Clinical Research
Copyright ©2005 Baishideng Publishing Group Inc.
World J Gastroenterol. May 28, 2005; 11(20): 3112-3117
Published online May 28, 2005. doi: 10.3748/wjg.v11.i20.3112
Table 1 Demographics and baseline characteristics of erosive esophagitis patients treated with esomeprazole or omeprazole (mean±SE).
Esomeprazole 40 mg n = 25Omeprazole 20 mg n = 23P
Age (yr)49.2±3.759.0±3.40.0596
Sex (male%)20 (80)18 (78.3)1.0000
Body weight (kg)68.4±2.470.9±2.50.4779
Height (cm)166.7±1.3169.0±1.40.2096
Basal reflux symptoms (VAS)
Heartburn29.4±5.723.6±5.90.2683
Nausea18.7±5.513.8±5.80.8520
Regurgitation29.8±6.124.5±6.40.3365
Vomiting14.0±4.78.8±4.90.5702
Belching47.0±6.025.2±6.30.0121
Dysphagia7.5±5.014.7±5.20.7421
Epigastric pain15.8±5.516.7±5.80.9223
LA grade of erosive esophagitis [n (%)]0.6617
A15 (60)11 (47.8)
B7 (28)7 (30.4)
C2 (8)2 (8.7)
D1 (4)3 (13.0)
Hp infection status10 (40)11 (47.8)0.5643
Table 2 Changes of reflux symptoms assessed on visual analog scale of studied patients 8 wk after esomeprazole or omeprazole treatment (mean±SE).
Reflux symptomsEsomeprazole n = 22Omeprazole n = 22P
Heartburn-22.3±2.1-21.4±2.20.5453
Nausea-11.9±2.2-12.7±2.40.8867
Regurgitation-22.4±2.2-20.4±2.30.8598
Vomiting-9.1±1.61-8.8±1.70.4438
Belching-24.1±4.3-17.9±4.60.0113
Dysphagia-8.4±1.4-6.5±1.50.8044
Epigastric pain-10.6±2.0-11.1±2.10.1747
Table 3 Changed reflux symptoms of studied patients 8 wk after esomeprazole or omeprazole treatment (%).
Esomeprazole (n = 22)Omeprazole (n = 20)P
HeartburnImproved50.065.00.0993
No change50.025.0
Worse0.010
RegurgitationImproved77.385.01.0000
No change18.215.0
Worse4.50.0
DysphagiaImproved36.435.00.8697
No change63.660.0
Worse0.05
Epigastric painImproved27.350.00.1895
No change63.650.0
Worse9.10.0
NauseaImproved22.735.00.5036
No change68.265.0
Worse9.10
VomitingImproved22.740.00.3200
No change77.360.0
Worse0.00.0
BelchingImproved54.545.00.8999
No change36.445.0
Worse9.110
Table 4 AE in studied patients 8 wk after esomeprazole or omeprazole treatment (ITT).
Esomeprazole (n = 25) n(%)Omeprazole (n = 23) n (%)P
Patient with at least one AE7 (28.0)6 (26.1)1.0000
Constipation2 (8.0)1 (4.4)1.0000
Dry skin1 (4.0)3 (13.0)0.3381
Diarrhea1 (4.0)1 (4.4)1.0000
Headache1 (4.0)1 (4.4)1.0000
Somnolence1 (4.0)1 (4.4)1.0000
Cellulites0 (0.0)1 (4.4)0.4792
Bronchitis0 (0.0)1 (4.4)0.4792