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©The Author(s) 2016.
World J Gastrointest Pharmacol Ther. Feb 6, 2016; 7(1): 145-155
Published online Feb 6, 2016. doi: 10.4292/wjgpt.v7.i1.145
Published online Feb 6, 2016. doi: 10.4292/wjgpt.v7.i1.145
Table 1 Gastroesophageal reflux disease - health related quality of life, esophageal acid exposure and esophageal manometry at baseline and 12 and 24-mo post-lower esophageal sphincter - electrical stimulation therapy
| Incomplete responders | Complete responders | |||||||
| Visit interval(subject number) | Median (IQR) | P value | Visit interval(subject number) | Median (IQR) | P value | |||
| Baseline ON-PPI | Baseline OFF-PPI | Baseline ON-PPI | Baseline OFF-PPI | |||||
| GERD-HRQL scores | Baseline on PPI (16) | 9.5 (9-10) | 0.012 | Baseline ON PPI (7) | 4 (2.5-6) | 0.13 | 0.02 | |
| Baseline off PPI (16) | 24 (20.8-26.3) | 0.0013 | < 0.001 | Baseline OFF PPI (7) (16) | 21 (21-23) | 0.40 | 0.02 | |
| 12 mo (16) | 2.5 (0-4) | 0.0011 | 12 mo (7) | 1 (0-2.5) | ||||
| 24 mo (14) | 0 (0-2.8) | 24 mo (7) | 0 (0-3) | |||||
| Percent of 24-h esophageal pH < 4.0 | Baseline off PPI (16) | 9.8 (7.8-11.5) | < 0.001 | Baseline OFF PPI (7) | 16.7 (7.5-17.8) | 0.09 | ||
| Total | 12 mo (16) | 3.0 (1.9-6.3) | 0.003 | 12 mo (6) | 3.5 (2.1-6.1) | 0.12 | ||
| 24 mo (13) | 4.6 (1.6-5.1) | 24 mo (5) | 7.5 (5.1-12.6) | |||||
| Percent 24-h esophageal pH < 4.0 | Baseline off PPI (16) | 9.4 (7.3-13.6) | < 0.001 | Baseline OFF PPI (7) | 10.4 (10.1-15.2) | 0.03 | ||
| Upright | 12 mo (16) | 3.9 (3.1-5.2) | < 0.001 | 12 mo (6) | 5.0 (2.3-7.8) | 0.06 | ||
| 24 mo (13) | 5.5 (1.8-7.2) | 24 mo (5) | 5.0 (4.3-6.8) | |||||
| % 24-h esophageal pH < 4.0 | Baseline off PPI (16) | 5.8 (1.7-10.3) | 0.10 | Baseline OFF PPI (7) | 8.3 (3.2-22) | 0.30 | ||
| Supine | 12 mo (16) | 0.4 (0.0-5.9) | 0.56 | 12 mo (6) | 1.0 (0.0-3) | 1.00 | ||
| 24 mo (13) | 0.5 (0.2-4.1) | 24 mo (5) | 11.1 (0.6-18.9) | |||||
| DeMeester score | Baseline off PPI (16) | 34.8 (29.6-43.8) | < 0.001 | Baseline OFF PPI (7) | 67 (31.9-70.2) | 0.09 | ||
| 12 mo (16) | 10.8 (5.9-28.3) | 0.02 | 12 mo (6) | 17.6 (10.2-24.5) | 0.13 | |||
| 24 mo (13) | 15.4 (8-20) | 24 mo (5) | 30.0 (18.1-54.5) | |||||
| Percent patients with abnormal distal esophageal pH (pH < 4.0 for > 4%) | Baseline off PPI (16) | 94% | 0.008 | Baseline OFF PPI (7) | 100% | 0.13 | ||
| 12 mo (16) | 38% | 0.021 | 12 mo (6) | 33% | 0.33 | |||
| 24 mo (13) | 54% | 24 mo (5) | 80% | |||||
| Percent 24-h proximal esophageal pH < 4.0 | Baseline off PPI (16) | 0.2 (0.1-1.2) | 0.006 | Baseline OFF PPI (7) | 0.6 (0.4-2) | 0.06 | ||
| 12 mo (16) | 0.0 (0-0) | 0.006 | 12 mo (6) | 0.0 (0-0.1) | 0.13 | |||
| 24 mo (13) | 0.0 (0-0) | 24 mo (5) | 0.0 (0-0.1) | |||||
| Percent 24-h proximal esophageal pH < 4.0 | Baseline off PPI (16) | 0.4 (0.2-1.9) | 0.006 | Baseline OFF PPI (7) | 1.1 (0.6-2.6) | |||
| 12 mo (16) | 0.0 (0-0) | 0.008 | 12 mo (6) | 0.0 (0-0.1) | 0.06 | |||
