Clinical Trials Study
Copyright ©The Author(s) 2021.
World J Gastroenterol. Jul 28, 2021; 27(28): 4710-4721
Published online Jul 28, 2021. doi: 10.3748/wjg.v27.i28.4710
Table 1 Gastroesophageal reflux disease-Q scale scoring changes
Treatment, n = 116
Control, n = 130
Mean difference (95% confidence interval)
P value
Before treatment10.53 ± 2.0110.10 ± 1.640.434 (0.067 to 0.077)0.077
2 wk treatment8.25 ± 1.85a7.99 ± 1.85a0.266 (0.100 to 0.112)0.108
4 wk treatment7.36 ± 1.71a7.21 ± 1.63a0.147 (0.463 to 0.483)0.469
1 mo withdrawal7.59 ± 1.82a7.59 ± 1.47a0.003 (0.301 to 0.309)0.301
3 mo withdrawal7.56 ± 1.78a7.44 ± 1.54a0.114 (0.826 to 0.841)0.837
aP < 0.01, 2 wk treatment, 4 wk treatment, 1 mo of withdrawal, 3 mo of withdrawal were compared with before treatment.
Table 2 Changes in patients with reduced lower esophageal sphincter pressure
Treatment, n = 39
Control, n = 41
P value
Pre-treatment, mmHg7.99 ± 2.928.26 ± 2.970.646
Post-treatment, mmHg16.15 ± 4.90a,b13.23 ± 3.71a0.003
Mean difference (95% confidence interval)-8.158 (0.000 to 0.000)-4.917 (0.000 to 0.000)
P value00.000a
aP < 0.01, compared with pre-treatment in the group.
bP < 0.05, compared with the control group after treatment.
Table 3 Changes in patients with small intermittent contractions
Treatment, n = 52
Control, n = 49
P value
Pre-treatment, %30.48 ± 10.3933.67 ± 9.500.077
Post-treatment, %27.11 ± 8.47b29.79 ± 8.770.063
Mean difference (95% confidence interval)3.365 (0.035 to 0.043)3.469 (0.057 to 0.066)
P value0.0370.051
bP < 0.05, compared with pre-treatment in the group.
Table 4 Changes in patients with large intermittent contractions
Treatment, n = 7
Control, n = 9
P value
Pre-treatment, %22.85 ± 7.5518.88 ± 6.000.261
Post-treatment, %17.14 ± 4.87b15.55 ± 5.270.529
Mean difference (95% confidence interval)5.714 (0.119 to 0.132)3.333 (0.237 to 0.254)
P value0.0460.083
bP < 0.05, compared with pre-treatment in the group.
Table 5 Changes in patients with ineffective swallowing > 50%
Treatment, n = 49
Control, n = 48
P value
Pre-treatment, %85.30 ± 15.4283.12 ± 17.030.647
Post-treatment, %63.46 ± 21.07a,b72.29 ± 21.52a0.016
Mean difference (95% confidence interval)21.837 (0.000 to 0.000)10.833 (0.002 to 0.004)
P value00.003
aP < 0.01, compared with pre-treatment in the group.
bP < 0.05, compared with the control group after treatment.
Table 6 Changes in patients with increased pre-phase contractions
Treatment, n = 21
Control, n = 25
P value
Pre-treatment, %24.52 ± 8.0426.00 ± 8.160.503
Post-treatment, %19.04 ± 6.24b23.20 ± 7.480.052
Mean difference (95% confidence interval)5.476 (0.025 to 0.032)2.800 (-1.894 to 7.494)
P value0.0350.23
bP < 0.05, compared with pre-treatment in the group.
Table 7 Changes in patients with distal contractile integral less than 450 mmHg·s·cm
Treatment, n = 23
Control, n = 23
P value
Pre-treatment, mmHg·s·cm237.80 ± 87.62243.97 ± 86.530.373
Post-treatment, mmHg·s·cm417.53 ± 128.22b400.26 ± 136.63b0.111
Mean difference (95% confidence interval)-179.731 (0.000 to 0.000)-156.283 (0.000 to 0.000)
P value00
bP < 0.05, compared with pre-treatment in the group.
Table 8 Follow-up results at 1 mo after completing treatment, n (%)
Treatment, n = 116
Control, n = 130
P value
Not on medication97 (83.6)b86 (66.2)0.002
Maintenance medication12 (10.3)16 (12.3)-
Intermittent medication1 (0.9)14 (10.8)-
On-demand medication6 (5.2)14 (10.8)-
bP < 0.05, compared with pre-treatment in the group.
Table 9 Follow-up results at 3 mo after completing treatment, n (%)
Treatment, n = 116
Control, n = 130
P value
Not on medication85 (73.3)b71 (54.6)0
Maintenance medication14 (12.1)25 (19.2)
Intermittent medication6 (5.2)9 (6.9)
On-demand medication11 (9.5)25 (19.2)
bP < 0.05, compared with pre-treatment in the group.