The Efficacy of Rebamipide or Ecabet Sodium Supplementation for Helicobacter pylori Eradication Therapy Compared with Quadruple (Concomitant) Regimen

Joonhwan Kim; Kyungwon Kim; Jun Soo Lee; Su Young Kim; Kyung Oh Kim; Yoon Jae Kim; Kwang an Kwon; Dong Kyun Park; Jun-Won Chung

doi:10.4166/kjg.2018.71.4.204

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Kim, Kim, Lee, Kim, Kim, Kim, Kwon, Park, and Chung: The Efficacy of Rebamipide or Ecabet Sodium Supplementation for Helicobacter pylori Eradication Therapy Compared with Quadruple (Concomitant) Regimen

Original Article

Korean J Gastroenterol 2018;71(4):204-212.

Published online: 4 October 2018

DOI: https://doi.org/10.4166/kjg.2018.71.4.204

The Efficacy of Rebamipide or Ecabet Sodium Supplementation for Helicobacter pylori Eradication Therapy Compared with Quadruple (Concomitant) Regimen

Joonhwan Kim, Kyungwon Kim, Jun Soo Lee, Su Young Kim, Kyung Oh Kim, Yoon Jae Kim, Kwang an Kwon, Dong Kyun Park, Jun-Won Chung

Division of Gastroenterology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea

Correspondence to: Jun-Won Chung, Division of Gastroenterology, Department of Internal Medicine, Gachon University Gil Medical Center, 21 Namdong-daero 774beon-gil, Namdong-gu, Incheon 21565, Korea. Tel: +82-32-460-3778, Fax: +82-32-460-3408, E-mail: junwonchung@daum.net

Received 19 December 2017 Revised 13 February 2018 Accepted 2 March 2018

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background/Aims

Although some previous studies reported that a treatment combined with mucoprotective agent could improve the eradication rate in dual or triple therapy, there are other reports that question the efficacy of combining these drugs in concomitant therapy (CoCTx). The aim of this study was to investigate the effects of rebamipide or ecabet on the Helicobacter pylori (H. pylori) eradication combined with CoCTx.

Methods

We retrospectively reviewed the medical records of 277 patients with proven H. pylori infection. They were assigned to one of 3 regimens for 10 days, twice daily: (a) CoCTx (n=118): lansoprazole 30 mg, amoxicillin 1 g, metronidazole 500 mg, and clarithromycin 500 mg; (b) CoCTx+rebamipide (100 mg) (n=85); (c) CoCTx+ecabet (1 g) (n=74).

Results

The baseline characteristics were not significantly different. H. pylori eradication rates were 82.2% (97/118) in CoCTx, 90.6% (77/85) in CoCTx+rebamipide, and 89.2% (66/74) in CoCTx+ecabet (p=0.17), which were statistically insignificant. Overall adverse events were more frequently reported in the CoCTx+rebamipide (50.6%. 43/85) and CoCTx+ecabet (44.6%, 33/74) groups than in the CoCTx (32.2%, 38/118) (p = 0.03) group. Drug compliances were not different between three groups (CoCTx: 95.8%, 113/118; CoCT+rebamipide: 92.9%, 79/85; CoCTx+ecabet 98.6%,73/74) (p=0.209). Multivariate analysis showed that the risk of eradication failure was significantly increased with decreased drug compliance (odds ratio 3.52, 95% confidence interval 1.00–12.32; p=0.05).

Conclusions

Addition of these mucoprotective agent was not superior to CoCTx alone for eradicating H. pylori infection with frequent adverse events. Rather, drug compliance is the most related factor affecting the eradication rate. Our data suggest the importance of drug compliance over the drugs used.

Keywords: Helicobacter pylori, Therapeutics, Rebamipide, Ecabet sodium

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Fig. 1.

Comparison of major outcomes among the three groups. (A) Eradication rate. (B) Adverse events. (C) Compliance.

Table 1.

