JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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Absence of platelet recovery following Helicobacter pylori eradication in childhood chronic idiopathic thrombocytopenic purpura: a multi-center randomized controlled trial.

OBJECTIVE: To investigate the effect of Helicobacter pylori eradication on platelet recovery in childhood chronic idiopathic thrombocytopenic purpura (ITP).

PATIENTS AND METHODS: A multi-center randomized controlled trial was conducted. Patients aged 4-18 years, diagnosed with chronic ITP, defined by platelet count below 100 x 10(9)/L lasting more than 6 months without identified causes, were enrolled and underwent (13)C-urea breath test for diagnosis of H. pylori infection. Patients who received prednisolone more than 0.5 mg/kg per day or received other platelet-enhancing therapy were excluded. Patients with H. pylori infection were randomized into two groups: treatment and control groups. Treatment group received a standard protocol for H. pylori eradication and repeated (13)C-UBT at 4-6 weeks to confirm successful therapy while the control group received no specific treatment. Monthly platelet count was monitored for 6 months in both groups. Primary outcome was platelet recovery, defined by platelet count over 100 x 10(9)/L for at least 3 months.

RESULTS: Of the 55 ITP children, 16 (29.1%) had H. pylori infection. There were no differences in age, sex, duration of disease, platelet count, and the dose of prednisolone between the treatment group (n = 7) and control group (n = 9). One patient in control group was withdrawn due to massive gastrointestinal bleeding requiring a high dose prednisolone. At 6 months, platelet recovery was demonstrated in one patient in the treatment group as well as one in the control group.

CONCLUSION: No beneficial effect of H. pylori eradication on platelet recovery in childhood chronic ITP was identified.

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