Abstract
IntroductionChronic hepatitis B (CHB) is a global public health problem. Antiviral therapy is the primary treatment. Studies have shown that a combined therapy of traditional Chinese medicine (TCM) and conventional antiviral drugs has better efficacy than conventional antiviral for treatment of CHB. YinQiSanHuang-antiviral decoction (YQSH) is a TCM compound preparation that has shown an effect on anti-hepatitis B virus and on slowing progression of hepatitis B-related liver diseases. To evaluate the efficacy and safety of YQSH combined with entecavir and its preventive effect on hepatitis B cirrhosis, we designed this randomized, double-blind and placebo-controlled trial. The objective is that the combination of YinQiSanHuang-antiviral decoction with entecavir will reduce the annual incidence of liver fibrosis/cirrhosis to 1%.MethodsThis is a multicenter, randomized, placebo-controlled, double-blinded trial involving five hospitals. A total of 802 patients are randomly allocated to two groups: the YQSH group (n = 401) or the placebo group (n = 401). The YQSH group receives YQSH with entecavir; the placebo group receives granules of placebo with entecavir. Patients receive treatment for 52 weeks and then are followed up for 52 ± 2 weeks. The primary outcome measure is the annual incidence of cirrhosis. The secondary outcome measures are hepatitis B virus DNA negative rate, hepatitis B surface antigen negative rate, hepatitis B e antigen seroconversion rate, liver function (alanine aminotransferase, aspartate aminotransferase , gamma-glutamyl transferase , alkaline phosphatase , serum albumin, and total bilirubin), spleen thickness, evaluation scores of patients’ clinical symptoms, and safety assessment. Outcomes will be assessed at baseline and after treatment.DiscussionCombination therapy could become a trend for treatment of CHB, and this trial expects to provide credible clinical evidence for the future combination of TCM and conventional antiviral drugs for the treatment of CHB.Trial registrationChinese Clinical Trial Registry: ChiCTR1900021521. Registered on 25 February 2019.
Highlights
Chronic hepatitis B (CHB) is a global public health problem
Combination therapy could become a trend for treatment of CHB, and this trial expects to provide credible clinical evidence for the future combination of traditional Chinese medicine (TCM) and conventional antiviral drugs for the treatment of CHB
In 2015, an estimated 887, 000 deaths resulted from hepatitis B, mostly from cirrhosis and hepatocellular carcinoma (HCC, i.e., primary liver cancer) [3]; of these CHB is responsible for 30% of all deaths from cirrhosis and 40% of those from Hepatocellular carcinoma (HCC) [4,5,6]
Summary
YinQiSanHuang-antiviral decoction (YQSH) is a TCM compound preparation that has shown an effect on anti-hepatitis B virus and on slowing progression of hepatitis B-related liver diseases. As a global health problem, more than 257 million people worldwide suffer from chronic HBV infection [1, 2]. It is estimated that in China there are 20–30 million people with CHB, 1 million with liver cirrhosis, and 0.3 million with HCC caused by hepatitis B [9]. Antiviral therapy is the primary link to slow the conversion of CHB into cirrhosis and can effectively restore liver function and improve survival rate in patients with CHB [11, 12]. NAs are well tolerated and exhibit an early and potent antiviral effect, the selection of resistant mutants and nephrotoxicity during long-term therapy limit their use [13, 14]
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