title: Randomised, double-blind, placebo-controlled trial to determine whether steroids reduce the incidence and severity of nephropathy in Henoch-Schonlein Purpura (HSP).
abstract: BACKGROUND
  The long-term prognosis of Henoch-Schönlein Purpura (HSP) is predominantly determined by the extent of renal involvement. There is no consensus as to whether treatment with prednisolone at presentation can prevent or ameliorate the progression of nephropathy in HSP.
  
  
  METHODS
  Children under 18 years of age with new-onset HSP were randomly assigned to receive prednisolone or placebo for 14 days. The primary outcomes were (a) the presence of proteinuria at 12 months (defined as urine protein : creatinine ratio (UP : UC) >20 mg/mmol) and (b) the need for additional treatment (defined as the presence of hypertension requiring treatment or renal biopsy anomalies or the need for treatment of renal disease) during the 12 month study period.
  
  
  RESULTS
  352 children were randomised. Of those patients with laboratory UP : UC results available at 12 months, 18/123 (15%) patients on prednisolone and 13/124 (10%) patients on placebo had UP : UC >20 mg/mmol. There was no significant difference in the proportion of patients with UP : UC >20 mg/mmol at 12 months between the treatment groups (OR (prednisolone/placebo)=1.46, 95% CI 0.68 to 3.14, n=247), even after adjusting for baseline proteinuria and medications known to affect proteinuria (adjusted OR=1.29, 95% CI 0.58 to 2.82, n=247). Similarly, there was no significant difference in the time needed for additional treatment between the two groups (hazard ratio (HR) (prednisolone/placebo)=0.53, 95% CI 0.18 to 1.59, n=323).
  
  
  CONCLUSIONS
  This is the largest trial of the role of steroids in children with HSP. We found no evidence to suggest that early treatment with prednisolone reduces the prevalence of proteinuria 12 months after disease onset in children with HSP.
  
  
  BACKGROUND
  ISRCTN71445600.
authors.affiliation: Department of Paediatric Nephrology, Bristol Royal Hospital for Children, , Bristol, UK.
authors.forename: Jan
authors.initials: J
authors.lastname: Dudley
authors.forename: Graham
authors.initials: G
authors.lastname: Smith
authors.forename: Anne
authors.initials: A
authors.lastname: Llewelyn-Edwards
authors.forename: Kate
authors.initials: K
authors.lastname: Bayliss
authors.forename: Katie
authors.initials: K
authors.lastname: Pike
authors.forename: Jane
authors.initials: J
authors.lastname: Tizard
mesh_terms: D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D011695:IgA Vasculitis / Q000150:complications* / Q000188:drug therapy; D015994:Incidence; D007668:Kidney / Q000503:physiopathology*; D007674:Kidney Diseases / Q000150:complications* / Q000188:drug therapy / Q000453:epidemiology; D016015:Logistic Models; D008297:Male; D011239:Prednisolone / Q000008:administration & dosage / Q000627:therapeutic use*; D011507:Proteinuria / Q000150:complications* / Q000188:drug therapy / Q000453:epidemiology; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D005938:Glucocorticoids; D011239:Prednisolone
keywords: General Paediatrics; Nephrology