Ten-day bismuth-containing quadruple therapy versus 7-day proton pump inhibitor-clarithromycin containing triple therapy as first-line empirical therapy for the Helicobacter pylori infection in Korea: a randomized open-label trial

Table 3 Adverse events and compliance^a

Events	7-day STT	10-day BQT	P value
Events	(n = 164)	(n = 160)	P value
Adverse events, no. (%)
Taste alteration	47 (28.7)	7 (4.4)	< 0.001
Nausea	14 (8.5)	38 (23.8)	< 0.001
Vomiting	0 (0)	10 (6.3)	0.001
Diarrhea	25 (15.2)	28 (17.5)	0.583
Abdominal discomfort	25 (15.2)	35 (21.9)	0.124
Skin rash or urticaria	2 (1.2)	6 (3.8)	0.170
Dizziness	9 (5.5)	15 (9.4)	0.182
Headache	5 (3.0)	19 (11.9)	0.002
Insomnia	5 (3.0)	2 (1.3)	0.448
Dyspepsia	17 (10.4)	33 (20.6)	0.011
General weakness	3 (1.8)	13 (8.1)	0.009
Dyspnea	1 (0.6)	1 (0.6)	> 0.999
Anorexia	0 (0)	9 (5.6)	0.002
Dry mouth	5 (3.0)	2 (1.3)	0.448
Chest discomfort	0 (0)	2 (1.3)	0.243
Any adverse event,^b no. (%)	94 (57.3)	108 (67.5)	0.059
Compliance with the study drugs, no. (%)			< 0.001
Participants who took ≥ 80% of study drugs	145 (88.4)	117 (73.1)
Participants who took < 80% of study drugs	19 (11.6)	43 (26.9)
Participants with low compliance due to adverse events,^c no. (%)	15 (9.1)	37 (23.1)	0.001

STT, proton-pump inhibitor-clarithromycin containing standard triple therapy; BQT, bismuth-containing quadruple therapy
^aThis analysis was performed in the safety population, which included all participants who underwent randomization and received at least one dose allocated treatment. Thirteen participants in the 7-day PPI-clarithromycin containing triple therapy group and fifteen in the 10-day bismuth-containing quadruple therapy group were excluded in this analysis
^bThere was no participant who had any serious adverse events including death, life-threatening events, hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, and medically important event or reaction
^cLow compliance was defined when participant took less than 80% of the study drugs

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