Objective To summarise clinical trials that compared the incidence of coronary abnormality between intravenous immune globulin (IVIG) plus corticosteroid therapy and IVIG therapy alone, and to determine the overall efficacy and safety of IVIG plus corticosteroid therapy for the initial treatment of Kawasaki disease.

Background Although use of IVIG as initial therapy has been established in Kawasaki disease, the role of corticosteroids therapy is controversial.

Methods Medline, The Cochrane Library, The Clinical Trials, and Embase Database were searched for published clinical studies up to 31 March 2012. Studies that compare the efficacy of IVIG plus corticosteroid with that of IVIG in treating Kawasaki disease were included. The coronary outcome and adverse events were analysed by meta-analysis.

Results 9 clinical studies with a total of 1011 patients were identified. Meta-analysis of the 9 studies showed that IVIG plus corticosteroid therapy significantly reduced the risk of coronary abnormality (OR: 0.3; 95% CI 0.20 to 0.46). Similar results were observed in subgroup analyses of randomised controlled studies (OR: 0.3; 95% CI 0.18 to 0.5), studies focused on patients with a high risk of IVIG resistance (OR: 0.2; 95% CI 0.1 to 0.36) and studies with blinded-endpoint manner (OR: 0.32; 95% CI 0.19 to 0.55). There was no significant difference in the incidence of severe adverse events between the IVIG plus corticosteroid group, and the IVIG group (OR: 1.24; 95% CI 0.33 to 4.67).

Conclusions Combination of corticosteroid with the conventional regimen of IVIG as an initial treatment strategy could reduce the risk of coronary abnormality.