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The efficacy of steroid therapy for the prevention of nephritis and treatment of the extrarenal symptoms of Henoch-Schönlein purpura (HSP) is controversial, owing to various limitations in studies of this approach, such as retrospective nature, lack of randomization or control groups, and small patient sample sizes.To evaluate the efficacy of early prednisone therapy for preventing or treating extrarenal and renal symptoms in children with HSP.This was a randomized, double-blind study. Inclusion criteria for the study were age >16 years and a clinical diagnosis of HSP. Exclusion criteria were concurrent thrombocytopenia, systemic vasculitis, established nephritis at disease onset and contraindication for prednisone therapy. Oral prednisone was administered twice daily at a dose of 1.0 mg/kg/day (maximum 50 mg) for the first 14 days, followed by a weaning dose of 0.5 mg/kg/day for 1 week and then 0.5 mg/kg/day on alternate days for an additional week. Prednisone 5.0 mg tablets and placebo tablets were similar in size, and were supplied in batches of 200 tablets in similar containers marked with sequential numbers.The primary end point was renal involvement, diagnosed on the basis of urinary findings (proteinuria or hematuria) at 1, 3, and 6 months. The secondary end points were the severity and duration of abdominal and joint symptoms during treatment, according to the symptom diary.In total, 176 patients participated in the study and 171 (84 in the prednisone group and 87 in the placebo group) completed the trial. The two groups had similar age and sex distributions at the time of enrollment, as well as similar baseline characteristics in terms of symptoms. Prednisone was effective in reducing extrarenal symptoms, in that the mean sum of severity scores for abdominal pain (P = 0.029) and joint pain (P = 0.03) were significantly lower in the prednisone group than in the placebo group within 2 weeks of diagnosis, according to symptom diary. Compared with the placebo group, patients in the prednisone group experienced fewer days with abdominal pain (mean difference 1.2 days) and joint pain (mean difference 1.3 days), although these results were not statistically significant. Prednisone did not reduce the incidence of renal symptoms; 38 patients in the prednisone group and 36 in the placebo group developed nephritis during 6 months' follow-up. Renal symptoms resolved significantly more rapidly in the prednisone group than in the placebo group. Prednisone therapy was most effective in treating renal disease in patients aged >6 years who had (or developed) renal symptoms during the first month after the diagnosis of HSP; 15 (63%) of the 24 patients in this category in the prednisone group were free of renal symptoms after treatment, compared with 3 (15%) of 20 in the placebo group (difference 48%, 95% CI 19-68%, P = 0.001). There were no serious adverse effects in either group.Compared with placebo, early prednisone therapy controlled extrarenal symptoms more effectively and reduced the severity of nephritis, although it did not prevent the development of renal involvement.