Randomised, double-blind, placebo-controlled trial to determine whether steroids reduce the incidence and severity of nephropathy in Henoch-Schönlein Purpura (HSP)
Arch Dis Child 2013;98:756-763 doi:10.1136/archdischild-2013-303642
Jan Dudley1, , Graham Smith2, , Anne Llewelyn-Edwards3, , Kate Bayliss4, , Katie Pike4, , Jane Tizard1, Author Affiliations, Department of Paediatric Nephrology, Bristol Royal Hospital for Children, Bristol, UK , Department of Paediatric Nephrology, University Hospital of Wales, Cardiff, UK , Velindre Cancer Centre, Cardiff, UK , Bristol Heart Institute, University of Bristol, Bristol, UK
The role of corticosteroids in HSP to reduce the risk of developing nephropathy has always been controversial because there have never been good quality studies.
The best study to date has just been published in Arch Dis Child and effectively demonstrates that steroids are either of no help or of sufficiently small effect not to justify treating large numbers of patients with HSP to prevent a small difference in the risk of developing renal complications in a small proportion of patients.
Clinical bottom line: Don’t use steroids to reduce the risk of renal complications of HSP
In the RCH Clinical Practice Guidelines we had previously recommended the use of steroids based on previous studies (link 1 and link 2) but this new study is better and we have amended our guidelines in light of this just published evidence.
We now say:
The use of prednisolone has not been shown to make clinically important improvements in the rate of long-term renal complications. It has been shown to reduce the duration of abdominal and joint pain and may reduce the risk of abdominal complications. It may be considered for use in patients with more than mild joint or abdominal pain. Consider prednisolone 1mg/kg while symptoms persist.
The recommendation for use in abdominal/Joint pain comes from
Corticosteroids May Improve Clinical Outcomes During Hospitalization for Henoch-Schönlein Purpura
PEDIATRICS Vol. 126 No. 4 October 2010, pp. 674-681 link
The Dudley/Tizard article is available at:
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.