Between-group differences in participant-reported outcome measures
| Omeprazole (n=20) | Placebo (n=20) | Adjusted between-group difference (omeprazole minus placebo) at end of treatment (95% CI)* | |||
| Baseline | End of treatment | Baseline | End of treatment | ||
| LCQ—total | 15.3 (3.3) | 15.3 (3.8) | 15.1 (3.2) | 15.3 (3.6) | −0.10 (−2.19 to 1.98) |
| LCQ—physical domain | 5.1 (1.1) | 5.0 (1.1) | 5.2 (1.0) | 5.1 (1.1) | 0.02 (−0.54 to 0.57) |
| LCQ—psychological domain | 5.0 (1.4) | 5.0 (1.7) | 4.8 (1.2) | 5.1 (1.3) | −0.21 (−1.10 to 0.68) |
| LCQ—social domain | 5.2 (1.1) | 5.3 (1.3) | 5.1 (1.3) | 5.1 (1.4) | 0.13 (−0.67 to 0.94) |
| DeMRQ | 0.85 (0.81) | 0.65 (1.18) | 1.35 (1.14) | 1.2 (1.24) | ND† |
| GIQLI | 106.7 (18.8) | 105.6 (20.6) | 104.0 (18.2) | 101.2 (21.2) | 2.15 (−7.20 to 11.49) |
| RSI | 14.0 (10.2) | 14.2 (8.3) | 17.0 (9.4) | 15.1 (11.0) | 0.67 (−4.77 to 6.11) |
Data are presented as mean (SD) (complete-case analysis set; n=40).
*Between-group difference at end of treatment was calculated using ANCOVA, adjusted for baseline value and shows the change relative to that in the placebo group. ND: not done
† Not done as model assumptions not satisfied. For LCQ and GIQLI a higher score indicates improvement, for DeMRQ and RSI a lower score indicates improvement.
DeMRQ, De Meester reflux-related symptoms questionnaire; GIQLI, Gastrointestinal Quality of Life Index; LCQ, Leicester Cough Questionnaire; RSI, Reflux Symptoms Index.