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

Trials

Gao-Hui Li¹  Wen-Liang Lv¹  Ting-Ting Zhang¹  Shuang Liu¹  Wen-hui Zhou¹  Jing Chen¹  Qing-Juan Wu¹  Qing-Nan Wang¹  Qiang Zhang¹  Jiu-Chong Wang¹  Juan-Mei Li¹  Lei Xu²  Ruo-Xuan Zhang²  Xin Zhao²  Zheng-Min Cao²  Si-Tong Chen² 

[1] Guang’anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China;Guang’anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China;Graduate School of Beijing University of Chinese Medicine, Beijing, China;

关键词: Chronic hepatitis B;    Cirrhosis;    Traditional Chinese medicine;    Clinical trial;    Efficacy;   

DOI  :  10.1186/s13063-020-04395-y

来源: Springer

【 摘 要 】

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.

【 授权许可】

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