
 Dyspepsia (RDQ) 2.95 (1.21) 2.05 (1.31) 1.44 (1.92) 0.137 0.006 0.400
 Regurgitation (RDQ) 3.02 (1.09) 2.46 (1.28) 0.98 (1.72) 0.398 < 0.001 0.003
Gastroesophageal reflux disease health-related quality of life (GERD-HRQL) 26.43 (7.22) 18.86 (9.12) 10.05 (13.54) 0.053 < 0.001 0.020
 Heartburn (GERD-HRQL) 16.90 (5.75) 11.67 (6.94) 7.48 (9.81) 0.078 < 0.001 0.189
Reflux Symptom Index 22.62 (8.33) 19.62 (7.29) 8.76 (11.02) 0.151 < 0.001 < 0.001
 Hoarseness 2.19 (1.75) 2.29 (1.42) 0.95 (1.50) 0.979 0.034 0.020
 Throat clearing 2.90 (1.23) 2.90 (0.92) 1.23 (1.51) > 0.999 < 0.001 < 0.001
 Excess throat mucus or postnasal drip 3.48 (1.14) 2.95 (0.84) 1.43 (1.56) 0.368 < 0.001 < 0.001
 Difficulty swallowing foods, liquids or pills 2.14 (1.28) 1.19 (1.18) 0.48 (0.96) 0.029 < 0.001 0.129
 Coughing after eating or after lying down 2.47 (1.57) 2.29 (1.35) 0.86 (1.53) 0.909 0.002 0.008
 Breathing difficulties or chocking episodes 1.57 (1.50) 1.19 (1.08) 0.38 (0.86) 0.550 0.005 0.075
 Troublesome or annoying cough 2.14 (1.49) 2.33 (1.53) 0.90 (1.45) 0.910 0.025 0.008
 Sensation or something sticking or a lump in the throat (globus) 2.48 (1.44) 1.71 (1.10) 1.10 (1.76) 0.216 0.009 0.359
 Heartburn, chest pain, indigestion or stomach acid coming up 3.24 (1.30) 2.76 (1.30) 1.43 (1.86) 0.566 < 0.001 0.016
Excess flatulence 2.62 (1.75) 2.24 (1.45) 0.70 (1.38) 0.702 < 0.001 0.006
  1. Values represent means (standard deviations). PPI, proton pump inhibitor; TF, transoral fundoplication.