Gut Liver.  2015 May;9(3):340-345. 10.5009/gnl13399.

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

• KMID: 2155641
• DOI: http://doi.org/10.5009/gnl13399

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).

Keyword

Helicobacter pylori; Pronase

MeSH Terms

Adult
Amoxicillin/therapeutic use
Anti-Bacterial Agents/*therapeutic use
Clarithromycin/therapeutic use
Drug Administration Schedule
Drug Therapy, Combination/methods
Female
Gastric Mucosa/drug effects/microbiology
Helicobacter Infections/*drug therapy
Helicobacter pylori/*drug effects
Humans
Male
Middle Aged
Pronase/*therapeutic use
Prospective Studies
Proton Pump Inhibitors/*therapeutic use
Single-Blind Method
Treatment Outcome
Amoxicillin
Anti-Bacterial Agents
Clarithromycin
Pronase
Proton Pump Inhibitors