Randomized Clinical Trial
Copyright ©The Author(s) 2015.
World J Gastroenterol. Sep 21, 2015; 21(35): 10234-10241
Published online Sep 21, 2015. doi: 10.3748/wjg.v21.i35.10234
Table 1 Demographic and clinical data at baseline (intention-to-treat population) n (%)
MBSTHybridP value
Included in ITT analysis140144-
Age, mean ± SD (yr)58.9 ± 12.858.8 ± 11.90.922
Gender (male)58 (41.4)72 (50.0)0.155
Current smoker8 (5.7)9 (6.3)0.849
Alcohol drinking18 (12.9)15 (10.4)0.581
Diabetes7 (5.0)6 (4.2)0.783
Hypertension27 (19.3)20 (13.9)0.264
Previous history of peptic ulcer19 (13.6)18 (12.5)0.537
Endoscopic diagnosis0.783
HPAG117 (83.6)136 (94.4)
Gastric ulcer8 (5.7)6 (4.2)
Duodenal ulcer5 (3.6)0 (0.0)
Gastric and duodenal ulcer2 (1.4)2 (1.4)
Adenoma8 (5.7)0 (0.0)
Positive CLO test106 (75.7)116 (80.6)0.389
H. pylori colonization0.234
Negative7 (5.0)13 (9.0)
Mild66 (47.1)65 (45.1)
Moderate52 (37.1)43 (29.9)
Marked15 (10.7)23 (16.0)
Atrophic change11 (7.8)14 (9.8)0.122
Intestinal metaplasia10 (7.2)16 (11.1)0.239
Drop out4 (2.8)6 (4.1)0.285
Noncompliance0 (0.0)0 (0.0)
Follow-up loss4 (2.8)6 (4.1)
Discontinued therapy0 (0.0)0 (0.0)
due to adverse events
Table 2 Helicobacter pylori eradication rates
MBSTHybridP value
ITT analysis
Eradication rate91.4% (128/140)79.2% (114/144)0.013
95%CI90.2%-92.9%77.3%-80.7%
PP analysis
Eradication rate94.1% (128/136)82.6% (114/138)0.003
95%CI92.9%-95.6%80.6%-84.1%
Table 3 Adverse events and compliance n (%)
MBSTHybridP value
Adverse events(n = 136)(n = 138)
Bloating/dyspepsia4 (2.9)5 (3.6)
Taste distortion4 (2.9)4 (2.9)
Epigastric discomfort4 (2.9)7 (5.1)
Nausea2 (1.5)4 (2.9)
Abdominal pain0 (0.0)0 (0.0)
Diarrhea2 (1.5)7 (5.1)
Total16 (11.8)27 (19.6)0.019
Compliance136 (100.0)138 (100.0)