title: Sequential metronidazole-furazolidone or clarithromycin-furazolidone compared to clarithromycin-based quadruple regimens for the eradication of Helicobacter pylori in peptic ulcer disease: a double-blind randomized controlled trial.
abstract: BACKGROUND
  Furazolidone is a much cheaper drug with a very low resistance against Helicobacter pylori compared to clarithromycin. We aim to evaluate safety and efficacy of a sequential furazolidone-based regimen versus clarithromycin-based therapy in H. pylori eradication for ulcer disease.
  
  
  METHODS
  Patients with proven peptic ulcer or duodenitis were randomized into three groups: OAB-M-F; metronidazole (M) (500 mg bid) for the first 5 days, followed by furazolidone (F) (200 mg bid) for the second 5 days; OAC-P; clarithromycin (C) (500 mg bid) for 10 days; and OAB-C-F; clarithromycin (500 mg bid) for the first 5 days and furazolidone (200 mg bid) for the second 5 days. All groups received omeprazole (O) (20 mg bid) and amoxicillin (A) (1 g bid). Groups OAB-M-F and OAB-C-F were also given bismuth subcitrate (B) (240 mg bid), whereas a placebo (P) was given to group OAC-P. Adverse events were scored and recorded. Two months after treatment, a C(13) -urea breath test was performed.
  
  
  RESULTS
  Three hundred and ten patients were enrolled and 92 (OAB-M-F), 95 (OAC-P), and 98 (OAB-C-F) completed the study. The intention-to-treat eradication rates were 78.5% (95% CI = 69-85), 81.1% (95% CI = 73-88), and 82% (95% CI = 74-89), and per-protocol eradication rates were 91.3% (95% CI = 83-96), 90.4% (95% CI = 82-95), and 88.7% (95% CI = 81-94), for group OAB-M-F, OAC-P, and OAB-C-F, respectively. Eradication rate differences did not reach statistical significance. The most common adverse event, bad taste, occurred in all groups, but more frequently in groups OAC-P (34%) and OAB-C-F (32%), than OAB-M-F (14%) (p < .05). Adverse symptoms score were 0.88 ± 2.05 in group OAB-M-F, 1.15 ± 1.40 in group OAC-P, and 1.87 ± 1.62 in group OAB-C-F.
  
  
  CONCLUSIONS
  Furazolidone can replace clarithromycin in H. pylori eradication regimens because of lack of development of resistance and very low cost.
authors.affiliation: Digestive Disease Research Center, Iran University of Medical Sciences, Tehran, Iran.
authors.forename: Saghi
authors.initials: S
authors.lastname: Riahizadeh
authors.forename: Reza
authors.initials: R
authors.lastname: Malekzadeh
authors.forename: Shahram
authors.initials: S
authors.lastname: Agah
authors.forename: Nasrin
authors.initials: N
authors.lastname: Zendehdel
authors.forename: Rasoul
authors.initials: R
authors.lastname: Sotoudehmanesh
authors.forename: Naser
authors.initials: N
authors.lastname: Ebrahimi-Dariani
authors.forename: Akram
authors.initials: A
authors.lastname: Pourshams
authors.forename: Homayoon
authors.initials: H
authors.lastname: Vahedi
authors.forename: Javad
authors.initials: J
authors.lastname: Mikaeli
authors.forename: Morteza
authors.initials: M
authors.lastname: Khatibian
authors.forename: Sadegh
authors.initials: S
authors.lastname: Massarrat
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D017291:Clarithromycin / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005664:Furazolidone / Q000008:administration & dosage* / Q000009:adverse effects; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects / Q000502:physiology; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D010437:Peptic Ulcer / Q000188:drug therapy* / Q000382:microbiology; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D008795:Metronidazole; D005664:Furazolidone; D017291:Clarithromycin