Table 4.
Baseline compared with 6-month resultsa
| Variable | Gatekeeper group (n = 51) | Sham group (n = 26) | ∆ Sham vs ∆ GK at 6 months (p Value) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Baselineb | 6 Monthsb | Mean ∆ | p Value | Baselineb | 6 Monthsb | Mean ∆ | p Value | ||
| Heartburn (HRQL) | 27.6 ± 4.6 (21–42) | 13.7 ± 10.1 (0–35) | −13.9 | <0.0001 | 26.6 ± 4.9 (20–38) | 16.4 ± 9.7 (0–34) | −10.2 | <0.0001 | 0.146 |
| Regurgitation (HRQL) | 17.8 ± 8.1 (0–30) | 8.8 ± 7.5 (0–23) | −9.0 | <0.0001 | 18 ± 5.4 (5–27) | 11.1 ± 7.9 (0–27) | −6.9 | 0.0003 | 0.330 |
| LES resting pressure (mmHg) | 14.6 ± 8.5 (1–36.6) | 17 ± 10.9 (1.3–48.7) | 2.4 | 0.079 | 19.9 ± 12.4 (1–39.1) | 16.8 ± 10.8 (3.5–42.1) | −3.1 | 0.162 | 0.026 |
| Total % of time pH was <4 | 12.7 ± 5.7 (3.5–27.4) | 11.4 ± 9.3 (0.7–58.7) | −1.2 | 0.021 | 14.3 ± 6.3 (3.6–28.4) | 10.7 ± 5.2 (1.5–20.3) | −3.6 | 0.003 | 0.270 |
| DeMeester score | 43.4 ± 20.1 (11.9–118.3) | 39 ± 29 (2.7–172.6) | −4.4 | 0.027 | 47.1 ± 20.4 (13.3–102.6) | 35.8 ± 17.2 (3.9–74) | −11.3 | 0.001 | 0.573 |
| SF-36 PCS | 45.9 ± 8.9 (22.6–59.8) | 49.8 ± 7.7 (26–61.6) | 3.9 | 0.006 | 45.8 ± 9.9 (22.2–59.7) | 49.4 ± 9 (26.4–63.5) | 3.6 | 0.002 | 0.821 |
| SF-36 MCS | 51.6 ± 10.4 (24.1–71.7) | 51.4 ± 8.8 (30.1–60.7) | −0.1 | 0.925 | 51.5 ± 9.3 (28.2–63.6) | 48.6 ± 11.6 (25.3–61.4) | −2.9 | 0.325 | 0.347 |
HRQL health-related quality of life, LES lower esophageal sphincter, SF-36 Medical Outcomes Survey Short Form 36, PCS Physical component Scale, MCS Mental Component Scale
aComparison of baseline and 6-month data in both treatment groups showed that within a treatment group, heartburn and regurgitation symptoms improved. The between-group comparison at 6 months showed no significant difference except for LES resting pressure, which was greater in the Gatekeeper group
bBaseline and 6-month data only for patients who completed the 6-month follow-up questionnaire