Demographic Data and Endoscopic Findings of Three Patient Groups

Characteristics	Concomitant therapy (n=118)	Concomitant+rebamipide therapy (n=85)	Concomitant+ecabet therapy (n=74)	p-value
Mean age (years)	52.6±11.3	53.1±10.4	55.5±12.2	0.19
Sex (M/F)	60/58	45/40	36/38	0.86
Weight (kg)	64.1±11.2	65.5±11.8	64.5±11.3	0.70
Height (cm)	164.2±8.0	165.9±8.6	164.2±8.5	0.30
Body mass index	23.7±3.6	23.6±2.8	23.9±3.6	0.89
Smoking	23 (19.5)	21 (24.7)	13 (17.6)	0.50
Alcohol	43 (36.4)	42 (49.4)	33 (44.6)	0.17
Endoscopic finding				0.09
Peptic ulcer	54 (46.2)	21 (25.0)	29 (39.2)
EGC (after ESD)	7 (6.0)	9 (10.7)	8 (10.8)
Gastritis	48 (41.0)	47 (56.0)	34 (45.9)
Gastric polyp	8 (6.8)	7 (8.3)	3 (4.1)
Peptic ulcer stage				0.66
Active stage	8 (14.8)	5 (23.8)	8 (27.6)
Healing stage	7 (13.0)	2 (9.5)	4 (13.8)
Scar stage	39 (72.2)	14 (66.7)	17 (58.6)

Values are presented as mean±standard deviation or n (%) unless otherwise indicated.

M, male; F, female; EGC, early gastric cancer; ESD, endoscopic submucosal dissection.

Table 2.

Adverse Events during Helicobacter pylori Eradication Therapy

	Concomitant therapy (n=118)	Concomitant+rebamipide therapy (n=85)	Concomitant+ecabet therap (n=74)	py p-value
Abdominal pain	6 (5.1)	9 (10.6)	1 (1.4)	0.02
Diarrhea	3 (2.5)	5 (5.9)	6 (8.1)	0.36
Dizziness	2 (1.7)	4 (4.7)	6 (8.1)	0.04
Nausea	6 (5.1)	10 (11.8)	6 (8.1)	0.22
Taste disturbance	15 (12.7)	7 (8.2)	6 (8.1)	0.46
Headache	2 (1.7)	0 (0)	1 (1.4)	0.50
General weakness	4 (3.4)	8 (9.4)	7 (9.5)	0.19
Overall	38 (32.2)	43 (50.6)	33 (44.6)	0.03

Values are presented as n (%).

Table 3.

Risk Factors Associated with Helicobacter pylori Eradication Failure

Variables	Patients	Univariate		Multivariate
Variables	Patients	OR (95% CI)	p-value	OR (95% CI)	p-value
Gender			0.32
Male	141 (50.9)	1 (reference)
Female	136 (49.1)	1.43 (0.71–2.87)
Age (yr)			0.58
<60	205 (74.0)	1 (reference)
≥60	72 (26.0)	1.24 (0.58–2.66)
BMI			0.35
>25	191 (69.0)	1 (reference)
≤25	86 (31.0)	0.68 (0.31–1.51)
Smoking			0.48
(+)	57 (20.6)	1 (reference)
(–)	220 (79.4)	1.39 (0.55–3.52)
Alcohol			0.09		0.175
(+)	118 (42.6)	1 (reference)		0.59 (0.28–1.27)
(–)	159 (57.4)	1.90 (0.90–4.02)
Endoscopic findings			0.71
PU	104 (37.8)	1 (reference)
Others ^a	171 (62.2)	0.88 (0.43–1.78)
Peptic ulcer stage			0.95
S	70 (67.3)	1 (reference)
A+H	34 (32.7)	1.03 (0.32–3.31)
Eradication regimen
Concomitant	118 (42.6)	1 (reference)		0.41 (reference)
Concomitant+rebamipide	85 (30.7)	0.48 (0.20–1.14)	0.09	0.48 (0.20–1.16)	0.10
Concomitant+ecabet	74 (26.7)	0.56 (0.23–1.34)	0.19	0.61 (0.25–1.47)	0.27
Compliance			0.05	3.52 (1.00–12.32)	0.05
Good	265 (95.7)	1 (reference)
Poor	12 (4.3)	3.52 (1.00–12.32)

Values are presented as n (%) unless otherwise indicated.

OR, odds ratio; CI, confidence interval; BMI, body mass index; PU, peptic ulcer; S, scar stage; A, active stage; H, healing stage.

^a Early gastric cancer (after endoscopic submucosal dissection)+gastritis+gastric polyp.

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