| 24 mo (13) | 0.0 (0-0.1) | 24 mo (5) | 0.0 (0-0.1) | 0.13 | ||||
| Percent 24-h proximal esophageal pH < 4.0 | Baseline off PPI (16) | 0.0 (0-0.1) | 0.20 | Baseline OFF PPI (7) | 0.1 (0.0-1.3) | 0.37 | ||
| Supine | 12 mo (16) | 0.0 (0-0) | 0.37 | 12 mo (6) | 0.0 (0-0) | 0.37 | ||
| 24 mo (13) | 0.0 (0-0) | 24 mo (5) | 0.0 (0-0) | |||||
| Percent patients with abnormal proximal esophageal pH (pH < 4.0 for > 1.1%) | Baseline OFF PPI (16) | 29% | 0.13 | Baseline OFF PPI (7) | 33% | 0.50 | ||
| 12 mo (16) | 0% | 0.18 | 12 mo (6) | 0% | 0.14 | |||
| 24 mo (13) | 0% | 24 mo (5) | 0% | |||||
| LES end expiratory pressure (mmHg) | Baseline OFF PPI (16) | 8.2 (6.8-9.8) | Baseline OFF PPI (7) | 8.8 (5.7-10.5) | ||||
| 12 mo (16) | 12 (7.8-18) | 12 mo (6) | 9.5 (4.5-14.5) | |||||
| 24 mo (13) | 6 (4-10) | 24 mo (5) | 6 (4-9) | |||||
| LES respiratory mean pressure (mmHg) | Baseline OFF PPI (16) | 17.2 (16.1-20.9) | Baseline OFF PPI (7) | 2 (1.9-2.5) | ||||
| 12 mo (16) | 12 (17.5-29) | 12 mo (6) | 2.7 (2.2-3.0) | |||||
| 24 mo (13) | 19 (16-22) | 24 mo (5) | 2.5 (2.4-2.6) | |||||
| LES length (cm) | Baseline off PPI (16) | 2.1 (1.8-2.6) | Baseline OFF PPI (7) | 2.0 (1.9-2.5) | ||||
| 12 mo (16) | 2.6 (2.3-2.9) | 12 mo (6) | 2.7 (2.2-3) | |||||
| 24 mo (11) | 2.3 (2.0-2.5) | 24 mo (5) | 2.5 (2.4-2.6) | |||||
| Percent peristaltic swallows | Baseline OFF PPI (16) | 100 (95-100) | Baseline OFF PPI (7) | 100 (98-100) | ||||
| 12 mo (16) | 100 (91-100) | 12 mo (6) | 98 (70-100) | |||||
| 24 mo (11) | 100 (85-100) | 24 mo (5) | 86 (85-100) | |||||
| Distal esophageal contraction amplitude (mmHg) | Baseline OFF PPI (16) | 78.3 (67-95) | Baseline OFF PPI (7) | 46.1 (39.9-54.5) | ||||
| 12 mo (16) | 71.5 (48.5-80.5) | 12 mo (6) | 40.5 (34.5-46.5) | |||||
| 24 mo (11) | 53.0 (42.5-69.5) | 24 mo (5) | 45.0 (41.0-53.0) | |||||
| Number of esophageal contractions > 30 mmHg | Baseline OFF PPI (16) | 18 (14-20) | Baseline OFF PPI (7) | 19 (11.5-19.5) | ||||
| 12 mo (16) | 19.5 (18.5-20.0) | 12 mo (6) | 16 (9.3-19.8) | |||||
| 24 mo (11) | 18.0 (8.0-20.0) | 24 mo (5) | 11.0 (6.0-15.0) | |||||
| Residual LES pressure (mmHg) | Baseline OFF PPI (16) | 6.5 (2.9-10.9) | Baseline OFF PPI (7) | 8.9 (7.4-10.9) | ||||
| 12 mo (16) | 8.0 (4.0-11.0) | 12 mo (6) | 7.0 (1.5-8.0) | |||||
| 24 mo (11) | 7.0 (4.5-11.5) | 24 mo (5) | 5.0 (4.0-10.0) | |||||
| SF-12 PCS | Baseline ON PPI (16) | 45 (41.5-49.5) | 0.38 | 0.28 | Baseline ON PPI (7) | 50 (46-52.5) | 0.34 | 0.03 |
| Baseline OFF PPI (16) | 46.5 (41.2-53) | 0.004 | 0.002 | Baseline OFF PPI (7) (16) | 45 (40.5-47) | 0.09 | 0.02 | |
| 12 mo (16) | 51.0 (42.8-55.2) | 12 mo (7) | 55 (47-55) | |||||
| 24 mo (14) | 54.5 (52.2-56.5) | 24 mo (7) | 55 (53-58.5) | |||||
| SF-12 MCS | Baseline ON PPI (16) | 49 (42.5-59) | 0.68 | 0.18 | Baseline ON PPI (16) | 43.0 (40.5-47.5) | 0.38 | 0.83 |
| Baseline OFF PPI (16) | 45 (36.5-54.2) | 0.01 | 0.002 | Baseline OFF PPI (16) | 54 (51-55.5) | 0.61 | 0.16 | |
