Table 4.
Intention to treat | Adjusted for treatment received | ||||
---|---|---|---|---|---|
Mean difference (95% CI)* | P value | Mean difference (95% CI)* | P value | ||
REFLUX total score† | 8.3 (3.2 to 13.4) | 0.001 | 11.6 (3.5 to 19.8) | 0.005 | |
REFLUX symptom scores: | |||||
General discomfort | 11.82 (6.50 to 17.14) | <0.001 | 15.59 (7.52 to 23.66) | <0.001 | |
Wind and frequency | 3.34 (−1.98 to 8.66) | 0.218‡ | 5.12 (−3.50 to 13.73) | 0.243‡ | |
Nausea and vomiting | 4.97 (1.53 to 8.41) | 0.005 | 7.32 (2.04 to 12.60) | 0.007 | |
Activity limitation | 5.97 (2.03 to 9.91) | 0.003 | 8.27 (2.03 to 14.52) | 0.010 | |
Constipation and swallowing | 2.54 (−2.09 to 7.18) | 0.281‡ | 4.11 (−3.40 to 11.62) | 0.282‡ | |
SF-36 scores (norm based): | |||||
Physical functioning | 2.01 (−0.26 to 4.28) | 0.082‡ | 3.35 (−0.33 to 7.03) | 0.074‡ | |
Role physical | 0.57 (−2.10 to 3.24) | 0.674‡ | 1.14 (−3.20 to 5.47) | 0.606‡ | |
Bodily pain | 1.52 (−0.90 to 3.94) | 0.218‡ | 1.65 (−2.25 to 5.54) | 0.406‡ | |
General health | 2.76 (0.21 to 5.31) | 0.034 | 3.79 (−0.29 to 7.88) | 0.068‡ | |
Vitality | 0.37 (−2.23 to 2.98) | 0.777‡ | 0.19 (−4.03 to 4.41) | 0.928‡ | |
Social functioning | 1.72 (−1.05 to 4.49) | 0.221‡ | 2.36 (−2.13 to 6.84) | 0.301‡ | |
Role emotional | 2.67 (0.07 to 5.27) | 0.044 | 4.56 (0.34 to 8.79) | 0.034 | |
Mental health | 0.59 (−1.96 to 3.14) | 0.650‡ | 0.40 (−3.72 to 4.51) | 0.849‡ | |
EQ-5D score | 0.047 (−0.013 to 0.108) | 0.126‡ | 0.069 (−0.029 to 0.167) | 0.168‡ |
*Difference is surgery group minus medical group. Analyses adjusted for body mass index, age, sex, baseline score, and baseline-group interaction unless stated otherwise.
†REFLUX questionnaire a disease-specific measure of quality of life (score range 0–100).
‡Adjusted for body mass index, age, sex, and baseline score.