Efficacy of 7-day and 14-day potassium-competitive acid blocker-based bismuth-containing quadruple regimen for Helicobacter pylori infection

Table 1 Baseline characteristics of the participants (intention-to-treat set), n (%)

Characteristic	7-day PC-BMT (n = 119)	14-day PC-BMT (n = 118)	14-day P-BMT (n = 117)	P value
Sex (male)	68 (57.1)	61 (51.7)	57 (48.7)	0.421
Age (years), median (IQR)	58.0 (13.0)	61.0 (16.0)	60.0 (13.0)	0.271
Body mass index (kg/m2), median (IQR)	24.5 (4.5)	23.5 (3.6)	23.6 (4.8)	0.387
Alcohol	50 (42.0)	40 (33.9)	54 (46.2)	0.150
Smoking	16 (13.5)	24 (20.3)	19 (16.2)	0.359
Endoscopic findings
Chronic atrophic gastritis	93 (78.2)	88 (74.6)	90 (76.9)	0.805
H. pylori-induced gastritis	17 (14.3)	21 (17.8)	14 (12.0)	0.446
Gastric ulcer				0.780
A1-H2	7 (5.9)	7 (5.9)	4 (3.4)
S1-S2	9 (7.6)	6 (5.1)	9 (7.7)
Duodenal ulcer				0.509
A1-H2	2 (1.7)	4 (3.4)	2 (1.7)
S1-S2	6 (5.2)	8 (7.0)	12 (10.4)
Endoscopic resection of early gastric cancer or gastric adenoma	4 (3.4)	7 (5.9)	8 (6.8)	0.469
Mucosa-associated lymphoid tissue lymphoma	0 (0.0)	0 (0.0)	2 (1.7)	0.109
Antibiotic resistance of H. pylori
Cultured	66 (55.5)	67 (56.8)	62 (53.0)	0.839
Single resistance	20 (30.3)	33 (49.3)	26 (41.9)	0.081
Clarithromycin resistance	10 (15.2)	14 (20.9)	8 (12.9)	0.446
Amoxicillin resistance	1 (1.5)	3 (4.5)	2 (3.2)	0.694
Metronidazole resistance	9 (13.6)	15 (22.4)	16 (25.8)	0.210
Tetracycline resistance	0 (0.0)	1 (1.5)	0 (0.0)	> 0.999
Dual resistance	8 (12.1)	6 (9.0)	7 (11.3)	0.830
Clarithromycin and amoxicillin	8 (12.1)	4 (6.0)	6 (9.7)	0.467
Clarithromycin and metronidazole	0 (0.0)	2 (3.0)	1 (1.6)	0.537
Multiple resistance	0 (0.0)	1 (1.5)	0 (0.0)	> 0.999
Compliance (%), median (IQR)	100.0 (0.0)	100.0 (0.0)	100.0 (0.0)	0.671
Poor compliance (< 80%)	3 (2.5)	7 (5.9)	6 (5.1)	0.417

IQR: Interquartile range; H. pylori: Helicobacter pylori; P-BMT: Proton pump inhibitor-based bismuth-containing quadruple regimen; PC-BMT: Potassium-competitive acid blocker-based bismuth-containing quadruple regimen.

Table 2 Helicobacter pylori eradication rate according to the treatment group

Analysis	7-day PC-BMT	14-day PC-BMT	14-day P-BMT	7-day PC-BMT vs 14-day P-BMT		14-day PC-BMT vs 14-day P-BMT
				Difference (95%CI)	P value	Difference (95%CI)	P value
ITT	76.5% (91/119)	78.8% (93/118)	77.8% (91/117)	-1.3% (-12.0 to 9.4)	0.111	1.0% (-9.5 to 11.6)	0.047
Modified ITT	80.5% (91/113)	83.8% (93/111)	80.5% (91/113)	0% (-10.3 to 10.3)	0.064	3.3% (-6.8 to 13.3)	0.014
Per-protocol	81.7% (89/109)	87.5% (91/104)	79.3% (84/106)	2.4% (-8.2 to 13.0)	0.027	8.3% (-1.8 to 18.3)	0.001

Non-inferiority margin of -8%. ITT: Intention-to-treat; P-BMT: Proton pump inhibitor-based bismuth-containing quadruple regimen; PC-BMT: Potassium-competitive acid blocker-based bismuth-containing quadruple regimen.

