Efficacy and safety of YinQiSanHuang-antiviral decoction in chronic hepatitis B: study protocol for a randomized, placeb
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Efficacy and safety of YinQiSanHuangantiviral decoction in chronic hepatitis B: study protocol for a randomized, placebocontrolled, double-blinded trial Qing-Juan Wu1, Wen-Liang Lv1* , Juan-Mei Li1, Ting-Ting Zhang1, Wen-hui Zhou1, Qiang Zhang1, Jiu-Chong Wang1, Qing-Nan Wang1, Ruo-Xuan Zhang1,2, Xin Zhao1,2, Si-Tong Chen1,2, Shuang Liu1, Gao-Hui Li1, Zheng-Min Cao1,2, Lei Xu1,2 and Jing Chen1
Abstract Introduction: Chronic 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 placebocontrolled trial. The objective is that the combination of YinQiSanHuang-antiviral decoction with entecavir will reduce the annual incidence of liver fibrosis/cirrhosis to 1%. Methods: This 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. Discussion: Combination 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 registration: Chinese Clinical Trial Registry: ChiCTR1900021521. Registered on 25 February 2019. Keywords: Chronic hepatitis B, Cirrhosis, Traditional Chinese medicine, Clinical trial, Efficacy
* Correspondence: [email protected] 1 Guang’anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format,
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