H pylori eradication: A randomized prospective study of triple therapy with or without ecabet sodium

Table 1 Demographic data and endoscopic findings of 257 patients with H pylori infection who were randomly assigned to standard triple therapy (group A) or triple therapy plus ecabet sodium (group B)

	Group A	Group B	P value
Patients	129	128
Age (yr) (mean ± SD)	54.3 ± 13.2	53.4 ± 12.4	0.562
Gender (male/female)	68/61	80/48	0.112
BMI (kg/m2) (mean ± SD)	23.3 ± 2.9	23.2 ± 3.0	0.768
Smoking	32 (24.8%)	32 (25.0%)	0.971
Alcohol consumption	40 (31.0%)	56 (43.8%)	0.035
Endoscopic findings			0.333
Gastric ulcer	62	66
Duodenal ulcer	37	26
Gastroduodenal ulcer	8	6
Gastric cancer1	7	5
Gastric MALT lymphoma	0	1
Gastritis	15	24

¹Patients who had received endoscopic treatment for early gastric cancer or adenoma.

Table 2 ITT and PP analysis of H pylori eradication in patients who were randomly assigned to standard triple therapy (group A) or triple therapy plus ecabet sodium (group B)

	Group A	Group B	P value
Eradication rate
ITT1	72.1% (93/129)	78.9% (101/128)	0.204
PP	78.8% (93/118)	88.6% (101/114)	0.044

¹In this analysis, the patients with unknown outcome were counted as treatment failures.

Table 3 Side effects during standard triple therapy (group A) and triple therapy plus ecabet sodium (group B)

Side effects	Group A	Group B	P value
Metallic taste	14	5	0.033
Nausea/vomiting	1	4	0.213
Abdominal pain	2	2	1.000
Constipation	1	0	1.000
Diarrhea	7	3	0.333
Dizziness	1	6	0.066
Skin rash	0	3	0.122
Oral mucositis	2	1	1.000
Others	4	7	0.347