Eradication of Helicobacter pylori: a prospective comparative randomized trial of standard versus optimized quadruple therapy

Figures & data

Figure 1. Flow diagram of this study.

ITT: Intention-to-treat; PP: Per-protocol; Qs-14: Standard quadruple therapy including 2 g amoxcillin; Qo-14: Optimized quadruple therapy including 3 g amoxcillin; UBT: 13C-urea breath test.

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

Characteristics	Qs-14 (n = 44)	Qo-14 (n = 44)	p-value
Age (year) (mean+/- SD)	39.5 ± 12.38	44 ± 12.50	0.443
Gender (male/female)	16/28	17/27	0.826
Comorbidity	19 (43.2%)	21 (47.7%)	0.669
Endoscopic findings
Non-nodular congestive gastropathy	34 (77.2%)	36 (81.8%)	0.597
Congestive and nodular gastropathy	8 (18.1%)	7 (15.9%)	0.777
Erosive gastritis	2 (4.5%)	2 (4.5%)	0.692
Bulbar ulcer	5 (11.3%)	7 (15.9%)	0.534
Gastric ulcer	0 (0%)	1 (2.3%)	0.500

Table 2. The major outcomes of the two groups of patients.

Characteristics	Qs-14 (n = 44)	Eradication rate Qo-14 (n = 44)	p-value
ITT	31/44 (70.4%)	37/44 (84%)	0.127
PP	21/27 (77.7%)	23/28 (82.1%)	0.473
Adverse events	8/44 (18.2%)	3/44 (6.8%)	0.5

Table 3. Adverse events in the two groups of patients.

Adverse events (AE)	Number of AE (%) Qs-14 (n = 44)	Number of AE (%) Qo-14 (n = 44)	p-value
Dysgeusia	1 (2.3%)	0 (0%)	0.500
Dyspepsia	0 (0%)	1 (2.3%)	0.500
Nausea	1 (2.3%)	1 (2.3%)	0.500
Vomiting	1 (2.3%)	0 (0%)	0.534
Diarrhea	2 (4.5%)	1 (2.3%)	0.500
Asthenia	1 (2.3%)	0 (0%)	0.500
Facial edema	1 (2.3%)	0 (0%)	0.500
Headache	1 (2,3%)	0 (0%)	0.500

Table 4. Factors influencing the efficacy of H. pylori eradication.

Principal parameters	Study population: n = 55
	Eradication failure	Eradication success	p-value
Age = <50 years	7/11 (63.6%)	27/44 (61.3%)	0.770
Female gender	7/11 (63.6%)	26/44 (59%)	0.783
BMI >=25 kg/m^2	7/11 (63.6%)	28/44 (63.6%)	0.518
Diabetes	0/11 (0%)	6/44 (13.6%)	0.244
Tobocco	3/11 (27.2%)	10/44 (22.7%)	0.751
Alcohol	1/11 (9%)	5/44 (11.3%)	0.656
Low level of education: illiterate/primary	6/11 (54.5%)	17/44 (38.6%)	0.2
Poor socio-economic conditions	11/11 (100%)	31/44 (70.4%)	0.002^†
Peptic ulcer disease	1/11 (9%)	6/44 (13.6%)	0.686
High density of H. pylori	2/11 (18.1%)	3/44 (6.8%)	0.241
Rural origin	3/11 (27.2%)	1/44 (2.27%)	0.008^†

† Bold values indicate the statically significant values.