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