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

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).

• Authors: Chang Seok Bang, Yeon Soo Kim, Sang Hyun Park, Jin Bong Kim, Gwang Ho Baik, Ki Tae Suk, Jai Hoon Yoon, Dong Joon Kim
• Journal: Gut and liver (Gut Liver) Vol. 9 Issue 3 Pg. 340-5 (May 23 2015) ISSN: 2005-1212 [Electronic] Korea (South)
• PMID: 25167799 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Anti-Bacterial Agents
• Proton Pump Inhibitors
• Amoxicillin
• Pronase
• Clarithromycin

Topics

• 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