Outcomes of furazolidone- and amoxicillin-based quadruple therapy for Helicobacter pylori infection and predictors of failed eradication

Table 1 Baseline demographic and clinical characteristics (n = 992) n (%)

Variable	Information
Age (mean age ± SD)	46.7 ± 12.4
Gender
Male	501 (50.5)
Female	491 (49.5)
Smoking history	199/859 (23.2)
Alcohol intake history	231/859 (26.9)
Educational level
< 7 yr	164 (16.5)
7-9 yr	249 (25.1)
10-12 yr	197 (19.9)
13-16 yr	229 (23.1)
> 16 yr	20 (2.0)
Unknown	133 (13.4)
Diagnosis
Functional dyspepsia	478 (48.2)
Peptic ulcers	259 (26.1)
Erosive esophagitis	69 (7.0)
Other sources of upper GI bleeding	5 (0.5)
Gastric tumors	6 (0.6)
Asymptomatic gastritis	75 (7.6)
13C-UBT positive during health checkup	100 (10.1)
Number of previous H. pylori treatment(s)
None	842 (84.9)
One	127 (12.8)
Two or more	23 (2.3)
PPI type
Esomeprazole	264 (26.6)
Rabeprazole	224 (22.6)
Pantoprazole	435 (43.9)
Other PPIs	69 (7.0)
Bismuth dose
400 mg per day	213 (21.5)
600 mg per day	391 (39.4)
800 mg per day	388 (39.1)
Duration of regimen
14-d regimen	971 (97.9)
10-d regimen	21 (2.1)

GI: Gastrointestinal; PPI: Proton pump inhibitor;

¹³C-UBT: ¹³C-urea breath test.

Table 2 Helicobacter pylori eradication rates with furazolidone- and amoxicillin-based quadruple therapy: Overall and by subgroup % (95%CI)

Variable	n/N	Eradication rate
Overall	937/992	94.5 (94.1-95.9)
Primary	800/842	95.0 (93.5-96.5)
Rescue	137/150	91.3 (86.8-95.8)
Adverse events1
Without	683/715	95.5 (94.0-97.0)2
With	130/144	90.3 (85.5-95.1)

¹Patients who completed the study protocol were divided into two groups: without or with adverse events during therapy. Eradication rates of two groups were calculated and the difference between the two groups was analyzed.

²Eradication rates were higher among patients without (mean difference = 5.2%, 95%CI: 0.7%-11.7%, P = 0.01) compared to those with adverse events during therapy. n: Number of successful eradication; N: Number of total patients.

Table 3 Adverse events of furazolidone- and amoxicillin-based quadruple therapy (n = 859) n (%)

Adverse event	Number	Severe	Impact on treatment
Abdominal discomfort	39 (4.5)	-	2 stopped prior to completion (10, 12 d)
Dizziness	11 (1.3)	2 (0.2)	4 stopped prior to completion (7, 10, 10, 12 d); 1 experienced dizziness after drinking alcohol and stopped prior to completion (10 d); 1 took 50% medicine
Nausea (with/without vomiting)	20 (2.3)	-	1 took 75% medicine
Fatigue	11 (1.3)	1 (0.1)	1 stopped prior to completion (12 d); 1 changed to traditional Chinese medicine during therapy (7 d)
Anorexia	13 (1.5)	-	1 took 80% medicine
Skin rash/pruritus	18 (2.1)	3 (0.4)	4 stopped prior to completion (4, 7, 10, 11 d); 2 changed to other regimens during therapy (2, 10 d); 1 took half of amoxicillin and all other drugs
Fever	2 (0.2)	2 (0.2)	2 stopped prior to completion (7, 9 d)
Diarrhea	9 (1.1)	1 (0.1)	1 stopped prior to completion (less than 7 d)
Constipation	3 (0.4)	-	-
Flatulence	2 (0.2)	-	-
Muscle pain or spasm (shoulder/back)	3 (0.4)	-	-
Acid regurgitation	1 (0.1)	-	-
Abdominal pain	4 (0.5)	1 (0.1)	2 stopped prior to completion (7,10 d)
Weight loss	3 (0.4)	-	-
Bitter taste/dry throat	2 (0.2)	-	1 took 75% medicine
Belching	1 (0.1)	-	-
Chest congestion	1 (0.1)	-	-
Heartburn	1 (0.1)	-	-
Total	144 (16.8)	10 (1.2)	24 (2.8)

Table 4 Univariate and multivariate analyses for predictors of failed Helicobacter pylori eradication

Factor		Eradication rate	P value1	Multivariate2
		n/N (%)		OR (95%CI)	P value
Age (yr)	< 60	781/827 (94.4)	0.96	-	-
	≥ 60	156/165 (94.5)
Gender	Male	469/501 (93.6)	0.24	-	-
	Female	468/491 (95.3)
Education2	< 7 yr	150/164 (91.5)	0.29	-	-
	7-9 yr	237/249 (95.2)
	10-12 yr	187/197 (94.9)
	13-16 yr	219/229 (95.6)
	> 16 yr	20/20 (100)
Number of previous H. pylori treatment(s)	None	800/842 (95.0)	0.002	Reference	-
	One	119/127 (93.7)		1.2 (0.5-2.7)	0.73
	Two or more	18/23 (78.3)		7.4 (2.2-24.9)	0.001
Diagnosis	Functional dyspepsia	453/478 (94.8)	0.49	-	-
	Peptic ulcers	245/259 (94.6)
	Erosive esophagitis	67/69 (97.1)
	Other sources of upper GI bleeding	4/5 (80.0)
	Gastric neoplasm	6/6 (100.0)
	Asymptomatic gastritis	68/75 (90.7)
	13C-UBT positive during health checkup	94/100 (94.0)
PPI type	Esomeprazole	253/264 (95.8)	0.42	-	-
	Rabeprazole	209/224 (93.3)
	Pantoprazole	408/435 (93.8)
	Other PPIs	67/69 (97.1)
Bismuth	400 mg per day	204/213 (95.8)	0.4	-	-
	600 mg per day	371/391 (94.9)
	800 mg per day	362/388 (93.3)
Duration of regimen	10 d	19/21 (90.5)	0.33	-	-
	14 d	918/971 (94.5)
Adherence2	Took 80% medicine or more	782/819 (95.5)	< 0.001	Reference	-
	Took less than 80% medicine	31/40 (77.5)		6.7 (2.8-15.8)	< 0.001
Smoking2	Non-smoker	631/660 (95.6)	0.004	Reference	-
	Abstinence during therapy	77/80 (96.3)		0.7 (0.2-2.7)	0.65
	Smoking during therapy	105/119 (88.2)		1.9 (0.9-4.3)	0.10
Alcohol2	Non-alcohol user	600/628 (95.5)	< 0.001	Reference	-
	Abstinence during therapy	186/197 (94.4)		1.0 (0.4-2.3)	1.00
	Alcohol use during therapy	27/34 (79.4)		4.4 (1.5-12.3)	0.008

¹Univariate analysis;

²Data analyzed only for patients who completed the study protocol (n = 859). n: Number of successful eradication; N: Number of total patients; GI: Gastrointestinal; PPI: Proton pump inhibitor;

¹³C-UBT: ¹³C-urea breath test.