Objectives: The study objective was to evaluate the use of Danshen formulations in preventing renal disease in Henoch-Schönlein Purpura (HSP) either as sole agents or in combination with other drug regimens.
Methods: Search strategy--Databases searched were the Cochrane Central Register of Controlled Trials, PubMed, Embase (Excerpta Medica Database), the Chinese Biomedicine Database, CNKI (Chinese National Knowledge Infrastructure), and VIP-database for all relevant studies without any language restriction. The cut-off date for the search was October 2010. Selection criteria--All randomized controlled trials with enrolled patients of all ages without renal disease before random assignment were included. The primary outcomes were the number of patients who developed renal disease and the incidence of adverse effects of drugs. Data collection and analysis--For dichotomous outcomes, the incidence of renal disease in patients with HSP was calculated as a relative risk with 95% confidence intervals. For continuous outcomes, the weighted mean difference with 95% confidence intervals was used.
Results: A total of five trials (513 children aged 2-14 years old) were included in the meta-analyses, which indicated that Danshen formulations (injections or tablets) with symptomatic therapy significantly reduced the risk of developing renal disease in children with HSP compared to symptomatic therapy alone 6-12 months after treatment (relative risk: 0.35, 95% confidence interval: 0.20-0.61). Adverse effects of Danshen formulations were not explicitly reported in these studies.
Conclusions: Danshen formulations may help prevent renal disease in children with HSP without serious side-effects. However, the evidence is of low quality (as assessed using the GRADE approach), and thus there is insufficient proof to strongly recommend the use of Danshen formulations in children with HSP. Large, properly randomized, placebo-controlled, double-blind studies are needed to substantiate its use.