Regional multi-center randomized trial of three vonoprazan-amoxicillin dosing regimens for Helicobacter pylori eradication in Sichuan Province, China

Table 1 Therapeutic effects

Efficacy observation table
Symptom	Score before treatment	Score after treatment
Nausea
Vomiting
Loss of appetite
Abdominal distension
Abdominal pain
Diarrhea
Constipation
Belching
Acid regurgitation
Bitter taste
Heartburn
Halitosis
Total score

Symptom assessment and efficacy evaluation: Symptoms were scored from 0 (asymptomatic) to 4 (most severe). Efficacy was categorized based on the reduction in total symptom score post-treatment: Markedly effective (≤ 1/3 of baseline), effective (≤ 2/3 of baseline), or ineffective (> 2/3 of baseline). The overall clinical effectiveness rate included both "Markedly Effective" and "Effective" outcomes.

Table 2 Baseline demographics and clinical symptoms, n (%)

		0.5 g-QID	0.75 g-QID	1.0 g-TID	P value
		568	574	575
Gender	Female	338 (59.5)	367 (63.9)	318 (55.3)	0.012
	Male	230 (40.5)	207 (36.1)	257 (44.7)
Age [median (IQR)]		46.0 (35.0-54.0)	47.0 (36.0-57.0)	45.0 (33.0-55.0)	0.021
	Lost to follow-up	14 (2.5)	10 (1.7)	17 (3.0)	0.494
	Poor adherence	10 (1.8)	11 (1.9)	10 (1.7)	0.982
Symptom relief group	Asymptomatic	340 (59.9)	317 (55.2)	325 (56.5)	0.186
	No symptom relief	6 (1.1)	7 (1.2)	9 (1.6)
	Symptom relief	208 (36.6)	240 (41.8)	224 (39.0)
Efficacy	Markedly effective	171 (83.8)	204 (88.7)	203 (91.9)	0.017
	Ineffective	21 (10.3)	10 (4.3)	7 (3.2)
	Effective	12 (5.9)	16 (7.0)	11 (5.0)
Pretreatment score [median (IQR)]		2.0 (2.0-4.0)	3.0 (2.0-4.0)	3.0 (2.0-4.0)	0.170
Post treatment score [median (IQR)]		0.0 (0.0-0.0)	0.0 (0.0-0.0)	0.0 (0.0-0.0)	0.169
Adverse events		31 (5.46)	30 (5.23)	43 (7.48)	0.187

P < 0.05 was considered statistically significant. Between-group differences were assessed using χ² tests for categorical variables and Kruskal-Wallis test for continuous variables (age, pretreatment score, and posttreatment score).

Table 3 Eradication rate of Helicobacter pylori

Dosage	0.5 g-QID (95%CI) (%)	0.75 g-QID (95%CI) (%)	1 g-TID (95%CI) (%)	P value
ITT	93.31	93.55	92.35	0.696
95%CI	91.15-95.09	91.42-95.23	90.11-94.17
mITT	95.67	95.21	95.16	0.911
95%CI	93.84-96.98	93.33-96.55	93.27-96.51
PP	97.43	97.11	96.90	0.870
95%CI	95.73-98.46	95.35-98.21	95.09-98.05

ITT: Intention-to-treat; PP: Per-protocol; mITT: Modified intention-to-treat.

Table 4 Adverse events, n (%)

ADR	0.5 g-QID	0.75 g-QID	1.0 g-TID	P value
Nausea	10 (1.8)	9 (1.6)	10 (1.7)	0.8215
Vomiting	2 (0.4)	2 (0.3)	0 (0.0)	0.2467
Decreased appetite	0 (0.0)	1 (0.2)	0 (0.0)	0.4996
Abdominal distension	9 (1.6)	10 (1.7)	7 (1.2)	0.4772
Abdominal pain	5 (0.9)	4 (0.7)	7 (1.2)	0.5469
Diarrhea	8 (1.4)	11 (1.9)	8 (1.4)	0.4996
Constipation	1 (0.2)	3 (0.5)	3 (0.5)	0.6244
Black stool	0 (0.0)	1 (0.2)	0 (0.0)	0.4996
Altered taste	0 (0.0)	1 (0.2)	0 (0.0)	0.4996
Xerostomia	0 (0.0)	2 (0.3)	5 (0.9)	0.0620
Bitter taste in mouth	0 (0.0)	1 (0.2)	0 (0.0)	0.4996
Headache	1 (0.2)	0 (0.0)	0 (0.0)	0.4969
Dizziness	2 (0.4)	1 (0.2)	1 (0.2)	0.6224
Rash	1 (0.2)	0 (0.0)	3 (0.5)	0.2493
Chest tightness	1 (0.2)	0 (0.0)	0 (0.0)	0.4969
Palpitations	0 (0.0)	1 (0.2)	0 (0.0)	0.4996
Belching	1 (0.2)	1 (0.2)	0 (0.0)	0.4969
Heartburn	0 (0.0)	0 (0.0)	1 (0.2)	1.0000

ADR: Adverse drug reactions.

Table 5 Age-stratified analysis of eradication efficacy, adherence, and adverse events across the three vonoprazan-amoxicillin regimens, n (%)

Regimen	Age group	n (ITT)	Eradicated	Adherence ≥ 80%	Adverse events	P value (by age)
0.5 g-QID	18-39	205	194 (94.6)	200 (97.6)	6 (2.9)	< 0.05
	40-59	285	270 (94.7)	281 (98.6)	21 (7.4)	< 0.05
	60-70	78	66 (84.6)	77 (98.7)	4 (5.1)	< 0.05
0.75 g-QID	18-39	188	179 (95.2)	181 (96.3)	19 (10.1)	< 0.05
	40-59	282	273 (96.8)	279 (98.9)	7 (2.5)	< 0.05
	60-70	104	85 (81.7)	103 (99.0)	4 (3.8)	< 0.05
1 g-TID	18-39	234	214 (91.5)	228 (97.4)	14 (6.0)	> 0.05
	40-59	281	265 (94.3)	277 (98.6)	28 (10.0)	> 0.05
	60-70	60	52 (86.7)	60 (100.0)	1 (1.7)	> 0.05

ITT: Intention-to-treat.