Low-dose vs standard-dose minocycline in bismuth quadruple therapy for first-line Helicobacter pylori eradication: A randomized controlled, noninferiority trial

Table 1 Demographic and clinical data of all patients, n (%)

Variables	Low-dose group (n = 120)	Standard-dose group (n = 120)	P value
Male sex	63 (52.5)	58 (48.3)	0.519
Age (year), mean ± SD	65.4 ± 4.4	66.3 ± 5.0	0.137
Smoking	64 (53.3)	59 (49.2)	0.518
Alcohol	62 (51.7)	60 (50.0)	0.796
Coronary artery disease	56 (46.7)	57 (47.5)	0.897
Diabetes	61 (50.8)	62 (51.7)	0.897
Hypertension	53 (44.2)	54 (45.0)	0.897
Use of NSAIDs	34 (28.3)	30 (25.0)	0.559
BMI (kg/m2), mean ± SD	22.9 ± 2.9	23.5 ± 4.0	0.16
Concomitant peptic ulcers
Gastric ulcer	10	11	0.951
Duodenal ulcer	15	16

BMI: Body mass index; NSAID: Nonsteroidal anti-inflammatory drug.

Table 2 Helicobacter pylori eradication rate between the two groups, % (n/total)

Regimens	Low-dose group	Standard-dose group	P value (difference)	P value (noninferiority)	95%CI
ITT analysis	84.2 (101/120)	87.5 (105/120)	0.459	0.069	-10.7% to 4.1%
PP analysis	91.0 (101/111)	92.9 (105/113)	0.595	0.013a	-7.9% to 4.1%

^aP < 0.05.

ITT: Intention-to-treat; PP: Per-protocol.

Table 3 Adverse events between the two groups, n (%)

Variables	Low-dose group (n = 120)	Standard-dose group (n = 120)	P value
Total	22 (18.3)	39 (32.5)	0.012a
AE grade
Mild	11 (9.2)	24 (20.0)	0.017a
Moderate	5 (4.2)	12 (10.0)	0.078
Severe	6 (5.0)	3 (2.5)	0.497
Main AE
Anorexia	2 (1.7)	5 (4.2)	0.443
Nausea	3 (2.5)	5 (4.2)	0.719
Vomiting	4 (3.3)	5 (4.2)	1.000
Diarrhea	5 (4.2)	6 (5.0)	0.760
Bloating	6 (5.0)	8 (6.7)	0.582
Skin rash	1 (0.8)	5 (4.2)	0.215
Dizziness	1 (0.8)	5 (4.2)	0.215
Discontinued due to AEs
Severe diarrhea	4 (3.3)	1 (0.8)	0.366
Vomiting	2 (1.7)	2 (1.7)	1.000
Personal reasons	2 (1.7)	3 (2.5)	1.000
Compliance	118 (98.3)	117 (97.5)	1.000

^aP < 0.05.

AE: Adverse event.

Table 4 Ulcer healing rates between the two groups

Group	Ulcer healing status				Healing rates (%)
	Complete healing	Marked healing	Partial healing	Non- healing
Low-dose group	9	8	5	3	88.0
Standard-dose group	10	8	5	4	85.2
P value	1.000

Table 5 Cost-effectiveness ratios between the two groups

Group	E (%)	C (CNY)	C/E
Low-dose group (n = 120)	91.0%	321.7	3.54
Standard-dose group (n = 120)	92.9%	402.9	4.34

E: Effectiveness; C: Cost; C/E: Cost-effectiveness ratio.