Background: Huaiqihuang (HQH) granule is a traditional Chinese herbal complex that has been used as an adjuvant treatment in clinics for the primary nephrotic syndrome (PNS) for many years. However, the effectiveness and safety of HQH have not been systematically discussed. This review aimed to evaluate the effectiveness and safety of HQH in paediatric patients with PNS.

Methods: The following databases were searched from inception to Mar 2019: MEDLINE, Cochrane Library, EMBASE, CNKI, Wanfang Database, the Chinese Scientific Journal Database and the Chinese biomedical literature service system. All the randomized controlled trials (RCTs) eligible for inclusion were included. The primary outcomes were relapse, infection, remission and adverse events. The secondary outcomes included serum immunoglobulin levels (IgA, IgG or IgM), T-lymphocyte subtype (CD3+ , CD4+ , CD8+ , CD4+ /CD8+), IL-10, TNF-α , TNF-γ , total cholesterol and time of proteinuria turning negative.

Results: Fourteen RCTs (885 patients) were identified. Treatment with HQH reduced the chance of relapse [relative risk (RR): 0.47; 95% CI: 0.34, 0.66; P < 0.001] and infections (RR: 0.47; 95% CI: 0.35, 0.62; P < 0.001). No significant difference was found in adverse events. HQH also increased the serum levels of IgA [weighted mean difference (WMD): 0.40; 95% CI: 0.20, 0.60; P < 0.001] and IgG (WMD: 1.58; 95% CI: 1.38–1.78; P < 0.001), as well as CD4 + [standard mean difference (SMD): 0.90; 95% CI: 0.12–1.68; P = 0.02], CD3 + (WMD: 4.04; 95% CI: 3.27–4.82; P < 0.001), and the CD4 + /CD8 + ratio (WMD: 0.31; 95% CI: 0.21–0.41; P < 0.001), but decreased the level of CD8 + cells (WMD: –3.39; 95% CI: −5.73–1.05; P = 0.004). No statistically significant difference was found in IgM (WMD: 0.05; 95% CI: −0.13, 0.24; P = 0.57).