| 12 mo (16) | 52.5 (43.8-58.0) | 12 mo (16) | 50 (47.5-53.5) | |||||
| 24 mo (14) | 60.5 (54.5-62) | 24 mo (14) | 44 (38.5-50) | |||||
Table 2 Severity of heartburn and regurgitation was significantly improved in both groups during the study, with significant difference between the 2 subgroups
| Incomplete responders | Complete responders | |||||||
| Visit interval(subject number) | Median (IQR) | P value | Visit interval(subject number) | Median (IQR) | P value | |||
| Baseline ON-PPI | Baseline OFF-PPI | Baseline ON-PPI | Baseline OFF-PPI | |||||
| Percent diary days with heartburn severity | Baseline OFF PPI (14) | Baseline OFF PPI (6) | ||||||
| 12 mo (15) | < 0.001 | 12 mo (6) | 0.03 | |||||
| 24 mo (12) | < 0.001 | 24 mo (7) | 0.03 | |||||
| None | Baseline OFF PPI (14) | 0 (0-10) | Baseline OFF PPI (6) | 0 (0-14) | ||||
| 12 mo (15) | 88 (42-100) | 12 mo (6) | 83 (54-100) | |||||
| 24 mo (12) | 86 (73-100) | 24 mo (7) | 79 (32-93) | |||||
| Mild | Baseline OFF PPI (14) | 19 (14-29) | Baseline OFF PPI (6) | 14 (0-14) | ||||
| 12 mo (15) | 0 (0-32) | 12 mo (6) | 0 (0-25) | |||||
| 24 mo (12) | 7 (0-14) | 24 mo (7) | 7 (0-18) | |||||
| Moderate | Baseline OFF PPI (14) | 46 (31-66) | Baseline OFF PPI (6) | 62 (46-68) | ||||
| 12 mo (15) | 0 (0-7) | 12 mo (6) | 0 (0-11) | |||||
| 24 mo (12) | 0 (0-7) | 24 mo (7) | 7 (0-29) | |||||
| Baseline OFF PPI (14) | 11 (0-29) | Baseline OFF PPI (6) | 8 (4-21) | |||||
| Severe | 12 mo (15) | 0 (0-0) | 12 mo (6) | 0 (0-1) | ||||
| 24 mo (12) | 0 (0-0) | 24 mo (7) | 0 (0-4) | |||||
| % Diary days with regurgitation severity | Baseline OFF PPI (14) | Baseline OFF PPI (6) | 0.03 | 0.03 | ||||
| 12 mo (15) | < 0.003 | 12 mo (6) | ||||||
| 24 mo (12) | < 0.03 | 24 mo (7) | ||||||
| None | Baseline OFF PPI (14) | 35 (7-70) | Baseline OFF PPI (6) | 4 (0-8) | ||||
| 12 mo (15) | 100 (100-100) | 12 mo (6) | 100 (100-100) | |||||
| 24 mo (12) | 100 (95-100) | 24 mo (7) | 100 (86-100) | |||||
| Mild | Baseline OFF PPI (14) | 8 (7-20) | Baseline OFF PPI (6) | 19 (9-54) | ||||
| 12 mo (15) | 0 (0-0) | 12 mo (6) | 0 (0-0) | |||||
| 24 mo (12) | 0 (0-0) | 24 mo (7) | 0 (0-4) | |||||
| Moderate | Baseline OFF PPI (14) | 30 (4-57) | Baseline OFF PPI (6) | 29 (11-46) | ||||
| 12 mo (15) | 0 (0-0) | 12 mo (6) | 0 (0-0) | |||||
| 24 mo (12) | 0 (0-0) | 24 mo (7) | 0 (0-4) | |||||
| Baseline OFF PPI (14) | 0 (0-21) | Baseline OFF PPI (6) | 0 (0-16) | |||||
| Severe | 12 mo (15) | 0 (0-0) | 12 mo (6) | 0 (0-0) | ||||
| 24 mo (12) | 24 mo (7) | 0 (0-0) | ||||||
- Citation: Soffer E, Rodríguez L, Rodriguez P, Gómez B, Neto MG, Crowell MD. Effect of electrical stimulation of the lower esophageal sphincter in gastroesophageal reflux disease patients refractory to proton pump inhibitors. World J Gastrointest Pharmacol Ther 2016; 7(1): 145-155
- URL: https://www.wjgnet.com/2150-5349/full/v7/i1/145.htm
- DOI: https://dx.doi.org/10.4292/wjgpt.v7.i1.145