The prospective multiple-centre randomized controlled clinical study of high-dose amoxicillin-proton pump inhibitor dual therapy for H. pylori infection in Sichuan areas

Figures & data

Table 1. Therapeutic effect observation table.

Symptoms	Pre-treatment score	Post-treatment score	Curative
Nausea
Vomiting
Loss of appetite
Abdominal pain
Abdominal distension
Diarrhoea
Constipation
Belching
Acid regurgitation
Bitter taste
Heartburn
Total score

Evaluate the symptom scores of all subjects before and after treatment. 0 point: no symptoms; 1 point: mild symptoms; 2 points: moderate, tolerable; 3 points: serious, affecting work and life; 4 points: severe, unable to live a normal life. The total symptom score is the sum of all symptom scores. Markedly effective: the total symptom score of the patients is 1/3 of the pre-treatment score and less than that of the pre-treatment score. Effective: the score after treatment is 2/3 or less than that before treatment. Ineffective: the score after treatment is more than 2/3 of that before treatment. Take the markedly effective and effective as the clinical total effective.

Figure 1. Analysis flowchart. ITT: intention-to-treat; mITT: modified intention-to-treat; PP: per-protocol.

Table 2. Demographic characteristics and symptom score.

General characteristics	Dual therapy group	Quadruple therapy group	p Value
Gender			.689
Male	212	197
Female	284	278
Age			.640
Mean ± SD	46.65 ± 13.840	46.23 ± 14.202
Total score of symptoms before initial treatment (median and quartile spacing P25–P75)	5 (2–8)	4 (2–8)	.890
Total score of symptoms after initial treatment (median and quartile spacing P25–P75)	1 (0–2)	1 (0–2)	.091
The degree of symptoms relief			.451
Markedly effective	57.9%	53.3%
Effective	18.5%	19.8%
Ineffective	2.8%	4%
Not marked	20.8%	22.9%
Adverse events			<.01
Yes	13.3%	28.2%
No	86.7%	71.8%
Compliance			.951
Good	99.19% (492/496)	99.16% (471/475)
Bad	0.81% (4/496)	0.84% (4/475)

Table 3. Eradication rate of H. pylori.

Analysis method	Dual therapy group	Quadruple therapy group	p Value
ITT	88.31% (438/496) (85.6–93.2%)	85.26% (405/475) (84.1–91.7%)	.158
mITT	88.66% (438/494) (86.3–93.8%)	85.44% (405/474) (84.5–91.9%)	.186
PP	91.63% (438/478) (87.4–95.1%)	90.60% (405/447) (86.6–94.2%)	.116

Table 4. Adverse events.

Adverse events	Dual therapy group	Quadruple therapy group	p Value
Diarrhoea	15	21	.249
Abdominal distension	13	16	.494
Abdominal pain	3	10	.042
Dizziness	2	3	.619
Bitter taste	4	47	<.01
Nausea	5	12	.071
Headache	3	1	.338
Constipation	4	3	.747
Belching	2	9	.028
Swallowing discomfort	1	1	.976
Vomiting	3	5	.440
Acid regurgitation	4	4	.951
Chest tightness	1	0	.328
Heartburn	0	1	.307
Bad breath	3	6	.285
Insomnia	5	2	.280
Fatigue	3	3	.958
Black stool	4	22	<.01
Paresthaesia of limbs	1	0	.328
Drowsiness	0	1	.307
Skin pruritus	1	0	.328
Dry mouth	9	12	.446
Loss of appetite	2	10	.016
Taste change	0	1	.307
Blackened tongue coating	0	3	.076
Yellow urination	1	1	.974

Data availability statement

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.