Hybrid vs sequential therapy for eradication of Helicobacter pylori in Taiwan: A prospective randomized trial

Table 1 Demographic distribution of the subjects receiving different eradication regimens

Characteristic	Hybrid therapy (n = 88)	Sequential therapy (n = 87)	P value
Age (mean ± SD), yr	52.1 ± 13.0	54.6 ± 13.2	0.26
Gender (male/female)	39/49	25/62	0.04
Smoking	14	6	0.10
Alcohol consumption	20	18	0.74
Ingestion of coffee	61	57	0.59
NSAID user	8	8	0.96
Underlying diseases	26	23	0.77
Endoscopic finding (Peptic ulcer/non-ulcer dyspepsia)	46/42	32/55	0.06
Helicobacter pylori density (mild/moderate/marked)	8/42/38	4/57/26	0.26

Table 2 Outcomes of sequential and hybrid therapy

Variable	Hybrid therapy			Sequential therapy			P value
	Patients	Eradication rate	95%CI	Patients	Eradication rate	95%CI
Intension-to-treat analysis	88	92.0%	86.4-97.7	87	78.2%	69.5-86.8	0.01
Per-protocol analysis	84	96.4%	92.5-100.4	83	81.9%	73.6-90.2	0.01

Table 3 Adverse events during treatment

	Hybrid therapy	Sequential therapy	P value
Compliance, n (%)	84 (97.7)	83 (97.6)	0.99
Side effects, n (%)	52 (59)	60 (69)	0.22
Diarrhea	16/1/11	15/0/0	0.42
Constipation	1/0/0	2/0/0	0.50
Anorexia	0	1/0/0	0.70
Nausea	4/1/0	9/0/1	0.92
Vomiting	5/2/0	3/1/0	0.57
Abdominal pain	5/0/0	9/0/0	0.87
Skin rash	3/2/0	1/2/0	0.74
Headache	9/1/1	16/1/1	0.41
Dizziness	6/1/0	9/0/0	0.70
Bitter taste	25/6/0	36/3/0	0.17
Fatigue	3/0/0	4/0/0	0.30

¹Numbers of patients who suffered from, mild, moderate, and severe adverse events.

Table 4 Univariate analysis of the clinical factors influencing the efficacy of eradication therapy n (%)

Variable	Sequential therapy	P value	Hybrid therapy	P value
Resistance (n = 124)	n = 59		n = 65
Metronidazole		0.22		0.74
Susceptible	32 (84.2)		37 (94.9)
Resistant	14 (66.7)		25 (96.1)
Clarithromycin		0.73		0.51
Susceptible	37 (77.1)		54 (94.7)
Resistant	9 (81.8)		8 (100)
Tetracycline		0.59		NA
Susceptible	45 (77.6)		62 (95.4)
Resistant	1 (100)
Levofloxacin		0.46		0.45
Susceptible	36 (75.0)		52 (94.5)
Resistant	10 (90.9)		10 (100)
Amoxicillin		NA		NA
Susceptible	46 (78.0)		62 (95.4)
Resistant
Dual resistance		0.66		0.65
Present	5 (71.4)		4 (100)
Absent	41 (78.8)		58 (95.0)
Compliance		0.47		0.66
Good	66 (79.5)		78 (94.0)
Poor	2 (100)		3 (100)
Smoking		0.2		0.31
Present	6 (100)		14 (100)
Absent	62 (78.5)		67 (93.1)
Alcohol		0.29		0.21
Present	16 (88.9)		20 (100)
Absent	52 (77.6)		61 (92.4)
Gastroduodenal disease		0.91		0.57
Non-ulcer dyspepsia	43 (79.6)		38 (92.7)
Peptic ulcer	25 (80.6)		43 (95.6)
Bacterial density		0.31		0.4
Mild	4 (100)		7 (87.5)
Moderate/marked	64 (79.0)		74 (94.9)