Table 3 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 | ||
| 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 | ||
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