Sequential therapy for H. pylori in children – own experience
Journal Title: Postępy Nauk Medycznych - Year 2011, Vol 24, Issue 12
Abstract
Introduction. Due to the increasing resistance of H. pylori to different antibiotics, the efficiency of classical tri-drug therapy in children in Poland is taking out about 68%. Proposed solution is the sequential therapy.Material and Methods. This prospective study, carried out in a double-blind, randomized testing paradigm, assessed the efficiency of a 10-day sequence therapy in children with abdominal pain providing indication for endoscopy. Antibiotic or proton pump inhibitor therapy during the last 4 weeks and past attempts to eradicate H. pylori were the excluding criteria. Infection was confirmed with two of four tests (UBT &ndash; urease breath test, urease, histopathology or fecal &ndash; monoclonal ELISA test &ndash; Amplified IDEIA&trade; Hp StAR&trade;). Group A received sequential treatment consisting of: amoxycyllin, 50 mg/kg/day in two doses and omeprazole, 1 mg/kg/day in two doses during 5 days, followed by clarithromycin, 20 mg/kg/day plus tinidazole, 20 mg/kg/day plus omeprazole, 1 mg/kg/day in two doses during 5 days. Group B received standard treatment consisting of: amoxycyllin, 50 mg/kg/day plus clarithromycin, 20 mg/kg/day plus omeprazole, 1 mg/kg/day in two doses during 7 days, followed by placebo, 2 times per day for the next 3 days. The drug sets were prepared in the hospital pharmacy with minimum variation of taste and shape. The content of the sets was decoded after conclusion of the examination.Eradication efficiency was assessed by means of <sup>13</sup>C urea breath test (UBT) and a fecal test, at 6-8 weeks. Results of treatment in the two schemes were compared using co-variation analysis (ANCOVA) in a general Linear Model. Other parameters in the assessment included Relative Risk (RR) and the number of patients that had to be treated in order to obtain a favorable end point (NNT). The difference between study groups was considered significant when the p value was &lt; 0.05 or when the 95% CI for RR did not exceed 1.0 (equivalent to p &lt; 0.05). Results. As predicted by randomization 107 patients were included in the study, of these 54 in group A and 53 in group B. The final analysis encompassed 52 children in group A and 51 in group B. The numbers of patients that recovered at 6-8 weeks after termination of therapy were: in group A &ndash; 45 out of 52 (86.5%; CI &ndash; 77%, 96%), in group B &ndash; 35 out of 51 (68.6%; CI95 &ndash; 57%, 80%). Statistical analysis revealed a significant difference between the efficiencies of the two therapies (p = 0.0322); the chance of recovery for a patient treated with the sequential method was 3 times higher than for a patient treated in a standard way. RR amounted to 1.2 (95% CI 1.02 to 1.6). NNT was about 6.Conclusions. A 10-day sequential therapy is in children in Poland more effective than standard treatment, with a very low rate of side effects in either group and can be a the first choice therapy in Poland.
Authors and Affiliations
Piotr Albrecht, Maria Kotowska, Marcin Banasiuk, Agnieszka Gawrońska, Edyta Sienkiewicz, Izabella Łazowska-Przeorek, Aleksandra Banaszkiewicz, Katarzyna Karolewska-Bochenek, Andrzej Radzikowski
Keywords
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