Efficacy and safety of YinQiSanHuang-antiviral decoction on chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trial

Abstract

Introduction: Chronic hepatitis B (CHB) is a global public health problem. Antiviral therapy is the primary treatment. Studies shown that 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, and has shown its effect on anti-hepatitis B virus and 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, which objective is “the combination of YinQiSanHuang-antiviral decoction with entecavir reduce the annual incidence of liver fibrosis / cirrhosis to 1%”.Methods: This is a multicenter, randomized, placebo-controlled, double-blinded trial, 5 hospitals involved in. Totally 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 granule 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 HBV-DNA negative rate, HBsAg negative rate, HBeAg seroconversion rate, liver function (Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), alkaline phosphatase (ALP), serum albumin (ALB) and total bilirubin (TBIL)), spleen thickness, evaluation scores of patients’ clinical symptoms and safety assessment. Outcomes will be assessed at baseline and after treatment.Discussion: Combination therapy could become a trendy of treatment of CHB, this trial expecting to provide credible clinical evidence for the future combination of TCM and conventional antiviral drugs for the treatment of CHB.Trial registration: ChiCTR1900021521, this protocol was registered in the Chinese Clinical Trial Registry (URL: http://www.chictr.org.cn) on February 25th, 2019.