Treatment effects at 6 and 12 months open-label follow-up
| Variable | Baseline | 6 Months | 12 Months | p Values* | |||
|---|---|---|---|---|---|---|---|
| Absolute values | %† | Absolute values | %† | B-6 | B-12 | ||
| NA, not assessed; NS, not significant; SF-20. | |||||||
| *Statistical comparisons between baseline and 6 months (B-6), and between baseline and 12 months (B-12). | |||||||
| †Percentage of change compared with baseline. | |||||||
| ‡Frequency×severity (range 0–24), off antisecretory drugs. | |||||||
| §Short-Form General Health Survey (higher scores for better function, except for bodily pain perception; range 0–100), off antisecretory drugs | |||||||
| Heartburn score‡ | 16 (6) | 8.3 (8.6) | −48 | 7.5 (7.7) | −53 | <0.001 | <0.001 |
| Heartburn frequency | 4.9 (1.4) | 2.7 (2.3) | −45 | 2.6 (2.3) | −47 | <0.001 | <0.001 |
| Heartburn severity | 3.1 (1) | 2 (1.5) | −35 | 1.7 (1.5) | −45 | <0.001 | <0.001 |
| Regurgitation score‡ | 15.1 (5.1) | 8.2 (7.7) | −46 | 8.4 (8.4) | −44 | <0.001 | <0.001 |
| Regurgitation frequency | 4.9 (1.1) | 2.9 (2.3) | −41 | 3 (2.6) | −39 | <0.001 | <0.001 |
| Regurgitation severity | 3 (0.8) | 1.9 (1.3) | −37 | 1.7 (1.5) | −43 | <0.001 | <0.001 |
| SF-20§ | |||||||
| Physical health | 49 (35) | NA | 66 (37) | +35 | <0.001 | ||
| Role function | 63 (47) | NA | 78 (40) | +24 | 0.03 | ||
| Social function | 72 (33) | NA | 77 (32) | +7 | NS | ||
| Mental health | 76 (17) | NA | 76 (17) | +0 | NS | ||
| General health | 46 (25) | NA | 56 (29) | +22 | <0.001 | ||
| Bodily pain perception | 64 (31) | NA | 40 (36) | −38 | <0.001 | ||