Heavy proteinuria (protein in the urine), hypoalbuminaemia (low blood albumin levels), oedema (a build-up of fluid, resulting in swelling) and hypercholesterolaemia (high blood cholesterol) are the major characteristics of nephrotic syndrome. At present, the primary drugs for nephrotic syndrome are corticosteroids, alkylating agents and cyclosporin. However there are many adverse effects associated with their use. This review identified nine studies (461 participants) comparing Huangqi type formulations with control drugs. The results of this review suggest that Huangqi type formulations may have a positive effect on nephrotic syndrome by increasing plasma albumin and reducing urine albumin excretion, blood cholesterol and triglycerides. Huangqi type formulation may reduce some adverse effects of other drugs used for treating nephrotic syndrome, however these were only reported in two studies. The methodological quality of the nine included studies was poor and was the major limitation of this review. The types of pathology, sex and age of the patients, as well as the duration and dosage of the Huangqi type formulations could not be analysed.
Huangqi and Huangqi type formulations may have some positive effects in treating nephrotic syndrome by increasing plasma albumin and reducing urine albumin excretion, blood cholesterol and triglycerides, and decreasing the number who don't show improvement at three months. Some formulations showed an increase in the number of patients achieving complete or partial remission, however study and participant numbers were small.
Patients with primary nephrotic syndrome mostly need immunosuppression to achieve remission, but many of them either relapse after immunosuppression therapy or resistant to it. On the other hand, immunosuppression therapy could increase the adverse effect. Huangqi and Huangqi type formulations have been used to treat nephrotic syndrome for years in China, however the effects and safety of these formulations have not been systematically reviewed. This is an update of a review first published in 2008.
To assess the benefits and harms of Huangqi and Huangqi type formulations in treating nephrotic syndrome in any age group, either as sole agents or in addition to other drug therapies.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Chinese Biomedicine Database (CBM), CNKI, VIP and reference lists of articles. There was no language restriction.
Date of search: April 2011.
All randomised controlled trials (RCTs) assessing the use of Huangqi or Huangqi type formulations in treating nephrotic syndrome in adults and children, either as sole agents or in addition to other drug therapies.
Two authors independently assessed study quality and extracted data. For dichotomous outcomes results were expressed as relative risk (RR) and 95% confidence intervals (CI). Continuous outcomes were expressed as mean difference (MD) with 95% CI.
Nine studies were identified. One was judged to be at high risk of bias for random sequence, the rest were judged to be at low risk of bias. All studies had high risk of bias for allocation concealment and performance bias; unclear risk for detection bias and low risk for attrition bias. Two studies had unclear risk reporting bias and the rest had low risk. No other potential threats to validity were found. Compared to control interventions, Huangqi type formulations had a positive effect on plasma albumin (MD 6.41 g/dL, 95% Cl 4.24 to 8.59), urine albumin excretion (-0.57 g/24 h, 95% CI -1.04 to -0.10), cholesterol (MD -1.70 mmol/L, 95% Cl -2.60 to -1.13) and triglycerides (-0.33 mmol/L, 95% CI -0.63 to -0.03); and more patients showed improvement at three months (RR 0.41, 95% CI 0.20 to 0.84). There was no significant difference between Huangqi type formulations and control interventions for complete (RR 1.59, 95% CI 0.29 to 8.65) or partial remission (RR 1.22, 95% CI 0.57 to 2.58). While some formulations showed improvement in the number of patients achieving complete or partial remission, the number of studies (usually one per formulation), and the number patients (ranging from 38 to 78) were small. Relapse was reported at varying time points, ranging from three months to three years, and therefore these results were not pooled. Complications of nephrotic syndrome and adverse events were only reported by two studies; Only one study reported complications of nephrotic syndrome (infection) and another reported adverse reactions to treatment (Cushing's syndrome, steroid withdrawal syndrome, respiratory tract infection, and upper gastrointestinal haemorrhage). Both studies reported those treated with Huangqi type formulations had significantly less complications or adverse reactions.