Clinical Trials Study
Copyright ©The Author(s) 2018.
World J Gastroenterol. Jun 7, 2018; 24(21): 2291-2299
Published online Jun 7, 2018. doi: 10.3748/wjg.v24.i21.2291
Table 1 Study population
Population characteristicsResult
Total subjects in the study, n30
Male/Female, n18/12
Ethnic characteristicNon-Hispanic Caucasians 100%
Age, yr, mean ± SD34.7 ± 9.3
BMI, kg/m2, mean ± SD26.7 ± 6.9
Weight, kg, mean ± SD82.5 ± 17.9
Waist/hip ratio, mean ± SD0.91 ± 0.08
Smoking, yes, n (%)6 (20)
Alcohol use, yes, n (%)14 (46.7)
Alcohol, g/d, mean ± SD1.1 ± 1.7
Dietary fiber intake, g/d, mean ± SD6.0 ± 2.3
Hiatal hernia
Presence, n (%)16 (53.3)
Size, cm, mean ± SD0.9 ± 0.5
Esophageal motility disorders per Chicago 3.0
Ineffective esophageal motility, n (%)14 (46.7)
Fragmented peristalsis, n (%)9 (30.0)
Normal, n (%)7 (23.3)
Mean stool frequency per week, mean ± SD7.0 ± 2.0
Table 2 Results of the study
BaselineEOTP value
Symptoms’ characteristics
Presence of heartburn during 7 d, % of patients93.3400.000438
GERD-Q score, mean ± SD10.9 ± 1.76.0 ± 2.30.000003
High resolution esophageal manometry (lower esophageal sphincter function)
At rest, mean ± SD
Mean resting pressure, mmHg22.0 ± 9.426.5 ± 11.30.37
Minimal resting pressure, mmHg5.41 ± 10.111.3 ± 9.40.023
Average, after 10 swallows of water, mean ± SD
Mean resting pressure, mmHg20.5 ± 9.522.0 ± 10.30.11
Minimal resting pressure, mmHg14.1 ± 8.014.9 ± 6.40.008
Residual pressure, mmHg7.5 ± 6.17.0 ± 5.40.94
% Relaxation49.7 ± 15.051.3 ± 190.3
Esophageal 24-hrs pH-impedance, mean ± SD
Number of refluxes67.9 ± 17.742.4 ± 13.50.000002
Number of acid refluxes43.2 ± 14.730.3 ± 15.30.002415
Number of weak acid refluxes23.9 ± 11.711.3 ± 8.270.000016
Number of non-acid refluxes0.7 ± 1.10.6 ± 1.70.34
Mean pH5.9 ± 0.85.7 ± 0.90.06
% time pH < 45.6 ± 4.85.5 ± 7.570.20
Maximal reflux time, min10.6 ± 125.3 ± 3.70.017
Number of high gastroesophageal refluxes (17 cm above LES), mean ± SD23.1 ± 9.212.2 ± 6.60.000004
Gastric acid exposure
Mean pH, mean ± SD1.2 ± 0.291.3 ± 0.360.35