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Additive Effect of Pronase on the Eradication Rate of First-Line Therapy for Helicobacter pylori Infection.

Bang CS, Kim YS, Park SH, Kim JB, Baik GH, Suk KT, Yoon JH, Kim DJ - Gut Liver (2015)

Bottom Line: We evaluated the additive effects of pronase combined with standard triple therapy for H. pylori eradication.In the per-protocol analysis, the eradication rates were 87.5% versus 68.1% (p=0.027).There were no significant differences concerning adverse reactions between the two groups.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.

ABSTRACT

Background/aims: Helicobacter pylori colonizes on the apical surface of gastric surface mucosal cells and the surface mucous gel layer. Pronase is a premedication enzyme for endoscopy that can disrupt the gastric mucus layer. We evaluated the additive effects of pronase combined with standard triple therapy for H. pylori eradication.

Methods: This prospective, single-blinded, randomized, controlled study was conducted between June and October 2012. A total of 116 patients with H. pylori infection were enrolled in the study (n=112 patients, excluding four patients who failed to meet the inclusion criteria) and were assigned to receive either the standard triple therapy, which consists of a proton pump inhibitor with amoxicillin and clarithromycin twice a day for 7 days (PAC), or pronase (20,000 tyrosine units) combined with the standard triple therapy twice a day for 7 days (PACE).

Results: In the intention-to-treat analysis, the eradication rates of PAC versus PACE were 76.4% versus 56.1% (p=0.029). In the per-protocol analysis, the eradication rates were 87.5% versus 68.1% (p=0.027). There were no significant differences concerning adverse reactions between the two groups.

Conclusions: According to the interim analysis of the trial, pronase does not have an additive effect on the eradication of H. pylori infection (ClinicalTrial.gov NCT01645761).

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Related in: MedlinePlus

Flow chart of the study design.
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f1-gnl-09-340: Flow chart of the study design.

Mentions: Of the 116 eligible patients initially enrolled in this study, four patients were excluded due to their refusal to participate; as a result, a total of 112 patients (55 male and 56 female) participated. The characteristics of enrolled patients are summarized in Table 1. They were randomly allocated (55 patients in PAC vs 57 patients in PACE). After finishing the eradication therapy, seven patients in PAC and 10 patients in PACE group were lost to follow-up. Finally, 95 patients (48 patients in PAC vs 47 patients in PACE) were included in the PP analysis. A study flow diagram is demonstrated in Fig. 1.


Additive Effect of Pronase on the Eradication Rate of First-Line Therapy for Helicobacter pylori Infection.

Bang CS, Kim YS, Park SH, Kim JB, Baik GH, Suk KT, Yoon JH, Kim DJ - Gut Liver (2015)

Flow chart of the study design.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4413967&req=5

f1-gnl-09-340: Flow chart of the study design.
Mentions: Of the 116 eligible patients initially enrolled in this study, four patients were excluded due to their refusal to participate; as a result, a total of 112 patients (55 male and 56 female) participated. The characteristics of enrolled patients are summarized in Table 1. They were randomly allocated (55 patients in PAC vs 57 patients in PACE). After finishing the eradication therapy, seven patients in PAC and 10 patients in PACE group were lost to follow-up. Finally, 95 patients (48 patients in PAC vs 47 patients in PACE) were included in the PP analysis. A study flow diagram is demonstrated in Fig. 1.

Bottom Line: We evaluated the additive effects of pronase combined with standard triple therapy for H. pylori eradication.In the per-protocol analysis, the eradication rates were 87.5% versus 68.1% (p=0.027).There were no significant differences concerning adverse reactions between the two groups.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.

ABSTRACT

Background/aims: Helicobacter pylori colonizes on the apical surface of gastric surface mucosal cells and the surface mucous gel layer. Pronase is a premedication enzyme for endoscopy that can disrupt the gastric mucus layer. We evaluated the additive effects of pronase combined with standard triple therapy for H. pylori eradication.

Methods: This prospective, single-blinded, randomized, controlled study was conducted between June and October 2012. A total of 116 patients with H. pylori infection were enrolled in the study (n=112 patients, excluding four patients who failed to meet the inclusion criteria) and were assigned to receive either the standard triple therapy, which consists of a proton pump inhibitor with amoxicillin and clarithromycin twice a day for 7 days (PAC), or pronase (20,000 tyrosine units) combined with the standard triple therapy twice a day for 7 days (PACE).

Results: In the intention-to-treat analysis, the eradication rates of PAC versus PACE were 76.4% versus 56.1% (p=0.029). In the per-protocol analysis, the eradication rates were 87.5% versus 68.1% (p=0.027). There were no significant differences concerning adverse reactions between the two groups.

Conclusions: According to the interim analysis of the trial, pronase does not have an additive effect on the eradication of H. pylori infection (ClinicalTrial.gov NCT01645761).

Show MeSH
Related in: MedlinePlus