Abstract
Objective: Hyperbilirubinemia is one of the most devastating pathologies induced by various liver diseases. Formulae related to Paeoniae Radix Rubra (PRR) at high doses have been applied to treat hyperbilirubinemia in traditional Chinese medicine (TCM). The aim of this systematic review and meta-analysis is to assess the efficacy and safety of formulae relevant to high-dose PRR in patients suffering from hyperbilirubinemia induced by viral hepatitis.Methods: We performed a meta-analysis of randomized-controlled clinical trials to evaluate the efficacy and safety of formulae that apply a high dose of PRR for hyperbilirubinemia. Seven databases were searched until April, 2015. All studies were included according to detailed criteria and assessed for methodological quality. The outcome measurements were recorded for further analysis using the RevMan 5.2.11 software.Results: Fifteen articles involving 1323 patients with hyperbilirubinemia were included. Formulae with high-dose PRR might promote the efficacy of either a combined application ([OR: 3.98, 95% CI (2.91, 5.43)]; P < 0.01) or a single application ([OR: 4.00, 95% CI (1.50, 10.68)]; P < 0.01) for hyperbilirubinemia. The indices of TBIL, ALT, and AST significantly decreased ([MD: –75.57, 95% CI (−94.88, −56.26)], [MD: −26.54, 95% CI (−36.19, −16.88)], and ([MD: −28.94, 95% CI (−46.26, −11.61)]; P < 0.01), respectively. In addition, formulae with high-dose PRR could enhance the treatment efficacy of hyperbilirubinemia triggered by hepatitis B ([OR: 2.98, 95% CI (1.75, 5.05)]; P < 0.01). Furthermore, the efficacy was enhanced with an increasing dosage of PRR. Two articles reported that no side effects occurred in clinical trials, and three studies noted that patients presented light digestive tract symptoms.Conclusion: Formulae relevant to high-dose PRR ameliorate hyperbilirubinemia and might constitute a promising therapeutic approach. For widespread acceptance by practitioners, more rigorously designed multicenter, double-blind, randomized, and large-scale controlled trials are required.
Highlights
Hyperbilirubinemia presenting high serum bilirubin or severe jaundice is one of the most devastating pathologies in patients with various liver diseases (Duan et al, 2006)
Because most of the formulae-form therapy was applied in traditional Chinese medicine (TCM), the 15 studies that had been screened were all published in Chinese
Formulae with high-dose Paeoniae Radix Rubra (PRR) with essential treatment or as a single application were used in the trial group, whereas essential treatment was applied in the control group in all studies
Summary
Hyperbilirubinemia presenting high serum bilirubin or severe jaundice is one of the most devastating pathologies in patients with various liver diseases (Duan et al, 2006). Current therapies for hyperbilirubinemia mainly focus on a combination of decreasing serum bilirubin, liver protection, regulating transaminase levels, and nutrition support. There are unstable curative rates as well as side effects in the clinic. Ursodeoxycholic acid (UDCA) and Ademetionine are the firstline drugs used to decrease serum bilirubin. The inconsistent efficiency and expensive medical costs are common obstacles for some patients (Hou et al, 2010). Potassium magnesium aspartate as an adjuvant is limited by its efficacy in decreasing serum bilirubin. Glucocorticosteroid therapy, due to side effects and the possibility of symptom rebound, is controversial, when treating hyperbilirubinemia for a long duration (Zhang and Shen, 2011)
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