Sofalcone, a mucoprotective agent, increases the cure rate of Helicobacter pylori infection when combined with rabeprazole, amoxicillin and clarithromycin

Table 1 Patients’ characteristics.

	Group A1	Group B1	Group C1
Mean age, yr (range)	45.3 (21-73)	47.2 (27-71)	45.6 (21-71)
Male/female	41/14	42/12	42/14
Mean weight, kg (range)	60.7 (42.5-70.0)	59.8 (40.5-70.0)	58.7 (38.5-79.0)
Smokers (%)	23 (41.8)	28 (51.6)	24 (42.6)
Alcohol drinkers (%)	21 (38.1)	28 (51.6)	23 (41.1)
Gastric ulcer (%)	34 (61.8)	31 (57.4)	36 (64.3)
Duodenal ulcer (%)	19 (34.5)	21 (38.9)	19 (33.9)
Gastroduodenal ulcer (%)	2 (3.6)	2 (3.7)	1 (1.8)
Active ulcer (%)	27 (49.1)	32 (59.3)	28 (50.0)

¹Group A: triple therapy with rabeprazole (10 mg twice daily), clarithromycin (200 mg twice daily) and amoxicillin (750 mg twice daily). Group B: sofalcone (100 mg thrice daily) plus the triple therapy. Group C: polaprezinc (150 mg twice daily) plus the triple therapy. Patients received the medications for 7 d in each group.

Table 2 Intention-to-treat and per protocol cure rates of H pylori infection.

Group1	Intention-to-treat (%)	95% CI2	Per protocol (%)	95% CI
A	78.2 (43/55)	66.9-89.4	81.1 (43/53)	70.2-92.0
B	87.0 (47/54)	77.8-96.4	94.0 (47/50)	87.2-100.0
C	80.4 (45/56)	69.6-91.1	84.9 (45/53)	73.1-93.6

¹See Table 1 for the definition of each group. Patients received the medications for 7 d in each group;

²CI: Confidence intervals.

Table 3 Adverse events in the three treatment groups (n, %).

	Group A1	Group B1	Group C1
Diarrhea or soft stool	8 (14.5)	7 (13.0)	9 (16.1)
Heart burn	1 (1.8)	4 (7.4)	1 (1.8)
Nausea	1 (1.8)	1 (1.9)	0 (0.0)
Skin rash	0 (0.0)	0 (0.0)	1 (1.8)
Total	10 (18.2)	12 (22.2)	11 (19.6)

¹See Table 1 for the definition of each group. Patients received the medications for 7 d in each group.