title: N-acetyl cysteine as an adjunct to standard anti-Helicobacter pylori eradication regimen in patients with dyspepsia: A prospective randomized, open-label trial.
abstract: BACKGROUND
  Increasing antibiotic resistance of Helicobacter pylori (H. pylori) which is associated with diseases of the upper gastrointestinal tract, has made alternative treatments necessary. This study compares the efficacy of adding N-acetyl cysteine (NAC) to standard regimen for H. pylori eradication.
  
  
  METHODS
  We conducted a randomized, open-label trial, comparing the efficacy of 14 days of quadruple therapy with Amoxicillin, Bismuth citrate, Omeprazole, Clarithromycin (group A) versus 14 days of above regimen plus NAC (group B) in adult patients with dyspepsia. Primary objective was H. pylori eradication. Compliance and side effects were determined by questionnaires. Our analysis was by intention-to-treat (ITT) and per-protocol. This study is registered with www.IRCT.ir, number: IRCT201201078634N1.
  
  
  RESULTS
  A total of 121 participants aged 21-76 years with a mean age of 44.5 ± 14.1, and 52.9% female, were randomly allocated a treatment: 60 with 14-day standard therapy and 61 with 14-day standard therapy with NAC. The eradication rate in groups A and B with ITT analyses was 49/60 (81.7%; 95% [confidence intervals] CI = 71.6-91.8%) and 50/61 (82%; 95% CI = 72-91.9%), respectively (P = 0.96). In per-protocol analysis, the rate of H. pylori eradication in groups A and B was 45/54 (83.3%; 95% CI = 73.1-93.6%) and 45/53 (84.9%; 95% CI = 74.9-94.9%), respectively (P = 0.82). Minor well tolerated side effects were reported in 15 (34.9%) and 21 (35.6%) patients of groups A and B, respectively, and only one therapy cessation in group A was created.
  
  
  CONCLUSIONS
  Standard 14-day triple-drug therapy with NAC is not preferable to standard drug regimens for H. pylori infection.
authors.affiliation: Poursina Hakim Research Center Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
authors.forename: Mohammad Hassan
authors.initials: MH
authors.lastname: Emami
authors.affiliation: Kermanshah University of Medical Sciences, Kermanshah, Iran.
authors.forename: Mehdi
authors.initials: M
authors.lastname: Zobeiri
authors.affiliation: Poursina Hakim Research Institute of Isfahan, Iran.
authors.forename: Hojatolah
authors.initials: H
authors.lastname: Rahimi
authors.affiliation: Department of Community Medicine, Islamic Azad University, Najafabad Branch, Iran.
authors.forename: Fariba
authors.initials: F
authors.lastname: Arjomandi
authors.affiliation: Department of Internal Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
authors.forename: Hamed
authors.initials: H
authors.lastname: Daghagzadeh
authors.affiliation: Poursina Hakim Research Center Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
authors.forename: Peyman
authors.initials: P
authors.lastname: Adibi
authors.affiliation: Department of Gastroenterology and Liver Disease, Ahvaz University of Medical Sciences, Ahvaz, Iran.
authors.forename: Jalal
authors.initials: J
authors.lastname: Hashemi
keywords: Helicobacter pylori; Helicobacter pylori eradication; N-acetyl cysteine