Efficacy of moxifloxacin-based sequential therapy for first-line eradication of Helicobacter pylori infection in gastrointestinal disease

doi:10.3748/wjg.v21.i16.5032

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World Journal of Gastroenterology

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1007-9327

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Randomized Clinical Trial

World J Gastroenterol. Apr 28, 2015; 21(16): 5032-5038
Published online Apr 28, 2015. doi: 10.3748/wjg.v21.i16.5032

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

	MOX-ST	CLA-ST	P value
Included in ITT analysis	80	81	NS
Age (yr), mean ± SD	59.3 ± 13.1	59.4 ± 13.1	0.235
Gender (male)	34 (42.5)	33 (40.7)	0.773
BMI (kg/m²), mean ± SD	22.9 ± 2.2	22.7 ± 2.9	0.352
Current smoker	11 (13.7)	10 (12.3)	0.385
Alcohol drinking	13 (16.2)	9 (11.1)	0.351
Diabetes	5 (6.2)	8 (9.8)	0.125
Hypertension	19 (23.7)	23 (28.3)	0.407
Previous history of peptic ulcer	12 (15.0)	9 (11.1)	0.348
Endoscopic diagnosis			0.624
Gastritis	70 (87.6)	70 (86.6)
Gastric ulcer	4 (5.0)	5 (6.1)
Duodenal ulcer	1 (1.2)	1 (1.2)
Gastric and duodenal ulcer	1 (1.2)	0 (0.0)
Adenoma	4 (5.0)	4 (4.9)
Dysplasia	0 (0.0)	1 (1.2)
Positive CLOtest	59 (73.7)	62 (76.5)	0.955
H. pylori colonization			0.588
Negative	3 (3.7)	5 (6.1)
Mild	34 (42.5)	36 (44.4)
Moderate	32 (40.0)	24 (29.6)
Marked	11 (13.8)	16 (19.9)
Atrophic change	8 (10.0)	2 (2.4)	0.087
Intestinal metaplasia	10 (12.5)	13 (16.0)	0.761
Drop out	2 (2.5)	4 (4.9)	0.113
Noncompliance	0 (0.0)	0 (0.0)
Follow-up loss	2 (2.5)	4 (4.9)
Discontinued therapy due to adverse events	0 (0.0)	0 (0.0)

MOX-ST: 14-d moxifloxacin-based sequential therapy; CLA-ST: 14-d clarithromycin-based sequential therapy; ITT: Intention-to-treat; SD: Standard deviation; BMI: Body mass index; CLOtest: Rapid urease test; H. pylori: Helicobacter pylori; NS: Not significant; BMI: Body mass index.

Table 2 Helicobacter pylori eradication rates

	MOX-ST	CLA-ST	P value
ITT analysis
Eradication rate	91.3% (73/80)	71.6% (58/81)	0.014
95%CI	86.2%-95.4%	65.8%-77.4%
PP analysis
Eradication rate	93.6% (73/78)	75.3% (58/77)	0.022
95%CI	89.1%-98.1%	69.4%-81.8%

ITT: Intention-to-treat; PP: Per-protocol; CI: Confidence interval; MOX-ST: 14-d moxifloxacin-based sequential therapy; CLA-ST: 14-d clarithromycin-based sequential therapy.

Table 3 Univariate analysis of clinical factors influencing the efficacy

	MOX-ST		CLA-ST
	Eradication rate	P value	Eradication rate	P value
Age (yr)		0.436		0.002
< 60	97.2% (35/36)		81.1% (30/37)
≥ 60	90.4% (38/42)		70.0% (28/40)
Gender		0.383		0.622
Male	91.1% (31/34)		71.8% (23/32)
Female	95.4% (42/44)		77.7% (35/45)
Body mass index		0.651		0.743
< 25	95.2% (20/21)		86.9% (20/23)
≥ 25	92.9% (53/57)		70.3% (38/54)
Smoking		0.585		0.377
(-)	97.0% (65/67)		77.6% (52/67)
(+)	72.7% (8/11)		60.0% (6/10)
Alcohol		0.417		0.082
(-)	96.9% (63/65)		77.9% (53/68)
(+)	76.9% (10/13)		55.5% (5/9)
Diabetes		0.706		0.107
(-)	94.5% (70/74)		76.8% (53/69)
(+)	75.0% (3/4)		62.5% (5/8)
Hypertension		0.322		0.096
(-)	91.6% (55/60)		79.6% (43/54)
(+)	100.0% (18/18)		65.2% (15/23)
History of ulcer		0.454		0.828
(-)	92.5% (62/67)		75.0% (51/68)
(+)	100.0% (11/11)		77.7% (7/9)
Presence of ulcer		0.352		0.076
(-)	92.6% (63/68)		78.7% (52/66)
(+)	100.0% (10/10)		54.5% (6/11)
Positive CLOtest		0.259		0.374
(-)	76.1% (16/21)		63.1% (12/19)
(+)	100.0% (57/57)		79.3% (46/58)
Atrophic change		0.111		0.071
(-)	95.7% (67/70)		76.0% (57/75)
(+)	75.0% (6/8)		50.0% (1/2)
Intestinal metaplasia		0.270		0.322
(-)	95.5% (65/68)		76.5% (49/64)
(+)	80.0% (8/10)		69.2% (9/13)
Bacterial density		0.296		0.507
None	66.7% (2/3)		60.0% (3/5)
Mild	90.6% (29/32)		67.6% (23/34)
Moderate	100.0% (32/32)		78.2% (18/23)
Marked	90.9% (10/11)		93.3% (14/15)
Compliance		NS		NS
Poor	0.0% (0/0)		0.0% (0/0)
Good	93.6% (73/78)		75.3% (58/77)
Adverse events		0.493		0.494
(-)	92.6% (63/68)		77.6% (45/58)
(+)	100.0% (10/10)		68.4% (13/19)

MOX-ST: 14-d moxifloxacin-based sequential therapy; CLA-ST: 14-d clarithromycin-based sequential therapy; CLOtest: Rapid urease test; NS: Not significant.

Table 4 Adverse events and compliance n (%)

Adverse events	MOX-ST(n = 78)	CLA-ST(n = 77)	P value
Bloating/dyspepsia	4 (5.1)	4 (5.3)	0.383
Taste distortion	3 (3.8)	5 (6.4)	0.316
Epigastric discomfort	2 (2.6)	5 (6.4)	0.296
Nausea	1 (1.3)	1 (1.3)	0.505
Abdominal pain	0 (0.0)	1 (1.3)	0.309
Diarrhea	0 (0.0)	3 (3.9)	0.075
Constipation	0 (0.0)	0 (0.0)	NS
Total	10 (12.8)	19 (24.6)	0.038
Compliance, n (%)	78 (100.0)	77 (100.0)	NS

MOX-ST: 14-d moxifloxacin-based sequential therapy; CLA-ST: 14-dclarithromycin-based sequential therapy; NS: Not significant.

Citation: Hwang JJ, Lee DH, Lee AR, Yoon H, Shin CM, Park YS, Kim N. Efficacy of moxifloxacin-based sequential therapy for first-line eradication of Helicobacter pylori infection in gastrointestinal disease. World J Gastroenterol 2015; 21(16): 5032-5038
URL: https://www.wjgnet.com/1007-9327/full/v21/i16/5032.htm
DOI: https://dx.doi.org/10.3748/wjg.v21.i16.5032