Table 3.
Comparison of the two treatment groups at baselinea
| Variable | Gatekeeper group (n = 75) | Sham group (n = 43) | p Value |
|---|---|---|---|
| Gender: n (%) | |||
| Female | 25 (33.3) | 18 (41.9) | 0.428 |
| Male | 50 (66.7) | 25 (58.1) | |
| Age (years) | |||
| Mean ± SD | 47.9 ± 11.59 | 52.6 ± 11.80 | 0.035 |
| Range | (23.7–70.3) | (23.5–76) | |
| BMI | |||
| Mean ± SD | 27.8 ± 3.39 | 27.5 ± 3.81 | 0.677 |
| Range | (19–35) | (18.6–34.6) | |
| Patients with hiatal hernia: n (%)b | |||
| None | 25 (34.2) | 16 (37.2) | 0.516 |
| 1 cm | 21 (28.8) | 13 (30.2) | |
| 2 cm | 17 (23.3) | 12 (28) | |
| 3 cm | 10 (13.7) | 2 (4.6) | |
| Patients with esophagitis: n (%) | |||
| None | 66 (88) | 40 (93) | 0.795 |
| Grade A | 6 (8) | 2 (4.67) | |
| Grade B | 3 (4) | 1 (2.33) | |
| Heartburn score per HRQL | 26.9 ± 4.5 (20–42) | 26 ± 4.77 (20–38) | 0.296 |
| Regurgitation score per HRQL | 17.7 ± 7.38 (0–30) | 17.7 ± 4.93 (5–27) | 0.98 |
| LES resting pressure per manometry (mmHg) | 13.4 ± 8.19 (0–36.6) | 17.9 ± 11.32 (1–39.1) | 0.017 |
| Total % time pH was <4 | 12.4 ± 6.28 (3.5–43.5) | 12.3 ± 5.81 (3.6–28.4) | 0.902 |
| DeMeester score | 42.7 ± 21.39 (11.9–142.3) | 41.6 ± 19 (13.3–102.6) | 0.792 |
| SF-36 PCS | 45.2 ± 9.08 (22.6–59.8) | 46.9 ± 8.62 (22.2–59.7) | 0.316 |
| SF-36 MCS | 50.2 ± 11.02 (16.9–71.7) | 51.2 ± 8.79 (28.2–63.6) | 0.601 |
SD standard deviation, BMI body mass index, 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
aThe two treatment groups showed no statistically significant difference at baseline except for age and LES resting pressure, which were greater in the sham group
bData were missing for two Gatekeeper patients