Early prednisone therapy in Henoch-Schönlein purpura: A randomized, double-blind, placebo-controlled trial

doi:10.1016/j.jpeds.2006.03.024

The Journal of Pediatrics

Volume 149, Issue 2, August 2006, Pages 241-247

https://doi.org/10.1016/j.jpeds.2006.03.024 Get rights and content

Objective

To evaluate the efficacy of early prednisone therapy in preventing renal and treating extrarenal and renal symptoms in Henoch-Schönlein purpura (HSP) in a placebo-controlled trial.

Study design

A total of 171 patients (84 treated with prednisone and 87 receiving placebo) were included and followed up for 6 months. The endpoints were renal involvement at 1, 3, and 6 months and healing of extrarenal symptoms. The analyses were performed on an intent-to-treat basis.

Results

Prednisone (1 mg/kg/day for 2 weeks, with weaning over the subsequent 2 weeks) was effective in reducing the intensity of abdominal pain (pain score, 2.5 vs 4.8; P = .029) and joint pain (4.6 vs 7.3; P = .030). Prednisone did not prevent the development of renal symptoms but was effective in treating them; renal symptoms resolved in 61% of the prednisone patients after treatment, compared with 34% of the placebo patients (difference = 27%; 95% confidence interval = 3% to 47%; P = .024).

Conclusions

The general use of prednisone in HSP is not supported, but patients with disturbing symptoms may benefit from early treatment, because prednisone reduces extrarenal symptoms and is effective in altering (but not preventing) the course of renal involvement.

Section snippets

Methods

For this prospective, double-blinded, placebo-controlled trial of the effect of early prednisone on HSP, a total of 240 children with newly diagnosed HSP were screened at 4 university hospitals and 10 regional hospitals between 1999 and 2005. Criteria for entry into the study were age under 16 years and a clinical diagnosis of HSP (ie, typically distributed purpura or petechiae with or without gastrointestinal and/or joint pain). Exclusion criteria were thrombocytopenia, systemic vasculitis,

Results

The 2 groups had similar age and sex distributions at the time of enrollment, as well as similar baseline characteristics in terms of symptoms (Table I).

Discussion

Although reports on the use of corticosteroids to treat HSP first appeared around 1950,¹⁵ no prospective placebo-controlled studies with sample size and power calculations have been published to date. Because the incidence of HSP is 20.4/100,000 children per year,¹ compiling a patient series of adequate size for a placebo-controlled trial is not easy; this is likely why evidence-based data on the efficacy of steroid treatment for HSP are lacking. Here we report a prospective, randomized,

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Original articleEarly prednisone therapy in Henoch-Schönlein purpura: A randomized, double-blind, placebo-controlled trial

Objective

Study design

Results

Conclusions

Section snippets

Methods

Results

Discussion

Lancet

Lancet

Lancet

Kidney Int

Anaphylactoid purpura in children (Schönlein-Henoch syndrome)

Am J Dis Child

Henoch-Schönlein nephritislong-term prognosis of unselected patients

Arch Dis Child

Primary IgA nephropathies in childrenprognosis and treatment

Adv Nephrol

Renal involvement in Schönlein-Henoch purpura

Acta Paediatr Scand

Original article
Early prednisone therapy in Henoch-Schönlein purpura: A randomized, double-blind, placebo-controlled trial