Table 3 Helicobacter pylori eradication rate according to the antibiotic resistance (per-protocol set)

Antibiotic resistance	7-day PC-BMT	14-day PC-BMT	14-day P-BMT	7-day PC-BMT vs 14-day P-BMT		14-day PC-BMT vs 14-day P-BMT
				Difference (95%CI)	P value	Difference (95%CI)	P value
Single-resistant strain	81.3% (13/16)	89.7% (26/29)	87.0% (20/23)	-5.7% (-29.3 to 17.9)	0.674	2.7% (-15.0 to 20.4)	> 0.999
Clarithromycin-resistant strain	87.5% (7/8)	90.9% (10/11)	87.5% (7/8)	0.0% (-32.4 to 32.4)	> 0.999	3.4% (-25.1 to 32.0)	> 0.999
Amoxicillin-resistant strain	0.0% (0/1)	50.0% (1/2)	100.0% (2/2)	-100.0% (-100.0 to -100.0)	0.333	-50.0% (-100.0 to 19.3)	> 0.999
Metronidazole-resistant strain	85.7% (6/7)	93.3% (14/15)	84.6% (11/13)	1.1% (-31.4 to 33.6)	> 0.999	8.7% (-14.6 to 32.0)	0.583
Tetracycline-resistant strain	N/A	100.0% (1/1)	N/A	N/A	N/A	N/A	N/A
Dual-resistant strain	75.0% (6/8)	60.0% (3/5)	100.0% (5/5)	-25.0% (-55.0 to 5.0)	0.487	-40.0% (-82.9 to 2.9)	0.444
Clarithromycin and amoxicillin	75.0% (6/8)	33.3% (1/3)	100.0% (4/4)	-25.0% (-55.0 to 5.0)	0.515	-66.7% (-100.0 to -13.3)	0.143
Clarithromycin and metronidazole	N/A	100.0% (2/2)	100.0% (1/1)	N/A	N/A	N/A	> 0.999
Multiple-resistant strain	N/A	100.0% (1/1)	N/A	N/A	N/A	N/A	N/A
No antibiotic-resistant strain	80.0% (28/35)	91.3% (21/23)	82.1 % (23/28)	-2.1% (-21.6 to 17.3)	0.830	9.2% (-9.1 to 27.4)	0.436
Culture no growth	84.0% (42/50)	87.0% (40/46)	72.0% (36/50)	12.0% (-4.1 to 28.1)	0.148	15.0% (-0.9 to 30.8)	0.083

N/A: Not applicable; P-BMT: Proton pump inhibitor-based bismuth-containing quadruple regimen; PC-BMT: Potassium-competitive acid blocker-based bismuth-containing quadruple regimen.

Table 4 Overall summary of adverse events (intention-to-treat set), n (%)

Variable	7-day PC-BMT (n = 119)		14-day PC-BMT (n = 118)		14-day P-BMT (n = 117)
	n	Frequency	n	Frequency	n	Frequency
Adverse event	23 (19.3)	34	36 (30.5)	51	32 (27.4)	40
95%CI	12.7-27.6		22.4-39.7		19.5-36.4
P value	0.145		0.594
Drug-related adverse event	23 (19.3)	34	35 (29.7)	50	31 (26.5)	39
95%CI	12.7-27.6		21.6-38.8		18.7-35.5
P value	0.190		0.589
Serious adverse event	0	0	0	0	0	0

Frequency indicates the number of adverse events. P-BMT: Proton pump inhibitor-based bismuth-containing quadruple regimen; PC-BMT: Potassium-competitive acid blocker-based bismuth-containing quadruple regimen.