Fourteen- vs seven-day bismuth-based quadruple therapy for second-line Helicobacter pylori eradication

Table 1 Demographic and clinical data at baseline (intention-to-treat population) n (%)

	PBMT-7	PBMT-14	P value
Included in ITT analysis	543	247	ns
Age (mean ± SD, yr)	54.83 ± 11.97	54.69 ± 11.86	0.779
Gender (male)	277 (51.0)	129 (52.2)	0.648
Current smoker	81 (14.9)	47 (19.0)	0.175
Alcohol drinking	118 (21.7)	50 (20.2)	0.641
Diabetes	54 (9.9)	31 (12.6)	0.322
Hypertension	128 (23.6)	53 (21.5)	0.524
Endoscopic diagnosis			0.598
Gastritis	257 (47.4)	146 (59.1)
Gastric ulcer	93 (17.1)	18 (7.3)
Duodenal ulcer	170 (31.3)	73 (29.6)
Gastric and duodenal ulcer	23 (4.2)	10 (4.0)

PBMT-7: 7-d bismuth-based quadruple therapy; PBMT-14: 14-d bismuth-based quadruple therapy; ITT: Intention-to-treat.

Table 2 Helicobacter pylori eradication rates

	PBMT-7	PBMT-14	P value
ITT analysis
Eradication rate	366 (67.4)	180 (72.8)	0.028
95%CI	63.1%-71.7%	67.4%-78.2%
PP analysis
Eradication rate	366 (78.2)	18 (84.1)	0.009
95%CI	72.1%-84.0%	76.8%-90.8%

ITT: Intention-to-treat; PP: Per-protocol; PBMT-7: 7-d bismuth-based quadruple therapy; PBMT-14: 14-d bismuth-based quadruple therapy.

Table 3 Adverse events and compliance n (%)

Adverse events	PBMT-7 (n = 478)	PBMT-14 (n = 222)	P-value
Bloating/dyspepsia	3 (0.6)	7 (3.2)
Dry mouth	4 (0.8)	0 (0.0)
Taste distortion	2 (0.4)	1 (0.5)
Epigastric discomfort	15 (3.1)	5 (2.3)
Nausea	16 (3.3)	13 (5.9)
Diarrhea	8 (1.7)	7 (3.2)
Urticaria	3 (0.6)	3 (1.4)
Headache	0 (0.0)	1 (0.5)
Chest discomfort	0 (0.0)	1 (0.5)
Total	51 (10.7)	38 (17.1)	0.487
Compliance	468 (97.9)	214 (96.4)	0.304

PBMT-7: 7-d bismuth-based quadruple therapy; PBMT-14: 14-d bismuth-based quadruple therapy.