BACKGROUND: The role of Helicobacter pylori remains unclear in children with recurrent abdominal pain (RAP). In this study children with RAP were included in a double blind treatment study to elucidate whether symptoms disappear in children with a H. pylori infection and RAP, if the bacteria are eradicated. METHODS:Thirty-seven H. pylori-infected children aged 4.9-14.5 years (median 9.8 years) with RAP were included. H. pylori was identified by histology and culture. The children were treated with amoxicillin and metronidazole for 14 days. A re-endoscopy including biopsies for histology and culture was done at least one month after the end of treatment. Simple questions for symptoms were asked and blood for serology was repeated 3 and 6 months after the end of treatment. During the observation period the results of the re-endoscopy and the serology 3 and 6 months after the re-endoscopy were blinded for 23 patients and opened to 14 of the patients according to the choice of the families. RESULTS: The eradication rates were 81% (30/37) in the total group and 74% (17/23) in the blinded group. The IgG antibodies to H. pylori decreased significantly 3 (p =.03) as well as 6 months after end of treatment (p <.001) in children with successful eradication. The number of children with RAP decreased after examination and treatment and the well-being improved after 6 months in almost 95% of the children. However, no correlation was seen between eradication of H. pylori and disappearance of RAP, neither after 3 nor after 6 months' observation in the total group of patients (p =.94 and p =.90) or in the blinded group (p =.42 and p =.65). CONCLUSIONS: These results do not provide evidence for a causal relationship between RAP and H. pylori.
RCT Entities:
BACKGROUND: The role of Helicobacter pylori remains unclear in children with recurrent abdominal pain (RAP). In this study children with RAP were included in a double blind treatment study to elucidate whether symptoms disappear in children with a H. pyloriinfection and RAP, if the bacteria are eradicated. METHODS: Thirty-seven H. pylori-infected children aged 4.9-14.5 years (median 9.8 years) with RAP were included. H. pylori was identified by histology and culture. The children were treated with amoxicillin and metronidazole for 14 days. A re-endoscopy including biopsies for histology and culture was done at least one month after the end of treatment. Simple questions for symptoms were asked and blood for serology was repeated 3 and 6 months after the end of treatment. During the observation period the results of the re-endoscopy and the serology 3 and 6 months after the re-endoscopy were blinded for 23 patients and opened to 14 of the patients according to the choice of the families. RESULTS: The eradication rates were 81% (30/37) in the total group and 74% (17/23) in the blinded group. The IgG antibodies to H. pylori decreased significantly 3 (p =.03) as well as 6 months after end of treatment (p <.001) in children with successful eradication. The number of children with RAP decreased after examination and treatment and the well-being improved after 6 months in almost 95% of the children. However, no correlation was seen between eradication of H. pylori and disappearance of RAP, neither after 3 nor after 6 months' observation in the total group of patients (p =.94 and p =.90) or in the blinded group (p =.42 and p =.65). CONCLUSIONS: These results do not provide evidence for a causal relationship between RAP and H. pylori.
Authors: K Thakkar; L Chen; N Tatevian; R J Shulman; A McDuffie; M Tsou; M A Gilger; H B El-Serag Journal: Aliment Pharmacol Ther Date: 2009-07-02 Impact factor: 8.171