Evaluation of triple and quadruple Helicobacter pylori eradication therapies in Iranian children: a randomized clinical trial.
BACKGROUND
Clinical trials in children concerning Helicobacter pylori eradication treatments are scarce. The purpose of this study was to assess the efficacy of proton pump inhibitor (PPI)-based triple therapy using PPI, amoxicillin and clarithromycin in Iranian children. We also evaluated the efficacy of quadruple therapy with PPI, metronidazole, amoxicilin and bismuth citrate in Iranian children.


METHODS
This was a randomized clinical trial performed in Emam Khomeini Hospital between 2003 and 2004. Patients with confirmed H. pylori infection by histology were divided into two groups in a randomized 1:1 scheme: the triple regimen group (omeprazole, clarithromycin and amoxicillin for 10 days) and the quadruple regimen group (omeprazole, amoxicillin, metronidazole and bismuth citrate for 10 days). The eradication was assessed by the C-urea breath test 4 weeks after the end of treatment and analyzed by per-protocol and intention-to-treat approaches.


RESULTS
One hundred and twenty-two patients (mean age 12.36+/-3.06 years) were entered into the study. Only 100 patients completed the study (50 patients in each regimen group). The eradication rates by triple therapy were 92% and 75.5% for the "per-protocol" and "intention-to-treat" approaches, respectively. In the quadruple regimen group, the eradication rates were 84% by the per-protocol approach and 68.8% in the intention-to-treat approach. Symptom responses to therapy were reported in all patients with successful eradication (88% of all patients).


CONCLUSIONS
With regard to recent recommendations, we also suggest PPI, amoxicillin and clarithromycin triple therapy as a first-line eradication treatment, and quadruple therapies as a second-line option, in Iranian children.
Bahremand
Shahla
S
Department of Pediatrics, Emam Khomeini Hospital,Tehran University of Medical Sciences, Tehran, Iran.
Nematollahi
Laleh Razavi
LR
Fourutan
Hossein
H
Tirgari
Faroukh
F
Nouripour
Shamsollah
S
Mir
Elham
E
Aghakhani
Shahriar
S
D000293:Adolescent; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D017291:Clarithromycin / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D005260:Female; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D007223:Infant; D007492:Iran / Q000453:epidemiology; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use; D009853:Omeprazole / Q000627:therapeutic use*; D009942:Organometallic Compounds / Q000627:therapeutic use; D054328:Proton Pump Inhibitors; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D004791:Enzyme Inhibitors; D009942:Organometallic Compounds; D054328:Proton Pump Inhibitors; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin; C002791:bismuth tripotassium dicitrate; D009853:Omeprazole