A comparison between dexlansoprazole modified release–based and lansoprazole-based nonbismuth quadruple (concomitant) therapy for first-line Helicobacter pylori eradication: a prospective randomized trial

Figures & data

Figure 1 Schematic flowchart of study design.

Table 1 Demographic data and endoscopic appearance of two groups of patients

Characteristics	DACM (n=96, %)	LACM (n=98, %)	P-value
Age (year) (mean ± SD)	52.4±12.4	55.0±10.8	0.406
Gender (male/female)	41/51(46.9/53.1)	44/54(44.9/55.1)	0.782
Smoking	9(9.4)	7(7.1)	0.572
Alcohol consumption	13(13.5)	16(16.3)	0.587
Previous history of peptic ulcer	4(4.2)	3(3.1)	0.680
Endoscopic Findings
Gastritis	51(53.1)	49(50)	0.178
Gastric ulcer	28(29.2)	21(21.4)
Duodenal ulcer	10(10.4)	21(21.4)
Gastric and duodenal ulcer	7(7.3)	7(7.1)

Abbreviations: DACM, 7-day Dexlansoprazole MR-based concomitant therapy; LACM, 7-day Lansoprazole-based concomitant therapy; SD, standard deviation.

Figure 2 Patients’ deposition.

Table 2 The major outcomes of the two groups of patients

	Eradication rate
	DACM (n=96)	LACM (n=98)	P-value
Intention-to-treat*	86.1% (87/101)	90.1% (91/101)	0.384
Per-protocol	90.6% (87/96)	92.6% (91/98)	0.572
Adverse events	11.5% (11/96)	10.2% (10/98)	0.779
Compliance	100% (96/96)	100% (98/98)	–

Note: *In this analysis, patient with unknown outcome are counted as treatment failures.

Abbreviations: DACM, 7-day Dexlansoprazole MR-based concomitant therapy; LACM, 7-day Lansoprazole-based concomitant therapy.

Table 3 Adverse events of the two groups of patients

Adverse event	DACM(n=96, %)	LACM(n=98, %)	P-value
Abdominal pain	2 (2.1%)	3 (3.1)	0.667
Diarrhea	7 (7.3)	7 (7.1)	0.968
Dizziness	0	1 (1.0)	0.321
Headache	0	1 (1.0)	0.321
Nausea/vomiting	3(3.1)	2(2.0)	0.634

Abbreviations: DACM, 7-day Dexlansoprazole MR-based concomitant therapy; LACM, 7-day Lansoprazole-based concomitant therapy.

Table 4 Univariate analysis of the clinical factors influencing the efficacy of H. pylori eradication therapy

Principle parameter		Case no.	Eradication Rate (%)	P-value
Age	<60 years	120/127	94.5	0.057
	≥60 years	58/67	86.6
Sex	Female	96/105	91.4	0.859
	Male	82/89	92.1
Smoking	(−)	163/178	91.6	0.762
	(+)	15/16	93.8
Alcohol consumption	(−)	150/165	90.9	0.308
	(+)	28/29	96.6
Previous history of peptic ulcer	(−)	172/187	92.0	0.554
	(+)	6/7	85.7
Helicobacter pylori eradication (per-protocol)	DACM	87/96	90.6	0.572
	LACM	91/98	92.9
Compliance	Good	178/194	91.8	-
	Poor	0	–
Culture (n=38)
Amoxillin	Sensitive	35/38	92.1	-
	Resistant	0	–
Clarithromycin	Sensitive	29/30	96.7	0.043
	Resistant	6/8	75.0
Metronidazole	Sensitive	28/28	100.0	0.003
	Resistant	7/10	70.0
Dual resistant of clarithromycin and Metronidazole	(−)	34/35	97.1	<0.001
	(+)	1/3	33.3

Abbreviations: DACM, 7-day Dexlansoprazole MR-based concomitant therapy; LACM, 7-day Lansoprazole-based concomitant therapy.