title: Additive Effect of Pronase on the Eradication Rate of First-Line Therapy for Helicobacter pylori Infection.
abstract: OBJECTIVE
  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.affiliation: Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.
authors.forename: Chang Seok
authors.initials: CS
authors.lastname: Bang
authors.affiliation: Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.
authors.forename: Yeon Soo
authors.initials: YS
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.
authors.forename: Sang Hyun
authors.initials: SH
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.
authors.forename: Jin Bong
authors.initials: JB
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.
authors.forename: Gwang Ho
authors.initials: GH
authors.lastname: Baik
authors.affiliation: Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.
authors.forename: Ki Tae
authors.initials: KT
authors.lastname: Suk
authors.affiliation: Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.
authors.forename: Jai Hoon
authors.initials: JH
authors.lastname: Yoon
authors.affiliation: Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.
authors.forename: Dong Joon
authors.initials: DJ
authors.lastname: Kim
mesh_terms: D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005753:Gastric Mucosa / Q000187:drug effects / Q000382:microbiology; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011402:Pronase / Q000627:therapeutic use*; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D000658:Amoxicillin; D011402:Pronase; D017291:Clarithromycin
keywords: Helicobacter pylori; Pronase