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

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