Evaluation of Triple Therapy Regimens withMetronidazole or Clarithromycin for Helicobacter Pylori Eradication in Children

Abstract

Background: Half of the world's population is infected with helicobacter pylori. This organism is one of the main causes of peptic ulcer disease, gastritis and gastric cancer. This infection is most frequently acquired in childhood. There is strong evidence that eradication of infection improves healing and reduces the risk of recurrence and rebleeding in patientswith duodenal or gastric ulcer.There is no consensus as to treat infected childrenwithout ulcer. The aimof this studywas to compare the efficacy of two therapeutic regimens in eradication of infection in children.

Materials and Methods: This study was a double-blind randomized clinical trial conducted in Tabriz Children Hospital. A total of seventy children aged 4 to 15 years were studied. These patients were referred to Endoscopy Unit and upper endoscopy and biopsy were performed. They were positive for helicobacter pylori by histological confirmation.The patientswere randomly enrolled in two therapeutic groups: group-A(n=41) received omeprazole as a proton pump inhibitor, amoxicillin and metronidazole (PAM) and group-B (n=36) received omeprazole, amoxicillin and clarithromycin (PAC). The duration of treatment was two weeks in both groups. To confirm eradication, UBT was performed after 8 weeks of treatment. Data were analyzed using SPSS package version 15. P-value ‹0.05 was considered significant.

Results:Mean age in PAMand PAC groups were 8.8 ± 2.5 and 9.6 ± 2.9 years, respectively. The age difference was not statistically significant (P=0.24). The most common initial symptom was chronic abdominal pain in both PAM and PAC groups (81.3% and 76.3%, respectively). There was no statistical difference in frequency of initial symptom between the two groups (P=0.41). Side effects during treatment were seen in both PAMand PAC groups (23.7% and 19.7%, respectively). Most patients in both groups experienced symptoms improvement after treatment whether complete or partial. In PAM and PAC groups, symptoms improvement was seen in 92.1% and 91.2%, respectively. There was no significant statistical difference between the two groups (P=0.64). The intention to treat analysis in PAC and PAMgroups were 75%and 73%, respectively and per-protocol analyses were 87% and 78.9%, respectively. There was no statistical difference in helicobacter pylori eradication rates between the two groups (P=0.39).

Conclusion: Our study suggested that both PAM and PAC regimens are effective in eradication of infection. Eradication of infection also can cause significant improvement of initial symptoms.