Non-bismuth quadruple therapy for first-line Helicobacter pylori eradication: A randomized study in Japan

Table 1 Characteristics of patients

	Treatment groups
Characteristics	LACM7 (n = 59)	LAC7 (n = 60)	P value
Age (mean) (yr)	63 ± 8.7	60 ± 11.5	0.05
Sex (male/female)	48/11	45/15	0.40
Endoscopic diagnosis			0.37
Atrophic gastritis	31	23
Gastric ulcer	15	16
Duodenal ulcer	10	17

Table 2 Characteristics of patients whose Helicobacter pylori status was checked only by serological test

	Treatment groups
Characteristics	LACM7 (n = 52)	LAC7 (n = 44)	P value
Age (mean) (yr)	63 ± 8.9	63 ± 8.6	0.95
Sex (male/female)	41/11	33/1	0.66
Endoscopic diagnosis			0.34
Atrophic gastritis	24	13
Gastric ulcer	15	14
Duodenal ulcer	10	12

Table 3 Helicobacter pylori eradication rates

	Treatment groups
		LACM7		LAC7		P value
	Eradication	n	%	n	%
ITT analysis	Success	56	94.9	41	68.3	0.0002
	Failure	3	5.1	19	31.7
Per protocol analysis	Success	56	98.3	41	73.2	0.0001
	Failure	1	1.7	15	26.8

Table 4 Eradication rates excluding patients whose Helicobacter pylori status was checked only by serological test

		Treatment groups
		LACM7		LAC7		P value
	Eradication	n	%	n	%
ITT analysis	Success	49	94.2	30	68.2	0.0009
	Failure	3	5.8	14	31.8
Per protocol analysis	Success	49	98.0	30	75.0	0.0009
	Failure	1	2.0	10	25.0

Table 5 Degree of adverse events

	Treatment groups
	LACM7		LAC7		P value
Adverse events	n	%	n	%
None	32	57.1	33	61.1	0.67
Present	24	42.9	21	38.9

Table 6 Frequency of adverse events

Adverse events	LACM7n = 56 (%)	LAC7n = 54 (%)	P value
Diarrhea	17 (30.1)	13 (24.1)	0.53
Taste disturbance	7 (12.5)	2 (3.7)	0.16
Loss of appetite	5 (8.9)	0 (0.0)	0.06
Heart burn	5 (8.9)	4 (7.4)	1.00
Nausea	2 (3.6)	0 (0.0)	0.50
Abdominal pain/distention	7 (12.5)	3 (5.6)	0.32
Belching	3 (5.4)	2 (3.7)	1.00
Rash	0 (0.0)	1 (1.9)	0.49
General fatigue	2 (3.6)	1 (1.9)	1.00